Document #1
00/00/00
CONCEALING FROM FDA
FRAUD/MISREPRESENTATION
MISCELLANEOUS - RECKLESS/CONSCEOUS DESREGARD

"Internal Audit and Corrective Action Plan" prepared by Dow Corning of its Toxicology Laboratory. The audit uncovered four studies in which a former Dow Corning employee (Mark Bejarano) created false data and violated Good Laboratory Practices (GLP). The studies which were falsified are a lifetime breast implant
gel study in rats, a bio-durability study of elastomer in orthopedic devices, a breast implant elastomer study.
The falsification involved the technician, Bejarano. who created multiple slides from a single animal and labeled them as though they had come from different animals. The report states, "It has been acknowledged by Mr. Bejarano that he: did create multiple slides, made a mistake, acted on his own, acted contrary to
his Dow Corning training, and did not tell his supervisor or anyone else what he had done." (p.4 or Temporary Dow Corning Bates Number 411) Dow Corning claims that none of the four studies were published or relied on for data on the safety of breast implants, that an outside audit will also be done, and that Dow Corning will examine its operating procedures for the toxicology laboratory to make sure it complies with applicable regulatory requirements.

Appendix A is a list of studies in Dow Corning's PMAA master file and a list of studies in Dow Corning Corporation's blue book. Appendix B is a list of studies containing duplicate slides created by Mark Bejarano. Appendix C is qualifications of the consultant.
CITE: DCC 411000406 - 411000525, Exhibit 25 to Zimmer Deposition; Exhibit 4 to
Bejarano Deposition; Exhibit 5 to Bey Deposition; Exhibit 35 to McKennon
Deposition. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #2
00/00/00
ACKNOWLEDGEMENT OF NEED FOR TESTING
TESTING

Research Project Description titled "Organosilicone Anticholesterol Agents" The intent of this experiment is to isolate organosilicon compounds capable of lowering total serum cholesterol in several species and of ameliorating atheromata in rabbits. Data collected coincidental to other experiments have indicated a number of organosilicon compounds that can lower serum cholesterol, triglycerides, and/or phospholipids in normally fed mice and rats. Dimethylpolysiloxanes can ameliorate atheromata in rabbits.
CITE: DCC 16001089 - 16001091, Exhibit to Bennett Deposition.
Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #3
00/00/00
ACKNOWLEDGEMTN OF NEED FOR TESTING
COHESIVENESS-LIQUID COMPONENT OF GEL
KNOWLEDGE OF SYSTEMIC DISEASE
TESTING

Dow Corning Research Project Description entitled "Metabolism of Organosilicone Compounds." The intent is to study systematically the absorption, distribution, storage, metabolism and elimination of those organosilicon structures forming the basis of silicon chemistry as exploited by Dow Corning. There have been no systematic explorations of the metabolism of these classes of organosilicon compounds. Such explorations are necessary for their predictive value in selecting and developing efficacious biological applications, and in defining
the environmental impact of all present and future products.
CITE: DCC 16001081 - 16001083, Exhibit to Bennett Deposition, and Exhibit to Isquith Deposition.
Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #4
00/00/00
est. 1970
ACKNOWLEDGEMENT OF NEED FOR TESTING
KNOWLEDGE OF SYSTEMIC DISEASE
MISCELLANEOUS - COMPLICATIONS
MISCELLANEOUS - ORGANIZATIONAL SURVEY
TESTING

Draft of the "Proposed Agreement For Cooperative Research Program between Dow Corning and Lepetit Pharmaceutical Company to research the use of silicone compounds in biological systems. "These silicon chemicals will likely be used systemically rather than locally, and their utility in biological systems may
dependent more upon their chemical, rather than their physical properties. (p.1)The proposal notes that Dow Corning has acquired information that certain silicones are biologically active and has instituted a Biomedical Research Laboratory in July 1965 "to probe the potential utility of such silicon chemicals across the broad disciplines of biology, i.e., plant sciences, microbiology and animal science." (p. 2) Dow Corning Does have the capability to conduct research on silicons in the pharmaceutical areas while Lepetit "has been
engaged in specific endocrine cooperative research program with DC for a period of two years." (p. 3) The proposal states that the parties would cooperate to develop new silicon chemicals as drugs including silicones with activity as androgen depression, central nervous system depression, antimicrobial activity,
etc. (pp. 3-4). Additionally, Dow Corning and Lepetit personnel will exchange research and information and will travel to the other's facilities.

CITE: DCC 2801011379 - 281010391, Exhibit to Bennett Deposition (also used as
Exhibit 65 by Dow Corning), Exhibit to Blocksma Deposition (used by Dow
Corning), Exhibit to Isquith Deposition, Exhibit to LeBeau Deposition, Exhibit
to Petraitis Deposition, Exhibit to Rowe Deposition, Exhibit 17 to Popoff
Deposition, Exhibit to Julius Johnson Deposition, and Exhibit to MDL LeVier Deposition.
WITNESS: Bennett (Authenticated in Bennett, Vol. II, p. 455-457).
DISPOSITION: Not admitted in Toole (II) v. Baxter Healthcare.
Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #5
00/00/00
KNOWLEDGE OF SYSTEMIC DISEASE
MISCELLANEOUS
MISCELLANEOUS - COMPLICATIONS
TESTING
TISSUE REACTION

Script of an internal Dow Corning seminar presented by Dr. Isquith, and Tony Bennett and Pat Walters on the subject of microbiology. Isquith states that, "Our (Biomedical Research) primary function is to investigate the microbiology of organosilicon compounds through basic research. A secondary function is the development of utility from the information gathered, either academically or in an applied form. A third function is that of service. We are interested in the preservation, biodegradability, and microbiology of existing Dow Corning products." (p. 2) Abbott notes that the Microbiology Section has "the capability of conducting research in most areas of microbiology (i.e., Virology, tissue culture, immunology, mycology, bacteriology, etc.)" (p. 3) He notes that one function is to search for organisms capable of silicone degradation. (p.3) There is also a section on Page 3 which is crossed out on Silanols and then a handwritten outline on Silanols (Slide 2) beginning on page 4. Abbott states that silanols have provided "much basic research information on the relationship of organosilicon compounds to microorganisms and has suggested new areas of research." (p. 6)
CITE: Temporary Dow Corning Bats Number 671 - 685, Exhibit 4 to Isquith
Deposition. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #6
00/00/00
ACKNOWLEDGEMENT OF NEED FOR TESTING
TESTING

Research Project Description titled "Antiparkinsonism Activity of 2,6-cis- and 2,6-trans-(PHMESIO)2(ME2SIO)2)." The objective is to evaluate   PhMeSiO)2(Me2SiO)2) as an antiparkinsonism agent. It has been shown that these compounds increase whole brain dopamine within
5 days of daily oral administration.
CITE: DCC 16001084 - 16001085, Exhibit to Isquith Deposition, Exhibit to LeVier
Deposition. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #7
00/00/00
COHESIVENESS - LIQUID COMPONENT OF GEL
MISCELLANEOUS - COMPLICATIONS
TESTING

Report titled "Discussion of Toxicology of Various Dow Corning Products." Topics include gel bleed, silicone transport across the skin, the need for further testing. Dr. Carson recommended that all possible evidence of adverse effects be collected with supporting data of literature on our part to show that Dow Corning has no part in these. The presence of Low Molecular Weight in 350 cs. is the same as in lower cs.
CITE: DCC 281041877 - 281041882.
Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #8
00/00/00
KNOWLEDGE OF SYSTEMIC DISEASE
MISCELLANEOUS
TESTING

Handwritten synopsis by Lake titled "Status of Biological Testing of Sila-admantoner Compounds, Dow Corning Report 4234" of research projects and patent activity. It includes notes regarding fibroblasts and immunopotentiation, antigen modification, and joint research on in vitro carcinogen bioassay.
CITE: LAK 133, Exhibit to Radonovich Deposition, Exhibit to Boley Deposition,
and Exhibit to Lake Deposition.

Document #9
00/00/00
TESTING
TISSUE REACTION

Dow Corning document: "I. Silicone Oils as Miticides (or mite-repellents)"; "II.
Aphid Control with Silicone Emulsions"; "III. Effect Of Silicone Emulsions On
Mealy Bugs"; and "IV. Effects Of Silicone Oils on Cockroaches." The document was
authored by "JWR" (unknown who this is). "Mites do not willingly invade silicone
treated bean plants if untreated ones are available." (DCC 16001144). Mites are
not controlled by silicone-treated cucumber plants, possibly because the
silicone oil is absorbed into the plant. A silicone spray was "completely
effective in discouraging them. It is possible that a minor component,
relatively volatile, may be acting as a contact insecticide." (Id.)
Wild mustard plants sprayed with DC 200 fluid 10 cs. eliminated aphids. "The
impression gained is that the insecticidal (or repellent) activity is due to
some component of the fluid which has gone (presumably by evaporation or by
becoming chemically bound within the plant) or a hydroxy-ended material. It
seems worthwhile attempting to identify the active species and trying to modify
it chemically to obtain a long-term effect." (DCC 61001145).
Pachysandra plants, infested with mealy bugs, were sprayed with an
antitranspirant emulsion with 5% silicone. After 5 days, all mealy bugs on the
treated plants were eliminated. "The silicone appears to be slower acting here
than upon other insects; possibly a repellent, rather than an insecticidal,
effect is involved." (DCC 61001146).
In the 1950s, Texaco and Shell did studies on hydrocarbon oils as insect
attractants. In 1968, it was found by Gorzinski (of Dow Corning) that DC 360
fluid appeared to have an insect attractant and insecticidal activity.
Cockroaches were attracted to the petri dish with silicone fluid. After coming
out of the fluid, they "never got more than a few inches from the dish before
dying." These results indicate "some type of activity existed in the DC 360
fluid...." (DCC 61001147).
CITE: DCC 16001144 - 16001147, Exhibit to Bennett Deposition, Exhibit 11 to
McKennon Deposition, Exhibit 8 to Harris County Gehring Deposition, Exhibit to
Harris County and MDL LeVier Depositions, Exhibit to Ryan Deposition, and
Exhibit to Isquith Deposition. WITNESS: Bennett (Authenticated in Bennett, Vol.
IV, p. 880;15 - 882:8). DISPOSITION: Admitted in Toole (II) v. Baxter
Healthcare.
Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #10
00/00/00
KNOWLEDGE OF SYSTEMIC DISEASE MISCELLANEOUS

LeVier, Dow Corning, memo to C. Lentz and Nelson regarding "Activities Related
to 2,6-cis." There are twelve Dow Corning Products currently being sold by the
Medical Business that could contain levels of 2,6-cis originating from SBM-18 in
excess of the estimated allowable body burden. Medical Products has no active
program to identify replacement stock other than conversion of developmental
products based on SGM-18 wherever possible. The greatest concern rests with the
replacement identified for SGM-18 (elastomer) in that it may be necessary to
re-qualify the new stock for medical use including long-term implantation
studies.
CITE: DCC 281031092, Exhibit to MDL and Harris County Tyler Deposition, Exhibit
8 to Harris County LeVier Deposition, Exhibit to MDL LeVier Deposition, and
Exhibit to Ryan Deposition, NOTE: See document # 11 for attachment.
Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #11
00/00/00
MISCELLANEOUS

Table of 2,6-cis levels in selected products which was attached to LeVier's memo
(see document # 10 above). MDX-4-4514 (elastomer), shunts, penile implants, chin
implants, and other products all contained 2,6-cis.
CITE: DCC 281031093, Exhibit to Tyler Deposition. NOTE: See document # 10.
Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #12
00/00/00
VIDEOTAPE PRODUCED AT ZIMMER DEPOSITION ON D4.
CITE: No Bates Number, Exhibit to Zimmer Deposition.
Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #13
10/08/92
COHESIVENESS - LIQUID COMPONENT OF GEL
MISCELLANEOUS
TESTING

"Catalog and Review of D4 Studies." This is a list of all studies by Dow Corning
on D4. There is a handwritten note at the top that says: "Meeting Oct. 16, 1992,
Stark/Bey/Zimmer."
CITE: DCC 260000855 - 260000878. WITNESS: Exhibit to Zimmer Deposition.
Dow Corning Trial Exhibit List Abstracts
PENDLTON/PSC Attorney Work Product/Privileged & Confidential

Document #14

00/00/00
MISCELLANEOUS - ORGANIZATIONAL SURVEY
MISCELLANEOUS - LOBBYING

List of "Desired Product Champion Features" includes that the relationship with
the product champion should fit the Dow Corning Silicone Group Business
Strategy. "PC (product champion) needs to understand and buy-in to the Silicones
Group Business Strategy." Listed features include that the PC serve as a
substantive resource to Dow Corning, be loyal to the company, have positive peer
influence, be politically astute, and demonstrate teamwork with Dow Corning. The
document lists the names of product champions in the United States and Europe
and includes a manual prepared by Lois Duel dated September 1, 1989 which
addresses issues such as the desired product champion features, the role of the
product champion, product champion management and specific product champion
issues.
CITE: KKA 210877 - 210886
Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #15
00/00/00
KNOWLEDGE OF LIQUID SILICONE DANGERS
MISCELLANEOUS
MISCELLANEOUS - COMPLICATIONS
TESTING

Confidential report entitled "Chronology of Silicone Injection." The report
provides a historical account from Dow Corning's perspective of the use of
liquid silicone injections and the establishment of the Center for Aid to
Medical Research. It notes that Dow Corning 200 fluid was used for industrial
applications. When the Medical Products Division was established in the early
1960's, the 200 fluid was designated Dow Corning 360 Medical Fluid. The report
notes that, "The original label on the new product carried the inscription
'formerly Dow Corning 200 Fluid.'" (DCC 267371450) The report also discussed the
indictments against Dow Corning officials for distributing the drug, 360 fluid,
and the pleas of no contest which were eventually entered.
CITE DCC 267371444 - 267371466. NOTE: The document also has Bates numbers QDC 124506 - 124528 on it as well as Bates numbers MM 369861 - 3698883.
Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #16
00/00/00
ACKNOWLEDGEMENT OF NEED FOR TESTING
SILICA
TESTING
TISSUE REACTION

W.D. Galloway reports on the "Analysis of Lifetime Carcinogenicity Study of
Silicone Gels" conducted by Dow Corning under GLP regulations using
Sprague-Dawley rats injected with Q7-2159A and MDF-0193 gels.
Galloway states:
"Both of the gel-implanted groups showed a large number of cancers compared to
the control group. Particularly striking was the number of sarcomas (principally
fibrosarcomas) which occurred in the treated groups."
"The only obvious deficiency is that only one dose level was used. Ordinarily,
three doses are used, and five are preferred. Based on the results obtained, I
have little doubt that NTP would classify these substances as likely animal
carcinogens."
"According to Dow Corning, ... the tumors were peculiar to rats, the so called
foreign body tumors."
"Absent epidemiologic data, and without waiting for results of additional
lifetime studies, knowledge of the mechanism by which these tumors was induced
is critical to estimating human risks. It is possible that the tumors were
chemically induced, rather than being induced by a by a physical mechanism, as
Dow suggests. If this is the case, then the argument that such tumors do not
occur in man is untenable. If the tumors were chemically induced, the active
agent is more likely to be one of the several chemicals which make up the gel,
rather than a metabolically produced reactive intermediate, since the tumors
which did occur did not occur selectively in metabolically active organs such as
the liver."
"Recent studies have shown that siloxanes may act as estrogen-like substances
and can enhance the growth of tumor cells."
CITE: M 780064 - 780065.
Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #17
00/00/00
COHESIVENESS - LIQUID COMPONENT OF GEL
KNOWLEDGE OF GEL BLEED
MISCELLANEOUS
SILICA

Dow Corning materials identification list for final devices. It lists all
materials used in final devices with a Dow Corning code number. The two
manufacturing sites, Michigan and Tennessee, use different identification codes.
The list also gives material formulations, indicates the need for a low-bleed
outer shell liner, identifies whether "responsive" gel or "firm" gel is used,
and notes the percentage of silica used in the formulations.
CITE: KMM 447209 - 4477224
Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #18
00/00/00
Post 10/92
COHESIVENESS - LIQUID COMPONENT OF GEL
KNOWLEDGE OF GEL BLEED
MISCELLANEOUS - COMPLICATIONS
RUPTURE
SHELL STRENGTH - THICKNESS

Dr. O. Gordon Robinson Presents a paper entitled "Rate of Rupture of Silicone
Prostheses: Excerpt From A Study Of Over #3000 Personal Cases and Twenty-Five
Years Experience" at the Symposium on Reoperative Aesthetic Surgery of the Face
and Breast in Naples. Florida. Robinson discusses results obtained after 115
patients were followed after the fall of 1990 after receiving breast implants.
Of the 115 patients, 57% had rupture of one or both implants. An additional 20%
had moderate to severe bleed on one or both sides. The patients had the implants
from six months to 25 years. Dr. Robinson concludes that all gel and bi-lumen
implants:
"should be replaced at about the eighth post-operative year because it can be
fairly well predicted that at this stage the prostheses in most cases would
still be intact and much easier to replace. If a period of time longer than
twelve to fourteen years is allowed to elapse, then the prostheses have a good
chance of being ruptured and the exchange would be much more difficult.
CITE: PSC Medical Articles CD, J 2698 - Exhibit 2 to Robinson Deposition,
Exhibit 25 to McKennon Deposition. WITNESS: Robinson. DISPOSITION: Not admitted in Toole (II) v. Baxter Healthcare
Dow Corning Trial Exhibit List
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #19
00/00/00
Post/10/92
KNOWLLEDGE OF GEL BLEED
MISCELLANEOUS - COMPLICATIONS
RUPTURE
SHELL DEGRADATION
SHELL STRENGTH - THICKNESS

Dr. O. Gordon Robinson's abstract of a paper entitled "Disruption Rate Of Silicone Gel Prostheses - A Report Of 200 Cases." 200 patients from 02/91 - 10/92 had their silicone gel implants removed. The time from implantation ranged from six months to 25 years. Robinson found that 104 or 52% had one or both implants ruptured, 43 or 21.5% had severe bleed, and 147 or 73.5% had "distortion" - rupture plus severe bleed. Based on this data, Robinson projected future rupture rates using the Kaplan-Meier survival curve, and concluded that in 20 years, only 3.4% of the patients will have both prostheses still intact. He states, "Gel filled mammary prostheses wear out and in a certain predictable time frame. Based on this study, patients can be advised with a certain degree of accuracy as to the probable condition of their prostheses."
CITE: No Bates Number, Exhibit 3 to Robinson Deposition. WITNESS: Robinson DISPOSITION: Not admitted in Toole (II) v. Baxter Healthcare.

Document #20
00/00/00
10/92
COHESIVENESS - LIQUID COMPONENT OF GEL
KNOWLEDGE OF GEL BLEED
KNOWLEDGE OF SYSTEMIC DISEASE
MISCELLANEOUS - COMPLICATIONS
RUPTURE
SHELL STRENGTH - THICKNESS

Dr. O. Golden Robinson presents a paper entitled "Breast Implant Removal Or Exchange: which updated his prior study of 200 patients. He has seen an additional 100 patients and presents nine charts of statistics. Chart 2 lists "symptoms" of patients including burning and pain, numbness and tingling in extremities, joint and muscle pain, joint and muscle dysfunction, enlarged liver, flu symptoms, loss of appetite, swelling, arthritis symptoms, fibrocystic disease, deformity, kidney failure, vision problems, chronic fatigue, lupus, rash, insomnia, and hair loss. Of the 300 patients, 154 had a ruptured prosthesis, and 214 had a "disrupted" prostheses, i.e. loss of integrity of the silicone shell or severe silicone bleed where silicone "strings out at least 12 inches from intact capsule." (p.1).
CITE: No Bates Number, Exhibit 4 to Robinson Deposition. WITNESS: Robinson DISPOSITION: Not admitted in Toole (II) v. Baxter Healthcare.
Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #21
00/00/00
Post 10/92
KNOWLEDGE OF SYSTEMIC DISEASE
MISCELLANEOUS - COMPLICATIONS
RUPTURE
RUPTURE - CLOSED CAPSULOMTOMY
SHELL DEGRADATION
SHELL STRENGTH - THICKNESS

Dr. O. Gordon Robinson's charts on the age of prostheses a significant number of implants ruptured 6-16 years post-implantation, ( observations at surgery 36.9% of his 73 patients were symptomatic), follow-up (most did not show any change in symptoms during follow-up), symptomatic (patient relates to prostheses-arthritic profile, refer, and "No Closed Capsulotomies"), asymptomatic (patient happy), and questions ("Do mammary prostheses last forever? What contributes to the silicone envelope wearing out? ... How do you tell if an implant is ruptured? ...."
CITE: No Bates Number, Exhibit 9 to Robinson Deposition. WITNESS: Robinson DISPOSITION: Not admitted in Toole (II) v. Baxter Healthcare.
Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #22
00/00/00
Post 10/92
COHESIVENESS - LIQUID COMPONENT OF GEL
KNOWLEDGE OF GEL BLEED
KNOWLEDGE OF SYSTEMIC DISEASE
MISCELLANEOUS - COMPLICATIONS
RUPTURE
SHELL STRENGTH - THICKNESS

Draft of Dr. O. Gordon Robinson's paper entitled, "Breast Implant Removal Or Exchange." This is a draft of document number 22.
CITE: No Bates Number, Exhibit 10 to Robinson Deposition. WITNESS: Robinson. DEPOSITION: Not admitted in Toole (II) v. Baxter Healthcare.
Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #23 through#31
00/00/00 #23
ANY FOLLOW-UP STUDIES BY DR. O. GORDON ROBINSON.
This includes an abstract by Dr. Robinson and Dr. Edwin Bradley entitled
"Disruption Rate of Silicone Gel Prostheses - A Report of 200 Cases" published
in the January 1995 issue of the American Medical Association Journal.
00/00/00 #24
PHOTOGRAPHS OF PLAINTIFF'S EXPLANT SURGERY
00/00/00 #25
EXPLANTED IMPLANTS OF PLAINTIFF AND PHOTOGRAPHS THEREOF.
00/00/00 #26
MEDICAL RECORDS OF PLAINTIFF.
00/00/00 #27
MEDICAL BILLS OF PLAINTIFF.
00/00/00 #28
PATHOLOGY SLIDES AND TISSUE SAMPLES OF PLAINTIFF.
00/00/00 #29
SPECIMEN BREAST IMPLANTS.
00/00/00 #30
SELECTED COMPLAINT REPORTS, FORMS AND/OR RESPONSES.
00/00/00 #31
ALL PRODUCT DATA SHEETS OF DOW CORNING FOR MAMMARY PROSTHESES.
Dow Corning Trial
Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #32

09/14/54
SILICA
KNOWLEDGE OF SYSTEMIC DESEASE

H.C. Spencer, Dow Chemical, note regarding "Dow Corning Hydrophobic Silica."
Testing shows a "high order of toxicity from dust inhalation."
CITE: TDC 5488.
Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #33

03/28/55
MISCELLANEOUS - COMPLICATIONS
SILICA
TISSUE REACTION

"Report Of Trip To Saranac Lake Laboratories" by V.K. Rowe of Dow Chemical
prepared for Dow Corning. Rowe and other Dow Chemical scientists visited Saranac
Laboratory to verify work they had done on D.C. Degusa silica for Dow Corning.
Rowe, et al. reviewed the work and wrote this report on the conclusions of the
tests.
Dow Corning silica consists of crystalline silica. Rowe states that, D.C. Degusa
(silica) dust is "capable of causing diffuse cellular infiltration and fibrotic
changes in the lungs and other organs of certain types of animals. It also
produces bronchitis and sometimes emphysema." However, he concludes that it is
not likely to cause silicosis" in the ordinary sense of the word. If fibrotic
changes of the lungs develop in man, they will probably be diffuse in character.
If exposure is stopped, a measure of recovery is quite possible. Exposure to
crystalline free silica reactivates and aggravates tuberculosis & causes
progressive lesions." (DCC 299000444).
CITE: DCC 266000443 - 266000453, Exhibit to Lynch Deposition, and Exhibit
to California Braley Deposition.
Dow Corning Trial Exhibit List Abstracts
PENDLETO/PSC Attorney Work Product/Privileged & Confidential

Document #34

01/00/56
TESTING
KNOWLEDGE OF LIQUID SILICONE DANGERS
GEL MIGRATION

Dow Corning Report No. 1377 on "The Physiological Assimilation Of DC 200 Fluid"
by M.B. Chenoweth (Dow Chemical), R. Holmes and F. Stark. A copy was distributed
to Collings, Bass, Kauppi, Hunter, Hutchison, Hyde, Blackburn, Bennett, McHard,
CRI, and others including Beamer of Dow Chemical. "An increasing use of
siloxanes for medicinal applications has resulted in the need for information on
their biological activity. Previous experiments of The Dow Chemical Company
Biochemical Department has shown that many of these compounds were
toxicologically inert. It was the purpose of this experiment to determine to
what extent the polydimethylsiloxanes were assimilated, and if so were they were
metabolized." (I 169). C14 labeled PDMS in antifoam emulsion was administered to
2 albino rats and 2 lactating dogs. "The preoperative care, administering of the
labeled fluid, sacrificing and dissecting of the animals was carried on by Dr.
M.B. Chenoweth of The Dow Chemical Biochemistry Department. Samples of tissue
were analyzed with the cooperation of Dow's Radiochemistry Laboratory." (I 171).
With intramuscular injection, the C14 siloxane was found in the intestines,
right adrenal, skin and hair, heart, skull bone, brain, kidney, urine, liver,
muscle, lung, renal fat, blood and spleen. (I 172). Rats fed with the material
had siloxane in the ileum, stomach and content, bladder and urine and kidney. (I
174). "The actual amount present may be greater by a factor of 3 corresponding
to total polydimethylsiloxane from Dow Corning 200 Fluid and from gum. It is
unlikely that the polydimethylsiloxane in the gum would be more readily
assimilated than the lower molecular weight 200 Fluid." (I 174). A lactating dog
fed with the material has siloxane in the skin and hair, brain, bile,, liver,
kidney, heart, milk, urine, skeletal muscle, lung, adrenal, and blood. (I 175).
A second lactating dog also had siloxane in the bile, skin and hair, adrenal,
urine, spleen, lung, heart, liver, thyroid, pancreas, blood from lung, skeletal
muscle, and milk. (I 175).
"The studies conducted along these lines (C14 labeled fluid) to date have shown
that these compounds are absorbed from the gastro-intestinal tracts to a slight
extent, the amount absorbed being of the order of .0001%. Toxicological studies
have shown these compounds to be inert." (I 175). There is a cite to the lab
notebooks for the studies. On 259803.
CITE: KMM 259794 - 259803, Exhibit to Harris County LeVier Deposition, Exhibit
to Tyler Deposition, Exhibit 20 to Harris County Zahalsky Deposition. DUPLICATE:
I 167 - 176.
Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #35

02/09/56
KNOWLEDGE OF LIQUID SILICONE DANGERS
MISCELLANEOUS
MISCELLANEOUS - COMPLICATIONS
TESTING

McGregor, Dow Corning, memo to Rowe, Dow Chemical Biochemical Research,
enclosing 9 samples of silicone fluids for determination of the effect of
intravenous injection. McGregor wants to know if any of the silicone fluids can
be tolerated when injected intravenously. The silicone samples include 200
fluid, 555 fluid, 710 fluid, antifoam AF emulsion (which contains 30% 200
fluid), and XEC-5027 (which contains 10% 200 fluid).
CITE: OOT 43674 - 43700, Exhibit to K. Olson Deposition, Exhibit to Rowe
Deposition, Exhibit 24 to Harris County Rowe Deposition. and Exhibit to
McHard Deposition.
Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #36

08/00/57
KNOWLEDGE OF LIQUID SILICONE DANGERS
MISCELLANEOUS
MISCELLANEOUS - COMPLICATIONS
TESTING
TISSUE REACTION

Study by Stark titled " The Physiological Activity Of Dow Corning 200 Fluid." By
a mechanism unknown at this time, a small amount of Dow Corning 200 Fluid is
absorbed through the skin by the adrenal and kidneys of a rabbit.
CITE: KMM 259804 - 295808.
Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #37

10/05/57
COHESIVENESS - LIQUID COMPONENT OF GEL
MISCELLANEOUS - COMPLICATIONS
TESTING
TISSUE REACTION

Dow Corning's version of a "Report Prepared for Dow Corning Corporation,
Midland, Michigan on Five Silicone Materials." The original report (see document
#38 below) was prepared by Dr. W. Deichmann of the University of Miami on
October 5, 1957 but was a report on six silicone materials. This version of Dr.
Deichmannís report was altered to delete one compound and to delete all adverse
effects identified in Dr. Deichmann's original report.
In this version, five Dow Corning silicones were fed to albino male and female
rats for a period of 90 days. The silicones were Dow Corning 200 Fluid (50, 350,
1000, 10000 and 60000 cs.). Based on the observations of body weight, food
intake, hematology, organ weight at necropsy, and their gross and microscopic
appearance, it was concluded that none of the Dow Corning 200 Fluids of the
viscosity range fed caused any harmful or deleterious effects.
CITE: KKM 7896 - 7930. NOTE: Includes a summary of animal safety studies
relating to dimethylpolysiloxane fluid. See document #38 for the original,
unaltered version of Dr. Deichmann's report produced by Dow Chemical. This
altered version of the report was produced by Dow Corning.
Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #38

10/05/57
COHESIVENESS - LIQUID COMPONENT OF GEL
MISCELLANEOUS - COMPLICATIONS
TESTING
TISSUE REACTION

Dr. W. Deichmann's original "Report Prepared for the Dow Corning Corporation,
Midland Michigan on Six Silicone Materials" Six Dow Corning silicones were fed
to albino male and female rats for a period of 90 days. The silicones were Dow
Corning 200 Fluid (50, 250, 1,000, 10,000, and 60,000 cs.) and Dow Corning
Z-4141 Solvent Free (the latter compound is the compound deleted by Dow Corning
is document #37 above).

ORIGINAL REPORT
DOW CORNING ALTERED REPORT
2 rats died during experiment
There was an apparent decrease in the number of leukocytes. This
difference is considered statistically significant. It is apparent
there is a depression in the output of granulocytes by the bone
marrow. 1 rat died.
There was an apparent decrease in the number of leukocytes. This is
not statistically significant. The dietary feeding of DC 200 fluids
had no significant effect upon the leukocyte counts of the treated
animals.
The livers of the rat fed Z-4141 were significantly greater than the
controls. This is consistent with the observation of liver damage in
these animals.
None of the organ weights differed from the controls
The feeding of the six compounds depressed the granulocytic elements
of the peripheral tail blood of female rats. The livers of the rats
fed Z-4141 were significantly heavier than the livers of the
controls and also demonstrated fatty infiltration or degeneration.
The feeding of the five compounds had no harmful or deleterious
effects
CITE: TDC 6079 - 6100. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #39

10/09/57
COHESIVENESS - LIQUID COMPONENT OF GEL
MISCELLANEOUS - COMPLICATIONS
TESTING
TISSUE REACTION

Dr. Deichmann, University of Miami, writes to McGregor, Dow Corning, enclosing
the results of the review of the six Dow Corning silicone compounds. He informs
McGregor that all six compounds depressed the granulocytic elements of the
peripheral (tail) blood of the female rats, and that the livers of rats fed
Z-4141 were significantly heavier than the controls and demonstrated fatty
infiltration or degeneration.
CITE: M 420103. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #40

12/09/57
KNOWLEDGE OF SYSTEMIC DISEASE
MISCELLANEOUS - COMPLICATIONS
TESTING
TISSUE REACTION

Letter from K.J. Olson and checked by V.K. Rowe, Dow Chemical Biochemical
Research, to R.R. McGregor of Dow Corning with copies to H.H. Gay (Dow Chemical)
and E.M. Adams (Dow Chemical ??) on "Results Of Range Finding Microbiological
And Toxicological Tests on B-756-92 (a linear dimethylpolysiloxane of 6 units
end-blocked with 2,4,5-trichlorophenxy radicals - being evaluated as potential
fungicide for athlete's foot)." The tests showed appreciable anti-fungal
activity. "If large amounts of the material are allowed to remain in contact
with large areas of skin, absorption may result in systemic injury and may even
produce death." Slight hyperemia followed the 3rd and 4th application and the
rabbit died "possibly due from systemic injury due to absorption through the
skin." The other 2 rabbits also died.
Attached is a data sheet prepared by Olson and McCollister, a toxicology work
sheet, "Request For Applications Testing," and eye contact, skin contact -
irritation, and skin contact absorption test records. NOTE: The document is
stamped, "This Report Is The Property Of The Dow Chemical Company."
CITE: TDC 6158 - 6175, Exhibit to K. Olson Deposition, and Exhibit to McHard
Deposition. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #41

04/09/58
ACKNOWLEDGEMENT OF NEED FOR TESTING
KNOWLEDGE OF SYSTEMIC DISEASE
MISCELLANEOUS
MISCELLANEOUS - COMPLICATIONS
TESTING
TISSUE REACTION

"Pharmacological Test Data For Various Organofunctional Silicon Compounds,
Report No. 1641," by Speier of Dow Corning. Pharmacological screening test data
for 61 organofunctional silicon compounds are examined for use in drugs. In
early 1952, a program was agreed upon with Eli Lilly for the pharmacological
examination of assorted organofunctional silicon compounds. "The screening of
these compounds has shown that a great many organofunctional silicon compounds
and polymers have totally unexpected activities. Certain ones proved to be
acutely toxic, even though closely similar structures were not especially
toxic." (DCC 281002214).
All the results are contained in Mellon Institute notebook 318 - all 61 tests in
this study contain a reference to notebook 318. There is also a reference to
Earl Warrick's work at the Mellon Institute at 281002226.
CITE DCC 281002213 - 281002230, Exhibit to Tyler, MDK and Harris County
Depositions, Exhibit to Bennett Deposition, Exhibit to McHard Deposition, and
Exhibit to Ryan Deposition.
WITNESS: Bennett (ancient document exception to hearsay).
DISPOSITION: Not introduced in Toole (II) v. Baxter Healthcare. Dow Corning
Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #42

07/31/58
KNOWLEDGE OF SYSTEMIC DISEASE
MISCELLANEOUS - COMPLICATIONS
TESTING
TISSUE REACTION

Olson, Dow Chemical Biochemical Research, letter to McGregor, Dow Corning, with
copies to Gay, Dow Chemical, and McHard regarding the results of skin
irritation, skin absorption and acute oral feeding tests on Dow Corning 555
Fluid and Ethylan (a modified lanolin), file no. T2.42-54-1.
In McGregor's 06/05/58 letter to Rowe he indicated that Helen Curtis Industries
had observed untoward systemic effects in rabbits and rats due to absorption of
the material through the skin. Autopsy revealed small yellowish bubbles and
petochone (illegible) on the liver and lungs. Olson applied the material to the
skin of rabbits and fed it to another group for 5 days/ The results for the skin
sensitization tests are illegible. There was a questionable to mild kidney
disturbance in animals fed 555 fluid.
The conclusions on 6532 state that DC 555 fluid has a low acute oral toxicity,
is essentially non-irritating to the skin upon prolonged repeated contact, and
that there is no indication that the material is absorbed through the skin in
sufficient amounts to produce systemic damage. Attached is a toxicology work
sheet, "Requests For Screening Or Application Testing," and skin contact
absorption and acute oral toxicity test results.
CITE: TDC 6526 - 6555, Exhibit to McHard Deposition, and Exhibit to K. Olson
Deposition. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #43

07/05/62
KNOWLEDGE OF LIQUID SILICONE DANGERS
MISCELLANEOUS - COMPLICATIONS
TESTING
TISSUE REACTION

Olson and Sadek, Dow Chemical Biochemical Research, letter to McHard, Dow
Corning, on toxicity by subcutaneous injection of Dow Corning 200 Fluids and Dow
Corning 555 And 550 Fluids. Dow Corning 200 fluid 10 cs. resulted in a moderate
inflammatory response in the subcutis as indicated by the presence of
polymorphonuclear cells and a very large mononuclear cells. "This type of
inflammatory reactions is interpreted as due to infection." With DC 555 and 550
Fluid, all injection sites showed evidence of inflammatory reaction indicated by
the presence by mononuclear cells and polymorphonnuclear cells.
CITE: TDC 7493 - 7515, Exhibit 9 to Hancock Deposition, Exhibit to McHard
Deposition, and Exhibit to K. Olson Deposition. Dow Corning Trial Exhibit List
Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #44

07/12/62
SHELL STRENGTH - THICKNESS

S. Braley, Dow Corning, reports on a telephone call with Dr. Gerow regarding his
findings from the use of the saline silastic prosthesis. A leak was discovered
during implantation and Dr. Gerow "sealed it with cement on the operating
table...." Also, he wanted Dow Corning to "make the Gel gooier." Dr. Gerow
reports that the saline he has been using in some of the silastic sacs has been
in animals for nine months and that the body sets up a chemical balance. He has
analyzed the fluid inside the sacs after this nine months and found protein, SO4
ions and also indications that the body had set up a balance of magnesium and
other ions. Finally, Dr. Gerow stated that the "direct injection technique has
worked out beautifully."
CITE: M 320001 - 320002. Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #45

09/14/62
TESTING

Dow Chemical Texas Division, Agricultural Research, study by F.C. Turner, K.G.
Seymour, and J.B. Jackson on "Tropical Application Of Various Solvents And
Solutions To Evaluate Dermal Irritation." Report No. 210. The report was
circulated many persons including K.W. McCory of Dow International; persons at
Bioproducts: Adm., J.E. Johnson; An.Sci. R and D, T.A. Hymas; Plt.Sci. R and D,
K.C. Barrons; Midland BRC Files, L.J. Lippie: Registration Section. G.E. Lynn;
Synthesis Group, W. Reifschneider; and Formulation Res., J.W. VanValkenburg; to
V.K. Rowe of Biochemical Research; and to the following persons at Pitman-Moore:
C.W. Hinman, G.R. Burch, and D.C. Brinkman.
Dow Corning 200 fluid - silicone oil with 49% espesol 5 content was administered
in 10 cc dosages to shaved strips on the hide to test for suitable solvents for
Ruelene. Dow Chemical hoped to find a solvent that didn't damage the hides of
cattle when Ruelene was administered. The DC 200 fluid was rated ad bad, which
indicated that the hide had extreme cracking or sloughing at 10 and 16 days
after application. (TDC 7542).
CITE: TDC 7537 - 7543. Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC
Attorney Work Product/Privileged & Confidential

Document #46

10/04/62
ACKNOWLEDGEMENT OF NEED FOR TESTING
COHESIVENESS - LIQUID COMPONENT OF GEL
KNOWLEDGE OF GEL BLEED
KNOWLEDGE OF LIQUID SILICONE DANGERS
SHELL STRENGTH - THICKNESS
TISSUE REACTION

S.Braley, Dow Corning, memo regarding telephone call to Dr. Thomas D. Cronin.
Braley told Cronin that the uncatalyzed breast material could not be sent out
because there were too many problems with it. The problems with measuring and
the variability of both the base material and the mixing techniques necessitates
different amounts of cross-link resulting, along with the variability in mixing
techniques, can cause difficulties.
Dr. Frank Gerow was also on the telephone and talked about the results he was
getting regarding tissue reaction to the direct injection of the material.
Cronin said that he is not concerned about leakage if he were to use the thin
material because a film forms around the implant retaining the material in
place. Cronin said that he is getting chlorine, potassium and proteins both in
and out through the wall of the bag. This is on apparently good bags.
It was decided that it would be wise to continue the work for long range testing
for the acceptability of the material.
CITE: OOM 320665 - 320666. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #47

10/31/63
KNOWLEDGE OF LIQUID SILICON DANGERS
GEL MIGRATION

Dr. Walter Berman writes to Silas Braley, Dow corning, reporting on his
injection of silicone fluid in mice. Two days after injection, silicone was
found in most organs including the brain, liver, spleen, intestinal wall,
adrenal and kidney. He also found "evidence of at least radio activity and most
probably silicone in the brain and all of the various other organs...."
CITE: M 420051 - 420052. Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #48

11/27/63
TESTING
TISSUE REACTION

Dow Chemical's Bioproducts Department report by Whitney, Pollock and Pauley on
"Fluorosilanes As Fumigants." Six flourosilanes:K-56,425 =
n-propyltrifluorosilane; K-56,426 = ethylmethyldifluorosilane; K-57,317=
trimethylfluorosilane; K-59,489 = mehtyltrifluorosilane; K-59,697
=chlorometthyldifluoromethylsilane; K-58,739 = silicon tetrafluoride; andK-681 =
methyl bromide were evaluated as fumigants for control of insects and
microorganisms. All were very active against post-embryonic stages of tests
insects. Tri and difluoro silanes were active against bacteria and molds. Most
of the compounds killed all flour beetle eggs at one lb/1000 cu. ft. with a
16-hour exposure.... A patent disclosure has been submitted and further research
is recommended for these and related compounds.
Results of toxicological work with mammals is reported in reports 55.11-56425-1,
55.11-56426-1, 55.11-56427-1, 55.11-57317-1, and 55.11-2-1. the usefulness of
these compounds has been reported in Patent Disclosure no. 16193. NOTE: None of
these reports or patent disclosures were produced to the PSC.
"Further exploration of the biological and physical properties of these and
related compounds is recommended."
CITE: TDC 8901- 8904. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #49

00/00/64
MISCELLANEOUS - COMPLICATIONS
SILICA STERILIZATION/CONTAMINATION
TISSUE REACTION

Braley, Dow Corning, states in the Trans American Society of Artificial Internal
Organs, "The Medical Silicones," that electrical charges exist on the surface of
the silicone elastomer. Silicone elastomers are described as non-adherence
products, nothing will stick to them. "However, because of the dialectic (sic)
properties of silicone rubber, it will develop a surface charge and can hold
dust, lint, (etc.).... This is not true adhesion." Additionally, the reason that
the attempt to create a silicone vascular prostheses, to be inserted in a blood
vessel, failed is because of the electrical charges on the surface which caused
the blood to clot at the ingress end of the silicone prostheses tube.
Braley also describes the chemical composition, the characteristics and the
various applications of silicone. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #50

01/13/64
GEL MIGRATION
KNOWLEDGE OF SYSTEMIC DISEASE
MISCELLANEOUS - COMPLICATIONS
TESTING
TISSUE REACTION
McHard memo to Hunter with copies to Braley, Dingman, Hobbs, and Stebleton
regarding "Notes on visit to Battelle Memorial Institute on December 19, 1963."
McHard and Hobbs met with representatives of Battelle and discussed the
"Toxicology of silicones - past and future.
1. Variation in toxicity with animal species. 2. Effect of polymer size on
toxicity. 3. Extent of body metabolism. 4. Fate in kidney and liver. 5. Fate of
catalysts. 6. Extent of carcinogenicity." Also discussed was silastics for
breast implants. Battelle's study showed that the physical properties of
silicone rubber when implanted were significantly affected/decreased. Also,
"There was considerable discussion on how the various polymer sizes may be
transported across the G.I. tract and how they may find their way into the
kidney, liver, and subsequently, the urine."
CITE: KMM 299059 - 299063. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #51
05/16-17/64 COHESIVENESS-LIQUID COMPONENT OF GELKNOWLEDGE OF LIQUID SILICONE DANGERS

KNOWLEDGE OF SYSTEMIC DISEASE

TISSUE REACTION

Silicone Injection committee Meeting on 05/16-17/64 attended by D.J. Badamo, S.

Braley, C.E. Haberstoch, R.R. McGregor, E.G. Mullison, S.L. Bass, H.D. Dingman,

E. Hodnett, M.J. Hunter, J.A. McHard, A.W. Rhodes and L.F. Stebleton of Dow

Corning; by Drs. Ashley, Blocksma, Dingman, Edgerton, Goulian, Lederer, Murray

and Rees, who are medical consultants; and by Steve Carson and Bernard Oster of

Food & Drug Research Laboratories. Materials considered for the injectable

trials: dimethyl siloxane 360 Medical Fluid "(formerly 299 fluid)"; phenylmethyl

siloxanes including 555- "cyclic, very low molecular weight, 704 - linear, very

low molecular weight, 550 - dimethyl and phenylmethyl copolymer; large amount of

phenyl...." and others.

CITE: DCC 267371390 - 267371417, Exhibit to McHard Deposition, and Exhibit to K.

Olson Deposition. DUPLICATE: m 30531 - 30558; KMM 183981 - 184009. Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #52

05/28/64

FRAUD/MISREPRESENTATION

GEL MIGRATION

MISCELLANEOUS - COMPLICATIONS

TISSUE REACTION

Braley memo to Ashley, Blocksma, R. Dingman, Edgerton, Goulian, Lederer, Murray,

Rees, Badamo, Bass, H. Dingman, Haberstroh, Hodnett, Honter, McHard, Mullison,

Rhodes, and Stebleton regarding the attached article in the May 25, 1964 issue

of "The Insider"s Newsletter." Unknown factors with silicone injections include

absorption, migration and hardening.. Braley writes, "We have no knowledge where

the reporter obtained this information. If anyone knows anything about this,

we'd appreciate hearing from him. We are trying to keep such articles as this

out of the public eye as much as possible."

CITE: M 350063 - 350064. Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & confidential


Document #53

09/22/64

KNOWLEDGE OF LIQUID SILICONE DANGERS

GEL MIGRATION

Thomas Rees letter to Braley, Dow Corning, regarding the finding of altered fat

cells in animals sub-cutaneously injected with silicone. Rees states that the

spleens of the mice that have been injected with massive amounts of the material

show definite collection of silicone within macrophages.

CITE: KMM 167416. Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC

Attorney Work Product/Privileged & Confidential


Document #54

09/24/64

TISSUE REACTION

SHELL DEGRADATION

SHELL STRENGTH - THICKNESS

Letter from Dr. Thomas Cronin to William Rhodes, General Manager of Dow Corning.

Dr. Cronin reports that Dr. Brauer had to remove seven implants when, at

intervals of 2-4 months, a blister would start in the scar and gradually break

down. "(S)ome clear, straw colored fluid would be released"

CITE: KMM 150269 - 150270. NOTE: Ivory flakes were being used to prepare the

implants prior to surgery. Dow Corning Trial Exhibit List

Abstracts/PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #55

11/12/64

EMBOLISM

KNOWLEDGE OF LIQUID SILICONE DANGERS

Harry Dingman, Dow Corning's Legal Counsel, writes to Ban Smart of the FDA and

informs him of a reported fatality following injection of a silicone. Dr.

Crenshaw, California, injected a woman with silicone (source and type unknown)

mixed with a vegetable oil. she "then went into a coma in a matter of a few

hours, and died within a few days. Dr. Aronow had not received a formal

coroner's report, but the informal comment was to the effect that death was due

to fat emboli in the lung and possibly in the liver. A suspicion of possible

encephalitis was being checked by having a culture run on the brain." (emphasis

added).

CITE: KKM 1275 - 1276. DUPLICATE: KMM 48637 - 48638.
Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #56

12/00/64

KNOWLEDGE OF LIQUID SILICONE DANGERS

MISCELLANEOUS - COMPLICATIONS

TISSUE REACTION

"Tissue Reactions to Injected Silicone Liquids, A Report of Three Cases,"

Archives of Dermatology, Vol. 90, 538-593 by Winer, Sternberg, Lehman and

Ashley. Drs. Oppenheimer and Russell observed fibrosarcomas developing in 1.7%

to 40% of the test animals. Drs. Hur and Neuman observed malignant epithelial

tumors that were believed to be of sweat gland origin. The conclusion drawn from

the test data is that "there seems to be sufficient evidence at this time that

complications of this nature are to be expected."

CITE: I 253 - 259, Exhibit 7 to McGhan Deposition, and Exhibit 16 to California

Braley Deposition. DUPLICATE: PSC Medical Articles CD, J 3598 - 3603.
Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #57

12/08/64

KNOWLEDGE OF LIQUID SILICONE DANGERS

TISSUE REACTION

Dr. Franklin Ashley writes to Silas Braley, Dow Corning, regarding a "girl in

Las Vegas who received the injections and had the eye trouble." The 28 year old

woman received 30 injections into the breast.

Ten to fifteen minutes following her final injection she noted onset of nausea

followed by dizziness and almost complete loss of vision. At the same time she

developed severe left anterior chest pains without dyspnea or tachypnea.

She was seen by an Internist who treated her with ACTH thinking that this

possibly represented an anaphylactoid reaction. Visual disturbance cleared

somewhat with ACTH. During this immediate post treatment period she experienced

some loss of memory, as well as poor coordination which cleared gradually over a

period of time. Also noted during this time was hematuria which lasted for one

day only; no recurrence has been noted.

One week following the onset of symptoms she was evaluated by Dr. Albouth, at

which time he noted a questionable positive Rhomberg and ophthalmologic findings

consisting of some loss of visual acuity and hemorrhages within and anterior to

the retina.

Follow-up to date has been over a six month period with the latest notation that

her gait has returned to normal. Her dizziness has disappeared, but she still

experiences some visual difficulties, specifically loss of visual acuity.

(emphasis added).

CITE KKH 63126 - 63127. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #58

01/29/65

KNOWLEDGE OF LIQUID SILICONE DANGERS

Franklin Ashley, UCLA Center for the Health Sciences, to Braley, Dow Corning,

reporting the death of a patient after various injections of silicone around the

face. (emphasis added).

CITE: M 340057. Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #59

04/01/65

CONCEALING FROM FDA

KNOWLEDGE OF LIQUID SILICONE DANGERS

Dr. Franklin Ashley responds to Silas Braley's, Dow Corning, letter concerning a

girl in Argentina who was injected with large amounts of silicone fluid. "I

believe this would fit in also with the observations of Goulian and others where

a large quantity was injected any one time, and was taken up by the lymphatics.

We have not observed this in any of our cases, however, probably due to the fact

that we inject only a small quantity each time.... I do not think this should be

reported to the FDA as it is an isolated case and from another country, and we

do not know exactly what they injected really." (emphasis added).

CITE: M 340044. Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #60

05/27/65

EMBOLISM

KNOWLEDGE OF LIQUID SILICONE DANGERS

Frank Ashley, M.D., reports to Silas Braley of Dow Corning regarding a

consultation with a patient in Las Vegas. Ashley states, "My diagnosis, of

course, was multiple silicone emboli from the liquid silicone and possible

additives, in the lungs, brain, liver, kidney and retina." (emphasis added).

CITE: M 340037. Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #61

06/24/65

KNOWLEDGE OF LIQUID SILICONE DANGERS

GEL MIGRATION

Dr. T. Rees writes a letter to Dr. Silas Braley and Fred Dennett, Dow Corning

Center for Aid to Medical Research. Dr. Rees states "The inevitable has

happened. We found a case of carcinoma of the breast in a 37 year old woman who

has had both breast heavily injected with pure silicone material." He states'

"The carcinoma itself was a very small, isolated, intraductal type of carcinoma

in the upper portion of the tail of the breast and there were some involved

lymph nodes in the axilla. There are multiple 'silicone cysts' throughout the

tissue and some of the silicone was injected in the immediate vicinity of the

carcinoma. Also of considerable interest is that there is evidence of silicone

deposits in the lymph nodes of the axilla and thus it appears that the silicone

is drained to a certain extent by the lymphatic system..... We are thinking of

writing this up as a case report, but would like the view of the entire

committee before we commence doing so. We are hesitant to report it because

undoubtedly it will create quite a stir but feel that the case must be reported

for the sake of thoroughness and completeness. We are open to counsel as to just

what manner this should be done. (emphasis added).

CITE: KMM 105815 - 105816, Exhibit to D. McGhan Deposition. DUPLICATE: KMM 3802 - 3803. Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #62

10/05/65

ACKNOWLEDGEMENT OF NEED FOR TESTING

MISCELLANEOUS - COMPLICATIONS

SILICA

TESTING

Hobbs memo to Snedeker with copies to McHard regarding "Recommendations for the

toxicological evaluation of J. Treated Dow Corning Silica Type A." "At the

present time very little is known on the toxicity of the various treated silicas

at Dow Corning.... The exact toxic manifestations are unknown. They will cause

death in laboratory animals by various routes of administration, including

inhalation, for a period of four hours or less. Although these are high

concentrations for a short period of time. we must assume until proven otherwise

that low concentrations over long periods of time are detrimental to health. It

is therefore our recommendation that acute range-finding studies be performed on

J Treated Silica." Testing programs (such as annual chest x-rays of workers)

have been run with the cooperation of the Dow Medical and Biochemistry

Departments on problems which have arisen with various chemicals. The programs

at Dow and Dow Corning were dropped but, "Recently problems have arisen with

chemicals and compounds which indicate that such a preventative medical testing

program is not only desirable but also advisable.... While toxicity studies are

being carried out on some of these materials at the Dow Biochemistry Department,

they are made with animals, usually on short term acute exposures. This type of

information does not indicate what might happen over long periods of time

subjected to less than acute exposures." The document also talks about a

Medical-Biological-Safety Committee."

CITE: KKA 230245 - 230249, Exhibit to McHard Deposition and Exhibit to K. Olson

Deposition. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #63

10/27/65

ACKNOWLEDGEMENT OF NEED FOR TESTING

COHESIVENESS - LIQUID COMPONENT OF GEL

GEL MIGRATION

SHELL DEGRADATION

SHELL STRENGTH - THICKNESS

TESTING

TISSUE REACTION

Burdick, Dow Corning, memo to Don McGhan, Weiler, VerVoort, and Pellikka

regarding "Mammary Implants." He states:

"There are still a number of questions concerning our breast units that have not

been answered. We know that a quantity of low molecular weigh material is

exuding from the bag, but that is all.

He suggests a test to extract the material and analyze it. Burdick states:

"This test should tell us how the gel is affecting the rubber bag. Adhesion and

tear strength should also be related to swell. The extractables may be of low

enough molecular weigh to migrate throughout the body. If so, what quantity are

we talking about?

CITE: OOM 321439 - 321449, Exhibit to Bennett Deposition and Exhibit to D.

McGhan Deposition. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #64

11/15/65

EMBOLISM

KNOWLEDGE OF LIQUID SILICONE DANGERS

Dr. Ashley authors a paper, "Silicone Fluid And Soft Tissue Augmentation, as a

result of the Boca Raton symposium. "Of significance is the fact that the

clinical use of silicon liquids in man preceded any responsible and controlled

experiments in animals." As a result of the concern, ASPRS set up a committee

consisting of Dr. Franklin Ashley, Dr. Ralph Blocksma, Dr. Reed Dingman, Dr.

Milton Edgerton, Dr. Dicran Goulian, Jr., Dr. Francis Lederer, Dr. Joseph

Murray, Dr. Norman Orentreich, and Dr. Thomas Rees.

Dr. Ashley provides a historical overview of the chemical properties and

development of silicone. He notes that with intravenous injection of silicone

fluid in animals, large doses are usually fatal in rabbits and can produce

emboli and death in dogs. He found no tissue reaction in animals when liquid

silicone was injected subcutaneously.

Dr. Ashley also notes that silicone oil "will have a tendency to disappear"

within the body and that:

"(S)ignificant questions ... remain unsolved. First, what is the body

distribution within its tissues of any absorbed material? Second, what is the

ultimate fate of the absorbed material? ... Third, if significant amounts are

absorbed, does the body excrete the material, and if so, how, and how much?

Fourth, if some is retained, in which organ or organs is a harmful effect

produced - if any? Indeed, there is some evidence that silicone oils may be

transported to far removed tissues and organs. In another study, one week after

the intramuscular injection of a rat with dimethyl polysiloxane, 90 per cent of

the C(14) labeled liquid oil was detected within the tissues of the intestinal

tract. The fate and presence of silicone oil in human biology is unknown."

(emphasis added). He further notes that, "In large subcutaneous injections of

silicone fluid, examination of the contents of the abdominal cavity showed that

the mesenteric and omental fat was abnormally firm, with loss of normal color

and adherence to adjacent viscera. This suggests that there may have been

transport of silicone oil through the abdominal cavity." (emphasis added).

Animal studies of injection of RTVS 5392 silicone fluid showed tumor development

in rats at eight, fifteen, and nineteen months after injection. MDX 44010

silicone fluid was also injected in mice, rats and monkeys. Nearly all animals

developed hair loss over the implanted site, and several rats developed

superficial cutaneous ulcers directly over the silicone mass. Both of these

symptoms resolved themselves within six weeks. He also noted a significant

"exothermic reaction," "pronounced local reactions," and tumor development in 3

of 6 rats at 14 and 16 months post-injection. He concludes:

"Although it is only speculation, the initial exothermic injection reaction and

tissue injury may have provided a carcinogenic influence.... (T)he incidence of

3:6 (3:22) should not be attributed to random chance occurrence.... Tumor

formation about buried synthetics has had important consideration by some, but

discounted by others.... (A) tumor incidence of 3:6 or 3:22 indicates a need for

further animal experimentation." (emphasis added). He notes that human clinical

experience in 35 patients noted breast abscess and apparent tumor formation. He

reports on three cases of carcinoma of the breast in women following injection

of silicone fluid. One woman developed a palpable axillary lymph node eight

months following injection and required a radical mastectomy. Surrounding the

cancerous lesion were "multiple small silicone cysts. The silicone was also

found in the axillary lymph modes removed with the radical specimen."

"At least two deaths are known to have followed the subcutaneous injection of

100.0ml. or more of Dow Corning 360 Medical liquid given in one single

administration.... At least one patient is known to have developed blindness

during the subcutaneous injection of Dow Corning 360 Medical liquid.... There is

no reason to believe that the human will tolerate intra-arterial and/or

intravenous injections any better than the experimental animals. (emphasis

added).

CITE: M 360096 - 360141. Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #65

01/14/66

ACKNOWLEDGEMENT OF NEED FOR TESTING

KNOWLEDGE OF SYSTEMIC DISEASE

MISCELLANEOUS - COMPLICATIONS

TESTING

TISSUE REACTION

McHard memo to Bass with copies to Bennett, Dingman, Hunter, W.T. Rossiter and

Rowe regarding "Toxicological testing of Dow Corning Pan Shield." McHard is

reporting on the results of a meeting today with Rowe and Bennett regarding DC

Pan Shield. An initial formulation of this product indicated no apparent

toxicological problems. However, the catalyst wasn't potent enough to cure on

the pan; therefore a new catalyst was used and the product reformulated. Based

on the results of the testing with the first catalyst, no toxicological problems

were anticipated and so marketing decisions were made about the product. As they

got into the 90-day testing program, the toxicological information was

insufficient to assure the degree of product safety necessary. Therefore, Rowe,

Bennett and McHard met today (1/14/66) to review this product. "(I)t is our

recommendation that marketing studies, even short-termed pilot tests, be

postponed until product safety data can be accumulated."

"There are indications that adequate non-toxic oral levels may not be achieved.

"It should also be borne in mind that if Dow Corning were obliged to defend the

safety of this product today in a court of law, we would be at a serious

disadvantage since we could be forced to disclose all data which has any bearing

on the components of the product. You can well appreciate what our position

would be in this event?"

CITE: DCC 281041086 - 281041087. Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #66

06/06/66

ACKNOWLEDGEMENT OF NEED FOR TESTING

MISCELLANEOUS - COMPLICATIONS

TESTING

TISSUE REACTION

Minutes of meeting with the FDA in Washington DC regarding Dow Corning 555

Fluid. Present were Steve Carson and Bernard Oser (FDRL), Otis Fancher (IBT),

Bass, Bennett, Dingman and McHard (all of DC) and Drs. Lehman, Marzulli and

Nelson with the FDA. McHard reported on the chemical composition of DC 555 and a

summary of Dow Corning's 555 fluid Safety Evaluation Program. DC 555 has been

used in cosmetic preparation for 12 years. It was decided to have more detailed

subacute tests performed on rabbits at IBT. The testicular size of the test

rabbits was reduced and spermatogenesis was depressed on microscopic

examination. The effect was traced to the DC 555 fluid in the hand cream. FDRL

then evaluated the fluid and found no such activity in rats or guinea pigs,

noted a marginal effect in dogs, and observed activity in the rabbit but not as

severe as that noted at IBT.

"A consultation was held with Drs. Oster*, Carson*, Calandra (Industrial

Bio-Test Labs.), and Rowe, toxicologist of the Dow Chemical Company. These

consultants felt that the data were indicative of a species specific response

and therefore it was suggested that a male monkey series be started in which the

material would be applied dermally repeatedly." The studies were done at IBT. A

dose applied dermally repeatedly." The studies were done at IBT. A dose of 5

mg.kg. produced a statistically significant effect. McHard mentioned that "the

effect requires 20 days of daily application in the rabbit, but the effect is

not grossly present until the 16th-17th day.:

Oral studies in monkeys was begun in 1965. It was noted that in the orally dosed

males, it was difficult to obtain ejaculate and a subsequent biopsy at 5 months

of oral dosing in the males showed a marked depression of spermatogenesis at the

2000 mg.kg. level, and 2 of 3 monkeys showed spermatogenic depression at the 50

mg.kg. level.

McHard commented on the isolation of chemical species to determine the active

agent. Dow Corning has not yet identified the specific structure which causes

the observed systemic effect. McHard also commented on the quality-control of

the product. McHard also noted that no ill effect had been observed or reported

from people at Dow Corning exposed in the production area. Dingman hoped that

the findings on DC 555 fluid would not cast any reflections on DC medical grade

360 fluid or industrial grade 200 fluids.

CITE: KMM 418744 - 418775, Exhibit to Bennett Deposition, Exhibit to Rowe

Deposition, and Exhibit to McHard Deposition.
Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #67

07/00/66

KNOWLEDGE OF LIQUID SILICONE DANGERS

GEL MIGRATION

T. Rees, et al., submits to Dow Corning a report titled "Visceral Response to

Subcutaneous and Intraperitoneal Injections of Polymethylsiloxane in Mice" which

evaluates histologically the systemic distribution of silicone fluid. Results

indicate silicone deposition in the spleen, liver, adrenals, pancreas, ovaries,

abdominal lymph nodes and kidneys of the test animals, suggesting distribution

by the reticuloendothelial mechanism.

CITE: KKM 31076 - 31087. Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #68

08/02/66

KNOWLEDGE OF LIQUID SILICONE DANGERS

KNOWLEDGE OF SYSTEMIC DISEASE

MISCELLANEOUS - COMPLICATIONS

TESTING

TISSUE REACTION

Braley memo to Ashley, Blocksma, Dingman, Edgerton, Goulian, Lederer, Murray,

Orentreich, Steve Carson, Bennett, Bennett, Hunter and McHard regarding the

attached letter and paper from Thomas Rees. Rees' letter is dated 7/26/66 and

notes that this is a privileged communication. "I hope this work doesn't open a

can of worms but I can't see any alternative to publishing it." The draft paper

notes that subcutaneous administration of massive amounts of silicone produces

considerable alteration of the tissue structure of the subcutis. The fat cells

in the immediate vicinity of the encapsulated silicone show varying degrees of

atrophy and the intracellular fat contains small regular vacuoles.

Intraperitoneal injections or subcutaneous doses in excess of a total dose of 7

ml in mice resulted in widespread microscopic lesions by 3 months. The silicone

also produced a generalized alteration of the abdominal and epicardial adipose

tissue. The fat cells showed a finely granular, eosinophilic cytoplasm. "In many

abdominal organs which included adrenals, lymph nodes, liver, kidney, spleen,

pancreas, and ovary, focal infiltrates of macrophages with abundant clear

cytoplasm were encountered. The nature of the cytoplasive material within the

macrophages has not been ascertained, but it is presumed to be silicone as those

lesions did not occur in control animals. The early adrenal lesions were found

at the corticomedullary junction; as the lesions become more extensive they

extended through the entire cortex. In the liver. lesions were observed in all

parts of the hepatic lobule. The results of this study indicate that

dimethylpolysiloxane fluid is deposited in the spleen, liver, adrenals,

pancreas, ovaries, abdominal lymph nodes, and kidneys of mice when given by

intraperitoneal injection of small amounts or by subcutaneous injection of large

amounts, 7-8 ml. Smaller subcutaneous doses, 1 ml. of liquid silicone in the

same animal species occasionally causes similar lesions which occur only in the

sona reticularis of the adrenal glands." "The mechanism of absorption and

systemic distribution of silicone fluid in mice is still unknown. Venous

embolism or phagocytosis with distribution in the reticuloendothelial system

seems to be likely possibilities. Most visceral lesions did not occur prior to

three months following injection except in isolated instances. This delay seems

to implicate the reticuloendothelial system as being the most likely method of

transfer."

CITE: KMM 31074 - 31087. Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #69

09/06/66

MISCELLANEOUS - ORGANIZATIONAL SURVEY

Minutes of the Board of Directors' Meeting for Dow Chemical Company with a

reference to a secrecy agreement with Dow Corning Corporation regarding the

biological properties of silicones.

CITE: TDC 11625 - 11627, Exhibit to Bennett Deposition and to Julius Johnson

Deposition. Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #70

10/10/66

KNOWLEDGE OF LIQUID SILICONE DANGERS

MISCELLANEOUS - PRODUCT LABELING

TESTING

Memo from Don McGhan (at Dow Corning) to McIntyre with copies to Pellikka,

Hutchison, Bennett, Burdick, Weiler and Diamond regarding "Biological Testing of

360 Fluid, Our Project No. 5152." Steve Carson of FDRL, Harry Dingman of Dow

Corning's legal staff, and McGhan "strongly suggest" that Dow Corning not

proceed with biological testing of Dow Corning 360 fluid in containers smaller

than 440 pounds. McGhan asks McIntyre to "review your marketing objective for

360 Medical Fluid and determine if biological labeling and certification is

required in container sizes smaller than 440 lbs. in order to increase sales of

the product."

CITE: KKA 7168, Exhibit to D. McGhan Deposition.
Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #71

10/12/66

MISCELLANEOUS - COMPLICATIONS

MISCELLANEOUS - SALES

STERILIZATION/CONTAMINATION

TESTING

"Chemical Research Progress Report (Restricted), Report No. 2964," by R. McCarty

and J. Speier - all of Dow Corning. Dr. Hunter established a committee of

Bennett, Hobbs, McCarty, Stark, Weyenberg and Speier to isolate and identify a

pharmacologically active substance believed to be present in DC 555 fluid..

Silanols are referenced on DCC 281002126 - 281002126 - they are "profoundly

toxic" and have effect as a CNS depressant. Silanols have been under study since

10/65. There is a reference to the Mellon Institute on DCC 281002127. Also note

that Dow Corning was using Dow Chemical's animals and testing facilities.

CITE: DCC 281002121 - 281002162, Exhibit to Bennett Deposition, Exhibit to

McHard Deposition, Exhibit to Ryan Deposition, Exhibit to Isquith Deposition and

Exhibit to LeVier Deposition. WITNESS: Bennett (ancient document exception to

hearsay). DISPOSITION: Admitted in Toole (II) v. Baxter Healthcare. Dow Corning

Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #72

01/10/67

ACKNOWLEDGEMENT OF NEED FOR TESTING

TESTING

Rowe memo to McHard with copies to Bennett, Dingman, Heuerman, and Hunter. This

memo is in reply to the 12/16 memo from McHard on Product Safety. Rowe has

looked over the IBT testing outline and feels that "in general, (it) contains

the type of information I believe is necessary. However, I do believe that some

of the work which has been listed should be done at an earlier stage and a

minimum of liability." Rowe gives advice on the types of tests and the timing of

the necessary tests in his critique of the IBR testing plan. Further, "I also

have my doubts about the wisdom of selling the material, even though it is

intra-state, before you at least have long-term studies going, and the data

indicates no likely hazard. I realize that intra-state sales can be made without

FDA approval, but nevertheless, if you were challenged, I fear that you would

have difficulty in convincing any court that you had acted in a responsible way

even though you might be within the limitations of the Federal Food, Drug, and

Cosmetic Act." He states that he will be happy to discuss any of these matters

further with McHard.

CITE: DCC 281041120. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #73

02/01/67

ACKNOWLEDGEMENT OF NEED FOR TESTING

KNOWLEDGE OF LIQUID SILICONE DANGERS

KNOWLEDGE OF SYSTEMIC DISEASE

MISCELLANEOUS - ORGANIZATIONAL SURVEY

TESTING

Minutes of the meeting of the Executive Committee. Includes notes regarding a

joint agreement with The Dow Chemical company pertaining to certain silicone

products designated as DC-555, DC-555A, and compounds derived from and related

thereto, and a joint development agreement relating to the physiological effects

resulting from ingestion or injection into the systems of animals and men of

particular physiologically active silicones.

CITE: DCC 1010001438 - 101001440, Exhibit to Bennett Deposition, Exhibit to

LeBeau Deposition, Exhibit to Rowe Deposition, Exhibit to Caldwell Deposition,

Exhibit to McHard Deposition, Exhibit to Julius Johnson Deposition, and Exhibit

to LeVier Deposition. Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #74

02/08/67

KNOWLEDGE OF LIQUID SILICONE DANGERS

KNOWLEDGE OF SYSTEMIC DISEASE

"Report to Dow Corning Corporation Rabbit Teratogenic Study, TX-114," by

Industrial Bio-Test Laboratories. Nine test groups consisting of fifteen

pregnant does were used in this study. It appears that TX-114 produces no

adverse effect upon maternal growth or upon the ability to carry the

reproduction process successfully form six to eighteen days inclusive. The

number of resorption sites noted appears to be proportional to the total amount

of material administered. It is felt that this reflects system damage to the

maternal organism which obscures the secondary effect upon the developing fetal

system. At a level of 200 mg/kg subcutaneously, slight alterations (clubbing of

extremities and umbilical hernias) were observed in proportions which approach

the upper limits of an expected non-treatment group. "(I)t is felt that the

material is non-teratogenic. However, the incidence of abnormalities seen at

lower levels, especially 200 mg/kg, would lead to a conclusion that the

teratogenic potential of the material should be investigated in at least one

other species and possibly in another rabbit strain." Eldon Frisch, Dow Corning,

in a 12/331/87 document, claims that this study was inconclusive. "(C)lubbing of

extremities and umbilical hernias were near the upper limit...." (emphasis

added).

CITE: I 661 - 702. DUPLICATE: KMM 115833 - 115873; (Referenced in KMM

407480 - 407482). NOTE: See 12/31/87 entry in Master Timeline.
Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #75

02/16/67

KNOWLEDGE OF GEL BLEED

KNOWLEDGE OF LIQUID SILICONE DANGERS

MISCELLANEOUS - COMPLICATIONS

TESTING

TISSUE REACTION

"Discussion Of Toxicology Of Various Dow Corning Products." A meeting was held

on 02/16/67, present were Steve Carson (FDRL), Fancher (IBT), V.K. Rowe (Dow

Chemical), Bennett, Boone, Braley, Bennett, Dingman, Hobbs, Hunter, Don McGhan,

McHard and Radzius. They discussed the IND's on file with the FDA including the

IND for burned hand, the silicone injection IND, the bladder treatment IND,

applications for Silastic rubber dental liner and dental impression material

such as permanent tooth implants using Silastic rubber to anchor tissue contact

material, implant testing on new or modified formulations, corneal implants,

in-dwelling catheters, needle and syringe treatment, DC 360 medical fluid,

elastomer for coating pacemakers, comparison of the reproductive studies carried

out at FDRL including the findings of club footing and resorption as a result of

the treatment, DC FS-1265 fluid and foot and hand protector products ("A recent

report as a result of a one-year feeding in rats did seem to show a dose-related

effect on testis and accessory sex organ weight but V.K. Rowe thought that

because of the species difference and the time involved in the test and the fact

that the test was oral and not dermal and since all of the dermal data looked

good, there should not be any reason to suspect this product" (DCC 281041880),

and tests on Dow Corning 555 fluid and 360 medical fluid.

A discussion was also held on the different viscosity grades of "Dow Corning 200

fluid or Dow Corning 360 fluid" compare with regard to polymer size

distribution. Although higher viscosities show broader distributions, "there

appears to be almost as much of the lower polymer ends in the 350-centistoke" as

in the lower viscosities. (DCC281041877). The agenda is located at 281041882.

CITE: DCC 281041877 - 281041882, Exhibit to Bennett Deposition, Exhibit to

McHard Deposition, Exhibit to Rowe Deposition, and Exhibit to LeVier Deposition.

Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #76

03/10/67

MISCELLANEOUS - COMPLICATIONS

TESTING

TISSUE REACTION

"Summary of Toxicological Testing of Dow Corning FS-1265 Fluid and Ointment,

Foot Protective" by "jar" (Joseph Radzius). It was reported to the FDA in June

1966 that Phenylmethyl polysiloxane - DC 555 fluid - exhibited biological

activity, i.e., a depressant effect on spermatogenesis and a reduction in

testicular size. Dow Corning elected to withdraw the product form the market.

Very recently Dow Corning received a report from FDRL on a 12-month oral

administration of FS-1265 fluid in rats which also showed a dose-related

spermatogenic arrest, depressed testicular and seminal vesicle size similar to

that observed for 555 fluid. Thus, this fluid also exhibits biological activity.

CITE: DCC 281041861 - 281041863. Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #77

03/14/67

TESTING

Dow Corning study titled "Biologically Active Organosilicon compounds, Report

No. 3035," by McCarty, Lee and Burk. Test data on 83 organosilicon compounds

which have proved active in biological screens. The activity listed includes

anti-cancer, anti-malarial, anti-echistosomasis, anthelmintics, soil bonding

agents, premergent herbicides, post-emergent herbicides, anti-coccidiosis,

fungicides and bactericides, contact insecticides, fumigants, anti-crusting

agents, and general pharmacological screen in which the compounds were examined

for use in drugs. Dow Chemical does the screen on agricultural, animal science,

solvent stabilizers, etc. on these compounds.

CITE: DCC 281002231 - 281002247, Exhibit to Tyler MDL and Harris County

Depositions, Exhibit to Bennett Deposition, Exhibit to Ryan Deposition, Exhibit

to Julius Johnson Deposition, Exhibit to Himnam Deposition, and Exhibit to

LeVier Deposition. Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #78

03/21/67

KNOWLEDGE OF LIQUID SILICONE DANGERS

KNOWLEDGE OF SYSTEMIC DISEASE

TESTING

TISSUE REACTION

S. Carson, Food and Drug Research Laboratories, issues report entitled "Summary

of Histopathological findings in Primates." Findings include cystic spaces with

vacuolated cell and a few foreign body type cells in soft tissues and around

minor salivary gland tissue and skeletal muscles, cystic spaces with vacuolated

cells and foreign body type giant cells in both breasts, acute necrotizing

pneumonitis in the lungs, similar changes in the submaxillary gland,

degenerative changes in the kidneys, pleural fibrosis and edema in the lungs,

small and large cystic spaces in the dermis and subcutaneous tissues, focal

calcification in the adrenal glands, chronic stomach inflammation, and chronic

phclonephritis in the kidneys. Include letter sent from F. Ashley to S. Carson

dated 12/02/66 enclosing pathological slides showing area and amount injected

and the autopsy date of the animal. Includes letter from S. Carson to S.

Sternberg dated 01/04/67 enclosing slides prepared from tissues of sumi apes

sent by Dr. Ashley; a member of the Silicone Injection Committee of the Dow

Corning Corporation (Carson and Food and Drug Research Laboratories are

consultants for Dow Corning Corporation). Carson writes:

"The tissues which Dr. Ashley submitted together with information regarding

total volumes injected and the date of the last injection (copy enclosed)

represent some of the most critical tissues available in the United States since

they involve between two and three years of chronic study....This material

represents the closest parallelism to human experience that we have been able to

obtain in any animal studies to date.

... We have mentioned that this material is precluded from use in mammary tissue

augmentation. However there is a considerable black market in a Japanese product

which contains a similar silicone fluid with some type of oil."

CITE: T 822 - 832, Exhibit 107 to Harris county Rathjen Deposition.

DUPLICATE: F 316 - 326. Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & confidential

Document (On PLAINTIFF'S LITERATURE LIST)

(this is between #78 & #79)

04/00/67

(ON PLAINTIFF'S LITERATURE LIST)

F. Ashley, S. Braley, T. Rees, D. Goulian and D. Ballantyne author "The Present

Status of Silicone Fluid in soft Tissue Augmentation" published in Plastic and

Reconstructive Surgery, Vol. 39, No. 4, 411-420. The clinical use of silicone

liquids in man preceded any responsible and controlled experiment in animals.

The unresolved problem related to silicone is migration to distant organs,

cautioning against its use for mammary augmentation. The authors report one case

of unnecessary force during the injection of silicone that may have caused

blindness in one patient by possibly disrupting the arterial or venous system.

They also caution against using silicone fluid with any additives such as olive

oil.

CITE: PSC Medical Articles CD, J 157 - 166. Dow Corning Trial Exhibit List

Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #79

04/28/67

GEL MIGRATION

KNOWLEDGE OF LIQUID SILICONE DANGERS

MISCELLANEOUS - COMPLICATIONS

TESTING

TISSUE REACTION

"Reproduction Study, Albino Rats, TX-114, Dow Corning Tox. File No. 1059-5"

conducted by Industrial BIO-TEST Laboratories, Inc. and sponsored by Dow Corning

Corporation. PDMS, 350 cs., was tested for its effects on fertility,

reproductive performance, embryongenesis and perinatal and postnatal performance

in rats and rabbits. Albino rats given up to 1000 mg of TX-114 per kilogram of

body weight daily by subcutaneous injection show normal growth patterns, have

the desire to mate and the ability to conceive, carry the reproduction process

to parturition and are able to successfully nourish the resulting progeny. The

offspring are free of external and internal malformations and are judged to be

normal as indicated by both normal survival indices and progeny body weights.

Treatment with TX-114 from implantation through the completion of organogenesis

did not produce teratogenic effects in the rat. Lactation, measured in rats by

dosing parental animals from the end of fetal organogenesis through the

lactation period, was unaffected by daily subcutaneous administration of TX-114.

CITE: P 13605 - 13611. Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #80

04/28/67

KNOWLEDGE OF LIQUID SILICONE DANGERS

TESTING

TISSUE REACTION

"Studies of the Effects of Dow Corning 360 Medical Grade fluid (MDX-4-4011) on

Reproduction in Rats and Rabbits" conducted at Food and Drug Research

Laboratories and sponsored by Dow Corning. This polysiloxane compound was

subcutaneously administered to rats and rabbits. One significant effect is a

dose-related incidence of in-utero mortality at 200mg. and 1000 mg. during the

third trimester of rat pregnancy. (FDA 26359 - 26377: T001064 - 001103). Eldon

Frisch, Dow Corning, in a 12/31/87 document claims that this study was

inconclusive. The fetuses of some rats had "slight increase in frequencies of

incomplete developed sternebra and incomplete closure of cranial bone. Some

rabbits in the FDRL study had slightly higher in utero mortality."

CITE: T 1064 - 1103 (Referenced in KMM 407480 - 407482). NOTE: See 12/31/87

entry. DUPLICATE T 996 - 1029. Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #81

07/19/67

MISCELLANEOUS

SILICA STERILIZATION/CONTAMINATION

"Dip Coated Mammary", project no. MD-50 by P. Lange, L. Crusen. This report

constitutes the final phase in the transfer of Medical Development Project No.

50, dip Coated Mammary, to the Medical Products Plant. This report contains the

raw material specifications, formulations, manufacturing procedures, formulation

specifications and the dip coating procedure and specifications.

CITE KMM 320434 - 320454. Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #82

08/17/67

CONCEALING FROM FDA

FRAUD/MISREPRESENTATION

KNOWLEDGE OF LIQUID SILICONE DANGERS

MISCELLANEOUS - PRODUCT LABELING

MISCELLANEOUS - RECKLESS/CONSCIOUS DISREGARD

Women's Wear Daily article titled "Dow Corning Indicted on Breast Expanding

Fluid." charges include illegal distribution and improper labeling of Medical

Fluid 360. It is charged that the labeling failed to include adequate directions

for use and adequate safety warnings. The indictment also charges that the drug

had not been approved by the FDA and had not been exempted from the normal

requirements of the Food, Drug and Cosmetics Act.

CITE: GEG 8984 - 8986. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #83

10/18/67

TESTING

J. McHard, Dow Corning, memo to I. Hutchinson, Bennett, Dingman, Hunter and Don

McGhan describing the policy in the toxicological evaluation of Silastic

silicone rubber for implant use. It involved a two year implantation in dogs

with one interim sacrifice in six months. Providing there was no toxicity and

tissues looked normal, marketing could begin after six months. Based on recent

information from the Medical Products Division, he believes that Dow corning is

not strictly adhering to its toxicological evaluation policy.

CITE: KMM 337147. Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/privileged & Confidential

Document (NOT ON PLAINTIFF'S EXHIBIT LIST)

(this is listed between #83 & #84)

10/30/67

(NOT ON PLAINTIFF'S EXHIBIT LIST)

Hobbs, Dow Corning, memo to H. Dingman, Hutchison, Don McGhan, McHard, and

Pellikka regarding "Minutes of Meeting Held October 27, 1967." The meeting was

held at the request of Hutchison: "to discuss toxicity testing of SILASTIC

implants and more specifically the penile implant.

Ira expressed his feelings relative to the necessity of 2-year toxicity studies

on new materials in dogs. In general he feels the 2-year study is not

necessarily due to the absence of carcinomas being produced when foreign bodies

have, through the years, been implanted into the human body. Ira did feel the

2-year data would be advantageous to have on record in case of product liability

and also if and when the FDA assumes the regulation of devices.

J.A. McHard expressed the recommendations of the Product Safety Committee based

on advice from various Dow Corning consultants, i.e., Steve Carson, V.K. Rowe,

Joe Calandra and (illegible). This recommendation is that new SILASTIC

(illegible). This recommendation is that new SILASTIC (illegible) to be used for

long-term implants shall have a 2-year carcinogenicity study in dogs.

Preliminary marketing could begin after the testing had progressed six months if

tissues are normal."

CITE DCC 204001107 - 204001108.

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #84

11/10/67

MISCELLANEOUS - COMPLICATIONS

TESTING

TISSUE REACTION

SILICA

Hobbs and Himmelsback memo to Barry, Bennett, Clark, Fenn, Greenhalgh, Hansen,

Hargreaves, Hedlund, Hunter, Hyde, Donkle, C. Lentz, Maneri, McHard, Nelson,

Quinn, Ragborg, Ringey, Stinton, Tyler, Weyenberg and Zeman regarding "Status of

the Toxicity and Industrial Safe Handling of J-DCA." J-DCA is Dow Corning Silica

A; results from a recent study indicate that under certain conditions, exposure

to this "will cause significant change in the links."

CITE: DCC 281041072 - 281041074. Dow Corning Trial Exhibit List Abstract

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #85

12/15/67

KNOWLEDGE OF LIQUID SILICONE DANGERS

TESTING

TISSUE REACTION

Food and Drug Research Laboratories issues its report to Dow Corning

Corporation, "Studies of the Effects of Injected Dow Corning 360 Fluid In Dogs."

Fifteen beagles were subcutaneously injected with Dow Corning 360 fluid in the

scapular region for ten successive days. There was a shifting of the injected

mass, signs of mange, fluctuations in weight, elevations of the hemoglobin

concentrations, differentials in the leukocytic counts, congestion and changes

in all organs. One of the beagles died with congestion of the liver, kidneys and

heart accompanied with hemorrphagic changes in the lungs and the adrenals.

CITE: T 1202 - 1209, Exhibit to Petratis Deposition. DUPLICATE: T 1251 - 1302;

KKH 8185 - 8290; FDA 33172 - 33227; F28 -79. Dow Corning Trial Exhibit List

Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #86

01/04/68

MISCELLANEOUS - ORGANIZATIONAL SURVEY

Minutes of the Board of Director's Meeting of Dow Chemical Company with a

reference to loans and advances made to Dow Corning Corporation.

CITE: TDC 11702 - 11703, Exhibit to Bennett Deposition, and Exhibit to Julius

Johnson Deposition. Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #87

02/20/68

KNOWLEDGE OF LIQUID SILICONE DANGERS

Bureau of Regulatory compliance reports on the prosecution of Dow Corning, Bass,

Rhodes, and McIntyre for selling a new drug - Dow Corning 360 Fluid - without an

approved New Drug Application.

CITE I 470. Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #88

02/28/68

KNOWLEDGE OF LIQUID SILICONE DANGERS

GEL MIGRATION

Steve Carson, Food and drug Research Laboratories, issues a Supplement to the

Report on "Studies of the Effects Of Injected Dow Corning 360 Fluid 350 cs In

Dogs. " Following a single subcutaneous injection, silicone was transported to

all organs via the lymphatic or vascular network.

"(D)espite parenteral route of administration, C(14) (DC 360 Fluid) was present

in the gastrointestinal tract, in the aorta and apparently in the lymphatic

pathways as evidenced by the lymph nodes, and salivary glands, thus suggesting

that transport and distribution in these animals was via the vascular system,

the lymphatic, and recirculation via the bilary tract."

Distribution occurs throughout the entire body with no apparent concentration in

any specific organ. In Dow Corning's Toxicology Report Reference 99, Dow

Corning's abstract states, "The distribution of radioactivity was ubiquitous

with evidence of greater activity in liver, spleen, kidneys, heart, lungs and

brain.

CITE: T 38842 - 38866, Exhibit 3 to Harris County Rathjen Deposition. DUPLICATE:

KKP 16422; FDA 26696 - 26701; I 1333 - 1341; KKP 16422 - 16431; M 100145 -

100154. Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #89

03/07/68

ACKNOWLEDGEMENT OF NEED FOR TESTING

MISCELLANEOUS - ORGANIZATIONAL SURVEY

TESTING

Minutes of the Board of Directors' Meeting of the Dow Corning Corporation with

reference to the officers of Dow Corning being approved to sell to Dow Corning

employees common stock in the Dow Chemical Company. The minutes also refer
to an agreement between Dow Corning and Dow Chemical for joint research, development, evaluation and commercialization programs on the physiological
effects of organosilicon compounds.

CITE: DCC 101001529 - 101001543, Exhibit to Bennett Deposition, Exhibit to

Julius Johnson Deposition. Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #90

04/22/68

TESTING

TISSUE REACTION

"Histopathological Findings In Animals of Various Species from Experiments

conducted by Thomas D. Rees" is prepared S. Carson and Food and Drug Research

Laboratories for Dow Corning Corporation. Findings using mice include various

tissue reactions in the liver, spleen, kidney, fat, adrenal glands, pancreas,

ovaries, uterus, endometrium, lymph nodes, small intestine, and stomach.

Findings using rats include various tissue reactions in the fat, spleen, kidney,

pancreas and adrenal glands. Findings in guinea pigs include various reaction in

the fat, kidney, pancreas, adrenal glands, spleen and liver. Findings using

hamsters include various tissue reactions in the fat, spleen and kidneys.

CITE: T 1467 - 1528. Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #91

04/26/68

ACKNOWLEDGEMENT OF NEED FOR TESTING

CONCEALING FROM FDA

MISCELLANEOUS - LOBBYING

MISCELLANEOUS - ORGANIZATIONAL SURVEY

TESTING

Rowe, Dow Chemical, letter to Goggin, the new President of Dow Corning (who was

recently transferred from Dow Chemical), regarding Dow Corning's need to

establish its own toxicology laboratory. Rowe states that Dow corning has a

"poor image" with the FDA which is "partly deserved, partly undeserved." He

suggests that Dow corning needs a "change in philosophy" to turn its image

around. He writes:

"Respect in Washington or elsewhere cannot be acquired except by earning it

through demonstrated competency, integrity, and an open willingness to

cooperate. I have had the feeling at times in the past that these desirable

characteristics have not always been apparent, in fact, it has seemed to me that

there has been a reluctance to deal openly with FDA. An antagonistic approach

toward FDA usually, in my experience, results in a reaction on their part which,

sooner or later, becomes apparent in one form or another and will be regretted."

(p. 1) Rowe recommends that Dow Corning create a position entitled "Director of

Government Regulatory Relations" to interact with the FDA and help Dow Corning's

image. He also recommends that Dow Corning Establish a toxicological laboratory

in-house so that they are able to "know and understand the physiological

properties of all such materials." (p. 6) The Dow Corning laboratory should be

patterned after the Dow Chemical laboratory. Rowe recommends Dow Corning hire

Ken Olson of Dow Chemical for this position. He also explains that:

"It appears to me that one of the most important areas for toxicological study

of DC materials, particularly those designed for use in or on human beings, is

that which may be called biochemical. By this I mean studies which will

completely describe the fate of materials applied to, or administered to, the

intact living organism including animals and plants." (p. 9)

CITE: DCC 410000031 - 4100000040, Exhibit 2 to Bennett Deposition, Exhibit 1 to

LeBeau Deposition, Exhibit 6 to K. Olson Deposition, and Exhibit to Rowe

Deposition. Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #92 & #93

05/23-24/68 (this is listed as #92 & #93)

ACKNOWLEDGEMTN OF NEED FOR TESTING

MISCELLANEOUS - COMPLICATIONS

TESTING

TISSUE REACTION

Minutes of Meeting at Midland on May 23-24, 1968 with representatives form Dow

Corning, Industrial Bio-Test, Food and Drug Research Laboratories, and the Dow

Chemical Company." Attending were Bennett, Calandra (IBT), Carson (FDRL),

Bennett, Frisch, Hobbs, Hunter, Hutchison, McHard, Radzius and Rowe, Dow

Chemical. The subject of the meeting was a "Toxicology Review of Dow Corning

Products."

CITE: DCC 281041054 - 281041059. Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #94

05/31/68

TESTING

TISSUE REACTION

FDA: "Informational Materials Supplied To clinical Investigators" provided to

the FDA sponsored by Dow Corning corporation for Dow Corning 360 Medical Fluid

100 Centistokes (as used for the immersion of burn victims). The purpose of this

study is to evaluate continual immersion therapy as a treatment modality in the

management of the burned patient. The fluid in which the patient is to be

studied is Dow Corning 360 Medical fluid of a viscosity of 100 centistokes. Dow

Corning 360 Medical Fluid (MDX-4-4066 Fluid) is a dimethylpolysiloxane fluid and

is identical to the product known to FDA scientists as Dow Corning 200 Fluid

except that more rigid quality control procedures have been established for the

medical grade product.

This fluid had been tested on pigs, monkeys, rabbits and dogs at Food and Drug

Research Laboratories. Observations were made of the effects of administration

to rabbits and rats of diets containing 1% Dow Corning 360 Medical fluid, 50 or

350 centistokes, for eight to twelve months, respectively. These were compared

to effects resulting from administration of the basal ration alone. No

significant differences were found between the groups receiving the

polysiloxanes and the basal control in growth or any of the parameters of

physiological function, organ weight, or tissue morphology.

Clinical experience with silicone immersion has included the immersion treatment

of thirteen healthy unburned control vs. eighteen burned victims and the

immersion treatment of one patient suffering from toxic epidermal necrolysis.

Results indicates that silicone immersion is contraindicated in burn cases with

open-chest injuries and/or venous cutdown on the leg. Continued immersion is

contraindicated if sever skin rash develops which does not resolve with adequate

skin hygiene and/or rigorous quality maintenance of the silicone fluid.

Immersion may precipitate or increase hallucination. Immersion results in

external fluid pressure on the chest which may produce sufficient splinting

effect to reduce chest motion and prevent adequate aeration of the lungs in

those patients who are debilitated or who have chest injuries. Intermittent

positive pressure breathing may be required in these cases to enhance aeration

of the lungs.

Skin rash has been observed in immersed patients. Severe and persistent skin

rash which does not resolve with adequate skin hygiene and quality maintenance

of the fluid is adequate reason to terminate immersion.

CITE: KMM 104968 - 105041. Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #95

06/03/68

COHESIVENESS - LIQUID COMPONENT OF GEL

GEL MIGRATION

TESTING

Dow Corning completes a study of the biological distribution of

dimethylpolysiloxane in adult male mice. Significant amounts of radioactivity

were found in the tissues and body fluids analyzed. The level of absorption and

the biological distribution of the radioactivity were not dependent upon the

molecular weight distribution of the fluid or the method by which the fluids

were administered.

CITE: DCC 281001381 - 281001399, Exhibit to Harris Country LeVier deposition,

Exhibit 3 to Harris Country Rathjen Deposition, Exhibit 19 to Harris County

Zahalsky Deposition, Exhibit to Harris County Tyler Deposition, and Exhibit to

Weyenberg Deposition. DUPLICATE: M 100155 - 100174; DCC 242031103 - 242031121;

FDA 43184 - 43202. Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #96

07/16/68

KNOWLEDGE OF LIQUID SILICONE DANGERS

KNOWLEDGE OF SYSTEMIC DISEASE

FDA: Dr. Wilson writes a letter to Dr. Inscoe of the FDA regarding his analysis

of the reproduction studies done on Dow Corning Medical Fluid 360 by Food and

Drug Research Laboratories. He states that the reports "were not presented in

such a way as to inspire complete confidence...." He also concludes the compound

causes an "appreciable increase in fetal death and resorption in rabbits" which

is dose related and also causes an increase in malformations in rabbits at

certain doses. Thus, "the compound under consideration cannot be declared to

have no teratogenic potential."

CITE: KMM 128723 - 128724. Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #97

08/08/68

GEL MIGRATION

TESTING

TISSUE REACTION

FDA: The FDA recommends that Dow Corning's IND 2702 remain ineligible for

reinstatement because of the lack of toxicity information, deficient protocols

and the lack of declaration that the IND has no teratogenic potential. The FDA

directs Dow Corning to provide data on the metabolic fate and migratory sites of

silicone, including studies on the kidney and liver.

CITE: FDA 28545 - 28547. NOTE: See 09/24/68 entry. Dow Corning Trial Exhibit

List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #98

10/09/68

KNOWLEDGE OF LIQUID SILICONE DANGERS

GEL MIGRATION

Hobbs, Toxicologist at Dow Corning, letter to Dr. Charles Riffkin, The Squibb

Institute for Medical Research, responding to his inquiry about the distribution

and fate of injected silicones. He encloses the study, "Studies of the Effects

of Injected DOW CORNING 360 Fluid, 350 cs., in Dogs," stating:

"The results of this study indicate that distribution occurs throughout the

entire body with no pronounced concentration in any specific organ. It is

evident by the preliminary nature of this study that the fate and chemical

nature of the material after it vacates the injection site is unknown.

CITE: FDA 27154 - 27155, Exhibit to K. Olson Deposition. Dow Corning Trial

Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #99

10/17/68

FRAUD/MISREPRESENTATION

MISCELLANEOUS - COMPLICATIONS

MISCELLANEOUS - PRODUCT LABELING

TESTING

Olson memo to Pail with copies to Bennett, Currie, Gergle, Hobbs, Hunter,

McHard, Radzius and Vaughn regarding "Suitability for Industrial Use of

Protective Hand Cream Formulated with Dow Corning FS-1265 Fluid Unstripped of

Cyclic Trimer." The Dow Corning Toxicology Department recommends the use of

Protective Hand Cream, industrially, does not pose a significant hazard, and

"represents an appropriate risk for Dow Corning." Olson reviews the studies to

date on FS-1265 Fluid including studies by IBT - 20 day subacute dermal study in

rabbits (spermatogenic depression was found to be mild to moderate in the

controls and not significantly different in the test groups); one-year dietary

feeding study in rats ("There was evidence of decreased spermatogenesis in the

male test animals"); IBT - 14 week dermal toxicity in rhesus monkeys (biopsies

at 30-days showed testicular hypoplasia); Dow Chemical (cyclic trimer possesses

a relatively high acute oral toxicity); and IBT - acute percutaneous absorption

study. He recommends industrial use of Protective Hand Cream containing less

than 15 p.p.m. of cyclic trimer and that this is an appropriate risk. "We wish

to emphasize that the front label flagrantly (sic) misrepresents the product

from an efficacy viewpoint. All data generated to date shows, unequivocally,

that the cream does not protect against the irritating properties of the

chemicals studied. Ethically, such advertising leaves much to be desired and is

frowned upon by government agencies and all who are charged with matters

pertaining to consumer protection and proper representation"

CITE: DCC 218041771 - 281041776, Exhibit to K. Olson Deposition, and Exhibit to

LeVier, Deposition. Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #100

11/29/68

KNOWLEDGE OF SYSTEMIC DISEASE

TESTING

TISSUE REACTION

Steven Carson, Food and Drug Research Laboratories, issues a report on "Chronic

Implantation Studies of Polysiloxanes In Dogs" contracted by Dow Corning. The

report states:

"Chronic implantation studies were conducted in dogs over a three year period

utilizing a variety of polysiloxane materials. When possible comparisons were

made between solid and perforated wafers of individual materials implanted into

intramuscular, subcutaneous and intraperitoneal sites. The number of implants

utilized, provided for microscopic examination of replicate tissues at each time

period, i.e. 3, 9, 24, and 36 months.

Inasmuch as each type of polysiloxane was evaluated independently no direct

comparison between materials is provided, however the physical forms of each

were compared. It may be concluded that in every instance the degree of reaction

about the perforated implants was less intense than that associated with the

solid implant, particularly with respect to the degree of fibrous reaction or

extent of hyalinization or inflammatory cell reaction.

Samples of polysiloxane materials 370, 372 (including Cronin breast), fine and

coarse sponge, silphenylene and LS each involved samples in which the physical

form of the implant was the major variable. In the instance of the sponge

implants (coarse and fine), a somewhat more intense connective and fibrous

tissue reaction was observed with fine sponge in the initial 9 month period but

lessened markedly at 24 and 36 months. The prosthetic breast samples with 372

revealed no untoward tissue reactions. Comparison of cured and uncured samples

386, 382, 5392, X-3-0855 and Medical Adhesive Type A generally revealed a more

severe inflammatory cell reaction at 3 months in the uncured samples of 386,

5392 as compared to the cured samples. This reaction was absent at 24 and 36

months. The Medical Adhesive Type A differed, in that the initial tissue

reactions were minimal in each.

Generally, no untoward chronic tissue reactions were noted with any of the

implant materials. Systemic tissue responses were not observed at 24 or 36

months. There was no evidence of tumorigenesis, with any of the samples or at

any of the sites of implantation over a 3 year period of testing in dogs."

The first page of this report states that "this report is not to be distributed

outside Dow Corning Corporation."

CITE: T 2033 - 2096, Exhibit 35 to Bennett Deposition (used by Dow Corning),

Exhibit 29 to MDL Rathjen Deposition (used by Dow Corning), and Exhibits 19 and

20 to Zahalsky Deposition. DUPLICATE: FDA 27384 - 27409. Dow Corning Trial

Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #101
01/29/69
SHELL STRENGTH - THICKNESS
RUPTURE

G. Robertson, Dow Corning, memo to Koning regarding a mammary implant ruptured 1 1/2 years after implantation which was returned by Dr. Crosby. Robertson states, "(T)he envelope edges adjacent to the rupture, appeared to be of a very low tear strength. The physical properties of this envelope may never have been adequate." (emphasis added).

CITE: KKH 1654.

Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #102

03/24/69

KNOWLEDGE OF LIQUID SILICONE DANGERS

KNOWLEDGE OF SYSTEMIC DISEASE

Dr. Franklin Ashley, a clinical investigator for IND 2702, writes to Dr. Frank

McDowell regarding an article by Bishoff and Bryson on the carcinogenicity of

silicone in fluid in rats and mice. Braley, Dow Corning, has reviewed the

article and has stated to Dr. Ashley that:

"According to what he says, and he would not want to say this to you, he feels

that this article is well written and should not be published. I agree."

CITE: OOM 320814. Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #103

06/10/69

MISCELLANEOUS - COMPLICATIONS

TESTING

TISSUE REACTION

Memo from Olson to Frisch with copies to Bennett, Hobbs, Hunter and Radzius

regarding "Telephone Communication with Dr. John Wilson of Johnson & Johnson."

Dr. Wilson, toxicologist at Johnson & Johnson, was contacted by telephone

regarding their subacute dermal rabbit study on Dow Corning 556 and 360 fluids

and Dow Corning MDDX-4-4122 wash resistant base. Dr. Wilson stated that the

materials had been applied to rabbit skin daily. All animals showed a trend

toward testicular atrophy. "There was a suggestion of dose-response relationship

with Dow Corning materials although the effects were not statistically

significant. A subacute oral rat study is in progress." Olson indicated to

Wilson that Dow Corning would be concerned about positive findings with the

second study and would be agreeable to meeting with them to compare their

respective data.

CITE: DCC 281041112, Exhibit to McHard Deposition, Exhibit to K. Olson

Deposition, and Exhibit to LeVier Deposition. Dow Corning Trial Exhibit List

Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #104

07/15/69

KNOWLEDGE OF LIQUID SILICONE DANGERS

GEL MIGRATION

Food and Drug Research laboratories report on the findings in the chronic

parenteral (intraperitoneal) study initiated by Dr. Ballantyne, Rees and

Hawthorne at the NYU School of Medicine. After silicone fluid in the peripheral

erythrocytes in early hematologic examinations was observed, Dow Corning

transferred the study and its financial sponsorship from NYU to Food and Drug

Research Laboratories. "When the animals received 51 cc and 62 cc of fluid,

inflammatory cells were observed in the spinal meninges (which was not stated in

earlier reports). Injections of large volumes of silicone produces wide spread

deposition throughout the reticuloendothelial system, silicone vacuole

accumulation in cells and a systemic distribution of silicone droplets.

CITE: T 2866 - 2945 (The study is referenced in FDA 26875 - 26889). NOTE: See

06/30/75 entry.

Document #105

08/06/69

ACKNOWLEDGEMENT OF NEED FOR TESTING

KNOWLEDGE OF SYSTEMIC DISEASE

TESTING

Isquith, Dow Corning Biomedical Research Laboratory, memo on the "Current Status

of Microbiological research." Isquith states that:

"The main purpose of the survey is to help in establishing the basic

relationship between organosilicon structure and biological activity, the

further pursuit of which rests with our own secondary stage research activity

into the physiology (metabolism, mechanism of action, site of action, etc.) of

the compounds and a good screening procedure for identification of developmental

potential. (DCC 16000004)

Another area for research is the development of a biological assay for

determination of organosilicone interferon induction. (DCC 16000004). Dow

Corning has developed sufficient expertise in viral methodology to conduct the

assay, but "there would be considerable advantage in using such a system (more

stable virus, greater lethality) as is currently being employed in a survey for

interferon inducers at Dow (Chemical) Human Health by Dr. N. Miner...." (DCC

16000005) He recommends using Dr. Miner's lab for seeking a long lasting

interferon inducer among organosilicone compounds. (DCC 16000006)

Finally, another area is the "Investigation of Physiological Effects of Some

Organosilicon Compounds." (DCC 16000011). Isquith concludes that the area of

microbiology in relation to organosilicon chemistry "is mushrooming at a pace

that even now we are unable to adequately provide this cover. A wise investment

at this time would be the hiring of a virologist (M.S. preferably) with training

in tissue culture, virology, and immunochemistry. I have not had time to

investigate thoroughly, but feel there is a good chance for development of

possible potential in the areas of hypersensitivity, graft rejection, and

autoimmune disease (arthritis, glomerulonephritis, etc.) which should be within

the scope of a person with the training I suggested." (DCC 16000014)

CITE: DCC 16000002 - 160000014, Exhibit 2 to Isquith Deposition, Exhibit 3 to

D.McGhan Deposition, Exhibit to Blocksma Deposition (used by plaintiffs and Dow

Corning), Exhibit to LeBeau Deposition, Exhibit to Bennett Deposition, Exhibit

to Boley Deposition, and Exhibit to Julius Johnson Deposition WITNESS: "Bennett

(Authenticated in Isquith, Vol. I, 119-120). Dow Corning Trial Exhibit List

Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #106

08/14/69

ACKNOWLEDGEMENT OF NEED FOR TESTING

MISCELLANEOUS - ORGANIZATIONAL SURVEY

TESTING

Letter of agreement between Dow Chemical Company, Dow Corning Corporation and

Lepetit SpA for a joint development program regarding the biological activity of

organosilicon compounds. The agreement requires the full disclosure of all

proprietary and confidential information of each party to the agreement to each

other party.

CIT: TDCH 1275 - 1276. Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #107

11/15/69

KNOWLEDGE OF SYSTEMIC DISEASE

MISCELLANEOUS - COMPLICATIONS

Doremire memo to Bennett regarding chemical warfare and riot control agents,

XZ8-3063. This is a silicone glycol. It goes through the skin as if there was no

skin there. "Do you have any suggestions for a chemical that could be added to

XZ8-3063 which would cause a variety of effects? These effects could vary from a

drug that would act as a simple tranquilizer to a drug which would cause a loss

of consciousness." In the case of riot control, the drug might be effective for

1/2 hour whereas a chemical warfare use might need 2-4 hours effectiveness. He

plans on checking with the "Analytical Laboratory on toxicity information.

CITE: DCC 281014081, Exhibit 3 to Harris County LeBeau Deposition, Exhibit to

Rowe Deposition, Exhibit to Bennett Deposition, Exhibit to McHard Deposition,

and Exhibit to Ryan Deposition. Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #108

00/00/70

00/00/71

00/00/72

FRAUD/MISREPRESENTATION

Dow Corning advertisement; "New sterile package provides Silastic Mammary

Prosthesis ready to implant. This convenient, sterile blister pack assures

greater product reliability, eliminates excessive handling and can be easily

opened with scissors." It also includes references to sizing rings and that the

mammary implant no longer is fitted with fixation patches.

CITE: M 700003; M 700008 - 700009. DUPLICATE; M 370049 - 370052; M370108 -

370109; M 370113 - 370114; KKH 62679 - 62682; M 700019 - 700020. Dow Corning

Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #109

09/20/76

Hobbs, Dow Corning, memo to Hinsch with a copy to Lentz regarding information

concerning migration of silicone gels. Hobbs states that experimentation had not

demonstrated migration of Dow Corning mammary gel

but this factor does not appear to be true for all silicone gels. Hobbs further

states that gels having a low consistency due to low levels of cross-linker

appear to migrate along tissue planes in much the same manner as large injected

doses of silicone fluid.

CITE: M 170104, Exhibit 130 to Burda Deposition; Exhibit 91 to Braley

Deposition. DUPLICATE: M 570060. NOTE: The document was listed as 00/00/70 on

Plaintiff's Trial Exhibit List. Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #110

01/12/70

KNOWLEDGE OF LIQUID SILICONE DANGERS

GEL MIGRATION

Silas Braley, Dow Corning, memo to various Dow Corning employees distributing

interim research report on the investigation of Dimethylpolysiloxane Fluid

Injections at the Institute of Reconstructive Plastic Surgery, New York

University. The interim report states that "our most interesting recent findings

indicate that in both mice and rats, injection of large volumes of liquid

silicone, either interperitoneally or subcutaneously, in multiple injections,

apparently produces a wide spread deposition of this material throughout the

reticuloendothelial system. A more recent finding of some interest is that there

is an apparent accumulation of silicone vacuoles both within the red cells and

the leukocytes of the peripheral blood in mice and rats, which appears about one

to three months after injection and persists for several months."

The NIH grant will run out in about one year and these studies will have to be

terminated. "It is our feeling that the evidence of systemic distribution of

silicone droplets or vacuoles can not necessarily be considered an adverse

effect, but is more likely related to total dosage. The dosages employed in

animals rarely can be achieved in man with the possible exception of breast

injections...."

CITE: T 2881 - 2885. NOTE: The report itself was an Exhibit to the K. Olson

Deposition (KKH 9841 - 9845). This document also has the Bates number OOM 321368

- 321672 on it. Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #111

02/02/70

STERILIZATION/CONTAMINATION

J.H. Wetters, Dow Corning Medical Products Plant, Report No. 229 to Burdick with

copies to Reilly, Mantle, Piper, Don McGhan, Houle and Robertson regarding

"White Particle Contamination of the Mammary Gel." The major contaminant was

found to be crystalline by microscopy and potassium chloride and potassium

bicarbonate by x-ray. Wetters cannot

explain the presence of potassium bicarbonate. The white poly lined can in which

it is contained could possibly be the source of this material.

J.P. Fitzgibbon feels that the crystalline potassium salts are the major portion

of the contamination. "Gordon Robertson and Ken Olson should be contacted for an

opinion as to whether these potassium salts are harmful." (MM 234057)

CITE: KMM 234056 - 234057. Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #112

02/18/70

KNOWLEDGE OF LIQUID SILICONE DANGERS

ACKNOWLEDGEMENT OF NEED FOR TESTING

TISSUE REACTION

Report prepared Food and Drug Research Laboratories for the Dow Corning

Toxicology department. There are relatively little specific experimental data

available on the reactivity of biological systems to silastics and

polymethylsiloxane (PMSs) fluids. Prior studies by other laboratories showed

"significant testicular atrophy resulted" from topical application

of a polymethylsiloxane fluid. In the present study, 15 applications of PMS

fluid was applied topically on rats, guinea pigs, rabbits and dogs for a 20-day

period, and was administered in the diets of rats and rabbits for eight months.

In the rabbits that were topically applied with PMS fluid, "the reduction in the

testicular weights of the PMS-treated rabbits is considered biologically

significant."

In the rats that had PMS administered orally for one year, growth was retarded

as early as the first week in feeding. The differences in weight gain between

the test and control groups was "statistically significant" during the third

week, with the weight gain in the test group lower than the control. In the

female rats, there were "notable endocrine effects," smaller ovaries, enlarged

pituitary, and increased weight in the adrenals and thyroids.

In the rabbits that had PMS administered orally for eight months, there was a

"trend toward decreased testicular size in the test group...," a tendency toward

lower hemoglobin and hematocrit in all rabbits in the test group, "some effect

of PMS fluid on sperm maturation...," and testicular atrophy in the test

rabbits.

CITE: T 2302 - 2341, Exhibit to K. Olson Deposition, and Exhibit to LeVier

Deposition. Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #113

02/19/70

KNOWLEDGE OF SYSTEMIC DISEASE

MISCELLANEOUS - COMPLICATIONS

SILICA

Dow Corning study titled "Acute Inhalation of 14C-Labeled J-DCA" (silica) by

Hobbs and Lacefield finds that the acute inhalation of a relatively large amount

of J-DCA appears to confine its residence and effect to the lung. The low levels

of J-DCA found systemically is a strong indication that the acute adverse

response is confined to the lung. This would also indicate the lung to be the

target organ from a chronic exposure.

CITE: DCCF 5008903 - 5008907, Exhibit to K. Olson Deposition. Dow Corning Trial

Exhibit List Abstract

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #114

03/02/70

KNOWLEDGE OF LIQUID SILICONE DANGERS

TESTING

D. Ballantyne letter to E. Hobbs, Dow Corning, answers questions about the

investigation regarding dimethylpolysiloxane fluid raised by Hobbs' letter of

02/19/70. Current findings show an apparent accumulation of silicone vacuoles

that were observed on the erythrocytes of rats only. He currently has studies

underway on mice and baboons but the results are not substantial at this time. A

research paper should appear in the April issue of the Reticuloendothelial

Society.

CITE: T 2888 - 2889. Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #115
04/13/70
KNOWLEDGE OF GEL BLEED
KNOWLEDGE OF SYSTEMIC DISEASE
MISCELLANEOUS - COMPLICATIONS
RUPTURE
TISSUE REACTION

Olson memo to Boone with copies to Hunter, Hobbs, Koning, Radzius and Stark regarding "Inflatable Mammary Toxicology." He responds to Boone's memo stating, "The stability of dextran solutions in an implant situation over the long haul, particularly if there is diffusion of body fluids across the membrane would be difficult to accurately assess without biological data generated under use conditions. It is important to know these things prior to marketing. With my cursory knowledge of the problem I would tend to feel that such a device might cause some patients and Dow Corning some degree of grief. I would think that a rather extensive clinical investigation is indicated in order to assess benefit versus risk for Dow Corning."
CITE: KMM 146382-146384.

Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #116

04/14/70

KNOWLEDGE OF SYSTEMIC DISEASETESTING

TISSUE REACTION

"Two-Year Implant Studies with Silastic Materials in dogs" by S. Carson and Food

and Drug Research Laboratories for Dow Corning Corporation. Carson states:

"A two-year study was undertaken to evaluate the effects associated with

implantation of silastic materials into three sites of beagle dogs. Its purpose

was to determine the tissue reaction and systemic effects associated with the

implantation of silastic materials into subcutaneous, intramuscular, or

intraperitoneal areas in dogs and to evaluate these responses to the implants

with relation to time. No adverse findings were seen which could be associated

with the implantation of the test materials. Fibrous capsule formation is the

only histomorphologic change found in these animals. Capsule formation was of a

1 to 2+ thickness during the first six months of study and ranged from 2+ to 3+

thickness during the final examination after two years of test. In several

cases, inflammatory cell reactions were also found. These were however

anticipated, and were observed at the six-month and two-year sacrifice periods.

The findings, therefore, are primarily associated with a minimal degree of

foreign body reaction and no adverse systemic pathological manifestations are

associated with the implantation of the silastic materials.

CITE: T 1529 - 1572. Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #117

04/20/70

TESTING

TISSUE REACTION

FRAUD/MISREPRESENTATION

KNOWLEDGE OF SYSTEMIC DISEASE

A study contracted to Food and Drug Research Laboratories by Dow Corning

entitles "Two Year Studies with Miniature Silastic Mammary Implants TX-202A and

TX-202"B in Dogs, Dow Corning Tox. File No. 1306-3" is sent to Dow Corning. In

this study, one of the four dogs died and the three others had a chronic

inflammatory response to the implants. While FDRL reports that the only adverse

effects two years after implantation are fibrous tissue encapsulation and

chronic inflammation, the attached chart (Table 3) shows reactions at 6 months

of "large granulomatous mass adjacent to capsule" and "liver and

kidney-congested." Dow Corning submitted this study, with the incorrect chart

(Table 3) as part of its PMA Double Lumen Silastic II and Silastic MSI Gel

Saline HP application.

CITE: F 462 - 483, Exhibit 9 to California Braley Deposition. DUPLICATE: p

A75\460 - 17482; T 2363 - 2383. NOTE: See 00/00/73 - F 12 - 16; P 17491 - 17496;

and Depo. of Bobby Purkait, MDL 926, p. 50-51, Exhibit 22 (07/09/93).

Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #118
05/06/70
RUPTURE
SHELL STRENGTH - THICKNESS

J.K. Boone, Dow Corning , handwritten note to F. Stark regarding inflatable mammary development assurance. Boone writes:

"The bags for the inflatable mammary prostheses are taken directly from the production of the standard seamless mammary. It is expected that gel filled bags are softened by the gel somewhat, giving an ultimately softer bag with somewhat higher elongation. Thickness of the bags varies with the size and width, but it is ordinarily between 0/010" and 0.020" with the average being about 0/017.

Several individual prostheses were subjected to severe testing (after filling and tube removal). They were slammed repeatedly against a smooth wall. Valves functioned well, bags can be broken under stress without the valves leaking.

To date, 153 of these devices have been submitted to quality assurance, and 18 of these have been rejected for a variety of reason. Leakage through the valve has not been a problem.

It is very difficult to project the eventual clinical failure rate for this device at this time. I would estimate failures less than 1% on devices successfully implanted, another failure rate should be expected for devices damaged during surgery. These will be immediately detectable as these devices are filled. This will cause professional irritation but little liability. Patients are being cautioned that these devices may break or leak at some later date.... The device now marketed (gel filled) has certainly not been complication free but to date it has not caused us severe liability problems. Over the long haul, I would guess that we might be sued about as often for hard, painful breasts as for 'shrinking' ones."

Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #119

06/01/70

ACKNOWLEDGEMENT OF NEED FOR TESTING

COHESIVENESS - LIQUID COMPONENT OF GEL

KNOWLEDGE OF GEL BLEED

MISCELLANEOUS - COMPLICATIONS

SILICA

TISSUE REACTION

Minutes of the Inflatable Mammary Meeting sent to Bennett, Boone, Bennett,

Hobbs, McIntyre, Olson, Rathjen and Stark.

CITE: KMM 77733 - 77750, Exhibit to Bennett Deposition and Exhibit to

Isquith Deposition. Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #120 (ALSO LISTED AS 121.)

06/16/70

TESTING

SHELL STRENGTH - THICKNESS

Boone, Dow Corning, memo to Hobbs and others regarding the "Physical Property

Testing on Two Year Implant Specimens." The study was by Food and Drug Research

Laboratories on silicone elastomers implanted intraperitoneally, intramuscularly

and subcutaneously. Fifteen dogs were tested with silicone elastomer and

seamless mammary constructions. The results showed "in almost all cases (that

there has been some rise in durometer with attendant loss in elongation and

increase in modulus of the materials."

CITE: T 1573 - 1577. (Document # 121 on the Trial Exhibit List states that this

document does not have a Bates Number). Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #122

07/08/70

COHESIVENESS - LIQUID COMPONENT OF GEL

KNOWLEDGE OF LIQUID SILICONE DANGERS

KNOWLEDGE OF SYSTEMIC DISEASE

MISCELLANEOUS - COMPLICATIONS

Olson letter to Michael Robbins, Pharmaceutical Division of The Dow Chemical

Company in Indianapolis, regarding Robbin's recent request for information on

the toxicity of dimethylpolysiloxane when injected intravenously into laboratory

animals. A search of the toxicology files at Dow Chemical reveals that

preliminary acute and subacute studies were conducted in 1956 on Dow Corning 200

Fluid, 350cs." He then summarizes the data where 2 of 4 rabbits died immediately

after being injected with DC 200 fluid at .50 g/kg, 2 of 4 died at 1 g/kg dose

and all 4 died at 2 g/kg dose.

CITE: FDA 27229 - 27230, Exhibit to K. Olson Deposition, and Exhibit to Hinman

Deposition. Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #123

09/23/70

MISCELLANEOUS

SHELL STRENGTH - THICKNESS

STERILIZATION/CONTAMINATION

Dow Corning Corporation Report entitled "Manufacture of Silastic Mammary

Prosthesis." The purpose of this report is to provide a detailed description of

the manufacturing processes involved in the production of Silastic Mammary

Prostheses. The report gives a detailed description of the manufacturing

facilities, product composition, processing materials, component specifications,

manufacturing process and quality assurances. This report also includes product

run sheets for the seamless mammary prosthesis and packaging component

information and specifications.

CITE: KMM 223739 - 223806. Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document # 124

01/21/71

ACKNOWLEDGEMENT OF NEED FOR TESTING

KNOWLEDGE OF SYSTEMIC DISEASE

MISCELLANEOUS - COMPLICATIONS

MISCELLANEOUS - ORGANIZATIONAL SURVEY

TESTING

Handwritten memo to Hunter from Bennett regarding "Trip Report -Europe, Jan.

6-20, 1971." Section 2, beginning on p.10, discusses a visit with Lepetit

Pharmaceutical co. in Milano on January 14-15, 1971. Present at this meeting

were Wm. Caldwell, Zeller - Director of Central R&D, Carati - Lepetit legal

counsel, Levier and Bennett. Levier and Bennett also met with Lerner.

CITE: DCC 281011474 - 281011491 (Temporary Dow Corning Bates Numbers 5455 -

5472), Exhibit to Bennett Deposition, Exhibit to Hinman Deposition, Exhibit to

Isquith Deposition, Exhibit to Julius Johnson Deposition, Exhibit to LeBeau

Deposition, and Exhibit to LeVier Deposition. Dow Corning Trial Exhibit List

Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #125

01/26/71

Wayne Koning, Dow Corning, memo to Forrest Stark regarding a returned implant by

Dr. Bankof. Jan Varner reported that this was an "old" style implant and that he

"was able to break through the envelope with minimal effort and perhaps there is

some degradation of the envelope over a period of time."

Koning reports to Stark that "Jan appears to be loosing confidence in the

stability of the envelopes physical properties over an extended period of time

because of frequent comments that are being given recently by large volumes

(sic) users that he calls on." Koning also states that, "The terms, friable,

disintegration and degradation are being used frequently in some areas to

describe the condition of the envelope of removed SILASTIC (R) mammary

prostheses." (emphasis added).

CITE: M 570119. DUPLICATE: KMM 335110 Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #126
03/09/71
COHESIVENESS - LIQUID COMPONENT OF GEL
RUPTURE
TISSUE REACTION

Morgan, Dow Corning, memo to Koning, regarding a complaint made by Dr. Condie concerning the composition of the silicone gel in a ruptured implant. The patient developed a reoccurring infection and staph infection four months post-op with fluid "oozing from the wound." The memo states "the prosthesis was practically empty of gel and what gel was there was extremely fluid and oozed out of the prosthesis and the surrounding tissue.... It appears to me that we have had a gel breakdown but I did not discuss this in any way with Dr. Condie." (emphasis added)

CITE: KMM 423343 - 423344. DUPLICATE: KKA 152366 - 152367; CO 82 - 83. NOTE: Dow Corning was using V. Mueller as its sales agent.

Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #127

05/11/71

KNOWLEDGE OF SYSTEMIC DISEASE

TISSUE REACTION

Dr. Glenn Burt, Department of the Army, letter to Silas Braley, Dow Corning,

reporting on an augmentation patient who "encountered a most traumatic

experience. On the second postoperative day the patient developed a fever which

during the next few days spiked tremendously - as high as 105 degrees - and the

patient went progressively down hill so

that we had to remove the prostheses on the twelfth post-operative day....

During this time she developed an erythematous rash, joint swellings,

considerable weakness, and an enlarged liver, all of which made us feel this was

a rejection type phenomenon." (emphasis added).

CITE: M 240089, Exhibit 46 to Hinsch Deposition (used by Dow Corning), Exhibit

to D. McGhan Deposition, Exhibit 21 to California Braley Deposition, and Exhibit

5 to Harris County Burchiel Deposition. Dow Corning Trial Exhibit List Exhibit

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #128

06/14/71

COHESIVENESS - LIQUID COMPONENT OF GEL

KNOWLEDGE OF SYSTEMIC DISEASE

TISSUE REACTION

Dr. Condie writes to Wayne Koning, Dow Corning, regarding a patient with breast

implants who developed and "allergic reaction in the skin over the right breast,

or an infection in the skin of the right breast. There was slight itching

associated with the condition. This was also associated with some swelling of

the upper lip and it was felt that she might have angioneurotic edema, however,

with antibiotic therapy the cellulitis cleared up. This was approximately 16

days after she was first seen for the condition." Six months later, the right

breast again became red and swollen. Upon aspiration, silicone escaped from the

needle's puncture wound, resulting in wide spread necrosis. The implant was

removed and Dr. Condie noted that "it was extremely difficult to remove all of

the silicone which was flowing and not gel like in consistency." Dr. Condie also

states that the silicone in this case was "extremely watery and flowed very

easily. I cannot help but feel in my own mind that there was something which

caused chemical change in the silicone, making it liquid instead of a gel. The

culture which was taken showed staph coagulasa positive." (emphasis added).

CITE: M 570103 - 570104. DUPLICATE: KMM 98372 - 98373; M 240090 -240091. Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #129

07/07/71

SHELL STRENGTH - THICKNESS

Manikian, Dow Corning, memo to Boone stating that he has accumulated data on the

"long term" stability of the envelope. He refers to three lost of mammaries - 1

from June 1966, 1 from August 1967, and 1 from April 1971. "There are changes in

the physical properties of the bag after filling. Contact with the gel seems to

soften the bag and lessen its tensile strength.... (W)e neither have data on the

properties of a bag immediately after filling nor have in storage a large enough

number of units to perform a controlled study."

CITE: KMM 220303. DUPLICATE: KMM 223111 - 223114.
Dow Corning Trial Exhibit List Abstract

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #130

12/13/71

STERILIZATION/CONTAMINATION

W. Koning memo to Bill Mantle, Dow Corning, which states "Bill, here is another

hairy implant from Jan! Please comment. Too bad they didn't reject before

unsealing the package."

CITE: KMM 423367. Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #131

12/00/71

EMBOLISM

GEL MIGRATION

KNOWLEDGE OF LIQUID SILICONE DANGERS

MISCELLANEOUS - COMPLICATIONS

Publication by Blocksma entitled "Experience With Demethylpolysiloxane Fluid In

Soft Tissue Augmentation." Plastic & Reconstructive Surgery, Vol. 48, No. 6,

564-567. The release of silicone fluid for general distribution could make every

general surgeon think he has become a plastic surgeon overnight. Used

improperly, silicone fluid has a serious potential for harm. Therefore the

author is opposed to the release of this material to any but bona-fide plastic

surgeons at this time.

CITE: DCC 204005370 - 204005374; Exhibit 71 to Braley Deposition, Exhibit to D.

McGhan Deposition, Exhibit 45 to Hinsch Deposition (used by Dow Corning), and

Exhibit 99 to Harris County Rathjen Deposition. Dow Corning Trial Exhibit List

Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #132

00/00/72

MISCELLANEOUS - COMPLICATIONS

TESTING

TISSUE REACTION

Article by Bennett, Gorzinski and LeBeau entitled "Structure-Activity

Relationships of Oral Organosiloxanes on the Male Reproductive System,"

Toxicology And Applied Pharmacology, Vol. 21, 55-67 (1972). The abstract at the

beginning of the article states that:

"A series of low molecular weight organosiloxanes depressed male reproductive

function in the mouse, rat, and rabbit. The rabbit was the most sensitive, and

the mouse was the least. Active compounds were found among

phenylmethyl-substituted silanes, linear disiloxanes, and trisiloxanes; cyclic

trisiloxanes and tetrasiloxanes. Cyclic siloxanes were the most active cyclic.

Monophenylheptamethylcyclotetrasiloxane was quite active; however, the presence

of an additional phenyl group enhanced activity providing the 2 phenyl groups

had the correct sterile configuration, i.e.,

2,6-cis-diphenylhexamethylcyclotetrasiloxane....

A spectrum of activity was noted in the male animal when active compounds were

administered po for 3-21 days. Small doses sequentially decreased seminal fluid,

seminal vesicle, prostate and testes weight, associated with decreased blood

levels of testosterone. Large doses caused adrenal hyperplasia, hepatomegaly,

decreased body weight, and decreased serum levels of cholesterol, phospholipids,

and alkaline phosphatase."

CITE: DCC 281000743 - 281000755. WITNESS: Bennett (Authenticated in Bennett,

Vol. II, p. 547-548). DISPOSITION: Admitted in Toole (II) v. Baxter Healthcare.

Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #133

04/00/72

FRAUD/MISREPRESENTATION

Dow Corning advertisement: "The Silastic Mammary Prosthesis makes a world of

difference." Over the past ten years "we have initiated 207 rigid quality

control tests to assure the reliability of every prosthesis manufactured. We

have continued to make significant design improvements. It is simply the most

reliable answer to breast augmentation and restoration following subcutaneous

mastectomy."

CITE: M 700010. DUPLICATE3: KKH 62691; KKH 62692; M 370064; M 370065; M370106; M 370123: M 700011. Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #134

04/07/72

GEL MIGRATION

"Dimethylpolysiloxane Fluid 14C (Dow Corning 260 Medical Fluid 14C) Distribution

and Disposition In Rats Following Subcutaneous Injection," by LeBeau and

Gorzinski of the Research Department of DC. A copy was sent to Ryan, Bennett,

Braley, Hunter, Isquith, Frye, LeVier, Speier, Stark, Boley and others. DC 360

fluid was administered subcutaneously to rats to measure the distribution of the

fluid in expired air, urine and feces at 8, 30, 60 and 90 days. The highest

percentage (.94%) was detected at the original injection site <10% was detected

in urine and feces. "There was a ubiquitous distribution of low concentrations

of radioactivity in the tissues and organs (<.02%). However, lymphatic tissue

near the injection site had a higher (ten-fold) concentration of radioactivity

of all tissues and organs examined suggesting migration via lymphatic routes."

Rodents receiving massive subcutaneous doses of silicone fluid were examined

histopathologically. Droplets of vacuoles were found throughout the

reticuloendothelia systems including the regional lymph nodes and extending to

the liver, spleen, kidneys and adrenals. Definitive proof of silicone fluid in

the droplets was not demonstrated but the authors assumed it was silicone fluid.

CITE: KMM 260056 and KMM 270609 - 270623, Exhibit to Bennett Deposition (used by plaintiffs and Dow Corning), Exhibit to Isquith Deposition, Exhibit to K. Olson

Deposition, and Exhibit 3 to Harris County Rathjen Deposition. NOTE: The exhibit

list also lists Bates Numbers T 2765 -2780 but there are no documents in the

binder with these numbers. DUPLICATE: DCC 205001829 - 205001841; KMM 173800 - 173816; DCC 204004553 - 204004580; Dow Corning Trial Exhibit List Abstract

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #135

04/24/-26/72

TESTING

FRAUD/MISREPRESENTATION

Article entitled, "Toxicological Studies, quality control, and efficacy of the

Silastic mammary prosthesis" is published in the journal Medical

Instrumentation. Authors are Gordon Robertson and Silas Braley of Dow Corning.

The article cites and discusses the FDRL Report on "Two-Year Studies With

Miniature Silastic Mammary Implants" (P 017460 - 017496). Robertson and Braley

reprint the 6 month test results in Medical Instrumentation and claim that these

are the results after 2 years of implantation.

CITE: F 12 - 26, Exhibit to Palensky Deposition, Exhibit 19 and 20 to California

Braley Deposition, and Exhibit to LeVier Deposition. DUPLICATE: KMM 249816 -

249822, J 5223 - 5226. Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #136

05/04/72

TISSUE REACTION

SHELL STRENGTH - THICKNESS

KNOWLEDGE OF GEL BLEED

GEL MIGRATION

ACKNOWLEDGEMENT OF NEED FOR TESTING

KNOWLEDGE OF LIQUID SILICONE DANGERS

Silas Braley, Dow Corning, letter to Dr. Douglas Lake expressing his

reservations about the use of silicone to fill inflatable implants. He states:

(T)here is a very good reasons for this: the silicone fluid being of the same

basic nature as the silicone polymer used to make the rubber will dissolve into

the rubber and very seriously weaken and soften it... Another factor which must

be taken into consideration if a silicone fluid is used to fill a silicone

rubber bag, is that the outer surface of such a bag will become oily with the

silicone fluid. This means that the fluid is now capable of being absorbed by

the body and very extensive toxicological work would have to be done to prove

that this is not deleterious to the tissues.... We rejected the silicone fluids

for the above reasons and went immediately to silicone gel. (emphasis added).

CITE: KMM 141906 - 141907, Exhibit 32 to California Braley Deposition.


Document #137

07/14/72

KNOWLEDGE OF SYSTEMIC DISEASE

MISCELLANEOUS - COMPLICATIONS

TESTING

TISSUE REACTION

Dow Corning Research Report No. 4006 (formerly classified) entitled "A

Toxicological Evaluation Of Trimethylsilanol (Me3Si(OH2) In The Rat." The

authors postulated that two potential end products of the biological degradation

of trimethyl en-blocked linear dimethylpolysiloxane polymers or cyclic

dimethylpolysiloxane polymers might to Me3SiOH and Me2Si(OH)2. Other studies are

currently underway at Dow Corning's Biomedical Research Department to determine

the potential for degradation of dimethylpolysiloxan polymeric species. (p. 4)

The authors conclude that there were no significantly different dose-related

values for body weight, food consumption, hematology or organ weight ratios for

liver, kidneys, adrenals, heart or gonads. There did appear to be a modest

dose-related significant elevation of blood glucose in the Me2Si(OH)2 treated

rats. There may also be a slight depression of the triglyceride blood level at

the low dose of Me3SiOH and total lipid is at the low level of normality for

this group as well. (p. 13)

CITE: DCC 281001689 - 281001726 (Temporary Dow Corning Bates Number 3424 -

3461), Exhibit 49 to Bennett Deposition (used by Dow Corning), Exhibit to Frye

Deposition, and Exhibit to Isquith Deposition.
Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #138

08/18/72

MISCELLANEOUS - COMPLICATIONS

SILICA

TESTING

TISSUE REACTION

Robert LeVier and Michael Jankowiak, Dow Corning, report on "The Effects of 20

CS DC-360 Fluid And Related Linear/Cyclic Dimethylpolysiloxanes Administered

Orally And Dermally For Four Weeks To Male And Female Rats On Whole Body Oxygen Consumption, Serum Total Cholesterol, Organ Weights, And Silicon Distribution." There was increase in tissue thyroid weight; potential of accumulation

increasing cholesterol; and slight increases in silicone levels for heart,

serum, urine, liver and thyroid. In addition, the female rat appeared to

accumulate more silicone than did the male rat.

CITE: DCD 154000169 - 154000188, Exhibit to Bennett Deposition. NOTE: The

exhibit list identified this document as T20844 - 20863.
Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #139
10/17/72
COHESIVENESS - LIQUID COMPONENT OF GEL
RUPTURE
SHELL STRENGTH - THICKNESS

Dr. Gregory letter to Rathjen regarding an implant he ruptured unknowingly during surgery. Three months after implantation, the patient experienced redness on her breast and perforation of the skin with the implant protruding outside and "Gel dripping out of the hole." He says that this "may be a blessing in disguise, because perhaps we have all been trying to make too soft and too fragile an envelope. I do not believe that the old envelope would have perforated as easily as this one did with the mosquito hemostat. Perhaps the viscosity of the Gel may have to be reconsidered in view of this particular type complication."
CITE: KMM 54876 - 54877, Exhibit 9 to Harris County Rathjen Deposition, and Exhibit to MDL Rathjen Deposition. DUPLICATE: B 949 - 950.
Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #149
05/02/73
SHELL STRENGTH - THICKNESS
RUPTURE

Gary Corbeill, Reliability Engineer for Dow Corning, analyzes a Silastic Round implant returned by Drs. Terino and Sengleman to Bill Mantle, who in turn sent them to Art Rathjen. Corbeill states that, "Due to their thin 'skin' these mammaries are delicate and will rupture when subjected to undue pressure." (emphasis added).
CITE: CR 160 - 161. NOTE: Bill Mantle is the sales representative for the Los Angeles area.
Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #150

05/22/73

ACKNOWLEDGEMENT OF NEED FOR TESTING

KNOWLEDGE OF SYSTEMIC DISEASE

Dow Corning Bioscience Research Laboratory "Research Project Description"

entitled "Exploratory Antigen Modification," prepared by Dr. Isquith of Dow

Corning. It was later re-titled "Silicon-containing Antigens." The objective is

"To determine the capability of organosiclicon-midified antigens to stimulate or

reduce immunogenic response." Isquith suggests a direct modification of antigens

by chemical attachment of low molecular weight organosilicon moieties" as an

alternative to other antigens (such as peanut oil) which cause adverse health

effects. (KMM 546449) He states that, "This project is aimed at examining the

effect, if any, of silicon-modification on known antigens. The value will be in

the immuno-therapeutic valve of the modified effects. An increase or decrease in

antibody synthesis, caused by antigen modification, may be desirable." (KKM

546453)

CITE: KMM 546448 - 546453, Exhibit to Bennett Deposition, Exhibit to Blocksma

Deposition (used by Dow Corning), Exhibit to Radonovich Deposition, Exhibit to

Isquith Deposition, Exhibit to Tyler Deposition, Exhibit to Boley Deposition,

Exhibit to LeVier Deposition, and Exhibit to Lake Deposition. This document also

has the Bates Number KMM 491075A - 491080A on it. WITNESS: Bennett

(Authenticated in Isquith, Vol. II, p. 355: 1-6 and 357: 13- 16). DEPOSITION:

Not introduced in Toole (II) v Baxter Healthcare.
Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product Privileged & Confidential

Document #151

06/00/73

COHESIVENESS - LIQUID COMPONENT OF GEL

ACKNOWLEDGEMENT OF NEED FOR TESTING

GEL MIGRATION

Dow Corning Bioscience Research Laboratory "Research Project Description:

entitled "Bioscience Research Support Project - Systemic Migration Of Prosthetic

Gel In The Rhesus Monkey." This cooperative project between Dow Corning's

Medical Products Business and Dr. Gerow will "to examine the efficacy of using

the gel as an injection or implantation for mammary augmentation. This project

is designed to examine the potential of gel components to migrate systemically

from the site of instillation." (DCC 16001066) "The gel is a complex mixture of

which the low molecular weight fraction (up to 1% w/w of the gel; 330 Fluid) is

assumed to offer the greatest potential for migration. Present data acquired in

rats indicate that such low molecular weight components tend to appear in depot

fat and lymph nodes and that maximum tissue concentrations are attained shortly

after instillation.... The relative contribution of the various routes of

elimination may include the lung, kidneys and liver based on the elimination of

orally administered permethylated cyclic tetramer...." (DCC 16001066)

None of the data to be gathered will allow definition of the structural types

that may migrate. The 330 Fluid fraction components of the gel "are the most

likely candidates ... (so) it may be advisable to repeat the study with a gel

formulation containing a minimum of low molecular weight linear and cyclic

siloxanes."

CITE: DCC 16001066 - 16001068, Exhibit to Bennett Deposition. WITNESS: Bennett

(Authenticated in Bennett, Vol. II, p. 546: 12-23). DISPOSITION: Admitted in

Toole (II) v. Baxter Healthcare. Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #152

06/00/73

ACKNOWLEDGEMENT OF NEED FOR TESTING

GEL MIGRATION

Dow Corning Bioscience Research Laboratory "Research Project Description"

entitled "Metabolism of Organosilicon Compounds." The objective is to "study

systematically the absorption, distribution, storage, metabolism and elimination

of those organosilicon structures forming the bases of silicon chemistry as

exploited by Dow Corning." (DCC 016001081) "There have been no systematic

explorations of the metabolism of classes of organoxilicone compounds. Such

explorations are necessary for their predictive value in selecting and

developing efficacious biological applications.... A few of the current projects

now requiring an understanding of metabolic potential include:

1. In vivio disposition of low molecular wt. linear/cyclic permethylated and

hydroxylated siloxanes in the breast prosthetic gel. (DCC Compounds to be

evaluated in the rhesus monkey include cyclic and linear D3 through D5.

CITE: DCC 16001081 - 16001083, Exhibit to Bennett Deposition. WITNESS: Bennett

(Authenticated in Bennett Depo., Vol. I p. 254-257). DISPOSITION: Admitted in

Toole (II) v. Baxter Healthcare. Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #153

06/00/73

ACKNOWLEDGEMENT OF NEED FOR TESTING

KNOWLEDGE OF SYSTEMIC DISEASE

Dow Corning Bioscience Research Laboratory "Research Project Description"

entitled "Silicon Adjuvants." The objective is to "investigate the action of

silicon compounds on the humoral and cellular immune response." (DCC 16001092)

"Substances which are non-immunogenic or only slightly immunogenic can often be

made strongly immunogenic by simultaneous administration with adjuvants." (Id.)

Because of the drawbacks with presently known adjuvants, research will determine

if the cellular or humoral response can be selectively enhanced through the use

of organosilicon compounds.

CITE: DCC 16001092 - 16001093, Exhibit to Bennett Deposition (used by plaintiffs

and as Exhibit 83 by Dow Corning), Exhibit to Boley Deposition, Exhibit to

Isquith Deposition, and Exhibit to MDL LeVier Deposition. WITNESS: Bennett

(Authenticated in Boley, Vol. I p. 141-143 and 153: 19 - 154:12).

DISPOSITION: Admitted in Toole (II) v. Baxter Healthcare.
Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #154

06/09/73

KNOWLEDGE OF LIQUID SILICONE DANGERS

MISCELLANEOUS

MISCELLANEOUS - SALES

Telephone call report by Braley with Dr. F. McDowell with copies to Rathjen,

Stark and Bennett regarding Bromley Freeman's paper on the use of free gel

implantation. "I explained Dow Corning's great concern with this situation and

that we had finally gone to outside counsel in Washington for advice. The

situation is serious enough that we are going to considerable length to notify

all persons that the breast implant is not to be cut open. The outside counsel

has felt that the FDA could interpret this used as a drug being furnished in a

very elaborate package, and could thus eliminate all beast implants of any

kind."

Dr. McDowell suggested getting an injunction against the FDA concerning the

injection program. Braley explained the "impossibility" of this and said that DC

does not have sufficient information to give to the FDA yet.

CITE: KMM 112207 - 112208, Exhibit to MDL Rathjen Deposition.
Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #155

06/16/73

ACKNOWLEDGEMENT OF NEED FOR TESTING

COHESIVENESS - LIQUID COMPONENT OF GEL

KNOWLEDGE OF SYSTEMIC DISEASE

Dow Corning bioscience Research Laboratory "Research Project Description"

entitled "Exploratory Hapten Modification." The objective is to "determine the

antigenic (haptenic as well as conjugate) capability of organosilicones of

various molecular weights and to explore their potential use as biological

tracers." (KMM 546454) Among the organosilicon compounds to be examined for

determination if they function as conjugates or complete immunogens are

dimethylpolysiloxanes. Research in this area will most certainly advance our

knowledge of the chemical reactions of organosilicone compounds to biological

chemicals.... The development of specific antibody in response to organosilicon

determinant groups would provide us with an exquisitely sensitive biological

tracer for detecting distribution and storage of organosilicones in the body."

(KMM 546455)

CITE: KMM 546454 - 546465, Exhibit to Bennett Deposition, Exhibit to Isquith

Deposition, Exhibit to Boley Deposition, Exhibit to LeVier Deposition, and

Exhibit to Lake Deposition. This document also has Bates Numbers KMM 491081A -

491083A on it. WITNESS: Bennett (Authenticated in Isquith, Vol. II, p. 378:21 -

379;16).

DISPOSITION; Admitted in Toole (II) v. Baxter Healthcare.
Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #156

6/19/73

KNOWLEDGE OF LIQUID SILICONE DANGERS

Joe Radqius, Dow Corning Food and Drug Counsel, memo to numerous Dow Corning

employees regarding "misuse of the Silastic Mammary Prosthesis." Radzius states

that, "we are now aware of isolated instances where

physicians are purchasing the Mammary Prosthesis and removing the gel from it

for subsequent implantation." (Kmm24296 - 242499). He recommends a warning be

put on the data sheets and information brochures. "If the matter is not given

our immediate attention, and if the practice continues, Dow Corning may have no

alternative but to remove the product from the market because of potential

liability."

CITE: KMM 242496 - 242499, Exhibit to Mantle Deposition, Exhibit 92 to Harris

County Rathjen Deposition, Exhibit to MDL Rathjen Deposition, and Exhibit to

Venn Deposition. DUPLICATE: OOM 880025 - 880027.
Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #157

08/00/73

SHELL STRENGTH - THICKNESS

Dow Corning mammary envelopes are in short supply. There are high losses at the

dipping machines for tears and poor release from the mandrels. The reject rate

at the dipper is in the range of 50%.

CITE: KMM 220138 - 220147. Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #158

08/01/73

GEL MIGRATION

KNOWLEDGE OF GEL BLEED

SHELL STRENGTH - THICKNESS

Study by Alcott titled "Physical Comparison Between Camp External Mammary

Prosthesis and Dow Corning Silastic External Mammary Prosthesis." The Camp

"Symmetry", external mammary prosthesis was found to be a tough, somewhat

unyielding prosthesis. A good fabrication system is used with good results. No

migration of silicone oils through the envelope is likely since the envelope is

not a silicone rubber. The envelope may resist body fluid and odors better than

silicone rubber. Camp's advertisement is quite misleading since it implies that

the same materials are used in implants.

CITE: KMM 354646 - 354651, Exhibit to Tyler Deposition.
Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #159

09/18/73

FRAUD/MISREPRESENTATION

CONCEALING FROM FDA

Art Rathjen, Dow Corning, memo to numerous Dow Corning employees regarding

"Precise Choice of Words/Accurate Written Reports When Returning Unusable

Or/Remove Mammary Implants To Quality Assurance." Rathjen discusses recent trip

reports which used the word "reject" when referring to a physician's use of the

Silastic. Other words or phrases sales person use which Rathjen does not like

include "faulty product," "faulty," and "defective." Words like this "are

imprecise and could be damaging to Dow Corning if they are used incorrectly when

repeating a condition or a set of circumstances.... If a patient elects to file

a lawsuit against the surgeon or Dow Corning, the patient's lawyers have a right

to review our written files. Our files must be disclosed and the attorneys are

entitled to use our records as evidence to try and prove their case against us."

(emphasis in original).

CITE: KMM 243010 - 243015, Exhibit to MDL Rathjen Deposition, Exhibit 4 to

Hinsch Deposition, Exhibit to Mantle Deposition, and Exhibit 62 to Harris

Country Rathjen Deposition. DUPLICATE: M 880016 - 880018; DCC 24000537 -

24000542; OOM 880016 - 880018. Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #160

10/00/73

ACKNOWLEDGEMENT OF NEED FOR TESTING

KNOWLEDGE OF SYSTEMIC DISEASE

MISCELLANEOUS - COMPLICATIONS

MISCELLANEOUS - ORGANIZATIONAL SURVEY

TESTING

TISSUE REACTION

Publication by Rowlett, Nichols, Bailey and Dion titled "Silicones -Can They

Further Improve The Quality of Life?," Dow Corning News, Vol. 15, No. 4, Sept. -

Oct. 1973. Includes a description of the Bioscience Facility, the History of

Bioscience activity at Dow Corning. States that 2,6-cis can alter their behavior

of the pituitary, the master gland that chemically controls the function of all

the other glands in the body. Describes Bioscience research as

opportunity-oriented or for developing profit making products.

CITE: DCC 282001118-282001149, Exhibit to Bennett Deposition, Exhibit to

Petraitis Deposition, Exhibit to Tyler Deposition, Exhibit to Boley Deposition,

and Exhibit 1 to Randonovich Deposition. DUPLICATE: LAK 1 - 11.
Dow Corning Trial/Exhibit List Abstracts

PENDLETON/;PSC Attorney Work Product/Privileged & Confidential


Document

10/08/73

(NOT LISTED ON PLAINTIFF'S EXHIBIT LIST)

Memo from Lake and Ng, Dow Corning, to Isquith and Bennett regarding

"Experimental Activities in the Virus and Cell Biology Section of Microbiology

1973-1974." The laboratory is now functional to analyze metabolism of cell

cultures, cytogenetics, serology, ultracentrifugation, chromatography,

electrophoresis, and fluorescent, phase and light microscopy. "The broad focus

of our mission is to circumscribe those areas in the total realm of virus and

cell biology where organosilicon entities manifest exploitable biological

activity. Antimetabolite, virucidal, antiviral, interference inducing, or

cytostatic activities are being sought." (LAK 12) Anticipated areas of research

include:

A. Endogenous Si and exogenously applied silicates: The notion that endogenous

Si and trace quantities of Si play a role in atherosclerosis, connective tissue

structure and function, mammalian cell aging, and lymphocyte transformation has

prompted interest in this area. (LAK 14)

B. Research will also be conducted on new agonists and chemotherapeutic agents

with selected groups of organosilicon compounds. Activities that will be

monitored include viral interference induction (interferon), antiviral activity

against 4 RNA and 4 DNA viruses, modification of cell growth kinetics and

modification of cultural characteristics.

C. Also, the authors seek to establish a method to measure the response and

processing of fluids resins and silastic materials in macrophages. (LAK 14)

CITE: LAK 12 - 15, Exhibit to Bennett Deposition, Exhibit to Lake Deposition,

and Exhibit 1 to Radonovich Deposition. WITNESS: Bennett (Authenticated in Lake,

Vol. 11, p. 306:19-23). DISPOSITION Not introduced in Toole (II) v. Baxter

Healthcare. Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #161

12/04/73

MISCELLANEOUS - SALES

Art Rathjen memo to numerous Dow Corning Employees informing them of an "Album

For Clinical Photographs, Silastic Mammary Prostheses." This album is later used

by sales persons.

CITE: DCC 24000523 - 24000524, Exhibit 23 to Harris County Rathjen Deposition,

Exhibit to MDL Rathjen Deposition. NOTE: See 12/13/73. DUPLICATE: DCC 266000237.

Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #162

12/13/73

MISCELLANEOUS - SALES

Maurice Popple memo to Art Rathjen, both of Dow Corning, stating, "Art, I am in

receipt of your pornographic picture album and think it's a great idea. As you

are aware, salesmen spend long weeks away from home and such an album is a

comfort to take along. I am awaiting with adrenalized anticipation the next

batch of photos .... Anyhow, I have always considered myself a leg man so I

don't claim any special expertise (sic) in the subject area."

CITE: KMM 46084, Exhibit 24 to Harris County Rathjen Deposition, Exhibit to MDL

Rathjen Deposition. NOTE: See 12/04/73. DUPLICATE: DCC 24000967.
Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #163

01/22/74

ACKNOWLEDGEMENT OF NEED FOR TESTING

COHESIVENESS - LIQUID COMPONENT OF GEL

MISCELLANEOUS - COMPLICATIONS

STERILIZATION/CONTAMINATION

TESTING

TISSUE REACTION

Abbott memo to Stark with copies to Bennett, Larson, Rathjen and Robertson

regarding "Summary of Gel Review Meeting, January 16, 1974." All of the gel

samples except X-30885 showed a reaction when implanted in rabbits at

Huntingdon, suggesting that some gel samples may not be properly cured and

"will, therefore, show a reaction." Also, he recovered the volatiles from the

gel which consisted of cyclic pentamer and constituents larger than pentamer.

Many gel samples tested are "highly contaminated with bacteria. Also the samples

that gave a reaction at IBT were found to be contaminated. The number of

organisms is so high that the antibiotics in the tissue culture medium will not

control them There is a possibility that the organisms involved are resistant to

the antibiotics which are in the medium. In a recent study in our laboratory, it

was found that S. auras (gram positive) can survive in mammary gel for approx.

120 days. Because of this data, we would like to isolate and identify the

bacterial that are present in the gel."

CITE: T 21169 - 221172, Exhibit to Harris Country LeVier Deposition and Exhibit

to MDL Rathjen Deposition. Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #164

01/23/74

KNOWLEDGE OF SYSTEMIC DISEASE

TESTING

Boley and LeVeir memo regarding organosilicon immunopotentiators. Forty-eight

silicon-containing compounds were examined in guinea pigs for their ability to

enhance serum antibody levels. Nine of the compounds showing high enhancing

activity were further evaluated in a rat model. Of the nine, four prolonged and

enhanced serum antibody levels.

CITE" DCC 281061454 - 281061486 (Temporary Dow Corning Bates Numbers
16362 - 16377), Exhibit to Bennett Deposition, Exhibit to Lake Deposition, Exhibit to

LeVier Deposition, and Exhibit to Isquith Deposition. Dow Corning Trial Exhibit

List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #165

02/18/74

SHELL STRENGTH - THICKNESS

Tom Talcott, Dow Corning, memo to Boone, Stark, Ringey, Hoyt, Houle, Polmanteer,

and Brodhagen regarding "Control of the Aesthetic Character of our Soft Contour

Mammary Prosthesis." Talcott states:

Some of us have felt for some time that we need to do much better on envelope

thickness control for the round prosthesis. Gel control maybe also, but this is

another separate subject. Envelope thickness control appears even more important

in the soft contour product line. This is because of the general shape of the

product. The envelope if too thin can be extended and/or sag, allowing the peak

of the projection to be grossly underfilled. There are also some severe

irregularities in the tooling for this product line that contribute to the

problem in certain sizes.

CITE: KKM 21110. Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document

03/00/74

(NOT ON PLAINTIFF'S EXHIBIT LIST)

Handwritten document produced by Dow Corning synopsizing three classified Dow

Corning reports: 1) Lake, Isquith and Bennett report "Status of Biological

Testing of Sila-adamantoner compounds, Dow Corning Internal Report 4234"; 2)

Lake, Schultz, Radonovich, Dittenber and Kociba report "Joint Research Contract

Report, February 197_, Evaluation of the Syrian hamster fibroblast system for

direct and host-mediated carcinogen bioassays"; and 3) Lake, Radonovich and

Boley's 1975 report "Immunopotentiating activity of dimethylpolysiloxanes and

phenylmethylpolysiloxanes. In preparation for submission to Infection &

Immunity." The note states that patent memos have been submitted on antigen

modification, immunopotentiators, and silicone substitutes for tissue culture.

CITE: LAK 133. Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/privileged & Confidential


Document #166

04/10/74

SHELL STRENGTH - THICKNESS

J.L. Boone, Dow Corning, memo to Hoyt, Talcott, Emmons, Polmanteer and Ringey

regarding production analysis for 1973-74. He chronicles problems during 1973

consisting of gel shipments, gel yellowing and platinum level adjustments,

extraordinary high tear losses, reject rates as high as 50% in some months,

contamination with "lemon-scented I.P.A.," and irregular thickness in envelopes

which cause a loss of 10,000 bags and a 10% breakage rate. During 1974, Dow

Corning experienced "extraordinarily high reject rates" with yields of

approximately 20-35% of the actual output. Reject losses were heavy at every

step and particularly at dipping and placing.

Boone states that the fixation patch on the envelope "covered up air bubbles and

other flaws that will reject the NFP style." Manufacture of the NFP mammary

requires considerably more skill and diligence. This is a "permanent problem

inherent in the design...." (emphasis added).

CITE: KMM 220138 - 220147. Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #167

06/11/74

KNOWLEDGE OF LIQUID SILICONE DANGERS

TESTING

Memo from Hobbs, Dow Corning, to Needleman about a study of DC 200 fluid

injected intravenously in rabbits. Seventeen of the twenty eight rabbits tested

died during the study probably due to lung, liver and kidney congestion.

CITE: FDA 27196 Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #168

06/28/74

KNOWLEDGE OF SYSTEMIC DISEASE

MISCELLANEOUS - COMPLICATIONS

TESTING

United States Patent No. 3,821,373 for "Organosilicon Compositions In Methods Of

Treatment Involving Increasing The Dopamine Content Of The Brain" granted to

Donald R. Bennett and Robert R. Levier of Dow Corning. The patent is for the

method by which the dopamine content of the brain is increased by administering

2,6-cis. The purpose of this is to alleviate some of the symptoms caused by

Parkinsonism, manganese poisoning, and similar diseases.

CITE: DCC 281001098 - 281001100, Exhibit 3 to Isquith Deposition, Exhibit 70 to

Bennett Deposition (used by Dow Corning). and Exhibit to LeVier Deposition. Dow

Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #169

08/20/74

MISCELLANEOUS - COMPLICATIONS

TESTING

TISSUE REACTION

Patent No. 3,830,912 for a method for decreasing the reproductive function of

mammals by Bennett and McHard, A method for altering the reproductivity function

of mammals by administering a pharmacologically effective amount to certain

organosilicon compounds. As a means of illustration, one can orally or

parenterally administer from 1.0 gn. To 5000 mg. per kilogram of body weight or

an organosilicon compound thereby rendering the subject infertile.

CITE: DCC 281061389 - 281061395, Exhibit 71 to Bennett Deposition (used by Dow

Corning). Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #170

08/21/74

MISCELLANEOUS - ORGANIZATIONAL SURVEY

Bennett memo to Tyler regarding technology generation and patents. Crises

primarily initiate needed technological change in biological affairs rather than

long range planning. Bioscience Research has a better credibility and interface

with outside biological businesses that it often has within Dow Corning.

Consensus between Dow Corning Legal and Federal Regulatory Agencies regarding

all biomedically-related activities and products should exist rather than the

current practices such as guarded "win-no lose" or compromise mechanisms.

CITE: LAK 62 - 64, Exhibit to Bennett Deposition and Exhibit to Tyler

Deposition. Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/ Privileged & Confidential


Document #171

09/23/74

KNOWLEDGE OF LIQUID SILICONE DANGERS

Frisch, Dow Corning, letter to James McDonough, Department of the Army,

regarding his letter of 09/12/74. Frisch states, "I want to emphasize that we do

not recommend implantation of the gel except when fabricated in devices with

intact silicone elastomer capsule."

CITE: DCC 240000861 - 240000862. Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #172

09/30/74

MISCELLANEOUS

TESTING

Bennett memo to Bennett, Hobbs, Larson, Radzius and Stark regarding the product

safety committee meeting. Handwritten note to complete gel chg. (Mam) and the

Lake transformation screen.

CITE: DCC 281061484. Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #173

09/30/74

MISCELLANEOUS - COMPLICATIONS

Bioscience Research Quarterly Status Report - July 1 - September 30, 1974. There

are reports on 2,6-cis and KABI; Microbiology's work on biodegradation, the

environmental effect on soil microflora, antimicrobial surface treatment,

nonabsorbable antimicrobials, development of carcinogen bioassay - "Dow Chemical

has yet to indicate the extent to which they will support this project," antigen

modification, and modulation of interferon response - "Four compounds ...

(Me2Si0)4 (and others) have been shown by W. Boley to have immune adjuvant

activity and are also being examined for their ability to potentiate IF

induction." (LAK 56). Under Plant Sciences, there are reports on

antitranspirants, large tree transplanting, cherry cracking, hormonal -

siloxqane diols could retard opening of flower and leaf buds, insecticide -

"previous information on spider-mite, mealy-bugs and aphids has been confirmed

and extended. Additional work has been done on mosquito larvae, tomato hornworm

and potato beetle, for all of which DC 200 fluid is effective, and on white fly

and ladybird larvae, which are not harmed by the fluid." (LAK 58). Under

Environmental, there is a report on the Idaho project - silicon analysis of

foliage, soil and water samples: and the Salzburg Road project - spills of

silicone fluids on soil to look at plant damage, effects on flowering and effect

on percent coverage of the plant species.

CITE : LAK 53 - 59, Exhibit to Blocksma Deposition (used by Dow Corning),

Exhibit to Bennett Deposition, Exhibit to Isquith Deposition, Exhibit to

Weyenberg Deposition, Exhibit 9 to Harris County Gehring Deposition, Exhibit to

Tyler Deposition, Exhibit to Ryan Deposition, Exhibit 5 to Lake Deposition (used

by Dow Corning), and Exhibit to LeVier Deposition. WITNESS: Bennett

(Authenticated in Bennett, Vol III, p. 749-750).

DISPOSITION: Not introduced in Toole (II) v. Baxter Healthcare.
Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #174

10/02/74

KNOWLEDGE OF SYSTEMIC DISEASE

TESTING

Dow Corning Bioscience Research Report No. 4319 by Boley and LeVier, Dow

Corning, entitled "Immunological Enhancing Activity Of Organosilicon Compounds

And Non-Functional Fluids." Forty-nine (49) silicon-containing compounds were

examined in guinea pigs to screen for "potential adjuvant activity." Nine

compounds showing "good antibody producing activity" were evaluated for their

ability to enhance serum antibody levels. Four compounds including (Me2Si0)4

showed good adjuvant activity. Dow Corning plans future work to evaluate these

four compounds for their ability to enhance the antibody response to viral,

bacterial and soluble proteins antigens.

Organosilicon compounds can stimulate the immune response. No information is

currently available about the mechanism of action of these compounds.

CITE: T 21287 - 21304, Exhibit to Dillon Deposition, Exhibit to Frye Deposition,

Exhibit to Bennett Deposition, Exhibit 14 to Edwards Deposition, Exhibit to

Isquith Deposition, Exhibit to Harris County Klykken Deposition, Exhibit to

LeVier Deposition, Exhibit to Lynch Deposition, Exhibit to Lake Deposition,

Exhibit to D. McGhan Deposition, Exhibit to Palensky Deposition, Exhibit to

Weyenberg Deposition, Exhibit to Compton Deposition, Exhibit 3 to Harris County

LeVier Deposition, Exhibit 18 to Zimmer Deposition, Exhibit to Boley Deposition,

Exhibit 1 to Harris County Boley Deposition; Exhibit to Hudson Deposition,

Exhibit 23 to Harris County Rich Deposition, Exhibit to Harris County Burda

Deposition, Exhibit to Frisch Deposition (used by Dow Corning), Exhibit to

Oppelt Deposition Exhibit to Peters Deposition, Exhibit 10 to California Braley

Deposition; Exhibit 1 to Dallas Espinoza Deposition, Exhibit to Radonovich

Deposition, and Exhibit to Harris County Tyler Deposition. DUPLICATE: This was

originally listed as P 14028 - 14046 on the exhibit list; DCC 80061481 -

80061530: F 86 - 103; DCC 281001575 - 281001589. WITNESS; Bennett (Authenticated

in Boley, Vol. I, p. 155:4-24).

DISPOSITION: Admitted in Toole (II) v. Baxter Healthcare.
Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document (Not Listed)


(Note: this is not numbered but is between 174 & 175)

10/21/74

(NOT ON PLAINTIFF'S EXHIBIT LIST)

Memo from G. Robertson, Dow Corning, to Bennett, Bennett, Hobbs, Radzius and

Stark with copies to Brodhagen and Larson regarding "Minutes of Product Safety

Committee Meeting, October 11, 1974." They discussed proposed changes for

mammary gel including using 360 fluid rather than 330 fluid (DCC 267380231).

CITE: DCC 267380231 - 267380234 (page 2 is missing). NOTE: This document also

has Bates Numbers QDC 118693 - 118696 and MM 220066 - 220069 on it

WITNESS: Bennett (Authenticated in Bennett, Vol. IV, p. 954-968).

DISPOSITION: Admitted in Toole (II) v. Baxter Healthcare.
Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #175

11/22/74

ACKNOWLEDGEMENT OF NEED FOR TESTING

MISCELLANEOUS

Stark memo to Frisch, Rathjen & Talcott with copies to Hoyt and Nelson regarding

"Capsular Contracture Studies." Stark writes, "THE WELL IS DRY! we cannot give

financial support for more studies of capsular contracture in '74 and '75 ... I

think our future role in these studies should be to provide input on the

technology of silicones and to provide samples of materials."

CITE: M 190131, Exhibit to MDL Rathjen Deposition. Dow Corning Trial Exhibit

List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #176

11/26/74

KNOWLEDGE OF LIQUID SILICONE DANGERS

TISSUE REACTION

Silas Braley, Dow Corning, telephone call report of his conversation with Dr.

Charles Vinnik. Braley states:

" Dr. Vinnik then launched into a very extended discussion of how terrible he

thinks the silicone fluid injections are and the fact that it is going to mean

the financial ruin of Dow Corning if we ever get it approved by the FDA. He said

that he had just treated the wife of a doctor from Saginaw who had obtained pure

#360 medical fluid directly from a friend at Dow Corning in the days before it

was restricted. She had exactly the same typical inflammatory and foreign body

reaction that the patients he had seen from Kleifgen and Dr. Haines in Las

Vegas. He said he has seen some good results in the face and thinks this is put

in in (sic) tiny amounts and in a highly vascular area, but to put it into other

areas of the body, he feels is catastrophic. He said he is going to do

everything he can to prevent this from ever becoming cleared until further work

has been done. He has gone to Senator Cannon and to the FDA commissioner to

protest the clearance of the IND. He states that he will offer himself as an

expert witness against anybody who chooses to use it in the future. (emphasis

added).

CITE: DCC 240000051, Exhibit 35 to California Braley Deposition.
Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #177

00/00/75

KNOWLEDGE OF SYSTEMIC DISEASE

TESTING

Abstract of Lake, Radonovich and Boley report entitled "Potentiation of

Endotoxin Induced Interferon In Mice Treated With Octamethylcyclotetrasiloxane."

D4 increases serum interferon levels in mice induced with bacterial endotoxin,

apparently potentiating production of "early" interferon induced by endotoxin

but not viral-induced "late" or "virus-type" interferon. Forty-eight hours after

intraperitoneal inoculation, mice exhibit weight loss, decreased spleen/liver

weight ratio, decreased in vivo carbon clearance and peritonial monocytosis.

CITE: LAK 65 - 66A, Exhibit to Bennett Deposition, Exhibit to Lake Deposition,

Exhibit to LeVier Deposition, and Exhibit 1 to Radonovich Deposition. NOTE: See

entry dated 10/30/75.

DUPLICATE: DCC 281061469 - 281061470.

WITNESS: Radonovich.

DISPOSITION: Admitted in Toole (II) v. Baxter Healthcare.
Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #178
01/13/75
SHELL STRENGTH - THICKNESS
COHESIVENESS - LIQUID COMPONENT OF GEL
RUPTURE

Brashier, Dow Corning, memo to Salisbury and VerVoort regarding a patient of Dr. Goldwyn's who reported a "stringy gooey substance" that was coming out of a woman's breast who had just been implanted. The patient snipped the substance with a scissors. The implants were removed and replaced and the same thing happened.

CITE: M 570188 - 570189

Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #179

01/22/75

KNOWLEDGE OF SYSTEMIC DISEASE

TESTING

Study by Lake, Radonovich and Boley with abstract titled "Potentiation of

Endotoxin Induced Interferon in Mice Treated With Octamethylcyclotetrasiloxane."

D4 has been found to increase serum interferon levels in mice induced with E.

coli endotoxin. Because spleen cells but not peritoneal exudate cells from D4

treated mice continue to produce augmented amounts of endotoxin-induced IF upon

removal and incubation in vitro, a direct interaction between IF producing

lymphoreticular organs and D4 is being considered.

CITE: LAK 67, Exhibit to Radonovich Deposition, and Exhibit to Boley Deposition.


Document #180

(Note: this is all that is listed for #180)

01/22/75

DUPLICATE OF DOCUMENT # 177 (see above). Dow Corning Trial Exhibit List

Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #181 & 182

(Note: #181 (ALSO LISTED AS #182)

01/22/75

TESTING

MISCELLANEOUS - SALES

Hoyt, Dow Corning, memo to Rathjen with copies to Salisbury, Talbot, Thompson,

Houle, Meads, Leach, Polmanteer, Boone and Nelson regarding "Mammary Prosthesis

Task Force." He announces that a Dow Corning Task Force has been organized to

further development of the Silastic Mammary prosthesis, Low Profile Round and

Contour, with "flo gel" and which will be packaged in a new sterile container.

Permanent members of this committee include: A. Rathjen (Chair), D. Houle, T.

Salisbury, J. Thompson, and T. Talcott. Active consultants include: T. Abbott,

G. Robertson, W. Larson, and Z. Bennett. The deadline for product introduction

is 06/01/75. There is a 90-day gel implantation test scheduled with Biometric.

Although there was no planned gel testing at Dow Corning's Biomedical facility,

this was requested by Robertson.

Hoyt writes that:

"I can't emphasize enough the urgency and importance of this project for the

business in 1975.The basic assignment is to insure rapid commercialization of a

new mammary prosthesis product line, incorporating new shapes, sterile pack, and

responsive gel. The low profile round - targeted for June 1 introduction/ low

profile contour - by September. The many variables connected with this

particular program make it a challenging management assignment but we can and

must make it happen. How this assignment is handled in detail is up to the Task

Group. We are primarily interested in the final result.... Because of our market

position and tight corporate business situation as we progress into 1975 we

really cannot accept any delays in getting the product onto the market. The big

mammary prosthesis sales months will be May, June, and July in which

approximately 36% of our total business sales will be made. Missing one of those

months would have a dramatic impact. We could, and might be able to accept

trade-offs, but certainly not delays.... I would like to emphasize that this

task and the assignment of all members has received total Business and PMG

support.

CITE: F535 -540, Exhibits 35, 37 and 94 to Harris County Rathjen Deposition,

Exhibit to MDL Rathjen Deposition. NOTE: In a rush to get the product to market,

Dow Corning cut the 90-day study short by 10 days. See 04/25/75 entry, which is

the result of the 80-day study. DUPLICATE: M 630061 - 630061; M 540001 - 540006.

Dow Corning Trial Exhibit List Abstract

PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #183

01/28/75

KNOWLEDGE OF GEL BLEED

Art Rathjen memo to numerous Dow Corning employees regarding "Gel Bleed - New

Gel In Mammary Prostheses Scheduled For June 1 Introduction." Rathjen writes

that, "there is only a two week period before the new 'flo-gel' is scheduled to

be formulated and filling begins. A question has not yet been answered is

whether or not there is an excessive bleed of the gel through the envelope....

We must address ourselves to this question immediately.... The stakes are too

high if a wrong decision is made." (emphasis added).

CITE: F 541, Exhibit 38 to Harris County Rathjen Deposition, Exhibit to MDL

Rathjen Deposition. DUPLICATE: KMM 260794; KMM 19824; FDA 19671 - 19672; M

150001. Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #184

01/31/75

KNOWLEDGE OF SYSTEMIC DISEASE

TESTING

Patent Memorandum Number 4320 by Boley, Lake and LeVier entitled "Organosilicon

Immunopotentiators" is received by Dow Corning's Patent Department on this date.

The memorandum essentially outlines findings that various organosilicon fluids

potentiate the formation of humoral antibody, modulate cell mediated immunity

and promote the induction of interferon by stimulation of the immune system."

The document also includes a memo dated 08/03/76 from J.I. Pulley to LeVier

noting that this patent memorandum has been inactivated and "that Dow Corning

would probably not reactivate work in this area in the near future." Another

memo dated 07/15/76 from Pulley to LeVier notes that "Dow Corning is no longer

actively involved in this (the use of silicone fluids as

immunopotentiators)...."

Another document is a "Patent Memorandum" by Boley and LeVier with the suggested

title of "Immunological Enhancing Activities of Organosilicon compounds and

Non-Functional Fluids" which was renamed to "Organosilicon Immunopotentiators."

Nine of 48 silicon-containing compounds showed a "strong immunological

enhancing" effect. Boley and LeVier wanted to explore possible applications of

these compounds including for potentiation of veterinarian vaccines and in the

"production of high quality and expensive experimental antibodies."

Some of these compounds were tested for their ability to augment or potentiate

endotoxin induction of IF. Dow Corning 200 fluid and D4 "show a significant

potentiation of endotoxin induced IF." (DCC 281061466).

There is also a one page abstract of the Lake, Radonovich and Boley report on

"Potentiation Of Endotoxin Induced Interferon In Mice Treated With

Octamethylcyclotetrasiloxane." Interferon appears to be involved in the Immune

response to bacterial, viral and protozoal infections. Substances able to

modulate the interferon response may be useful in the control of many infectious

diseases and cancer. This report describes the immunopotentiating activity of

some structurally defined linear and cyclic polydimethylsiloxane fluids which

have been found to mimic the potentiating effects of mineral oil adjuvants

(Boley and Levier Dow Corning Report 4319, 1974).

CITE: DCC 281061451 - 281061468 (Temporary Dow Corning Bates Number 16359 -

16379), Exhibit to Bennett Deposition, Exhibit to Isquith Deposition, Exhibit to

Lake Deposition, and Exhibit to LeVier Deposition.
Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #185

02/03/75

KNOWLEDGE OF SYSTEMIC DISEASE

TESTING

Patent department memo to Boley, LeVier and Lake regarding organosilicon

immunopotentiators patent memo assigned #4320.

CITE: DCC 281061471 (Temporary Dow Corning Bates Number 16379), Exhibit to Lake Deposition, and Exhibit to LeVier Deposition.
Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #186

02/13/75

SHELL STRENGTH - THICKNESS

J. Thompson, Cow Corning, memo to A. Rathjen that the new low profile round

envelopes are being dipped on the automatic dippers at a rate of 1,000 bags per

day, but, "PROBLEM: NO SPECIFICATION EXISTS TO Q.C. THESE BAGS!!! WHERE IS IT?

CITE: F 552 - 553, Exhibit to MDL Rathjen Deposition.
Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document 187

02/14/75

SHELL STRENGTH - THICKNESS

Dow Corning's Mammary Task Force meets. The minutes of the meeting report that

Dow Corning is "15 weeks, 170 days, 2,568 hours (and) 154,080 minutes" from the

06/01/75 deadline. Will Larson reported gel migration in monkeys with the new

gel. A "major point of contention" is that, "No specification exists on the

acceptable thickness for the low profile round envelope." TS&D and Production

have differing opinions on what is acceptable. There has also been a breakdown

in the special fabrication program, evidencing that acceptable envelope

fabrication was a problem. "RIGHT NOW I (Rathjen) CONSIDER THIS THE MAJOR

PROBLEM CONFRONTING THE TASK FORCE. I RECOMMEND THAT FILLING WILL NOT COMMENCE

UNTIL THERE IS AN AGREEMENT BETWEEN MARKETING, TS&D AND PRODUCTION AS TO WHAT IS

AN ACCEPTABLE ENVELOPE! (emphasis in original).

CITE: F 549 -551, Exhibit 40 to Harris County Rathjen Deposition, and Exhibit to

MDL Rathjen Deposition. DUPLICATE: KMM 446914 - 446916: M 540023 - 540025. NOTE: Why does Marketing decide what is an acceptable envelope?
Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #188

02/19/75

MISCELLANEOUS

Hommel memo to Rathjen with copies to Hagerman, Salisbury and Leach regarding

"Revision of the "Facts About Your New Look" Pamphlet." Rathjen volunteered to

compile information to revise the Facts About Your New Look brochure. Hommel

encloses "a series of questions which were submitted during a survey (by Karen

Lott) among a number of the ladies working in the advertising agency in Grand

Rapids. I think there is merit to giving due thought to these questions while

working toward the revision of the booklet."

CITE: M 400001, Exhibit 84 to Harris County Rathjen Deposition, and Exhibit to

MDL Rathjen Deposition. Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #189

02/25/75

COHESIVENESS - LIQUID COMPONENT OF GEL

KNOWLEDGE OF GEL BLEED

TISSUE REACTION

Nawash memo to Salisbury, both of Dow Corning, regarding low molecular weight

gel diffusion. He writes:

"The reactivity between free low molecular weight silicones and the subcutaneous

tissue seems to be of increasing concern among plastic surgeons. It is thought

that the soft gel used by Heyer-Schulte in the mammary implant is obtained by

mixing low viscosity silicone fluid in the regular gel. It is also thought that

the low molecular weight components of the fluid eventually diffuse through the

rubber envelope of the breast implant and elicit the untoward reaction which is

occasionally observed and results in an undesirable, relatively thick fibrous

capsule. I do not know the actual method used by Heyer-Schulte to obtain their

soft gel: nor do I know the process we developed for making our own soft gel.

However, If I may, I strongly recommend that we take measures to insure against

the presence of unwarranted free low molecular weight fluids in our now soft

breast implant.

CITE: M 190133, Exhibit to Nawash Deposition, and Exhibit to MDL Rathjen

Deposition. Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #190

04/25/75

TESTING

Biometric Final Report to Dow Corning on "Implantation Study in Rabbits with

Four (4) Mannary Gels." This is a report of an 80 day test using the new flo gel

or responsive gel - X7-2159A in rabbits. Results showed the "presence of mild,

subacute granulomatous inflammatory lesions...."

CITE: t 3740 - 3755, Exhibit to Peters Deposition, Exhibit 87 to Harris County

Talcott Deposition, and Exhibit to MDL Rathjen Deposition. DUPLICATE: P 16689 -

16694. NOTE: The 01/22/75 minutes of the first Mammary Task Force states that

this was supposed to be a 90-day test. See also 03/08/75 entry, with interim

report of the 90-day test. Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #191

04/25/75

MISCELLANEOUS

Boone memo to Talcott, Hoyt, Leach & Salisbury with copies to Rathjen and others

regarding the scale up of the new low profile contours and setting of

specifications. "I am not prepared to repeat the acrimonious exercises that were

encountered during the scale-up and specification setting of the low profile

round envelopes. That scale-up was accomplished with the Production Department

assuming fundamental responsibility for arriving at optimums after considerable

trial and error with eventual prototyping and specification recommendations

being done by this department. I am willing to repeat this work with the low

profile contour product line because we are certainly the best qualified to do

the work. If, however, there are any doubts as to the quality or intensity of

our desire to produce the thinnest product manufacturable, I will be happy to

relinquish this scale-up responsibility to any other group prepared to man and

supervise the equipment on a three-shift basis for the first several weeks of

production. This scale-up should lead to procedures, spec recommendations,

supporting data, and prototypes illustrating limits of acceptability for all

sizes."

CITE: KMM 220579, Exhibit to MDL Rathjen Deposition
Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #192

05/01/75

FRAUD/MISREPRESENTATION

KNOWLEDGE OF GEL BLEED

MISCELLANEOUS - SALES

Boone memo to Hoyt, Leach & Salisbury with copies to Larson, Talcott, Peters,

Brodhagen, Rathjen and Ringey regarding "Oily Effect on New Mammaries." They

have observed that the new mammaries tend "to bleed

noticeably after the product is massaged and handled. We are relatively

confident that the doctor will not see any appreciable bleed on the product as

it is removed from the package. The salesman, however, will experience bleed on

his detail samples, particularly the day after they have been squeezed. It would

be advisable for the salesman to understand this and clean his detail samples

prior to demonstrating to the customer."

CITE: KMM 220570, Exhibit to MDL Rathjen Deposition.
Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #193

05/13/75

KNOWLEDGE OF GEL BLEED

Tom Talcott, Dow Corning, memo to Larson, Dow Corning Mammary Task Force and

other Dow Corning colleagues, regarding silicone gel bleed from implants. He

states, "We are hearing complaints from the field about the demonstration

samples they are receiving. The general claim is that the units bleed profusely

after they have been flexed vigorously. This may tie into the soaking to wash

off excess gel which was occurring in the early stages of production or the time

interval between fill and cure.... Please run appropriate testing when you

receive these samples to determine if a bleed rate problem exists."

CITE: F 743, Exhibit 43 to Harris County Rathjen Deposition, and Exhibit 12 to

MDL Rathjen Deposition (used by Dow Corning). DULICATE: M 16003; M 570062; FDA 19586; Staff Report prepared by the Human Resources and Intergovernmental

Subcommittee of the Committee on Government Operations, December, 1992, p. 17.

Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #194

05/16/75

KNOWLEDGE OF GEL BLEED

Minutes of the meeting of the Dow Corning Mammary Task Force. Countdown to

product introduction is "2 weeks, 16 days, 384 hours, 23,040 minutes." Rathjen

began by reading a memo which officially turned the round and low profile rounds

"back to its jurisdiction." The minutes do not say what this jurisdiction is. On

the issue of gel bleed, "A range of solutions is possible - from reformulating

the gel to eliminating salesmen's abuse of the product during demonstrations. It

seems to be a function of the porosity of the envelope; the lower molecular

weight gel passes through the pores more easily, especially after stretching and

pulling."

CITE: F 590 - 596, Exhibit to MDL Rathjen Deposition, and Exhibit 44 to Harris

County Rathjen Deposition. DUPLICATE: KMM 446988 - 446991: M540064 - 540070. Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #195

05/16/75

KNOWLEDGE OF GEL BLEED

Tom Salisbury memo to Dow Corning sales force regarding the "Oily Phenomenon

With New Mammary Prostheses." Salisbury writes that, "It has been observed that

the new mammaries (sic) with responsive gel have a tendency to appear oily after

being manipulated. ... You should make plans to change demonstration samples

often. Also, be sure samples are clean and dry before customer detailing. Two

easy ways to clean demonstration samples while traveling, 1) wash with soap &

water in nearest washroom, dry with hand towels, 2) carry a small bottle of IPA

and rag."

CITE: F 635, Exhibit 2 to Hinsch Deposition, Exhibit 63 to Harris County Rathjen

Deposition, Exhibit to Nawash Deposition, and Exhibit to MDL Rathjen Deposition.

DUPLICATE: M 540071; KKA 152381; KKH 868: KMM

446993: KMM 148337: KMM 518441: DCC 80061333 - 80061334.
Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #196
05/23/75
COHESIVENESS - LIQUID COMPONENT OF GEL
RUPTURE REPLACEMENT

Minutes of the meeting of the Dow Corning Mammary Task Force. Countdown to product introduction, "1 week, 8 days, 192 hours, 11,520 minutes." The Task Force discussed the economic reasons for getting the contours on the market by 10/01/75. Also, "Marketing wanted to use a sealed bottle of gel as a sales aid to show the flowability and cohesiveness of the responsive gel. However, Talcott and Larson discouraged (this) because the gel may not retain constant properties with continued manipulation such as this. The aesthetics of doing thiswould probably not show our product in a good light." The Task Force decides on "aggressive marketing tactics" including rebates, consignment, back-up units-singles for immediate rupture - replacement, and price breaks for big users.CITE: F 599 - 601, Exhibit 45 to Harris County Rathjen Deposition, and Exhibit to MDL Rathjen Deposition. DUPLICATE: M 540087 - 540089.
Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #197

06/01/75

COHESIVENESS - LIQUID COMPONENT OF GEL

SHELL DEGRADATION

SHELL STRENGTH - THICKNESS

TESTING

Study titled "New responsive Gel - '"Effect on Mammary Envelope Physical

Properties" by James Vallender, cc to Rathjen. Conclusion, "the new gel seems to

cause slightly weaker envelope in ultimate properties but appears to cause

slightly less weakening on aging. The difference in effect on physicals by new

and old gel is considered insignificant."

The study was approved by Matherly and Stark.

CITE: OOT 41627 - 41629, Exhibit to Peters Deposition, Exhibit 112 to Harris

County Rathjen Deposition, Exhibit 129 to Burda Deposition (used by Dow

Corning), and Exhibit to MDL Rathjen Deposition. DUPLICATE: F 630
Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #198

06/30/75

KNOWLEDGE OF SYSTEMIC DISEASE

MISCELLANEOUS - COMPLICATIONS

TESTING

TISSUE REACTION

Study sent to Dowell by Lince, Pruitt, Neagele, Kenaga, Moss, Hymas Goring,

Bjork, Coulter, Johnson, Osborne, Getzendaner, Meulder, Seymour, Sheldon,

Barrons, Hinman, Laskowski, Gray, Hunter, Hanson, Little, Kurihara, Hamaker,

Meikle, Regoli, Magana, Dalman, Edumura, Geronimo, Turner, Ferguson, Simon,

Scott, MacDougal, Shaver, Fears and Regan regarding the rapidity of German roach

knock-down with fospirate formulated on dri-die.

Dow Chemical U.S.A. Ag-Organics Research in Walnut Creek, California report by

F.H. Dowell on "Rapidity of German Roach Knock-Down With Fospirate Formulated On Dri-Die." The report was distributed to numerous departments within Dow Chemical including Ag-Org. Information Center (M. Lince), Ag-Org. R&D Planning (name illegible), U.S. Area R&D Dir. M.E. Pruitt, Ag-Organics Dept. Manager RD

Naegele, Ag-Organics R&D Director R.E, Hefner, Ag-Org. Regist. D. McCollister

and E. Kenaga, Ag-Org. Chemistry Dir. R.D. Moss, Ag-Org. An. Health Devel. T.A.

Hymas, Plant Sci. R&D Dir. C.A.I. Goring, Ag-Org Areas Pestic. Coord. L.L.

Coulter, Corp. Prod. Dept. R.B. Johnson, Ag-Org. Synthesis Res. Mgr. D.W.

Osborne, Ag-Org. Residue/Metab. M.E. Getzendaner, Ag-Org. Formulations K.G.

Seymour, Ag-Org. Prod. Bus. Mgr. H.W. Sheldon, Ag-Org. R&D Tech. Advisor K.C.

Barrons, Chem. Biol. Res. C.W. Hinman, Ag-Org. Environ. Studies D.A. Laskowski,

Prod. Plan. Team R&D Spec. H.E. Gray, Res. Mgr. Field R&D R.C. Hunter: persons

in the Ag-Org. department at the Walnut Creek lab; and to people in

international locations.

The 2% fospirate + Dri-Die Formulation appears to combine flushing action,

residual rapid knock-down and indefinite slow residual action, all highly

desirable properties in a roach control formulation. Dri-Die (micronized silica

gel) is widely used for cockroach control.

CITE: TDCH 345 - 356, Exhibit to Bennett Deposition, Exhibit to Ryan Deposition,

and Exhibit to Hinman Deposition. Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #199

07/15/75

MISCELLANEOUS - COMPLICATIONS

TISSUE REACTION

Letter to Dr. Fleming from M. Popple, bcc to Rathjen, regarding patient with

excessive capsule contraction after mammaplasty

CITE: m 470064 - 470065, Exhibit to MDL Rathjen Deposition


Document #200

08/12/75

ACKNOWLEDGEMENT OF NEED FOR TSTING

KNOWLEDGE OF LIQUID SILICONE DANGERS

MISCELLANEOUS

TESTING

Dow Corning submits New Drug Application (NDA) for DYMASYL(R) Brand Injectable

Silicone for Soft Tissue Augmentation. The NDA 2702. Ancillary to the filing of

the New Drug Application, Dow Corning will pursue activities to elicit data

relative to safety and efficacy on a long-term basis.

CITE: M 410001 - 410003, Exhibit 25 to Harris County Rathjen Deposition.
Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #201

08/12/75

KNOWLEDGE OF GEL BLEED

MISCELLANEOUS - COMPLICATIONS

TISSUE REACTION

Dr. Upton (Cronin"s associate) letter to Rathjen regarding capsular contracture.

Dr. Wilflingseder and Dr. Laub have been able to demonstrate small particles of

free silicone inciting inflammatory reactions in adjacent soft tissue. They have

noted the same phenomenon. "Although the etiology of the problem is

multifaceted, I am sure, we still wonder if the surface of the silicone polymer

plays a significant role."

PENDLETON/PSC Attorney Work Product/Privileged & Confidential

CITE: DCD 173003034, Exhibit 27 to MDL Rathjen Deposition (used by plaintiffs

and Dow Corning), Exhibit 120 to Harris County Rathjen Deposition. DUPLICATE: M

190146.
Dow Corning Trial Exhibit List Abstracts


Document #202

08/28/75

TESTING

Tony Abbott, Dow Corning, memo to Bey and numerous other employees regarding

"Mammary Gel Biocompatability." Abbott states that he now has a test procedure

(Tissue Cell Culture) for evaluating biocompatability of products on a lot to

lot basis. Each lot of mammary gel consists of several drums of materials. "Test

results show that there is a difference in the biocompatability of the gel on a

drum to drum basis." Abbott also recommends a permanent solution to the problem

with the butyl carbitol acetate solvent as a catalyst. Wil Larson is working on

this.

CITE M 170101 - 170103. Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document

09/03/75

(NOT LISTED ON PLAINTIFF'S EXHIBIT LIST)

(this document is between #202 & #203)

Memo from Art Rathjen, Dow Corning, to Drs. Anderson, Ashley, Barrett, Blocksma,

Dingman, Dufourmoutel, Edgerton, Epstein, Giannestine, Goulian, Murray,

Orentreich, Rees, Smith, Stark and Vinnik regarding "News Release - Silicone

Fluid Injection." "Because of legal complications, any inquiries from the media

should be referred to Silas Braley or Joseph Radzius at Dow Corning." Rathjen encloses a Dow Corning news release stating that it has filed a New Drug Application with the FDA requesting approval to market silicone fluid for injections.

CITE: M 350161 - 350163, Exhibit 29 to Harris County Rathjen Deposition.
Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #203

09/10/75

KNOWLEDGE OF LIQUID SILICONE DANGERS

Silas Braley, Dow Corning, Summarizes a phone call with Dr. Charles Vinnik in

response to the press release. Braley states that Dr. Vinnik:

"wanted to know what we were doing about preventing this use so that all of the

incapable people don't get a hold of it for this kind of use.... He said that

the Moss subcommittee in Congress is all poised waiting for Vinnick's (sic)

statement to jump on an investigation of the silicone fluid injection story. He

has been keeping a lid on this all along.... He said he felt that the

information we have had given to us by the investigators is faulty. That his

information is much greater and much better and shows that volumes of silicones

under high pressure can cause all kinds of things that we do not have in our

study. He said that the longest we had was four years in monkeys and even that

showed fat necrosis. He explained fat necrosis as being identical with the

situations he has seen in the patients that he has treated in Lass Vegas.

(emphasis added).

CITE: DCC 240000054. DUPLICATE: KKM 3364.
Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #204

09/29/75

MISCELLANEOUS - COMPLICATIONS

SILICA

TISSUE REACTION

Letter to Rathjen from Dr. Laud regarding Dr. Wilflingseder's discovery, and

publication, of silicon dioxide (silica) in breast capsule specimens and "I was

able to tell him what I had learned at Dow Corning."

CITE KMM 29957. Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #205

10/06/75

TESTING

Abbott, Dow Corning, reports on "biocompatibility Evaluation Of Mammary Gel."

"The problem with biocompatibility is the butyl carbitol acetate solvent in the

catalyst.... There are localized high concentrations of BDA in the gel.

Evaluation of the compatibility of the solvent with the gel has shown that BCA

does not mix in the formulation at a very desirable rate." Also, "Visual

observations of uncured gel shows the presence of globules or highly contracted

pockets of the solvent.... The permanent solution to the problem involves the

replacement of the present solvent with a different solvent or a different

catalyst system."

CITE: KMM 39105 - 39121. Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #206

10/30/75

COHESIVENESS - LIQUID COMPONENT OF GEL

GEL MIGRATION

KNOWLEDGE OF SYSTEMIC DISEASE

TESTING

Dow Corning Bioscience Research Report No. 4509 by Lake and Radonovich entitled

"Action of Polydimethylsiloxanes on the Reticuloendothelial System of Mice:

Basic Cellular Interactions and Structure Activity." The abstract for this

report states that:

"Because of their hydrophobic character, dimethylpolysiloxanes of various

viscosities are known to distribute to the reticuloendothelial system (RES) in

association with phagocytes. The site, magnitude, specificity and time course of

murine RES response to high doses of various dimethylpolysiloxane fluids has

been studied to characterize the basic cellular interaction and immunological

consequences of dimethylsiloxane administration. Type I interferon production

and clearance of colloidal carbon were used to assess RES function. Linear 3,4

and cyclic 4,5 dimethylpolysiloxanes when given parenterally to mice caused a

transient response in lymphoreticular tissues with a maximum at 48 hours. This

response was found to involve phagocytic cells (macrophages) such that augmented

amounts of Type I endotoxin-induced interferon are made. Carbon clearance by the

RES is also depressed with the same time course as this hyper-reactivity to

interferon induction. Hexamethyldisiloxane and dimethysiloxanes greater than 5

siloxy units do not cause these changes, but do cause a characteristic

eosinophilia at an intraperitoneal inoculation site.

A consistent hypothesis for this observed increase in early interferon

production is that dimethylsiloxanes in the 305 size range are sub-lethally

surface active in macrophages of the RES. Like lead acetate and mineral

oil-surfactant mixtures, which are known to augment early interferon production,

low molecular weight dimethylsiloxanes decrease the phagocytic capacity of

macrophages. Because endotoxin is not cleared (phagocytosed) or detoxified, the

viable but phagocytically impaired macrophages undergo a prolonged and more

complete interaction with endotoxin. (OOT 42327)"

CITE: OOT 42325 - 42352, Exhibit 1 to Radonovich Deposition (abstract only),

Exhibit 23 to Harris County Hayes Deposition, Exhibit to Harris County Tyler

Deposition, Exhibit 11 to Zimmer Deposition, Exhibit to Lake Deposition, Exhibit

to Isquith Deposition, and Exhibit 23 to Harris County Rich Deposition.

DUPLICATE: DCC 281001636 - 281001662; DCC 281061445 - 281061450. WITNESS: Radonovich.

DISPOSITION: Admitted in Toole (II) v. Baxter Healthcare.
Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #207

11/03/75

MISCELLANEOUS - COMPLICATIONS

TISSUE REACTION

Letter to Rathjen from Dr. Laub regarding the Toronto meeting. "Dr. Bob Briggs

from New Jersey has seen several patients from the original study (mostly

Orentreich patients) who have had intractable swelling. ... This case is similar

to the ones reported at a meeting in Mexico City several years ago by physicians

from Buenos Aires. ... I have followed patients myself in this are 'suffering'

from the same condition. ..."

CITE: KKM 31788, Exhibit to MDL Rathjen Deposition.
Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document

(no number) dated 11/7/75

(this document is between #207 & #208)

11/07/75

(NOT LISTED ON PLAINTIFF'S EXHIBIT LIST)

Memo from Larson, Dow Corning, to Talcott with copies to Bey, Rathjen, and

Kelley regarding "Capsule Formation & Mammary Implants." Larson states that

Stark commented in a staff meeting that "implanted silica causes the formation

of a very heavy tough capsule.... Possibly we could minimize capsule formation

around the mammary prosthesis if they were over coated with a pure silicone

polymer.... These are the basis for the concept that maybe some exposed silica

on the very surface of the envelope rubber can cause excessive capsule formation

and that this might be minimized if the capsule were formed and interfaced

against pure silicone polymer." On M 190174 there is a handwritten note from

Talcott to Ron Kelley: "I'd like more proof of silica at interface causing

problems."

CITE: m 190174 - 190175. NOTE: M 190175 is a duplicate of M 190174 but it has

different marginalia on it. Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #208

11/18/75

MISCELLANEOUS - COMPLICATIONS

MISCELLANEOUS - RECKLESS/CONSCIOUS DISREGARD

TESTING

Memo to Boone, Leach, Meads, Polmanteer & Talcott from Bey regarding capsule

contracture studies. "Our TS&D budget situation for 1976 is simply this, we have

considerably less discretionary spending money for 1976 than we had in 1975. I

can't see any way we can support these proposals in 1976. I suggest we

discourage the proposals as much as possible...."

CITE: M 190186, Exhibit to MDL Rathjen Deposition.
Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #209

12/10/75

KNOWLEDGE OF LIQUID SILICONE DANGERS

Telephone call report by Silas Braley regarding a call with Richard Samuels

about a grand jury investigation being done on Hal Ellison for doing injections

of silicone fluid. Ellison had been receiving Dow Corning fluid through a

company called Silaco. Braley states that, "I told Mr. Samuels that we had been

fighting, the breast injections since we had heard about them and were trying to

get the information across to people. We find now that people are very confused

about breast injections vs. breast implants and I explained that the latter are

both ethical and legal and that the problems of injections do not apply. I asked

for his help in differentiating between these two procedures so that those women

who have had surgical augmentation will not worry when they read about the

horrors of injections." (emphasis added). The call report notes that additional

phone calls from Mr. Samuels occurred throughout the morning. Joe Radzius, Dow

Corning legal counsel, advised Braley that Dow Corning's position "from here on

in" was "no comment."

CITE: KKM 3537 - 3538 Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #210

12/12/75

KNOWLEDGE OF GEL BLEED

T. Talcott, Dow Corning, memo about a telephone call from Dr. Frank Gerow. Gerow

attended a meeting in Phoenix recently and reported that "the general tone to

him was something is coming through the envelope to the tissue." Gerow concluded

that Dow Corning needed a "100% tied up gel now." Talcott writes that he's

inclined to agree that something's coming through the envelope. "Could it be

miscellaneous contamination during our manufacturing process? Do we need an

audit of the process?'

CITE: F 636, Exhibit to Frisch Deposition, Exhibit to MDL Rathjen Deposition,

and Exhibit 64 to Harris County Rathjen Deposition. DUPLICATE: M 170143;

M190203; FDA 32914; DCC 242031351 - 242031352.
Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #211

12/12/75

TESTING

Franklin and Annelin, Dow Corning, report on "Subcutaneous Implants Of

Developmental Prosthetic Gels In Monkeys And Rats: Examination Of Tissue

Deposition And Urinary, Fecal, And Respiratory Elimination Routes." "In the

rats, dosed with the new production gel, only the axillary lymph showed an

increase in total silicon; a similar increase in hexane extractable silicon was

not observed.: In the monkeys, "the low cross-linker formulation moved along

tissue planes and formed only a very thin capsule."

CITE: KMM 140087 - 140104, Exhibit to Frisch Deposition, Exhibit 42 to Hinsch

Deposition (used by Dow Corning), Exhibit to LeVier Deposition, Exhibit 45 to

Harris County Peters Deposition, Exhibit 115 to Harris

County Rathjen Deposition, Exhibit 88 to Harris County Talcott Deposition,

Exhibit 92 to Bennett Deposition (used by Dow Corning), Exhibit 15 to MDL

Rathjen Deposition (used by Dow Corning), and Exhibit to Isquith Deposition.

DUPLICATE: P 17497 - 17515. Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #212
12/12/75
SHELL STRENGTH - THICKNESS
RUPTURE
ACKNOWLEDGEMENT OF NEED FOR TESTING

Rathjen, Dow Corning, memo to various Dow employees regarding Breast Symposium in Phoenix, Arizona on November 23-26, 1975. Reports that Dow has lost the number one position as "the innovator." He states:

"Surgery was performed by members of the faculty, put on tape, edited and viewed during the three day course. Each manufacturer donated implants for this use. Dr. Eugene Courtiss and Dr. Robert Winslow used our prostheses. In both instances the doctors broke an implant during their surgery. Fortunately these were edited from the tape; but ours were the only ones to break, and they really let us know about it. The Medical Products Business should consider a full scale research program to fully evaluate the current status of our gel (chemistry, toxicology) and to begin a concentrated program to develop a dry gel (dry to touch, cohesive, non-adhesive with absolutely no bleed). I would also like to see the development of a radio-opaque envelope which would allow the examination of an implant "in situ" if and when capsular contracture is suspected. How contracture develops by observing an implant "in situ" could contribute to a better design of an implant. (emphasis added).


CITE: M 190200 - 190202, Exhibit to Mantle Deposition, Exhibit 80 to Harris County Rathjen Deposition, and Exhibit to MDL Rathjen Deposition.
Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #213

00/00/76

FRAUD/MISREPRESENTATION

Dow Corning brochure, "Facts You Should Know About Your New Look," Which

contains the following question and answer: "How long will the implants last?

Based on laboratory findings and human experiences to date, a gel-filled breast

implant should last for a lifetime." (emphasis added).

CITE: M 650012 - 650019, Exhibit to Harris Country Jakubczak Deposition, 27 to

Harris County Peters Deposition (used by Dow Corning), Exhibit to MDL Rathjen

Deposition, and Exhibit 77 to Harris County Rathjen Deposition.

NOTE: From 1963-73, Dow Corning only "warned" of fluid accumulation and foreign

body reactions in its product inserts. From 10/74 - 09/76, Dow Corning added to

its product inserts the following for the Silastic implant: capsular

contracture/firmness, pain or discomfort from surgery, ptotic breasts,

additional surgeries/implantations, and the risks associated with surgery. See

PSC World of Warnings for Dow Corning and Dow Corning Wright.
Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #214

01/07/76

FRAUD/MISREPRESENTATION

KNOWLEDGE OF LIQUID SILICONE DANGERS

MISCELLANEOUS - COMPLICATIONS

STERILIZATION/CONTAMINATION

TISSUE REACTION

Testimony of Joseph Radzius to the California legislature regarding silicone

injections. He states that DC's study "absolutely contraindicates injection of

the fluid in the mammary area."

CITE: M 350149 -350155, Exhibit 33 to Harris County Rathjen Deposition, and

Exhibit to MDL Rathjen Deposition, NOTE: The document also has the Bates Numbers

DCD 173002728 -173002734 on it. Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #215
01/15/76
RUPTURE
SHELL STRENGTH - THICKNESS

Tom Talcott memo to Kelley and Rathjen, Dow Corning, discusses the recent Phoenix Breast Symposium in which Dow Corning introduced its new mammary. During the taped implantation surgery, two of Dow Corning's implants ruptured/broke. Talcott expresses dismay that at Dow Corning the consensus was that the envelope was "good enough" despite finding:

"gross thin spots and flaws in the form of significant bubbles.... The allowable flaws are written into our current specifications.... When will we learn at Dow Corning that making a product "just good enough' almost always leads to products that are 'not quite good enough'? It is unfortunate that the thinner dispersion, four dip method proved by Bartolo and Vallender in early 1974 appeared too expensive to plant personnel to even try, although a much higher acceptance rate would be obtained. I sincerely hope this experience will convince us to support programs for 'high quality' rather than 'just enough quality' in the future. (emphasis added).

CITE: F 534, Exhibit 65 to Harris County Rathjen Deposition. Exhibit to MDL Rathjen Deposition. DUPLICATE: DCC 8003157; M 600007; KMM 140185; KMM 380078.Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #216

01/22/76

TESTING

Dow Corning stated a Two-Year Implant Study with Q7-2159A and MDF-0193 at

Industrial Bio-Test Laboratories (IBT).

CITE: Referenced in KMM 390371. NOTE: See 02/03/78 entry.
Dow Corning Trial Exhibit List Abstracts

PENDLTON/PSC Attorney Work Product/Privileged & Confidential


Document #217

01/23/76

ACKNOWLEDGEMENT OF NEED FOR TESTING

Art Rathjen, Dow Corning, memo to numerous Dow Corning employees (Mammary Task Force) regarding "Research/Testing - Mammary Gel/Envelope." Rathjen states, "I have suggested verbally and in writing that we better get going on a basic long

range project relative to gel, its formulation, toxicology, etc. over and above

what is now underway. The same goes for the envelope. The complaint report from

Dr. Horowitz Manchester, Conn., is just one more flag." (emphasis added).

CITE: F 809, Exhibit to MDL Rathjen Deposition, and Exhibit 76 to Harris County

Rathjen Deposition. DUPLICATE: M 170171: M 580066: KKA 152383: DCC 17016569:

KKA88865: KMM 447050. Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #218

02/16/76

Rathjen, Dow Corning, memo to the IND 2702 clinical investigators - Ashley,

Blocksma, Dingman, Edgerton, Goulian, Murray, Orentreich and Rees - regarding

"Proposed California Legislation To Control Injection Of Silicone Fluid." Dr.

Ashley disagrees with regulating injections and states that breast injection

should be a contraindication to the use of liquid silicone.

CITE: M 350147 - 350148, Exhibit 33 to Harris County Rathjen Deposition.
Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #219
03/03/76
TISSUE REACTION
RUPTURE

Dr. Terino presents a paper on "Technique and Results of 50 Breast Capsule releases" at the California Society of Plastic Surgeons. He reports a 36.5% rate of contracture. Also, a Dow Corning implant was removed 10 years post-op. "Upon opening the capsule bilaterally there was a thick sticky layer of silicone outside the envelope. On taking theimplants out bilaterally there was no perforation from the envelope whatsoever, but there was clearly silicone on the outside. And pathology showed extensive foreign body giant cell granulomas."
CITE: M 290302 - 290306.

Document #220

03/17/76

TISSUE REACTION

KNOWLEDGE OF GEL BLEED

Art Rathjen, Dow Corning, memo to numerous Dow Corning employees regarding a

paper presented by Dr. Edward Terino at the California Society of Plastic

Surgeons on 03/03/76. The paper discussed a Dow Corning

Silastic implant removed 10 years post-op. Silicone was found on the outside of

the implant and "pathology showed extensive foreign body giant cell

granulomas.... This event, as described by Dr. Terino, cannot be ignored. An

attempt must be made to get an answer or explain this phenomenon before the

manuscript is submitted to the Journal for publication. If we don't, everyone of

the 350 member audience, the Journal readers, and the lawyers may interpret this

as proof that our gel causes problems."

CITE; F 833 - 834, Exhibit 36 to California Braley Deposition, Exhibit 66 to

Harris County Rathjen Deposition, and Exhibit to MDL Rathjen Deposition.

DUPLICATE: M 190247 - 190248; M 250038 - 250041; KMM242493 - 242494; DCC

240000437 - 240000438. See 03/03/76, 03/19/76 and 03/26/76 entries. The implants

were from lot number H0209. Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #221
03/19/76
KNOWLEDGE OF LIQUID SILICONE DANGERS
CONCEALING FROM FDA


Dow Corning's New Drug Application submitted pursuant to Section 505(b) of the
FDA Act, for the preparation Dymasyl (dimethylpolysiloxane) Fluid is not
approved. The FDA reviewed the application and found that the information
presented is inadequate. The application fails to report adequate animal studies
in support of the safety of the drug.
Presently reported carcinogenic studies in animals are inadequate to determine
the carcinogenic potential of dimethicone. It is recommended that new studies be
initiated in accordance with our current guidelines for testing of products for
carcinogenic potential.
The FDA also found that Dow Corning's application failed to report the clinical
studies in full detail, that there was no long-term data or patient follow-up,
that manufacturing instructions are ambiguous, that sterility tests were not
submitted, and that information on laboratory tests was not submitted. As a
result of this, the FDA has closed Dow Corning's NDA file. The Director, J.
Richard Crout, states, "(T)he only potentially acceptable indications for use of
dimethicone, on a benefit/risk basis, are for the major facial defects and
severe acne scars. We regard the benefit/risk ratio of dimethicone for minor
cosmetic uses as unacceptable." (emphasis added).
CITE: DCC 106006714 - 106006719, Exhibit 29 to California Braley Deposition, and
Exhibit to MDL Rathjen Deposition. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #222
03/19/76
ACKNOWLEDGEMENT OF NEED FOR TESTING
GEL MIGRATION
KNOWLEDGE OF GEL BLEED


Art Rathjen, Dow Corning, reports on the "backlash" from Dr. Terino's paper to
the California Society of Plastic Surgeons. Dr. Barker approached Rathjen after
Dr. Terino's presentation and stated he was also studying capsular contracture.
"He (Dr. Baker) also subscribes to the possibility that the migration of fluid
or low moleculars through the envelope which causes the greasy feel to the
envelope may be contributing to the contracture.... Nevertheless, the question
remains in his mind, as it does in a number of other plastic surgeons around the
country "Dr. Baker wants to take Dow Corning's Silastic implants in a centrifuge
to collect what is forced through the envelope. The quantity of what comes
through should then be implanted in animals in a very small quantity to see what
kind of tissue reaction develops. Rathjen thinks that it would be in the best
interest of Dow Corning if they were to "take the initiative" and attempt to do
something of a similar basis first. He states in this internal memo:
I think it would be embarrassing for Dow Corning and for any of our research
expertise if we find that this type of testing has to be left to a doctor in
this field. If he were to come up with something detrimental, I think we ought
to be prepared for it. (emphasis added).
CITE: M 160001 - 160002, Exhibit to MDL Rathjen Deposition, Exhibit 67 to Harris
County Rathjen Deposition. DUPLICATE: M 190249 - 190250; DCC 17031054.
Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Work Product/Privileged & Confidential

Document #223

03/19/76
SILICA

Hinsch, Dow Corning , memo to Criger, Hoyt and Leach with copies to Bey,
Petraitis, Larson and Rathjen) regarding a conversation with Dr. William Jervis.
Dr. Jervis claims that "silica (a component of the bag and gel of a mammary
prosthesis) is an irritant. Tom also said (according to the doctor) that the
silica in the silicone can be released from its entrapped state by over-curing
and that the bag of a gel implant was more over-cured than that of inflatables.
Tom admitted that some inflatables also probably had some of this silica on
them. Tom speculated to me later that a final polymer coating might help retain
the silica if that is in fact what is happening." (emphasis added).
CITE: KMM 74769, Exhibit to Frisch Deposition, Exhibit 49 to Hinsch Deposition
(used by Dow Corning), and Exhibit to MDL Rathjen Deposition. DUPLICATE: M
190251; KMM 120458. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #224

03/22/76
KNOWLEDGE OF GEL BLEED
GEL MIGRATION

Handwritten note to Milt Hinsch from Greg Bicket, both of Dow Corning,
discussing the bleed question and Dr. Terino's presentation. Bicket notes that
many persons are asking questions about, "What is that stuff on the outside of
DC's implant.... Do you want that bleeding into your patient's body ... will it
cause capsule contracture. We say they all do it; McGhan must be cleaning their
implant very carefully." He lists 8 questions including whether the gel migrates
and, if so, to what parts of the body and with what effects. Bicket feels
"uncomfortable" since he can't answer all of the questions. He notes that McGhan
is raising these questions with doctors.
CITE: M 160026 - 160027, Exhibit to Petraitis Deposition, and Exhibit to MDL
Rathjen Deposition. DUPLICATE: GEG 4026 - 4027; M 190255 - 190256, KMM 3831 -
3832. NOTE: This date is approximate and is based on the date on the top of the
page from the ASPRS meeting on 03/22/76.
Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #225

03/26/76
KNOWLEDGE OF GEL BLEED
FRAUD/MISREPRESENTATION

Art Rathjen, Dow Corning, letter to Dr. Terino with blind carbon copies to
numerous Dow Corning employees. Despite Rathjen's knowledge that gel bleeds
through the envelope, Rathjen tells Dr. Terino that this is "physically
impossible" from a polymer chemistry standpoint. He attempts to cast doubt on
Dr. Terino's claims that the substance on the outside of the Dow Corning implant
Dr. Terino examined was silicone gel, particularly since the implant was not
torn or ruptured. Rathjen suggests that Terino shouldn't publish his paper
stating, "I truly think it would be to the best interest of all concerned if we
try to get some answers before there is any further dissemination of information
which might be erroneous....(Rathjen) would like to ... help solve the mystery,
if that is possible, before your presentation is submitted for publication."
He requests that Dr. Terino send him any explanted Dow Corning prostheses with
"a strange color or a questionable envelope surface or seem to have a change in
the normal physical qualities."
CITE; M 250018 - 250019, Exhibit to MDL Rathjen Deposition, and Exhibit 68 to
Harris Country Rathjen Deposition. DUPLICATE; DCC 240000435 -240000436; M 570126
- 570127. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #226

03/31/76
ACKNOWLEDGEMENT OF NEED FOR TESTING
SHELL DEGRADATION

Art Rathjen, Dow Corning, memo to Overton, Bey, Bennett, Harlow, Hinsch, Lewis,
Stark, and VerVoort regarding "Your Request For Information, i.e., Radiation
Treatments Of The Breast Following Implantation - Dr. John Lindsay." He states:
"I want to re-affirm again that Dow Corning personnel cannot become involved in
medical judgments relative to patient care.... The following information is
conjecture. Depending on the amount of x-ray or gamma radiation, one could
expect the gel to stiffen with no major change to the physical properties of the
envelope. It can be suggested that some chemical reaction might take place with
the prosthesis, but we absolutely do not know what affect such a reaction would
have on tissue or systemically. It is also an assumption that the implant would
act as a screen for the tissue against the posterior side of the implant.
Obviously, the screening effect would be in relationship to the thickness and/or
density of the implant.... (In) no way do I agree that this be used to endorse
or suggest the safety and efficacy of radiation therapy following augmentation
using our SILASTIC Mammary Prosthesis. (emphasis added)
CITE: KMM 29699, Exhibit to MDL Rathjen Deposition.
Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #227

04/00/76
ACKNOWLEDGEMENT OF NEED FOR TESTING
A study entitled "Mammary Capsular Contraction (A Situation Analysis 1976)" by
P.A. Walters of Health & Human Services. Eldon Frisch, Dow Corning, receives the
report. Walters recommends the following:
"Concentrate the initial research effort in the one area Dow Corning knows best,
i.e. materials. Do not terminate any existing clinical programs with respect to
data generation on mammary capsule contracture. However, I would recommend
postponing Dow Corning's involvement in any new clinical program(s) until some
very basic research questions are answered. I realize that rejecting some
clinical proposals is very difficult because of the political and economic
implications, but participating also carries some very high risks. There is a
50/50 chance that the data may be bad data, i.e., damaging by implicating a
product.... Remember, a product which is implicated with bad data requires
additional expenditures of time, personnel and money to generate defensive
research. There are several data gaps which should be investigated before any
long-term clinical involvements are undertaken."
Walters recommends further studies on gel bleed and elastomer formulation.
(emphasis added).
CITE: KMM 4113 -4129, Exhibit 77 to Harris County Rathjen Deposition. DUPLICATE:
M 290021 - 290037. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #228
04/05/76
MISCELLANEOUS - COMPLICATIONS
MISCELLANEOUS - PRODUCT LABELING
RUPTURE - CLOSED CAPSULOTOMY
TISSUE REACTION

FDA: The FDA, after receiving information that some persons had experienced serious problems with silicone mammary and testicular implants, met with Dow Corning to inspect their files. Mr. Radzius, Dow Corning's Food and Drug counsel, and Milt Hinsch, Product Supervisor, Dow Corning, claim to John Nicholson, FDA, that current data shows approximately 18% of mammaries implanted will cause a contracture problem. Of this 18%, somewhat less than 10% will require corrective surgery or other techniques. Hinsch also states that a new technique of manually breaking the capsule has recently been developed and shows promise as a solution to contracture. Hinsch also stated that it has always been a policy of Dow Corning to include "adverse reactions" as part of its labeling but, recently, competitors have been using this statement in the literature as a tool to convince surgeons not to use Dow Corning's products.
CITE: FDA 17180 - 17182. NOTE: HINSCH was aware that the contracture data was much higher than 18%, i.e., see Dr. Terino's paper presented 03/76.

Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #229
04/13/76
KNOWLEDGE OF GEL BLEED

Milt Hinsch, Dow Corning, discussed how the market place is telling Dow Corning
that improvements can be made to the current production line including to the
envelope, gel, and design of the prosthesis. One suggested improvement would be
that the gel should be a no bleed gel with very low viscosity, "Doctors are now
being sensitized to the oiliness of our current prosthesis...." Hinsch wants Dow
Corning to place its name and product size on the mammary in case it needs to be
removed and replaced for any reason. "This is a consideration which will become
more important as time goes on."
CITE: M 160007 - 160008. DUPLICATE: GEG 4343; M 160079 - 160080; KKH 2632.
Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #230
04/14/76
KNOWLEDGE OF GEL BLEED
ACKNOWLEDGEMENT OF NEED FOR TESTING

Eldon Frisch, Dow Corning, responds to Milt Hinsch's memo on Greg Bicket's
questions on gel bleed. "The material which bleed from a mammary implant is a
polydimethylsiloxane, or more appropriately a silicone fluid. It comes from
within the gel.... Since the gel starts as a fluid, these materials are also
fluids, and they tend to migrate about in the gel, eventually dissolving in the
envelope and passing through it.... We have no scientific data to indicate
whether or not the presence of the fluid polydimethylsiloxane which bleeds
through the envelope increases or decreases the problems of capsular
contracture." He questions whether Dow Corning's field inventories are getting
too old, allowing "the bleed (to become) more evident." Frisch also talks about
injected silicone fluid studies which showed absorption of the silicone fluid
into the body. "We have no scientific evidence to indicate whether or not the
presence of the fluid polydimethylsiloxane which bleeds through the envelope
increases or decreases the problems of capsular contracture."
CITE: M 190259 - 190261, Exhibit 13 to California Braley Deposition (used by Dow
Corning), Exhibit to Petraitis Deposition, Exhibit to MDL Rathjen Deposition.
DUPLICATE: KKH 1561 - 1565; GEG 4023 -4025; M5700445 - 570047, KMM 3828 - 3830;
GEG 4246 - 4250. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #231
04/19/76
COHESIVENESS - LIQUID COMPONENT OF GEL
MISCELLANEOUS - SALES
RUPTURE
TESTING

Robertson memo to Blackmore, Coyne, Fredricksen, Pryor, Trischler, Doolittle, Flora, Hauser, McLellan and Murray regarding a discussion with Donald McGhan on 04/14/76. McGhan is now receiving Dow Corning silicone. For the gel uses McGhan prefers the GE product which has a lower level of low molecular weight components. McGhan mammary implants are also more consistent than Heyer-Schulte's because of the mandrel molding technique used - the madrels are polyester and cast individually.
CITE: MMM 1445 - 1450, Exhibit 6 to D. McGhan Deposition, Exhibit to Horgan Deposition, Exhibit 43 to Harris County D. McGhan Deposition, and Exhibit 68 to Harris County Coyne Deposition. DUPLICATE: MMM 666-671.
Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #232
04/20/76
SHELL STRENGTH - THICKNESS
RUPTURE

Milt Hinsch, Dow Corning, memo to Brodhagen, et al., regarding demonstration implants used at the "Aesthetic Show in Atlanta on April 11-15, 1976. He writes, "Of these 23 (demonstration implants), 5 had large bubbles in the gel, 1 broke when picked up, and 3 others developed bubbles in the gel around the patch area during the show. We were unable to show the entire line as planned."
CITE: KMM 219977.Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #233
04/22/76
Kelley, Dow Corning, memo to Hinsch with copies to C. Lentz, Criger, Leach,
Meads, Becker, Petraitis, Bey and Rathjen regarding "Milt Hinsch Memo of April
13 - Attached "Gel Filled Mammaries Of The Future.'" Kelley notes that the
attached memo from Hinsch documents specific marketplace requirements for the
mammary prosthesis line.
CITE: KKH 2633 Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #234

05/04/76
KNOWLEDGE OF GEL BLEED
GEL MIGRATION
TISSUE REACTION
Greg Bicket, Dow Corning, reports that he met with Dr. Richard Phares regarding
the Silastic Mammary Prosthesis. He is "interested in reports of freshly healed
augmentations failing to adhere with subsequent loss of implant. (Phares)
experienced this, and was upset to hear others reports of this at the
Southeastern meeting. Apparently, the theory is that the opposing faces of the
wound are closed, and in ten to fifteen days no appreciable healing has taken
place. The suture lines then break down, and the implants are not retained.
'Greasy implants" sliding into the pocket, providing a release agent against
healing, were postulated to be the cause."
Further, "The second area of concern was the reported actions of migrating
gel/fluid of other manufacturers' gel. Giant cells, granulomae, and siliconomae
were reported in and around the locations where the migrating gel/fluid was said
to have come to rest." Phares proposes a dog study.
CITE" M 600009 - 600010, Exhibit to MDL Rathjen Deposition, and Exhibit 79 to
Harris County Rathjen Deposition. DUPLICATE: F 713 - 714; KMM 380053; DCC
80010141 - 80010142. NOTE: Dow Corning never followed through with a dog study.
See 06/08/76 entry. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #235

05/11/76
SHELL STRENGTH - THICKNESS
SHELL DEGRADATION

Neal Langley and Jon Swanson, Dow Corning, report on the "Effects Of
Subcutaneous Implantation, Through Two Years, On The Physical Properties Of
Medical Grade Tough Rubber (MDF-0198)." MDF-0198 is a "new high performance
medical grade elastomer for orthopedic (sic) devices.... Questions to be
answered were: do physical properties change during implantation; are body fluid
absorbed into the elastomer; and is PDMS leached into the body during the two
year subcutaneous implantation period?" Langley and Swanson state that there was
little change in tensile strength, tear resistance and ultimate elongation.
"Maximum loss of PDMS into the body ranged from 0 to 0.7% of the sample weight
after 32 weeks and from 0 to 1.3% after two years.... This degradation may
become important over longer periods." There were significant changes in the
flaw propagation life after implantation, a 10% decrease in tensile strength and
flaw propagation life, a 20% decrease in elongation and a 5% increase in
modulus. "Differences to be noted between this study and service conditions
include the absence of flexing during implantation, and any differences between
the subcutaneous environment in dogs Vs the various locations in the human body
where the devices are in service."
CITE: T 21431 - 21444. DUPLICATE: KKH 68344 - 68357; DCC 204001179 -204001192.
Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #236

05/17/76
ACKNOWLEDGEMENT OF NEED FOR TESTING
Art Rathjen, Dow Corning, memo to Bey and C. Lentz regarding a capsular
contracture study proposed by Dr. James Penoff. "We are engulfed in qualified
speculation - nothing to date is truly quantitative or qualitative; therefore,
Dr. Penoff's suggestions for a course of action merit some serious
consideration." (emphasis added). Phase I of the proposed study includes:
A. Is there something in the implant that migrates out or off the mammary
prosthesis? yes or no!
B. Does it continue for the life of the implant or is it limited or controlled
for a period of time?
C. Does it come from the gel or envelope or both?
D. What is it?
E. Considering the evolution of the mammary prosthesis, have changes in both the
gel and envelope altered the degree or changed what might migrate through or off
the prosthesis?
Phase II would be pre-clinical implant testing to determine whether components
of the envelope and gel migrate. Phase III is human implantation.
CITE: F 715 - 716, Exhibit to MDL Rathjen Deposition, and Exhibit 78 to Harris
County Rathjen Deposition DUPLICATE: FDA 31438 - 31439; M 210001 - 210002.
Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #237

06/00/76
GEL MIGRATION
TESTING
TISSUE REACTION

Frugard's Dow Corning trip report from Heyer-Schulte's library. Includes
08/06/76 memo from J. Erhardt to T. Talcott regarding confidentiality agreement
with Dow Corning requiring all information being confidential for a period of
ten years from the date of disclosure of delivery. Frugard's trip report was
sent to S. Koorajian and is dated 07/14/76. Frugard reports that there are both
positive and negative aspects of his trip to Dow Corning.
On the positive side, he feels that he was successful in bringing back a
comprehensive summary of all of Dow Corning's animal data; or at least "all that
I was given access to". The negative aspect is that the data does not answer the
key questions concerning migration and its consequences. Many of the experiments
were not well controlled. The animal studies indicate no significant
pathological findings and, in cases were there were, they were attributed to
experimental procedures.
Frugard concludes that:
"due to the fact that there was no apparent difference in reaction to any of the
gels, the inflammatory response must be considered to depend solely on tissue
injury and not upon gel migration. This conclusion is tenuous at best
considering there were no controls. Perhaps all gels were reactive.... Gel
migrates into the capsule.... Unfortunately, the data collected in this study
does not answer questions concerning migration, even though that was the main
objective. I regret the fact that Dow Corning's data was lacking in quality and
left many questions unanswered."
CITE MD 114416 - 114428. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #238
06/02/76
SHELL STRENGTH - THICKNESS
RUPTURE

Mazelin, a Dow Corning sales representative, files Complaint Report F76023 for a rupture of a Silastic Round mammary implant. Dr. Kellett, the implanting physician, noted that this was the second rupture in the past few weeks. He "feels 'thinner' envelope weakens it (the implant) significantly."
CITE: CR 3172 - 3173.
Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #239
06/07/76
GEL MIGRATION
MISCELLANEOUS - COMPLICATIONS
RUPTURE
TISSUE REACTION

Braley, Dow Corning, telephone report concerning a conversation with Dr. Nicholas Georgiade. Dr. Georgiade's patient developed a mediastinal node enlargement and lung lesions and suspects gel migration from a ruptured implant. He notes that the patient's husband is a "smart ass" trial lawyer and wants to know how to handle this. He wants a letter from Dow Corning so that he has "enough information to counteract any feelers that this lawyer may put out."
CITE: M 250053, Exhibit 35 to Hinsch Deposition (used by Dow Corning), Exhibit 87 to Harris county Rathjen Deposition, Exhibit 39 to California Braley Deposition, Exhibit to MDL Rathjen Deposition. NOTE: for Rathjen's response, see M 250050 - 250052 dated 07/12/76 Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #240
06/08/76
ACKNOWLEDGEMENT OF NEED FOR TESTING

Art Rathjen memo to Al Bey, C. Lentz and others, all of Dow Corning, regarding
"G. Bicket Trip Report No. 504, May 4, 1976, i.e., Dr. Phares, St. Petersburg,
Florida." Rathjen states:
"I have proposed again and again that we must begin an in-depth study of our
gel, envelope, and bleed phenomenon. Capsule contracture isn't the only problem.
Time is going to run out on us if we do not get underway. Believe me when I tell
you that the A.S.P.R.S. is also going to begin their own investigation. A
committee will be organized, and they will come to the manufacturers asking
questions. It would certainly be to our advantage to be ready for them.
(emphasis added).
CITE: F 712, Exhibit to MDL Rathjen Deposition, and Exhibit 79 to Harris County
Rathjen Deposition. DUPLICATE: M 600011; GEG 003999; KMM 242518; DCC 80061401; M
600008. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #241

06/10/76
COHESIVENESS - LIQUID COMPONENT OF GEL
GEL MIGRATION
KNOWLEDGE OF GEL BLEED

Study by Brill titled "Development Of A Low Oiling Gel For The External Breast
Prosthesis." The resulting gel caused substantially less swell of the silicone
rubber envelope and gave a low rate of migration of silicone material through
the envelope compared to existing silicon gels formed from low viscosity fluids
and plasticizers. It was also shown that gels and fluids based on
methyltrifluoropropyl polymer as well as silicone organic copolymers could
produce a very low order of elastomeric swell and bleed with
polydimethylsiloxane envelope rubber.
CITE: KKH 63280 - 63299, Exhibit to Petraitis Deposition, and Exhibit to MDL
Rathjen Deposition. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #242

06/11/76
MISCELLANEOUS

W. Larson and Y. Peters, both of Dow Corning Corporation, issue an internal Dow
Corning report entitled "Medical Products, Technical Service and Development".
The authors report that:
"The mammary gel, MDDF0193, often develops a yellow color which detracts from
the appearance of the prosthesis. The cause of this problem has been traced back
to the catalyst, XY173. Four catalysts were evaluated on the basis of color,
XY173. Four catalysts were evaluated on the basis of color, XY173, XF95504, PtII
and MDDFoo69. The color intensity of the gels was found to decrease in the
following order: XY173 >XF95504 >PtII > MDF0069.
The results indicated that the easiest solution to the problem was to switch to
MDF0069."
CITE: KMM 8596 - 8605. NOTE: The first page states that this document is Dow
Corning Proprietary and that neither this document nor the information contained
in it may be reproduced except in TIS, nor distributed outside the company
without permission from the Director of Technical Service and Development.
Dow Corning Trial Exhibit List Abstract
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #243
06/25/76
SHELL STRENGTH - THICKNESS
RUPTURE

John Gallagher, Dow Corning, memo to Bob Becker regarding the "large increase in rupture returns in the past month...." Gallagher states that:

"All the doctors claim that the ruptures are happening from 90% of the prosthesis with the creases and large air bubbles. I had a discussion with Milt Hinsch today and he told me he has had three telephone calls, one from Tom Mazelin, one from Greg Whittaker, and one from Jim Reisma (sic - Reitsma), all having the same problem - an excessive amount of ruptures. I wanted to bring this to your attention because I have one customer that has had a return of thirty ruptures in the last three months.... We have enough problems with competition without worrying about ruptures constantly.

CITE: CR 3272.

Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #244
07/07/76
FRAUD/MISREPRESENTATION
GEL MIGRATION

Rathjen, Dow Corning, letter to Nicholas Georgiade responding to expressed
concerns regarding gel migration. Rathjen states:
"The first silicone gel-filled mammary prosthesis was implanted in a patient of
Dr. Tom Cronin's in 1962, and as of July 1976, she still has them, and her
course during the past 14 years has been uneventful. Since that time, mammary
implants numbering in the hundreds of thousands have been used for augmentation
and reconstruction of the breast.
The percentage of complications has been minimal, and very frankly, gel
migration due to breakage of the silicone envelope has not been a problem nor
can I recall when a surgeon has questioned us about this, relative to a Dow
Corning Product.
We also have test data on the implantation of our materials; and there is, to my
knowledge, no indication or proof that phagocytes pick up the material and carry
it off. I agree with Si on that Point - the size and consistency of the gel, and
even more specifically, our gel used in 1970 does not make it feasible."
CITE: KMM 354956 - 354957.l Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #245

07/12/76
FRAUD/MISREPRESENTATION
GEL MIGRATION

Rathjen, Dow Corning, letter to Dr. Nicholas Georgiade stating that he has never
heard of a problem of gel migration "relative to a Dow Corning product."
(emphasis added). He notes that the gel is "very cohesive." Rathjen also claims
that Dow Corning does not have any test data or knowledge showing that
phagocytes pick up the silicone and carry it through the body, claiming that
this is not "feasible."
CITE" M 250050 - 250052, Exhibits 36 and 37 to Hinsch Deposition (used by Dow
Corning), Exhibit 40 to California Braley Deposition, Exhibit 63 to MDL Rathjen
Deposition (used by plaintiffs and Dow Corning), Exhibit 88 to Harris County
Rathjen Deposition, and Exhibit 40 to California Braley Deposition. NOTE: There
are numerous instances of gel migration noted in Dow Corning's internal and
external tests as well as in letters from physicians. See, e.g., 04/00/67 - GEG
4301 - 4304; 04/01/67 - PSC Medical Articles CDE, J 157 - 166; 04/11/67 - T
38842 - 38866; and 08/02/71 - KMM419744). NOTE: Also see 06/07/76 telephone
report, M 250053. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #246

07/14/76
DOCUMENT DESTRUCTION
TESTING

Milt Hinsch, Dow Corning, memo to Rathjen, Kelley, Leach, Lentz, Bey, Bennett,
Hoyt, Mantle, and Nelson regarding "The Milt Hinsch Grant." Hinsch turned down a
request for funding by Dr. Tanski which Rathjen supported and then agreed to
fund a similar study by Drs. Horton and Rasato. Rathjen has suggested that Drs.
Horton and Rasato had gone "shopping" for funding and were turned down by
Heyer-Schulte already. Hinsch responds that it was a marketing sponsored
decision to support Horton and Rasato because they are product champions. In
response to Rathjen's question about what to do with the data Horton and Rasato
generate, Hinsch states,
"Question number 9 about what will we do with the data depends upon the data
which is generated, Art. It may turn out that we will take the paper on which
this data is printed, roll it up and light pipes and cigars with it." (emphasis
added).
CITE: M 190344 - 190345, Exhibit to MDL Rathjen Deposition, and Exhibit 82 to
Harris county Rathjen Deposition. Dow Corning Trial List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #247

07/15/76
KNOWLEDGE OF SYSTEMIC DISEASE
Pulley memo to LeVier regarding "Patent Memo 4240 - Insecticidal Activity of
Silicone Oils and Emulsions." The subject patent is being placed in our inactive
files in the Patent Department. Note: The referenced patent memo is not
attached.
CITE: DCC 281041374 (Temporary Dow Corning Bates Number 16359 - 16379), Exhibit
to Bennett Deposition, Exhibit to Isquith Deposition, Exhibit to Lake
Deposition, Exhibit to LeVier Deposition.
Dow Corning Trial Exhibit List Abstracts
Pendleton/PCS Attorney Work Product/Privileged & Confidential

Document #248

07/23/76
CONCEALING FROM FDA
FRAUD/MISREPRESENTATION

FDA: A hearing is held by the FDA Panel on Review of General and Plastic Surgery
Devices. On the issue of breast implants, J. Radqius, Dow Corning, states that
he has evidence that doctors may be altering the breast implants by injecting an
antibiotic into the prosthesis which is gradually released through the membrane
of the implant.
CITE: This document also has the Bates numbers KMM 489852A - 4900119A (This
document also has Bates numbers KMM 545507 - 545555, 547162, 545556 - 545557,
547163 - 547164, and 545558 - 545671 on it.) DULICATE: FDA 160 - 161 (Pages 150
and 151 only). Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #249

08/02/76
ACKNOWLEDGEMENT OF NEED FOR TESTING
KNOWLEDGE OF SYSTEMIC DISEASE

Hobbs, Dow Corning, memo to Atwell, Bey, LeVier, Radzius, Ryan, Smith, Stark,
Gamon, Lentz, Maneri, Tyler, Wehrly, and Weyenberg regarding "2,6-cis Toxicity."
Hobbs states:
"A six month chronic toxicity study conducted on 2,6-cis has demonstrated
possible relationship between the appearance of mammary tumors in the (word is
cut off) and the feeding of the chemical. This possibility may have implications
which involve products other than 2,6-cis. There are three major questions we
must answer concerning this possible effect:

1. Is the occurrence of mammary tumors an absolute response in the rat when fed
2,6-cis?
2. Do any of our products contain 2,6-cis?
3. Is the production of these tumors a result of the estrogenic activity of
2,6-cis or is it related to certain low molecular weight silicone compounds?
CITE: KMM 482556 - 482557, Exhibit to Tyler Deposition, Exhibit to Ryan
Deposition. NOTE: The right hand side of the page is cut off. Dow Corning Trial
Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
Document #250
08/03/76
KNOWLEDGE OF SYSTEMIC DISEASE
Pulley, Dow Corning, memo to LeVier concerning the inactivation of Patent
Memorandum 4320. Because LeVier represents "that the project which supported the
subject disclosure in on the shelf and that Dow Corning would probably not
reactivate work in this area in the near future," the patent memo is
inactivated, to be reactivated "whenever you consider it appropriate."
CITE; DCC 281061472, Exhibit to Bennett Deposition, Exhibit to Isquith
Deposition, Exhibit to Lake Deposition, and Exhibit to LeVier Deposition. NOTE;
Refer to entry dated 01/31/75. This was listed on Plaintiffs' Exhibit List in
Carter as "No Bates Number." Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #251
08/12/76
MISCELLANEOUS - COMPLICATIONS

Dr. John Wolfe, Detroit Medical Center, writes to Milt Hinsch of Dow Corning
expressing concerns regarding silicone mammary prostheses. Wolfe writes, "I
would like to stress to you that the present prostheses composed of silicone are
more than an inconvenience but a very serious problem. Very often women who have
an augmentation have severe mammary dysplasia. Severe mammary dysplasia is
related to a high incidence of developing breast cancer. Prostheses effectively
block from view a great amount of the breast tissue on radiographic
examination.... We have the situation where implants are being put into breast
which are at high risk for developing breast carcinoma and we are seriously
impairing our ability to recognize the carcinoma in its early and curable
stage."
CITE: COM 361 - 362. DUPLICATE; GEG 4090.
Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #252
08/23/76
GEL MIGRATION
KNOWLEDGE OF SYSTEMIC DISEASE
RUPTURE

Jim Rudy, President of Heyer-Schulte sends a "Dear Doctor" letter regarding "the possible and known problems and complications" of breast implants. It is noted that subtle processes of degradation should be expected to occur, and that the knowledge associated with long-term implantation is imperfect. If the implant is torn the gel will migrate and that is why Heyer-Schulte placed warnings in data sheets in May 1975. Doctors and patients should expect some patients to exhibit adverse response to silicone implants.

CITE: M 190413 - 190417, Exhibit 159 to Harris County Powell Deposition, Exhibit to Harris County LeVier Deposition, Exhibit to Nawash Deposition, and Exhibit 140 to Harris County Rathjen Deposition.

DUPLICATE: GEG 004050 - 004054; KMM 262028 - 262032; BAX 36899 - 36903. WITNESS: Rudy Exhibit 34; Hyans Exhibit 24. DISPOSITION: Admitted in Toole (II) v. Baxter Healthcare.

Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #256
09/22/76
GEL MIGRATION
RUPTURE/DEAR DOCTOR RESPONSE
TISSUE REACTION

Milt Hinsch memo to the Dow Corning sales force concerning Dow Corning's response to Heyer-Schulte's "Dear Doctor" letter discussing problems and complications of gel-filled mammary prosthesis. Hinsch claims that Dow Corning's implants are considered "non-active in the body" and he "would not expect shape or softness to change appreciably." Also, Dow Continues "to test 100% for cohesive gel during production" and "their gel offers the softest possible feel while retaining cohesiveness." Hinsch states that, "there are no cases of Dow Corning gel migration. Conversely, in documented cases where the envelope was ruptured, the gel did not migrate." He claims that all materials are subjected to "extremely sensitive" tests for tissue reaction and must show no tissue reaction to be accepted. Hinsch states that Dow Corning does not plan a written response to the " "Dear Doctor" letter.

CITE: M 240432 - 240433, Exhibit 8 to Hinsch Deposition (plaintiffs), Exhibit 44 to Hinsch Deposition (Dow Corning), Exhibit to Peters Deposition, Exhibit to Harris County Rudy Deposition, Exhibit 97 to Harris County Rathjen Deposition, Exhibit 2D to Harris County Talcott Deposition, Exhibit 113 to Burda Deposition, and Exhibit to MDL Rathjen Deposition. DUPLICATE: GEG 4048 - 4049; M 880029 - 880030; OOM 880029 -880030.

Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #257
10/01/76
KNOWLEDGE OF GEL BLEED
KNOWLEDGE OF LIQUID SILICONE DANGERS
KNOWLEDGE OF SYSTEMIC DISEASE
RUPTURE
STERILIZATION/CONTAMINATION
TISSUE REACTION

Donald Barker, M.D., presents a paper, "Reactions to Silicone Implants in the Guinea Pig," to the Scientific Session of the American Society of Plastic and Reconstructive Nurses.

CITE: GEG 4000 - 40006. NOTE: Paper was published in the Aesthetic Plastic Surgery in 1978, authored by Barker and Sherrill Lee Schultz, R.N.

Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #258

10/09/76

SHELL STRENGTH - THICKNESS

Bill Overton, a Dow Corning sales representative, files Complaint Report L76001

regarding service problems and thick envelopes on Silastic Round mammary

implants. In an accompanying memo dated 10/19/76 from Overton to Hinsch, Leach,

Darling, Brodhagen, Woodard, Hoyt, Schultz, and VerVoort, Overton states that,

"Frankly, I was a little surprised to see such a difference in the comparison

(between the new Silastics and the Silastics in Dr. Forrest's inventory).... Dr.

Forrest stated he felt the new SILASTIC stock had an envelope about three times

as thick, and also stated he would be able to feel the thick envelope in a

patient.... I know he was upset more at this point when he sort of threw the

implants from his locker onto the floor. If the implants I picked up from Dr.

Forrest are typical of mammary product we are making today, I can't help but

feel I will loose half of my business in the next six months. I prefer giving a

few extra out for breakage than lose $100M in sales.... We cannot afford to make

noticeable changes if we expect to retain present market." Dow Corning's Quality

Assurance Reliability Engineer noted that the returned implants did exceed

envelope thickness specifications and that there was inconsistency in envelope

thickness specifications and that there was inconsistency in envelope thickness

on the same implant as well as in comparing implants. (emphasis added).

CITE: CRM 200 - 203. Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #259

10/13/76

KNOWLEDGE OF LIQUID SILICONE DANGERS

MISCELLANEOUS - COMPLICATIONS

TISSUE REACTION

Report of 10/12/76 phone call from Dr. Colocho to Rathjen regarding 6 of Dr.

Colocho's patients with palpable nodes in the axillary area, and Dr. Colocho's

"very real concern" regarding possible gel bleed.

CITE: KKM 42792, Exhibit of Rathjen Deposition.
Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #260

10/15/76

KNOWLEDGE OF LIQUID SILICONE DANGERS

MISCELLANEOUS - COMPLICATIONS

TISSUE REACTION

Letter to Dr. Colocho from Rathjen submitting questions regarding Dr. Colocho's

6 implant patients with palpable nodes.

CITE: M 190376 - 190378, Exhibit 32 to MDL "Rathjen Deposition (used by Dow

Corning), and Exhibit 69 to Harris County Rathjen Deposition. DUPLICATE: M

240009 - 240011. Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #261

10/23/76

GEL MIGRATION

Art Rathjen, Senior Clinical Research Specialist for Dow Corning, writes to Kurt

Wagner, M.D. about a problem with gel migration, "Obviously, whether it is a Dow

Corning implant or a competitors' the fact that this phenomenon would exist is

disturbing enough. We have always been conscious of this possibility: therefore,

you certainly caught me off guard when you first reported that the gel from one

of our implants had indeed migrated to the groin." Rathjen claims that Dow

Corning did not supply any materials to competitors for the manufacture of

mammary implants until the first quarter of 1976. General Electric supplied the

materials. (emphasis added).

CITE: KKH1719. DUPLICATE: GEG 4009. Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #262 (Possible)

10/31/76 (NOT LISTED ON PLAINTIFF'S EXHIBIT LIST)

Art Rathjen, Senior Clinical Research Specialist for Dow Corning, writes to Kurt

Wagner, M.D. about a problem with gel migration. "Obviously, whether it is a

"Dow Corning implant or a competitors', the fact that this phenomenon would

exist is disturbing enough. We have always been conscious of this possibility;

therefore, you certainly caught me off guard when you first reported that the

gel from one of our implants had indeed migrated to the groin. " Rathjen claims

that Dow Corning did not supply any materials to competitors for the manufacture

of mammary implant until the first quarter of 1976. General Electric supplied

the materials. (emphasis added).

CITE: GEG 4009. Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #263
11/02/76
KNOWLEDGE OF LIQUID SILICONE DANGERS
TISSUE REACTION
RUPTURE

Dr. Charles Vinnik writes to Art Rathjen, Dow Corning, about a histologic response
to a patient whose breast implant ruptured. Dr. Vinnik states that "microscopically
it appeared to resemble the reaction (sic) seen around silicone injected breasts."
He also notes that the response to silicone materials in humans is "a very variable
thing...." (emphasis added)
CITE: KKH 6944 - 6945, Exhibit 47 to MDL Rathjen Deposition (used by Dow Corning).
Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #264

12/07/76

TISSUE REACTION

Guillermo Colocho. M.D., of New Mexico, letter to Art Rathjen, Dow Corning,

enclosing tissue specimens of patients who experienced problems with implants.

Patient number 1 had a small nodule in the right breast three years post-op.

Following biopsy, pathological diagnosis revealed lymphoid hyperplasia. Patient

number 2 developed multiple tender nodules and lumps in her breast five months

post-op. Following bilateral biopsies, pathological diagnosis revealed bilateral

lymphoid hyperplasia.

CITE: M 240013 - 240014, Exhibit 32 to MDL Rathjen Deposition (used by Dow

Corning), and Exhibit 69 to Harris County Rathjen Deposition.
Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #265

01/04/77

KNOWLEDGE OF SYSTEMIC DISEASE

MISCELLANEOUS - COMPLICATIONS

TISSUE REACTION

Patent No. 4,001,403 for a method for reducing the reproductive function of

mammals by Bennett and McHard. A method for altering the reproductive function

of mammals by administering a pharmacologically effective amount of certain

fluoroalkyl-substituted organosilicon compounds. As a means of illustration, one

can orally or parenterally administer from 1.00 mg. to 100 mg. per kilogram of

body weight of an organosilicon compound thereby rendering the subject (either a

male or female mammal) infertile.

CITE; DCC 281061 - 281061408, Exhibit 73 to Bennett Deposition (used by Dow

Corning). Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #266

01/10/77

ACKNOWLEDGEMENT OF NEED FOR TESTING

KNOWLEDGE OF GEL BLEED

Becker, Dow Corning, memo to C. Lentz regarding silicone found in tissue. He

writes, "The question of bleed and contracture is indeed of concern by our

competitors and the physician. There is no question in my mind that Dow

Corning's leadership position is expected to provide answers to the questions. I

am very surprised to find that we do not have any data on Si levels in tissue or

the distribution and fate of trace levels of polymer in the body." (emphasis

added).

CITE: F 810, Exhibit to California C. Lentz Deposition, Exhibit to Harris County

LeVier Deposition, Exhibit 70 to Harris County Rathjen Deposition, and Exhibit

to MDL Rathjen Deposition. DUPLICATE: KMM 260614; M 170124; KMM 380071. Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #267

10/18/77

KNOWLEDGE OF GEL BLEED

MISCELLANEOUS - COMPLICATIONS

MISCELLANEOUS - SALES

Rathjen, Dow Corning, memo to Bey, Hoyt, Hutchison, Lentz, and Nelson regarding

"observations Relative To Dow Corning's Future In The Mammary Implant And

External Breast Markets." Rathjen states; "In my opinion, we, Dow Corning, are

no longer the recognized leaders or innovators in either segment; and our

present position will continue to decline unless specific measure are taken now

to turn things around.... I am powerless to change anything, and my sphere of

influence in this business continues to diminish: hopefully, I still have the

privilege to express opinions even if they are not shared by all."

CITE: KMM 12998 - 13000 and 13004, Exhibit to MDL Rathjen Deposition, and

Exhibit 83 to Harris County Rathjen Deposition. DUPLICATE: m 190101.
Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #268

02/10/77

TISSUE REACTION

KNOWLEDGE OF SYSTEMIC DISEASE

Will Larson, Dow Corning, memo to Art Rathjen, Becker, Bennett, Bey, Kelley and

Lewis concerning an allergic reaction in a patient of Dr. Vanduyn. The patient

was implanted with a Silastic Mammary Prosthesis, No Fixation Patch. One month

following implantation, the patient contracted the flu. Shortly thereafter, the

implant "broke through" the healed incision and the implants were removed. The

augmentation was redone and, within days after the surgery, the implants again

"broke through." Dr. Vanduyn suggested a possible allergic reaction and asked if

there were any similar reports. Larson told him, "I was unaware of any allergic

reaction to silicones" (emphasis added).

CITE: M 240368 Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #269

02/17/77

KNOWLEDGE OF GEL BLEED

ACKNOWLEDGEMENT OF NEED FOR TESTING

Larson, Dow Corning, memo to Bennett, Hoyt and Rathjen regarding mammary bleed.

"The permeability of silicone elastomers is a well known phenomena....

Permeation in this case is ... toxicologically unknown.... It is of great

concern because of what can be made of the unknown...." Also, "We would also

anticipate bleed may be a function of heretofore unmeasured factors, e.g.

manipulation and stress.... Dow Corning's product development direction has been

an attempt to strike a balance between: 1)What we factually know about bleed.

2)What gel and envelope polymer intermediates can be produced. 3)What

toxicological data we have on materials. (and) 4What is a marketable product....

In conclusion, any physiological effect or consequence of this permeation

remains speculative. What can be done and what should be done is an open topic

of discussion." (emphasis added).

CITE: OOM 320448 - 320449, Exhibit to MDL Rathjen Deposition, and Exhibit 71 to

Harris County Rathjen Deposition. DUPLICATE: KMM 176928; KKH 2263: M 150002 -

150003: M 190423 - 190424. Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #270

02/25/77

ACKNOWLEDGEMENT OF NEED FOR TESTING

SHELL STRENGTH - THICKNESS

Rathjen, Dow Corning, memo to Hoyt, C.Lentz, and Nelson stating, for the record,

his objection to the Product Marketing Group's ("PMG") decision to market the

Silastic Inflatable Mammary Prosthesis. Rathjen believes a six month review of

clinical experience with the implant is necessary before a meaningful assessment

could be made regarding the efficacy of the implant. At the time, Dow Corning

was only six weeks into a clinical trial on the inflatable. He cites Bob Becker

who reported to the PMG that, based on his investigation of the envelope

production, he believed the quality of the inflatable envelope now was no better

than when Dow Corning made it in 1971-72, when the inflatable line failed.

CITE: KMM 3333245 - 333426, Exhibit to Oppelt Deposition, and Exhibit to MDL

Rathjen Deposition. Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #271
03/11/77
FRAUD/MISREPRESENTATION
MISCELLANEOUS - RECKLESS/CONSCIOUS DISREGARD
RUPTURE

"Thoughts relative to Meeting - March 10 - Inflatable - Telephone Conversation with Mel Nelson - March 11." Dow Corning held a meeting on March 10 with Hoyt, Meads, Bennett, LeVier, Leach, Petraitis, Radzius, Hinsch, Criger, Steele, Rathjen, and Lewis. The author is unidentified but believe it is Rathjen. The author states:

"I sat there and listened to the various opinions that were offered and it became evident to me that actually it was a matter of having everybody stroke one another hoping that a consensus of opinion would be developed that would allow a positive decision on the distribution and sales question with nobody taking firm responsibility for a final decision. In the meeting, when it got around to the legal aspects of product liability, Joe Radzius read the memo that had been delivered by Norm Lewis which stated that our liability was wide open and if we did have any problem that Dow Corning would have a very difficult time defending its position and the recommended course of action by Steve Giadard, Harry Dingman, and Norm Lewis was that we not accelerate the calendar (sic) or time relative to our distribution and sales of the product. The ultimate decision of this meeting was of course that they would continue on there (sic) course for a projected May 1 distribution and sales limited area and therefore, they were willing to take a chance over and above the recommendations of the legal department.

I continued to hold my position that I did not feel that it was prudent for Dow Corning to consider an early distribution and that we should wait until at least a six month period when the (sic) clinical evaluation data would be in and evaluated and therefore, I was certainly in the minority when Hoyt put it all to a vote at the end of the meeting.

Between Thursday, the 10th of the March and Friday, the 11th of March, I had occasion to think about this and I felt that I still couldn't live with this decision and therefore, at approximately 8:15 on Friday, March 11th, I called Hemlock and spoke with Mel Nelson. In doing so I told him I was concerned because the meeting yesterday was the fourth meeting on this same subject and it (sic) indicated to me that people were still uneasy and not entirely committed and to have such indecision requiring these repeated meetings to go over the same subject indicated a shakiness (sic) on the part of the parties concerned. I told Mel that I actually really felt that the people in that conference room on Thursday afternoon really wanted to be stroked. There was safety in numbers. I asked him who the person would be that one individually would be held accountable if this project were to get underway and things were to go to hell in a bushel basket, I did not get an answer to that and of course I think that Mel felt that ultimately he would be the one that had to make an accounting for this. But I find it hard to believe that he would allow himself to succumb to the pressures of several of the members of the Marketing Department and possibly Ron Kelley of TS&D, simply for the sake for getting 500 inflatable mammary prostheses out in 1977, which would only amount (to) $70,000. I think that the disregard for a plan and our disregard for the ethics of clinical testing and product reliability for (sic) to sale isn't worth jeopardizing for the sake of this small amount of money.

My second point to Mel on the phone was that I truly believe that this decision , as fostered by John Hoyt and Chuck Leach, is a violation of Ray Maneri's Codes of Business Conduct. I think the Marketing Department Planned very poorly and I think the PMG has not been very realistic in pushing forward in this and therefore, a decision to go ahead with an early marketing date violates Maneriís Codes of Business conduct in the U.S. area that was circulated by all Dow Corning employees. Ray has very emphatically stated in his little pamphlet (sic) that Dow Corning "Dow Corning will strive to assure product efficacy, assure that its products are of the highest practical quality and that product characteristics and potential hazards are made clearly known to the user." If they go with an early market introduction date, they have violated that statement in the code. Further on in the same pamphlet, it states "the product sold by Dow Corning will be thoroughly tested to determine their effect on the environment." Here again I feel that an early distribution would violate that part of the code. I made both of these points to Mel Nelson and pointing out that we were succumbing to Marketing pressure. I also brought up the subject of a problem we had years ago when the Marketing Department and Gordon McIntyre elected to distribute all the (sic) silicone foley catheter in the southern California area prior to any conclusive testing relative to safety and efficacy. That decision turned out to be a real fiasco (sic) in several months we had telephone calls and letters and telegrams from hospitals and Urologist and nurses from southern California relating incidents of balloon failure, balloons coming off the end of the catheter, etc. and immediately we had to cease and while we retrieve (sic) all of these catheters, our legal council (sic), Joe Radzius was down in Washington trying to keep the lid (sic on this thing so it would not become an official recall. This meeting on Thursday, bothered me because Joe was back in that meeting offering Legal Council (sic) which was opposite what had been voiced by Steve Gaidard and Harry Dingman and Norm Lewis in the memo that was left for Joe to discuss. All three of these people including the chief legal council (sic) for the corporation, Steve Giadard stated that there (sic) recommendation that we not go with an early market distribution, Joe on the other hand (stated) that he felt that the risk was worth it. I felt his contribution at the best (sic) biased because he had already made it known to the Corporation that he is resigning and so whatever he said would have little effect anything that would transpire past March 31, when he officially leaves the employment of Dow Corning.

I mentioned to Mel that I felt that the strength of the position by the Marketing Department, namely Hoyt, Leqach, Hinsch also pivoted on their having to save face within the last week they had a general sales meeting down in Houston and I come to find that they did announce to the sales force that the inflatable was coming and it would be offered for limited distribution. Now here some of these problems are being posed to them and would require their having to go back to the sales force and tell them that there (sic) initial decision was incorrect and retract all that they have said and therefore their credibility as being challenged I think that it wasn't in the best interest of this corporation to go down and tell the salesmen in the first place we are going to have a product, while it was still under test.

I think that we are indeed putting Dow Corning's name and reputation on the line for a measly (sic) $70,000 and there is not (sic) guarantee that there would be sale of pairs between May 1 and the end of the year. Finally I said to Mel Nelson that for the last several years we have (been) under strict criticism (sic) by the American society of Plastic and Reconstructive Surgeons because of our position with the silicone injection program. When we first got involved with the A.S.P.R.S. with the silicone symposium, we were accused as a Corporation of disregarding safety and efficacy data to jam our product through so that we could recoup (sic) some of our investment dollars and we were looked at as a large corporation who disregarded safety and efficacy standards to make money. I had to defend Dow Corning's position in this regard at the California Plastic and Reconstructive Society meeting last year because the same accusation was made that we were more interested in profit and dollars then (sic) we were in ethics and good testing. I told Mel that one of our current clinical evaluators for the inflatable was Dr. Verner Lindgren who is Vice-President elect of the A.S.P.R.S. and also Fred Grazer who, both of these men being very active in Society matters. I would find it hard (to) believe and in fact I would find it a very difficult thing to do, to go and have to tell these men that now that they are testing the product, that Dow Corning has taken upon themselves to market this product. Therefore I wanted a written statement from the Business stating the rational and the decision behind this move and that I would use that statement when these investigators were to be informed of Dow Corning's decision. Mel Nelson pointed out that the Business as a whole and the Business Board hadn't even gotten that far to consider what the ramifications would be and what the impact would be on these investigators were to be informed of Dow Corning's decision. Mel Nelson pointed out that the Business as a whole and the Business Board hadn't even gotten that far to consider what the ramifications would be and what the impact would be on these investigators and that this would be something that would have to be looked at in great detail. While I find this whole matter very disconcerting (sic), I personally am very uneasy about the whole thing. I find it hard to believe that after so many difficult experiences in the past that management for the Medical Products Business would be so narrow -- in their vision that they are going to go out and promote a product that has not been tested. It is my sincere hope that there will be a reversal to this decision. (emphasis added)."

CITE: KMM 333230 - 333234, Exhibit to Petraitis Deposition, and Exhibit to MDL Rathjen Deposition.
Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #272

03/16/77

GEL MIGRATION

Dr. Swanson calls Eldon Frisch, Dow Corning, noting that he had written to Zeke

Bennett urging that Dow Corning undertake appropriate studies to determine the

potential migration of silicone elastomer particles throughout the body. Dr.

Niebauer, San Francisco, is presenting a paper and speech about silicone

particle migration in monkeys, particularly in the liver. also, Dr. Rose from

the Massachusetts Institute of Technology will propose his theory on silicone

elastomer degradation by interaction with lipids at the upcoming Biomaterials

Meeting. Frisch suggests that Dow Corning attend these meetings and publish

their own position that "biodegradation does not occur." He also suggests an

animal study at the University of Michigan because they are "open to

suggestions." (emphasis added).

CITE: M 190441 - 190443, Exhibit to Harris County Tyler Deposition.
Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #273

03/22/77

MISCELLANEIOUS - COMPLICATIONS

TISSUE REACTIONS

Complaint report from Dr. Tony Emmett filed by Green. Report states that Dr.

Emmett has removed implants after a cancer was found in the breasts. This is one

of several such cases sighted by Emmett. The cancer cells have seemed to follow

the capsule.

CITE: COM 4331 - 433 Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #274

03/28/77

FRAUD/MISREPRESENTATION

KNOWLEDGE OF GEL BLEED

Dow Corning employee, D. Petraitis, memo regarding bleed studies for Dr. Barker.

There is serious concern whether any gel bleed data should be released to the

public because "any general release of this data could be misinterpreted or

misconstrued, and could result in severe repercussions in the public sector."

(emphasis added). Also, "The bleed measurement may not be representative of

actual in vivo results.... I still believe that Dow Corning should convey the

impression that we are indeed working in this area." (emphasis added).

CITE: F 633. DUPLICATE: KMM 264592. NOTE: Del Petraitis later worked for McGhan Nusel.
Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document 275

03/31/77

TISSUE REACTION

FRAUD/MISREPRESENTATION

KNOWLEDGE OF GEL BLEED

Leach, Dow Corning, memo to Bob Levier regarding "Contracture Phenomenon." Leach

refers to recommendations made by Pat Walters on contracture and states that Dow

Corning has taken no significant action on any of Walter's recommendations,

except for a "half-hearted" low priority program at Northwestern University. He

reports that he is losing customers because doctors believe Dow Corning implants

bleed more than others. Leach writes:

Several of our customers looking to us as leaders in the industry, asked me what

we were doing. I assured them, with crossed fingers, that Dow Corning too had an

active 'contracture/gel migration' study underway. This apparently satisfied

them for the moment, but one of these days they will be asking us for the

results of our studies....l I am not sure where this unrest is leading but

suspect that our PMG, as the steward of Dow Corning's implantable products,

should not be to (sic) comfortable with our current lack of focus and

coordinated leadership relating to this entire issue. I suggest that this

question be addressed at our next PMG Meeting and clear definition given as to

what answers we can reasonably be expected to have, and what steps need to be

taken to fill whatever gaps that may exist in our needed storeroom of knowledge.

In my opinion, the black clouds are ominous and should be given more attention.

(emphasis added).

CITE: F 717 - 718 (Handwritten note, "R-grand push. Where does Ron Kelley stand

w/summarizing available data? John.")' M 190439 - 190440 (Handwritten note,

"Chuck, excellent memo. We must not be complacent as in past. Unlikely other

co.ís research will favor us. Are we going to do something? Dick.") Exhibit to

MDL Rathjen Deposition. DUPLICATE: F 683 - 684; GEG 4028 - 4029; KMM 140266 - 140267.
Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #276

04/13/77

SHELL STRENGTH - THICKNESS

Petraitis, Dow Corning, memo to LeVeir, Rathjen, et al. about returned

inflatable implants. One of the implants had a pinhole leak which Petraitis

believed was not caused by procedures. Concerned about the problem Petraitis

recommends a halt to the current program plan as he is convinced the current

envelope is "questionable." Cycle testing had raised doubts regarding the

envelope, confirmed subsequently by the pinhole leak problem. He recommends Dow

Corning officially halt all additional clinical implantation, continue close

monitoring of those patients with inflatable implants to develop a data base,

emphasize improved envelope production and take a conservative, responsible

attitude before gearing up again. Finally, he strongly recommends Dow Corning

not take any assumptions regarding their envelope quality improvements until

they have some definite history.

CITE: KMM 333250, Exhibit 9 to Hinsch Deposition, and Exhibit to Petraitis

Deposition. Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/privileged & Confidential


Document #277

05/03/77

FRAUD/MISREPRESENTATION

SHELL STRENGTH - THICKNESS

STERILIZATION/CONTAMINATION

Hinsch, Dow Corning, memo to Kelley, Metevia and Petraitis regarding a

conversation he had with Jim Cox. The topic of conversation was Cox-Uphoff's

method of manufacturing mammary prostheses. Hinsch first states that at

Cox-Uphoff, when raw materials are received, they undergo additional filtering

because they are not as clean as they would like to have them. Secondly, Hinsch

comments on Cox's vulcanization times. Jim Cox suspects that he and the people

on the West Coast vulcanize their gel implants longer than Dow Corning. Cox's

comments lead Hinsch to believe that there is some correlation between his

longer vulcanization time and the lack of oily feel on the prosthesis. The third

and final comment concerned manufacturing double lumen implants. "Jim conceives

that he can 'dump' gel implants which are not ideally manufactured by using them

in these Double Lumen Prostheses.... This is something we should keep in mind

should we eventually move into the area of double lumen type of implants."

CITE: OOM 320455.

Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC attorney Work Product/Privileged & Confidential


Document #278

05/16/77

MISCELLANEOUS - LOBBYING

MISCELLANEOUS - ORGANIZATIONAL SURVEY

Helmer memo to Sanders regarding Breast Implant Manufacturers Association,

California meeting. 515(B): First meeting of manufacturers called by Dick

Compton of McGhan because he "desired that an association be formed of the

manufacturers of breast implants." Al Cohen requested a study be jointly funded

by manufacturers on the issue of constrictive capsules. Tom Talcott of

Heyer-Schulte tells Jerry Helmer of Surgitek that Heyer-Schulte is not in favor

of a trade association research program. Other manufacturers are not in favor of

trade association for joint research either and inform Dr. Jack Fisher, ASPRS,

they would instead support a workshop to discuss issues with plastic surgeons.

CITE: MEM 415 - 417, Exhibit to Lynch Deposition, Exhibit to D. McGhan

Deposition, Exhibit to Sanders Deposition, and Exhibit to Compton Deposition.

Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #279
05/26/77
RUPTURE
SHELL STRENGTH - THICKNESS
Complaint analysis prepared by Woodard and forwarded to Rathjen.

CITE: M 460026 - 460028 and M 570200 - 570203, Exhibit to MKL Rathjen Deposition.

Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #280
06/16/77
SHELL STRENGTH - THICKNESS
RUPTURE - CLOSED CAPSULOTOMY

A.H. Rathjen, Dow Corning, reports a telephone call from Dr. Ben T. Gregory regarding two incidents of ruptured mammaries immediately upon attempting to "pop a capsule," i.e., performing a closed capsulotomy. Upon explantation, Dr. Gregory found a quantity of loose gel. The doctor called to let the company know that, "He does not subscribe to those in his profession who claim that--under no circumstances when you 'pop a capsule' will you break and implant."

CITE: M 570125, Exhibit 13 to Harris County Rathjen Deposition. DUPLICATE: M 240322; KKH 001616.


Document #281
08/12/77
TISSUE REACTION
SHELL STRENGTH - THICKNESS
RUPTURE

Eldon Frisch, Dow Corning, memo to Virg Metevia regarding Dr. Julius Henry-Cohen's article on capsular contracture. Frisch states, "during discussions with John Madden, M.D., we had reached a conclusion that probably most cases which develop thick fibrous capsules do so because of trauma to the fibrous capsule which creates local tissue damage and minute ruptures in the capsule without producing a major rupture which leads to complete loss of capsule integrity.... Damage to fibrous tissue is generally painful, and associated with rupturing of small blood vessels leading to small hematomas and an increase in the inflammatory process." Frisch also states that ruptures most likely occur because "during certain activities such as love making, vigorous hugging, strenuous physical exercise," and that "physicians can completely rupture a fibrous tissue capsule by externally squeezing the implant." (emphasis added).

CITE: OOM 320474 - 320476. NOTE: Dow Corning was not warning in its product inserts of rupture or recommending that doctors not perform closed capsulotomies.

Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #282

08/24/77

KNOWLEDGE OF GEL BLEED

COHESIVENESS - LIQUID COMPONENT OF GEL

John R. Hilliard, Dow Corning, writes to Bob Gruber of Surgical Appliances

Industries Inc., regarding a new gel to consider as an alternative to the

current gel. The new gel, X7-2339, bleeds only 60% more than the current gel,

Z7-2339, while the pre-1976 gel bleeds almost 600% more than the current gel.

CITE: M 250044. Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #283

08/31/77
RUPTURE
TISSUE REACTION

Dow Corning Telephone call report noting a person who developed severe bilateral nfections seven days post-op. She entered the hospital with a temperature of 105 degrees in a "life threatening situation. Upon opening up the chest cavity, the doctor found large quantities of puss. ... In an effort to forestall a potential lawsuit, I told the doctor that I would recommend free replacement of these prostheses -- even though no rupture upon removal.

CITE: KHH 35213.

Dow Corning Trial Exhibit List Abstract
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #284

09/07/77

TISSUE REACTION

KNOWLEDGE OF SYSTEMIC DESEASE

Dr. Ashley sends Art Rathjen, Dow Corning, a letter and medical records of a

silicone injection patient who developed a mass the size of an orange and

experienced reddening, hardness and itching at the injection site on the thigh.

The pathology report notes there was a "chronic inflammation reaction."

CITE: KMM 418633 - 418656, Exhibit to MDL Rathjen Deposition. DUPLICATE: I 6182 - 6190.
Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #285

09/07/77

TISSUE REACTION

KNOWLEDGE OF SYSTEMIC DISEASE

Dr. Ashley sends Art Rathjen, Dow Corning, a letter and medical records of a

silicone injection patient who developed a mass the size of an orange and

experienced reddening, hardness and itching at the injection sit on the thigh.

The pathology report notes there was a "chronic inflammation reaction."

CITE: KMM 418633 - 418656, Exhibit to MDL Rathjen Deposition. DUPLICATE: I 6182 - 6190.
Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document

09/29/77

SHELL STRENGTH - THICKNESS

RUPTURE

Petraitis, Dow Corning, memo to Roush and Becker setting forth "The Reasons For

Proceeding With An Inflatable Introduction." Petraitis notes that the clinical

evaluations "indicated a high incidence of deflations: but claims that most were

caused by small pinholes in the envelope. He assumes he can improve the envelope

to prevent these pinholes by making it thicker. Petraitis concludes, "I feel

that any risk associated with marketing the inflatable made from the improved

envelope without additional clinicals is certainly worth taking.... The decision

to delay introduction is equivalent to eliminating the product forever."

CITE: KMM 149569 - 146570, Exhibit to Petraitis Deposition, and Exhibit to MDL

Rathjen Deposition. Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #286

09/30/77

ACKNOWLEDGEMENT OF NEED FOR TESTING

MISCELLANEOUS - RECKLESS/CONSCIOUS DISREGARD

Roush, Dow Corning, memo to the Medical Business Board announcing that the

Implants PMG has decided to introduce the inflatable mammary prosthesis at the

Plastic Surgery Show on October 30, l977. There is a risk being assumed in doing

this since the product has not been clinically tested. The PMG believes,

however, that the risk of the Product not performing is much smaller than the

risk of losing market share. Dow Corning was concerned with a permanent loss in

market share unless it moved quickly. (emphasis added).

CITE: KMM 333267. DUPLICATE: KMM 149564 - 149566.

Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #287
10/03/77
ACKNOWLEDGEMENT OF NEED FOR TESTING
RUPTURE
MISCELLANEOUS - RECKLESS/CONSCIOUS DISREGARD
FRAUD/MISREPRSENTATION

Rathjen, Dow Corning, memo to PMG and MPPBB (Medical Products Business Board) reiterating his objection to marketing the inflatable prosthesis when there are doubts about its efficacy. He notes, "This suggestion was turned down because some members of this business thought the product would indeed stand up. Well, it hasn't!" Rathjen believes the product's efficacy should be determined after clinical trials and not merely "on the bench...." He believes it is a "moral issue ... whether Dow Corning was really, truly being honest and straightforward with our customers?" He recommends the product be tested further on 50 patients over the next four to five months and hard facts be developed before introduction as surgeons believe a ten percent deflation rate is absolutely unthinkable. (emphasis added).
CITE: KMM 333259 - 333261, Exhibit to Oppelt Deposition, and Exhibit to MDL Rathjen Deposition. DUPLICATE: OOM 321512 - 321514. NOTE: The deflation rate with the inflatables over a nine month period was 12%.
Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #288

10/06/77

KNOWLEDGE OF SYSTEMIC DISEASE

STERILIZATION/CONTAMINATION

TISSUE REACTION

Hobbs memo to Atwell, Bey, Lentz, LeVier, Owen, Pearce, Ryan, A. Smith, F.

Stark, J. Campbell, S. Guittard, L. Tyler and D. Weyenberg regarding "Minutes

from 2,6-cis meeting of 9/20/77." Certain unvulcanized food grade elastomers

contain 250-450 ppm 2,6-cis, 996 resin contains approximately 50 ppm, and DC 550

fluid using the new process contains 1-5 ppm. The verbal results of the genetic

tests on 2,6-cis show positive results and "indicate aggressive action is

necessary to evaluate the potential hazard of this impurity." Hobbs states that

he has obtained technical and legal opinions from Joe Raddzius and Dr. Steve

Carson.

CITE: DCC 281031108, Exhibit to Tyler Deposition, and Exhibit to LeVier

Deposition. Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #289

10/20/77

COHESIVENESS - LIQUID COMPONENT OF GEL

FRAUD/MISREPRESENTATION

STERILIZATION/CONTAMINATION

Peters, Dow Corning, memo to Chandler with copies to Lentz Wendel and Rathjen

regarding mammary gel review, part II. The molecular weight given for the gels

are much lower than actual since the gels have a significant amount of branching

and are polydispersed. X7-2151 would be the better gel for implantation since

for a given penetration it has a high molecular weight distribution. The report

also lists trace metal amounts for various gels.

CITE KMM 453922 - 453928. Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #290
10/26/77
ACKNOWLEDGEMENT OF NEED FOR TESTING
RUPTURE
MISCELLANEOUS - RECKLESS/CONSCIOUS DISREGARD

Log of a telephone conversation in which Rathjen, Dow Corning, tells Dr. G. Perrin he is unhappy with the marketing department's decision to introduce an inflatable mammary that had a 14 percent deflation rate when tested. He says he was concerned about the decision and feels "there is an ethical matter involved here." Dr. Perrin replies "if you are too hasty (sic), things backfire on you. Both of us know that...." (emphasis added).
CITE: KMM 255487 - 255488

Document #291
10/26/77
ACKNOWLEDGEMENT OF NEED FOR TESTING
RUPTURE
MISCELLANEOUS - RECKLESS/CONSCIOUS DISREGARD

Log of a telephone conversation between Dr. Glazer and A. Rathjen, Dow Corning. Dr. Glazer says he is surprised they were putting the inflatable mammary implant on the market without all of the data being collected and feel such a move is premature. Rathjen agreed and stated, "There is no two ways about that, but it hasn't been tested...." Rathjen feels that he has "been muscled and I am mad because here we said we were going to stop and retrench and they insisted the thing keep going." Rathjen states that he is prepared to resign because his "reputation is on the line as it relates to the silicone injection fluid...." (emphasis added).
CITE: KMM 194463 - 194466, Exhibit to Oppelt Deposition, and Exhibit to MDL Rathjen Deposition.
Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #292

11/10/77

GEL MIGRATION

Dr. Jerrold Abraham responds to Eldon Frisch's letter of 10/21/77. He states, "I

am quite disappointed by your letter of October 21, 1977. It seems you remain

unwilling to accept the fact that I am able to identify the silicone material in

the tissues and to separate it from contamination from dust, glass, etc.... The

FDA has expressed interest in supporting some limited studies, but they will not

of course, support studies designed to improve your implantable devices. They

must limit their support to studies testing available devices already on the

market."

"I must have examined human tissue from patients with implants and find no

difficulty in identifying the silicone material migrating from prostheses in

joints." (emphasis added). Dr. Abraham goes on to request an opportunity to

review animal specimens from earlier studies and informs Frisch of improved

detection techniques. "This latter technique has provided additional

confirmation that the material we are looking at is indeed the

polydimethylsiloxane rubber. I urge you to reconsider and to aid in this study

of your long term animal implantation experiments."

CITE: OOM 320482 - 320483. Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #293

12/07/77

FRAUD/MISREPRESENTATION

Jim Bolland, Dow Corning, responds to Woodard analysis of Arm No. 0964 and

"Complaint Forms And Their Resolution." He indicates that the complaint

procedure does not seem like it designed to give doctors qualitative information

regarding their complaint. "If the idea of returning defect material to you is

to cover ourselves from the liability point of view then perhaps we should know

this and we will be careful not to tell the doctor that he can expect a full

report when his complaint is being investigated."

CITE: COM 494. Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #294
12/15/77
SHELL STRENGTH - THICKNESS
RUPTURE

Frank Lewis, Dow Corning, Memo to Milt Hinsch regarding the "inordinate rate" of ruptures occurring with mammary implants. Lewis lists four doctors who are experiencing "abnormal percentage(s) of ruptures." Dr. Don Davis of Lansing, Michigan with 14%, Dr. Fusilero of Lorain, Ohio with 32%, Dr. James Scarcella of Lakewood, Ohio with 12% and Dr. Richard Straith of Detroit, Michigan with 11%. Lewis states, "I am sure some of these were the fault of the doctor, but that alone could not account for such a high percentage of ruptures. These doctors have on the average ten years of experience in this procedure."
CITE: M 240328 - 240329. NOTE: A handwritten comment is at the bottom of the memorandum and reads, "A detailed study of mammary rupture frequency is being made and should be completed by 1/31/78 for the year 1977. Data to be made available from Midland Marketing." DUPLICATE: F 731 - 732; M 570147 - 570148; M 460300 - 460301; KMM 351899; KKH 1631 - 1632; KHH 67459 - 67460; KKA 88982. NOTE: No such studies have been located.
Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #295

00/00/78

COHESIVENESS - LIQUID COMPONENT OF GEL

KNOWLEDGE OF SYSTEMIC DISEASE

MISCELLANEOUS - COMPLICATIONS

TESTING

TISSUE REACTION

Publication by LeVier, Chandler and Wendell titled "The Pharmacology of Silanes

and Siloxanes, Biochemistry of Silicon and Related Problems." pages 473-514. The

salient features of silicon chemistry that may be considered of interest to life

scientists have been reviewed while the biochemistry of silicon compounds has

received only brief comment because this subject remains largely unexplored.

Indeed, so little is known that we continue to categorize structures only on the

basis of intended use with some consideration for bioavailability and a few

emerging trends relating activity to structure and reactivity. This approach at

least allows a clear division of though between popular silicones known for

their lack of bioactivity and the less well known reactive silicon compounds.

CITE: DCC 281061312 - 281061353; Exhibit 64 to Bennett Deposition (used by Dow

Corning). Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #296
01/20/78
SHELL STRENGTH - THICKNESS
RUPTURE

Rathjen, Dow Corning, memo to various members of the Marketing Department - Nelson, Hoyt, Bey and Hinsch - and to members from Dow Corning's in-house Legal Department - Steinberg and Lewis. Rathjen reports that the current deflation rate for the inflatable clinicals from January to August 1977 is 22%. Several patients had bilateral deflations.
CITE: KMM 333270. DUPLICATE: KMM 261276 - 261277.
Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #297

02/28/78

FRAUD/MISREPRESENTATION

MISCELLANEOUS - COMPLICATIONS

TISSUE REACTION

Tyler memo to Campbell, C. Lentz, John Ryan, Weyenberg, Gergle, Hartlein and

Maneri regarding "Adventitious 2,6-cis." "I am concerned lest Dow Corning

employees generate an unwarranted number of documents containing adventitious

2,6-cis.. I see no reason for any documents not authorized or reviewed by C.

Lentz or L. Tyler. Even the verbal communications can be very simple. We know of

no health problems associated with the extremely low levels of adventitious

2,6-cis in hundreds of Dow Corning products. However, there could be a

'business' risk associated with adventitious 2,6-cis. Because of (the business

risk) we are proceeding to eliminate adventitious 2,6-cis from almost all Dow

Corning products." There is a handwritten note to copy to Stark and LeVier.

CITE: DCC 281031106, Exhibit to "Weyenberg Deposition, Exhibit to Harris County

LeVier Deposition, Exhibit 9 to Harris County Tyler Deposition, Exhibit to MDL

Tyler Deposition, Exhibit to Ryan Deposition, and Exhibit to LeVier Deposition.

Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #298
03/02/78
SHELL STRENGTH - THICKNESS
RUPTURE

Dow Corning salesman, Frank Lewis, informs Milt Hinsch that he has experienced an "excessive number of ruptures" in the Detroit area. Numerous doctors report an increase in ruptures and are commenting, "Noticing a difference in the envelope."
CITE: F 729 - 730. DUPLICATE: M 570150 - 570151; KMM 3919 - 3920.
Dow Corning Trial Exhibit List AbstractsPENDLETON/PSC Attorney Work
Product/Privileged & Confidential

Document #299

03/10/78

ACKNOWLEDGEMENT OF NEED FOR TESTING

KNOWLEDGE OF LIQUID SILICONE DANGERS

TESTING

TISSUE REACTION

Study titled "Biological Evaluation of an Implantable Silicone Gel: Summary of

Acute and Chronic Studies" by Lentz, Chandler and LeVier. The authors report:

"The current data do not support the use of X7-2151 gel by direct

instillation. While no deleterious effects were noted, the long term

localization of the gel is uncertain as is the end point of the tissue

reaction. To permit use of this gel by instillation, future studies should

address the questions of whether the reaction stops short of complete

dispersal of the gel, whether gel fragments are carried to remote sites and

if so the fate of this material, whether this reaction is dependent upon the

ways of gel injected, and whether a similar fragmentation occurs in humans."

CITE: DCD 154000246 - 154000266, Exhibit to Weyenberg Deposition. DUPLICATE: KMM 174130 - 174159l. Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #300

03/16/78

ACKNOWLEDGEMENT OF NEED FOR TESTING

KNOWLEDGE OF SYSTEMIC DISEASE

Bob LeVier, Dow Corning, memo to Bey and Nelson (both are in the Marketing

Department) proposing development of the implantable gel implant. He writes,

"The 180-day rabbit gel implantation study led to two conclusions based on the

data:

l. The evidence for progressive subdivisions of gel is sufficient to warrant

the conclusion that a hypothesis favoring efficacy in mammary augmentation

and/or mammary reconstruction cannot be supported without further

experimentation.

2. The evidence for the presence of small isolates of gel surrounded by

potentially phagocytic cells is sufficient to raise a theoretical question

concerning dissemination of gel or its components.

LeVier states that animal studies are needed on these issues and on questions

relating to gel subdivision "by connective tissue and gel-associated systemic

toxicity," He has designed a study which will provide the "minimally required

information ... (in) the shortest practical time course for completion and at as

low a cost as possible." (emphasis added).

CITE: F 744 - 746. DUPLICATE: M 3320004 - 320005.
Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #301

04/10/78

STERILIZATION/CONTAMINATION

Dow Corning Complaint Report 20602 notes a "hair inside package."

CITE: CRM 296 - 300. DUPLICATE: KKH 33333.
Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #302
04/17/78
SHELL STRENGTH - THICKNESS
RUPTURE

Rathjen, Dow Corning, memo to Gant regarding the deflation problems of the Varifil Mammary Prosthesis. Some clinicians report deflation rates as high as 8 out of 13 patients. Rathjen states "the most important factor for all of us to keep in proper perspective is that a mammary implant, with very few exceptions, is expected to function and remain in the human body for the lifetime of the patient.... Therefore, in no way can we even remotely think that a mammary prosthesis that has functioned for six months and failed is any worse than one that has functioned for a year or 18 months, and then deflated. When a product stays inflated for four months and then deflates overnight, we can't blame the doctor." (emphasis added).
CITE KMM 333262 - 333264, Exhibit to MDL Rathjen Deposition.
Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #303

05/17/78

GEL MIGRATION

TESTING

TISSUE REACTION

Lentz, Chandler and LeVier, Dow Corning, report on the "Biological Evaluation Of

An Implantable Silicone Gel: Summary Of Acute And Chronic Studies." They write:

"The majority of subcutaneous implant sites at three and six months showed

subdivision of the gel mass by bands of fibrous connective tissue. The

current data does not support use of this gel by direct instillation. While

no deleterious effects were noted, the long term localization of the gel is

uncertain as is the endpoint of the tissue reaction. To permit use of this

gel by instillation, future studies should address the questions of whether

the reaction stops short of complete dispersal of the gel, whether gel

fragments are carried to remote sites and if so the fate of this material,

whether this reaction is dependent upon the mass of gel implanted, and

whether a similar fragmentation occurs in humans."

CITE: KMM 174130 - 174159, Exhibit 33 to Harris County Peters Deposition,

Exhibit 30 Rathjen Deposition (used by Dow Corning), Exhibit to Harris County

Tyler Deposition, Exhibit to Weyenberg Deposition, and Exhibit to Ryan

Deposition. DUPLICATE: KMM 453860 - 453893; DCC 80061699 - 80061732; DCC

281002010 - 281002045. Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #304

06/00/78

KNOWLEDGE OF GEL BLEED

MISCELLANEOUS - COMPLICATIONS

TISSUE REACTION

Donald E. Barker, M.D., Marvin I Retsky, M.D. and Sherill Schultz, R.N., report

in the Plastic and Reconstructive Surgery Journal that, "Modern silicone bag-gel

breast implants leak silicone gel through the bag, the amount leaked varies from

one implant to another and is not constant for any type or brand, and the

silicone will be found in fibrous thickening and various degrees of inflammation

will be found in capsules surrounding the implants...."

CITE: M 260116 - 2601121, Exhibit 44 to Harris County Duel Deposition (used by

Dow Corning), Exhibit 37 to Frisch Deposition (used by Dow Corning), Exhibit to

D. McGhan Deposition, Exhibit to Oppelt Deposition, Exhibit 2B to Harris County

Talcott Deposition (used by Dow Corning), Exhibit 2 (and 125) to Harris county

Rathjen Deposition, and Exhibit to Steward Deposition. DUPLICATE: D 3583 - 3585,

M 260269 - 260275. Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #305

09/06/78

SILICA

The Department of Health, Education and Welfare issues a pathology report on

monkeys exposed by inhalation to Amorphous Silica-F (99.5% of its particles are

less than one micron in size). Noting that "the abundance of vacuoles containing

fine bands of connective tissue is significant in view of previous reports that

amorphous silica is innocuous," the report concludes that the "effects of

particulates containing silica ... should be a cause for concern."

CITE: KMM 313106 - 313110. Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #306

10/18/78

FRAUD/MISREPRESENTATION

KNOWLEDGE OF LIQUID SILICONE DANGERS

MISCELLANEOUS - COMPLICATIONS

MISCELLANEIOUS - RECKLESS/CONSCIOUS DISREGARD

TISSUE REACTION

Swanson memo to Ludington, Hargreaves, Maneri, Layne, Tyler, "Reed, Griffin,

Klauser, Bott, Dion, Seeberger and Schumack regarding Zemker & Associates

communications clinic. A prepared question of Mr. Layne states that Dow

Corning's marketing strategy apparently dictates that the responsibility stops

with the doctor. But according to MS. Magazine there is a 60% complication rate.

The question asks that many people have trouble understanding that since Dow

spends a few million dollars promoting the safe sealants and defoamers to the

end user why doesnít it spend a red cent to give thousands of young women the

true facts about implants and at the same time warn them about silicone breast

injections. The question goes on to ask if Dow doesn't feel some ethical and

moral responsibility to do more than you are doing.

CITE: DCC 80021587 - 80021589, Exhibit to Tyler Deposition.
Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #307
00/00/79
RUPTURE - CLOSED CAPSULOTOMY
SHELL STRENGTH - THICKNESS

A brochure entitled "Suggested Surgical Procedures for Silastic Mammary Prostheses" states that "an alternative to surgical release of a tight capsule is the closed compression technique for rupturing a contracted capsule around a breast implant." (emphasis added).
CITE: M 660189 - 660204, Exhibit to MDL Rathjen Deposition.
Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #308
00/19/79
KNOWLEDGE OF SYSTEMIC DISEASE
GEL MIGRATION
RUPTURE

Handwritten letter advising that the gel represents a potential rupture or immunogenic problem and a mild inflammatory problem which is probably beneficial since this will stimulate encapsulation of the gel and help minimize gel migration. Gel will probably eventually be found in the regional lymph nodes. (emphasis added).
CITE: M 460274.
Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #309
02/13/79
SHELL STRENGTH - THICKNESS
RUPTURE
MISCELLANEOUS - RECKLESS/CONSCIOUS DISREGARD

Dow Corning minutes of a PMG (Product Marketing Group) meeting with R. Rylee, G. Jakubcvzak, A. Rathjen, M. Nelson, A. Bey and others. Three areas of importance concerning the inflatable mammary prosthesis were discussed- ethical/morality, legal, and business. The 1972 study was presented which showed there was a deficiency in the envelope.

Jakubczak reported failures in the clinicals were the result of pinholes of undetermined origin. (NOTE: This is inconsistent with Rathjen's prior memos.) Rathjen outlined his ethical concerns that "no matter when the product fails, it is the fact that it did fail...." There was discussion whether Dow Corning should stay in the market with the inflatable, do clinicals on the HP envelope, or market the HP. Marketing claimed that the field results showed there was no problem. Rathjen, however, stated that his clinical experience showed there was a "definite serious problem." (NOTE: See Rathjen's memos throughout 1977 and 1978). Bey, in Dow's Marketing Department, proposes that they put the HP on the market but increase envelope thickness to 7 mils. The HP will replace what's on the market but there will be "no recall."


Rylee questions two different sets of data from marketing and clinical and whether "Dow Corning is selling quality. The notes reflect: "1. Do we stay on the market with the existing product? (lack of clear existing data); 2. Do we introduce it without clinical trials?... A subjective decision." Dow then reviews the damages to patients: "Damages - minimal with deflation (saline) much more with gel migration." They again reaffirm there will be no recall, that the HP will be phased in, and Dow Corning will do limited clinical evaluations.
CITE: KMM 261081 - 261085, Exhibit to MDL Rathjen Deposition.
Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #310
02/27/79
GEL MIGRATION
KNOWLEDGE OF GEL BLEED
RUPTURE
SHELL STRENGTH - THICKNESS

Del Petraitis memo to Bill Oppelt, both of whom are former Dow Corning
employees who are now at McGhan Medical. Petraitis is critical of Dow
Corning's inflatable shells because of their method of dipping which results
in significant differences in thickness, making the shells "very susceptible
to aneurysm formation."

With gel-filled implants, the shell thicknesses are less. Also, he states that
Dow Corning's gel "achieves its responsiveness by utilizing a large quantity
of non-functional polymer in the gel formation.... This free polymer is not
chemically cross-linked and is only mechanically trapped in the gel matrix.
As a result, it is free to migrate through the shell and makes the entire implant
much more prone to the 'bleed' phenomenon."
CITE: MCG 8487 -8489, Exhibit to Coyne Deposition, Exhibit to Grosh
Deposition, Exhibit to Oppelt Deposition, Exhibit to Schreiber Deposition,
and Exhibit to Petraitis Deposition.
Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #311

04/04/79

KNOWLEDGE OF GEL BLEED

GEL MIGRATION

Gene Jakubczak, Dow Corning, memo responding to Bill Overton's, sales

representative in Texas, memo to Milt Hinsch discussing gel bleed and the effect

of therapeutic radiation. Jakubczak begins by stating, "I remain intrigued that

what appears to be obvious TS&D activities continue to be sent to the marketing

function. Is this by design? Is it due to lack of response from TS&D? Do sales

personnel understand TS&D functions? Do sales personnel understand who to

contact? Enough!!"

In response to question of mammary bleed, Jacubczak states that Dow Corning's

"fluid injection program ... does give some guidance on what happens when

polydimethylsiloxane is injected in-vivo. Dow Corning does have data from its

industrial sales effort on polydimethylsiloxane fluids. The buildup in organs is

reviewed however, I do not know what it says.... If you detect reluctance on

DC's part to provide data bear in mind that most surgeons (obviously not all) do

not deal well with scientific accuracy as it impacts on data interpretation."

(emphasis added).

With regard to Overton's question on what material is bleeding, Jacubczak states

that, "The material referred to as bleed represents the soluble fraction of the

prosthesis gel component. Bleed is silicone (polydimethylsiloxane polymer)...."

In addition, "Silicone bleed has been shown to move out and away from the gel

prosthesis. Insufficient information exists to say how much and where it travels

and accumulates, if it does, much less what are its affects. Dow Corning again

from the industrial sales side, does have data on polydimethylsiloxane fluid and

its bio path and the effects in the body." (emphasis added).

Finally, in response to whether there is any difficulty with x-ray and

mammography exams of women with breast implants, "experience will usually

overcome difficulties.' Also, Jakubvczak will review the effect of therapeutic

radiation on implants.

CITE: M 250045 - 250047. Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #312
06/29/77RUPTURE
SHELL STRENGTH - THICKNESS

Vaz da Silva, Dow Corning, memo to Venn and Beyruth regarding ruptures. She states, "Our sales could be bigger if these ruptures didn't happen. As I have already said, our Plastic Surgeons are afraid of using our Mammary Prosthesis and with complete reason. At first I was thinking that was (the) fault of the surgeons but now, I really don't think this." A handwritten note at the top of the document from Venn to Bob Becker states, "I think her comments are self explanatory. Hope we begin seeing more uniform envelopes and non-reinforced patches soon."
CITE: CR 4006 - 4007.
Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #313

07/03/79

KNOWLEDGE OF SYSTEMIC DISEASE

MISCELLANEOUS - COMPLICATIONS

TESTING

TISSUE REACTION

Study by Spielvogel, Robinson and Hanneman titled "Metabolism of Cis and Trans

2,6 Diphenylhexamethylcyclotetrasiloxane In The Rhesus Monkey, Rat and Man," by

Speilvogel, R.J. Robinson and Hanneman. A copy was sent to John Ryan, Bey, Frye,

Hobbs, C. Lentz, Boley, Nelson, Rylee, Stark, Tyler, Weyenberg and others.

CITE: DCC 281002046 - 281002085 (Temporary Dow Corning Bates Number 3781-3820),

Exhibit 6 to Isquith Deposition. Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #314

09/28/79

SHELL STRENGTH - THICKNESS

MISCELLANEOUS - RECKLESS/CONSCIOUS DISREGARD

Dr. Gordon Robinson Jr. letter to A. Rathjen, Dow Corning, stating he had to

replace 13 out of 16 inflatable mammaries that were part of the clinical trial

since they deflated. He states, "I feel like the handwriting is on the wall.

This was a bad adventure." (emphasis added).

CITE: KMM 256659 - 256660, Exhibit to MDL Rathjen Deposition.
Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #315
11/07/79
SHELL STRENGTH - THICKNESS
RUPTURE
COHESIVENESS - LIQUID COMPONENT OF GEL
GEL MIGRATION
TISSUE REACTION

Operative report from Dr. Vinnik's patient. Patient reported being involved in a "very trivial accident, when she struck her right breast against the 'monkey bars' while playing with her child in a playground." During explantation for the ruptured prostheses, Dr. Vinnik noted that the gel ran "down the patient's chest, onto the operating table and onto the floor.... This procedure is performed because of medical necessity as a ruptured breast implant can produce serious medical problems.... Free silicone gel, particularly when it is non-cohesive as (sic - has) been known to migrate through the local area, and produces severe granulomatous response." (emphasis added).
CITE: KMM 423161. NOTE: See KMM 423155 - 423156.
Dow Corning Trial Exhibit List Abstracts

Document #316
11/08/79
SHELL STRENGTH - THICKNESS
RUPTURE
Dr. Vinnik's cover letter to G. Jakubczak, Dow Corning, sending him the 11/07/79 operative report about a broken implant. He states, "The implant ... was definitely defective and decidedly not up to the proper standards.... I am very distressed about this apparent breakdown in quality control, as I have removed many broken Dow Corning products....

(Dow Corning) should have a recall ... of some sort to the physician."

CITE: KMM 423153 - 423154.
Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #317

11/13/79

KNOWLEDGE OF LIQUID SILICONE DANGERS

MISCELLANEOUS - COMPLICATIONS

TISSUE REACTIONS

Letter to Dr. Goldwyn from Dr. Murray, with a copy to Rathjen, regarding patient

who received 4 silicone injections, 4 years earlier, who was having pain and

lesions in her face near and adjacent to sites of injection; microscopic report

revealed epidermal inclusion cyst without any evidence of silicone fluid. Murray

will follow "with great interest because one wonders if some of the long term

results with liquid silicone may be undesirable."

CITE: DCC 106003480 - 106003481, Exhibit to MDL Rathjen Deposition
Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #318

00/00/80

ACKNOWLEDGEMENT OF NEED FOR TESTING

TESTING

Hunter handwritten notes regarding 2, 6-cis project new ventures milestones for

1980. He notes that Dow Corning used Dow Chemical's laboratory and its

subsidiary, Lepetit, to conduct testing on 2,-cis.

CITE: DCC 281031798. Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #319
01/22/80
KNOWLEDGE OF SYSTEMIC DISEASE
RUPTURE

Joseph Connelly, M.D., writes to Dow Corning Wright about a patient whose
Silastic implant ruptured when she was involved in car accident. The implants
were removed shortly thereafter because the patient experienced draining fluid
from the implant through the skin. The patient's family doctor performed tests
"which he says are suggestive of chronic lupus erythematosus." He wants to
know if Dow Corning has any information whether the silicone implants can
cause lupus. (emphasis added).
CITE: CM 1133 -1134. He writes a second letter on 04/01/80 because Dow
Corning did not respond to the first letter. For Dow Corning's response, see
04/23/l80 entry.
Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #320

03/14/80

KNOWLEDGE OF GEL BLEED

Milt Hinsch, Dow Corning, memo to Bartolo, Gant, Peters, Jakubczak, Haas, and

Smith stating that, "We are now saying (seeing) extremely greasy lots of Gel

Saline Mammary implants. The H.P. envelope accentuates gel bleed." (emphasis in

original).

CITE: KMM 518831. Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #321
04/14/80
RUPTURE
SHELL STRENGTH - THICKNESS

Memo from W. Lynch and W. Stich to the Medical Engineering Corporation
Field Force. They discuss Dow Corning's new shell material for their inflatable
implant and claim that this new shell has twice the tear resistance of their former
material. "Regrettably one of the characteristics of silicone rubber is that it has a
very low tear strength. Even if Dow Corning has made a shell with twice the tear
strength of what they presently have, the new value will still be low compared to
other materials, such as Saran Wrap." (emphasis added)
CITE: MEA 22 - 25. DUPLICATE: MEC 7835 - 7838: MEC 9278 - 9180,
Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #322
04/23/80
KNOWLEDGE OF SYSTEMIC DISEASE

Dow Corning responds to Joseph Connelly, M.D., concerning his inquiry about a patient who developed lupus erythematosus following a rupture of a Silastic mammary implant. William Boley, senior Group Leader for the Health Care Group Research, responds:

"Dow Corning has performed extensive safety testing, in animals, on the silicone materials from which SILASTIC breast implants are made. I have also reviewed our product complaint files. Your inquiry appears to be the first Dow Corning has received asking whether a silicone breast implant could be a causative agent for chronic lupus erythematosus.

The data Dow Corning has suggest that it would be highly improbable that your patient's symptom of chronic lupus erythematosus could be attributed to the silicone breast implants."

CITE: CM 1135. NOTE: See 01/22/80 entry.
Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #323

04/29/80

KNOWLEDGE OF GEL BLEED

MISCELLANEOUS - RECKLESS/CONSCIOUS DISREGARD

B. Schnabel, a Dow Corning salesman, writes Milt Hensch regarding a complaint

from a customer, F. Grazier, M.D. The doctor is complaining about excessive gel

bleed and a "greasy" feel to the envelopes. "The lot number involved is H129700.

It has been brought to my attention that this particular lot was put on the

market with prior knowledge of the bleed problem." Schnabel continues, "As you

know he (Dr. Grazer) had a bad experience with our varifils and with our gel

salines he has yet another bad experience and we wind up with egg on our face.

To put a questionable lot of mammaries on the market is inexcusable. I don't

know who is responsible for this decision, but it has to rank right up there

with the Pinto gas tank." (emphasis added).

CITE: F 629 - 630. DUPLICATE: M 250021; M 570058; F 628; KMM 232092 -232093; M

250022 - 250023; M 570059. Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document # 324

05/07/80

KNOWLEDGE OF GEL BLEED

Yolanda Sue Peters and R. Gant, Dow Corning, author an internal Lab Report For

Silastic II Mammary Implant Bleed Study. Gel bleed is "a property common to all

gel-filled prostheses" which is attributable to the semi-permeable nature of

silicones and the similarity in the composition of the gel and the envelope.

Test results show that the fluorosilicone coating of the mammary envelope

reduces the bleed by approximately 90%."

CITE: KMM 136950 - 136958. DUPLICATE: D 2926 - 2935; KMM 151111 -151120; T 8417

- 8425. Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #325

05/29/80

ACKNOWLEDGEMENT OF NEED FOR TESTING

TESTING

TISSUE REACTION

Report by Dow Corning Toxicology Department, authored by Ronald Annelin,

entitled, "Trace Analysis of Organosilicon In Human Urine And Milk By The ASFT

Technique." The report concerns the use of the Aqueous Silanol Functionality

Test to determine the organosilicon level in human urine following the

incidental inhalation of Dow Corning 344 Fluid Vapors. Also included is a single

analysis of human breast milk. All of these samples contained detectable amounts

of monomethyl and dimethyl silicon species. Nearly twenty percent of the

estimated intake of Dow Corning 344 fluid was excreted in the urine in the eight

hours following exposure. The presence of monomethyl silicon in the urine

suggests that cyclic dimethyl species undergo demethylation during human

metabolism.

Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential

CITE: DCC 284020681 - 284020686, Exhibit l to Frye Deposition, Exhibit 1 to

Petraitis Deposition, Exhibit to Isquith Deposition, and Exhibit 3 to MDL

Rathjen Deposition.


Document #326

07/01/80

DOCUMENT DESTRUCTION

M. Gill memo to J.C. Smith, Dow Corning, regarding returned materials -

complaints file. Gill reports that complaints had been taken to the Bio Lab for

investigation. "It was noticed that all boxes had been removed from the Bio Lab

and destroyed. It was discovered that the janitors had removed all these boxes

and destroyed them.... These complaints ... will not be investigated."

CITE: CR 5489 - 5490. DUPLICATE: KKM 25426 - 25427.
Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #327

07/16/80

TISSUE REACTION

KNOWLEDGE OF SYSTEMIC DESEASE

"R. LeVier, Dow Corning, memo to W. Boley and L. Veresh, regarding immediate

adverse reactions to mammary gel implants from two patients of Dr. Charles

Stone. Both patients experienced rapid evolution of wound edema with

inflammation and tissue breakdown 3-6 weeks after implantation. LeVier recalls 8

patients who experienced allergic reaction to silicone fluid. "It may be that

there is a small population capable of a vigorous immune rejection response to

silicone fluid/elastomer; could be a complement mediated response." (emphasis

added)

CITE: M 240072. DUPLICATE: KMM 197618. Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #328
07/22/80
COHESIVENESS - LIQUID COMPONENT OF GEL
RUPTURE
ACKNOWLEDGEMENT OF NEED FOR TESTING

Dr. Vinnik writes to Jakubczak, Dow Corning, regarding a "defective Dow Corning prosthesis." The patient reported a sudden onset of pain, changing consistency of the implant, and changing configuration of the left breast. Vinnik states:

"At surgery, you will note the Operative Report findings of an apparently defective gel in terms of both consistency, cohesiveness, and possibly color.... What we need to have accomplished is a thorough evaluation as to why this implant had a late failure. Was the problem inherent in the bag? Were there variabilities of thickness of shell, less than those of design tolerances? Why is this gel not cohesive as it should be? This is the second implant that we have removed which has been non-cohesive, and has shown spontaneous rupture for no apparent reason.... We need to consider whether or not a recall of all patients bearing this Lot number should be made. I think it may be wise to at least alert physicians that there may be a problem with this particular lot number.

CITE: KKH 53276 - 53277.
Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #328

07/22/80

COHESIVENESS - LIQUID COMPONENT OF GEL

RUPTURE

ACKNOWLEDGEMENT OF NEED FOR TESTING

Dr. Vinnik writes to Jakubczak, Dow Corning, regarding a "defective Dow Corning

prosthesis." The patient reported a sudden onset of pain, changing consistency

of the implant, and changing configuration of the left breast. Vinnik states:

"At surgery, you will note the Operative Report findings of an apparently

defective gel in terms of both consistency, cohesiveness, and possibly

color.... What we need to have accomplished is a thorough evaluation as to

why this implant had a late failure. Was the problem inherent in the bag?

Were there variabilities of thickness of shell, less than those of design

tolerances? Why is this gel not cohesive as it should be? This is the second

implant that we have removed which has been non-cohesive, and has shown

spontaneous rupture for no apparent reason.... We need to consider whether

or not a recall of all patients bearing this Lot number should be made. I

think it may be wise to at least alert physicians that there may be a

problem with this particular lot number."

CITE: KKH 53276 - 53277. Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #329

07/31/80

MISCELLANEOUS - COMPLICATIONS

TISSUE REACTION

Letter to Dr. Goldwyn from Dr. Woolf, cc to Rathjen, regarding patient in the

silicone study who "was doing very well until March of this year, when suddenly

the face flared up again on both sides. ... The temperature in the area she was

visiting in Mexico was about 110 degrees, and her face completely flared up

again. ... When she returned again, she had a definite abscess in the left

cheek, just beneath the anterior border of the zygomatic arch ... The abscessed

area has resolved, but she still has diffuse swelling in both cheeks, with some

overlying discoloration."

CITE: DCC 106006691 - 106006692, Exhibit to MDL Rathjen Deposition.
Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #330

11/19/80

KNOWLEDGE OF GEL BLEED

Handwritten note from J. Reitsma to M. Hinsch, both of Dow Corning Wright,

regarding problems with the gel-saline implants. He states, "Milt, I feel we

have a potential problem with the quality of our gel-saline mammary prosthesis,

that is gel bleed in excessive amounts going through the outer membrane in such

volume as to cause a greasy look and feel to the using surgeon." Several

physicians have refused to use the product stating that they have no confidence

in it - "it's to (sic) damn greasy." Reitsma informs Hinsch that the gel-saline

product "has me feeling uneasy about its quality and even safety. I can not in

good faith introduce this product to a competitive or new account."

CITE: KMM 232094 - 232095. Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #331

12/10/80

KNOWLEDGE OF SYSTEMIC DISEASE

MISCELLANEOUS - COMPLICATIONS

TESTING

TISSUE REACTION

"Metabolism of Octamethylcyclotetrasioxane in the Monkey, Report No. 5265," by

Spielvogel and Robinson. A copy was sent to Boley, Hobbs, C. Lentz, LeVier,

Stark, Frye, Ryan, Speier, Bey and others. D4 was administered orally to two

monkeys and the excretions (urine and feces) were collected and examined. Gas

chromatography-mass spectrometry revealed the presence of three metabolites:

dimethylsilanediol, tetramethy1-1,3-disiloxane diol and

hexamethyl-1c5-trisiloxane diol. The authors reasoned that D4 might undergo

metabolic transformation to either an alkyl hydroxylated and/or conjugated

species or silanol functional species that would likely be soluble in moderately

polar solvents." (KP 30523).

D4 appears to be well absorbed from the gastro-intestinal tract and broadly

distributed throughout the body. The primary route of excretion is urine. "The

bio-transformation of D4 is similar to that 2,6-cis and

2,6-trans-diphenylhexamethyltetrasiloxane and diphenysilanediol. All of the

compounds appear to be readily hydroxylated and as a result are converted from

highly lipophilic compounds to highly polar, easily excretable metabolites." (KP

30626). Also, "The metabolic fate of D4 closely parallels the metabolic fate of

2, 6-cis and 2, 6 - transdiphenylhexamethylcyclotetrasiloxane. All of the cyclic

siloxane compounds examined to date are metabolized to a series of low molecular

weight polar compounds that are predominantly excreted via the kidneys."

CITE: T 8796 - 8813, Exhibit to Harris County Ruhr Deposition, Exhibit to

Bennett Deposition, Exhibit to Isquith Deposition, Exhibit to LeVier Deposition,

Exhibit 4 to Stark Deposition, Exhibit to Compton Deposition, Exhibit to Ryan

Deposition, Exhibit to Isquith Deposition, and Exhibit 31 to Zimmer Deposition.

DUPLICATE: KKM 22739 - 227560 Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #332

02/09/81

KNOWLEDGE OF SYSTEMIC DISEASE

GEL MIGRATION

Boley, Dow Corning, memo to Frisch, LeVier, Spielvogel, Cooper, Rylee, and

Wessel regarding "Baboon Study To Evaluate the Fate of Silicone Wear Particles."

Boley notes that:

"Silicone particles have been found in the axillary lymph nodes of patients

with Silastic finger joints. These particles have been detected as a

consequence of biopsy of nodes that have become painful and enlarged.... Of

concern to the surgeon is whether these particles will continue to migrate

beyond the regional nodes into the thoracic or abdominal cavities. Since

concerns about malignancies requires that any chronic swelling of lymph

nodes be biopsied or excised, wear particles could create the need for a

surgeon to breach the body cavities.

CITE: KMM 328166 - 328167. DUPLICATE: KMM319434 - 319435. Dow Corning Trial

Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #333

03/05/81

KNOWLEDGE OF LIQUID SILICONE DANGERS

TESTING

Yolanda Sue Peters, Dow Corning, letter to Dr. Frank Gerow requesting his

information and data that supports the use of gel for implantation. All the data

Peters has contraindicates its use in this manner. She understands that Dr.

Gerow has both animal studies and clinical information on the implantation of

gel for augmentation of soft tissues areas such as the face and breast.

CITE: M 320037. Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #334

04/16/81

KNOWLEDGE OF SYSTEMIC DESEASE

TESTING

Gerry Schoenig, Toxicology Consultant for Dow Corning, reviews the data from the

Two-Year Implant Study of Q7-2159A and MDF-0193 Gels at Industrial Bio-Test

Laboratories (IBT). He finds "fibrosarcoma around implant and malignant lymphoma

in rat colony said we had a problem with cancer."

CITE: KMM 390371 Dow Corning Trial Exhibit List Exhibit Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #335

04/29/81

ACKNOWLEDGEMENT OF NEED FOR TESTING

GEL MIGRATION

KNOWLEDGE OF GEL BLEED

Peters, Dow Corning, memo to Jacubczak, Marlar, Rylee and Wessel reporting that

Dr. Gerow has requested an injectable gel for soft tissue augmentation (face and

breast). There is very little published data on the fate of implanted gel. Some

authors feel that the gel which bleeds from the envelope contributes to capsular

contracture. Dow Corning data indicates that the gel is subdivided by

vascularized connective tissue, which could result in the site of the

implantation becoming very firm (breast) and/or transport of gel away from the

site. No data was received from Dr. Gerow. Seventeen of twenty doctors who were

asked for their opinions said they were not in favor of the concept. The

commercialization of such a gel would require long term animal studies, careful

definition of the material, an IND and a campaign to overcome the bad press and

emotions associated with the disastrous results reported from silicone fluid

injection. (emphasis added).

CITE: KMM 140223 - 140228, Exhibit to Blocksma Deposition, Exhibit to Peters

Deposition, and Exhibit to MDL Rathjen Deposition.
Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #336

05/19/81

ACKNOWLEDGEMENT OF NEED FOR TESTING

DOCUMENT DESTRUCTION

Bill Boley memo to Sue Peters and other Dow Corning employees regarding

"Biological Safety Testing of LS Q4-2840." Boley has "serious reservations"

about using LS Q4-2840 to replace LS 422 as an internal coating for low bleed

mammary prostheses. Boley states, "My conservative nature requires me to say

that any material intended for long-term implantation in the human body should

have long-term animal implant testing." At present, "Q4-2840 as a formation

(has) no long-term implant data." However, Dow Corning decides to go with a 6

month study. "if in the future safety problems should arise due to the use of

Q4-2840 for this application I am sure the decision to not do 2-year animal

testing would be questioned. Therefore, I think it is important that this be a

business decision and not a personal decision.

In my judgment the proposed testing is adequate and ethically appropriate."

(emphasis added).

CITE: DCC 8200651 - 8200616. NOTE: On the copy M 170172, there is a handwritten

note dated 06/30/81 stating, "LS 422 may be discont. 2840 is potential repl. is

"HP" LS is (illegible) modulus closer than LS 422." NOTE: Attached to the

version of DCC8200615 is a one page handwritten note which states, "No

litigation reason to keep the records in this file. It should be brought into

Rec. Retention Policy Compliance." This Same handwritten notes is located at KKA

119791. DUPLICATE: D 885; M 170172; KKA 228295.
Dow Corning Trial Exhibit List Abstract

PENDLETON/PSC Attorney Work Product/ Privileged & Confidential

Document # 337
07/22/81
MISCELLANEOUS - RECKLESS/CONSCIOUS DESREGARD
RUPTURE

Hinsch, Dow Corning, memo to Jakubczak, Kelly, Burda, Jack Smith, Marlar,
and Wessel regarding a marked decline in sales of the Varifil inflatable. "For
1980, we had approximately $10,000 in prelitigation expenses for Varifil
mammary deflations. Y-T-D through July, 1981, we have approximately $16,000
in prelitigation expenses. With a decline in sales and an increase in prelitigation
expenses, we should review our position with this product again."
CITE: KMM 78011 - 78039
Dow Corning Trial Exhibit List Abstract
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #338

08/00/81

ACKNOWLEDGEMENT OF NEED FOR TESTING

FRAUD/MISREPRESENTATION

MISCELLANEOUS-ORGANIZATIONAL SURVEY

MISCELLANEOUS-PRODUCT LABELING

MISCELLANEOUS-SALES

TESTING

Dow Corning News for July/August 1981 containing an article on product

liability. The article discusses the three theories of product liability,

describes how Dow Corning fulfills its duty, and describes the anatomy of a

lawsuit. The article also states that Dow Corning should follow the

recommendations of Jenkins by continuing to refine its product, implement

stronger training, refine and clarify warnings, make sure these warnings are

explicit, review the marketability and pricing of products, continue strong

research efforts and continue to study each product as it is being used to make

sure any potential hazards are made known. The article also recommends that

Sales, Marketing and TS&D avoid denying the importance of written disclaimers as

found in the product literature, avoid making erroneous verbal representations

about a product's performance and avoid promising to take care of any problems

in the use of the products.

CITE: DCC 282001978 - 282001997. Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #339
09/16/81
TISSUE REACTION
RUPTURE
SHELL STRENGTH - THICKNESS
MISCELLANEOUS - RECKLESS/CONSCIOUS DESREGARD

C. Burda, Dow Corning, handwritten notes regarding the Varifil prosthesis,
"Probably most vulnerable in product line w/regards to efficacy and litigation.
Potential for class action suit. Product did not have clinical testing. Rathjen
recommended that product not be put into market. Charged w/writing protocol
but technical people did not follow... Poor field performance led to 78 decision
to go to Failure to Varify causes: 1. contracture, 2. infection, 3. rupture (good or
imperfect products both may fail). Varifil may have small pinhole & fluid will leak
out. Also may actually split...." (emphasis added).
CITE: KMM 78006 - 78007.
Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #340
09/16/81
SHELL STRENGTH - THICKNESS
RUPTURE
SHELL DEGRADATION
Dr. Vinnik letter to Bob Rylee, President of Dow Corning Wright. He states, "I am
considerably worried about the failure rate of gel implants, and this correlates with
the research that has been done by Mr. Garth W. Hastings of England on the matter
of shell fatigue." Dr. Vinnik reports a second patient experienced shell fatigue also.
CITE: KMM 427907.
Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #341
09/16/81
TISSUE REACTION
RUPTURE
KNOWLEDGE OF SYSTEMIC DISEASE

Dr. Vinnik's operative report to Dow Corning notes a patient who experienced
a rupture and found an "irregular nodular mass" in her right breast which "became
increasingly fibrotic and dense, raising some concern about malignancy. At surgery,
the right breast was found to be totally disrupted with the implant shell incorporated
within the gel mass.

Contiguous with the gel mass and separately isolated by capsule, was a roughly
4x6 cm irregular nodular mass which upon excision was an obvious siliconoma."
The attached pathology report notes that, "The process ranges from a fibrous
rather acellular one through concentrations of lymphocytes and plasma cells to
small foreign body type giant cells tending to form granulomas. One section
demonstrates an acute necrotizing inflammatory cell reaction."
CITE: F 687 - 689
Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #342
09/23/81
KNOWLEDGE OF LIQUID SILICONE DANGERS
SHELL STRENGTH - THICKNESS
TISSUE REACTION
RUPTURE
Dr. Vinnik writes a second letter to Bob Rylee, President of Dow Corning Wright,
regarding a failed silicone gel implant. He writes,

"(T)here is suspicion in my mind that we are dealing once again, with
a shell failure. You will see from the enclosed Pathology Report that this
patient had considerable silicone reaction to the extruded material. Review
of the sections by the same pathologist who has reviewed all of the silicone
injection material with me over the past twelve years shows this reaction to
be as marked a reaction as we ever saw with the silicone injections. I
believe this proves the point that 'pure silicone' can cause severe foreign
body reactions in susceptible individuals." (emphasis added).

CITE: F 685 - 686. DUPLICATE: M 780645 - 780646.
Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #343

11/16/81

SILICA

Gene Jakubczak, Dow Corning, informs Sue Peters of a telephone conversation with

Dr. Charles Vinnik on 10/10/81. Dr. Vinnik believes that the work performed by

Garth Hastings and Paul Wulfusander (sic: Wilflingseder) (his European

partners), concerning phagocytoses or silicone shedding from the breast

prosthesis, is a factor in the failure of an implant. Also, Dr. Vinnik thought

the LS bleed resistant mammary implant was "worse than what was brought out

previously." Jakubczak informs Dr. Vinnik, "that we would review the data ...

plus Dow Corning's own internal data to determine... the fate of silica shedding

from the breast prosthesis." Jakubczak says Dow Corning is also looking at data

on the permeation of drugs out of silicone.

CITE: F 728. DUPLICATE; KMM 447167; DCC 242031444. Dow Corning Trial Exhibit

List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #344

11/30/81

SHELL STRENGTH - THICKNESS

Sue Peters, Dow Corning, memo to Milt Hinsch discussing the shelf life of the

Silastic and Silastic II implants after (1) year. "After one year shelf life,

the Silastic standard mammary has a 78.6% decrease in tear resistance, a 31.6%

decrease in tensile strength, and a 23.3% decrease in elongation." "The Silastic

I and Silastic II No Barrier also have significant decreases in tear resistance,

tensile strength and elongation after a one year shelf life." (emphasis added).

CITE: M 160031 - 160036. DUPLICATE: M 180106 - 180107; M 570068 - 570073; D 247 - 248; F690 - 691; KKA 227400 - 227401; M 180136 - 180137). NOTE: Breast

implants lose 50% of their strength when left on the shelf for 1 year but

plastic surgeons were never informed. Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #345

12/10/81

MISCELLANEOUS - COMPLICATIONS

TESTING

TISSUE REACTIONS

Monthly activity summary for a 14-day subchronic oral gavage study with

octamethylcyclotetrasiloxane (D4) in rats absolute and relative liver weight

data. Lists organ weight data for females foe each animal number and to dosage

levels.

CITE: P 15115. Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #346

12/22/81

TESTING

TISSUE REACTION

Hughes Research and Development sends a letter to W. Boley, Dow Corning,

regarding the proportion of rats with malignant lymphoma in groups treated with

TX-1210 and TX-1211 fluid. It states "We feel that there is a treatment related

increase in the incidence of malignant lymphoma in male and female rats treated

with TX-1210 and TX-1211...."

CITE: KMM 33826 - 33827. DUPLICATE: KMM 330368 - 339374. NOTE: KMM
339368 includes KMM 339369 - 339374 which is a revision of the histopathology
report to evaluate the carcinogenic potential of TX-1208, TX-1209, TX-1210 and
TX-1211 (Dow Corning B-7811 implant study in albino rats).
Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #347
01/12/82
SHELL STRENGTH - THICKNESS
RUPTURE - CLOSED CAPSULOTOMY

Sue Peters, Dow Corning, memo to Milt Hinsch regarding closed capsulotomies
and the Silastic II mammary prosthesis. "Please make it very plain to your sales
people that it is incorrect to promote or to imply any benefit of this mammary
because of increased strength allowing a closed capsulotomy to be performed.
We have no data to support that type of claim or implication."
CITE: D 4897. NOTE: Dow Corning did not warn of the risks of closed capsulotomy
with the Silastic II until 1986.
Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #348

02/04/82

CONCEALING FROM FDA

FRAUD/MISREPRESENTATION

Handwritten notes concerning the history of the Dow Corning Varifil implant.

(Handwriting appears to be Chick Burda's). He notes that in 1977, Petraitis

warned Bey and Jakubczak that the "boob tester was indicating failure and

Petraitis wanted to spill the story but was not listened too (sic). Petraitis

quit." The author also noted that Rathjen was told that it was a business

decision and to "fall back." (emphasis added).

CITE: KMM 261745 - 261746. Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #349

03/30/82

SHELL STRENGTH - THICKNESS

SHELL DEGRADATION

Dr. Bernard Morgan writes to Dow Corning Wright regarding implants which "showed

heavy leaching and were almost disintegrated.... I would like to know if there

is a change in the envelope which produces spontaneous disintegration and/or

whether this leaching is a phenomenon which has been reported to you

previously."

CITE: KMM 23084 Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #350

04/08/82

CONCEALING FROM FDA

515(B): Betty Lock Wiles, Manager of Regulatory Affairs, Medical Engineering,

sends their outline on proposed reclassification to HIMA. (MCG 004946 - 004951).

Harvey Steinberg, Senior FDA Legal Counsel to Dow Corning, also sends their

outline and comments to HIMA.

CITE: MCG 4953 - 4956 Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #351
04/22/82
KNOWLEDGE OF LIQUID SILICONE DANGERS
TISSUE REACTION
RUPTURE
GEL MIGRATION
MISCELLANEOUS - PRODUCT LABELING

Dr. Vinnik sends a letter regarding his meeting with G. Jakubczak, Bob Rylee
and Tom Brown, Dow Corning, in which he details many breast implant problems
and his proposed solutions. He recommends changing the patient and physician
pamphlets to include warnings on shell fatigue, rupture, and gel migration. He
provided Jakubczak with the pathology reports of a patient who showed such "
...extensive and violent silicone reactions comparable to the worst of those seen
with the old silicone injections."
CITE: KMM 140193 - 140197. duplicate: KMM 243027 - 243031; MM354986- 354990.
Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #352

05/10/82

ACKNOWLEDGEMENT OF NEED FOR TESTING

KNOWLEDGE OF SYSTEMIC DISEASE

J. Cooper, Dow Corning, memo stating that the Two-Year Implant Study of Q7-2167

and Q7-2168 was flawed and useless. Cooper states that, "Prior to completion of

the study and interpretation of the results IBT (Industrial Bio-Test

Laboratories) was cited by the FDA for poor clinical/laboratory practices

including loss of records and falsification of data. The corporation was

subsequently dissolved." In addition, "the data were considered highly suspect

because of abnormally high disease rates among all of the test animal groups --

including the saline injected and untouched groups.... We have since had

opinions from several external pathologists and veterinarians that the colony

was disease ridden and the entire exercise was badly flawed and useless. We have

concluded this study has resulted in no usable information and that no

conclusions can be drawn from it. We are now back at the same point we were at

in 1975 except that we have expended $200M in the study and its subsequent

evaluation/condemnation." (emphasis added).

CITE: F 814 - 815. DUPLICATE: m 170070 - 170071: M 430209 - 430210; KMM 361951 - 361952; KMM 339375 - 339378. NOTE: Dow Corning has no long-term studies and, even though they admit that "we still need the two year study...," Dow Corning does not begin another such study until 1988.
Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #353

05/14/82

TISSUE REACTION

KNOWLEDGE OF SYSTEMIC DISEASE

Dr. Robert Parsons, Professor of Surgery at the University of Chicago, writes a

letter to Gene Jakubczak at Dow Corning informing them of their research on

implanted silicone prostheses. "our data suggest strongly that the fibrosis and

capsular contracture seen clinically maybe (sic) an immunologically mediated

phenomenon." (emphasis added). Dr. Parsons states that macrophages aggregate
and adhere to the surface and actively erode the silicone envelope after

implantation: macrophages ingest and process silicone; macrophag-lymphocyte

communication occurs by intracellular bridging in the lymph nodes and have

identified silicone containing microvacuoles in both the macrophages and

lymphocyte ends of the bridges; and significant inhibition of macrophage

migration by silicone sensitized lymphocytes in vitro has been shown. Dr.

Parsons, Dr. Heggers and their research assistant, Nir Kossovsky, suggest that

their work may enable them to develop a method of screening patients for

"hypersensitivity to silicone" before they are implanted.

The research team found that the body's reaction to silicone created giant

cells called macrophages that erode the silicone envelope and can migrate to the

lymph nodes. Dr. Parsons believes that the body's immune reaction could be

causing such problems as capsular contracture. Requests for finding from Dow

Corning for further research to better understand this immune response were

denied by the company.

CITE: F 748 - 749. DUPLICATE: FDA 19612 - 19613: KMM 447084 - 447085;
Staff Report prepared by the Human Resources and Intergovernmental
Subcommittee of the Committee on Government Operations, December, 1992, p. 15.
Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #354

05/17/82

FRAUD/MISREPRESENTATION

CONCEALING FROM FDA

Dow Corning submits its portion of the industry-coordinated response to the

proposed reclassification to HIMA. Dow Corning's portion consists of a

discussion of the long-term effect of silicone breast implants.

CITE: MCG 5454 -5462. Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #355

10/19/82

TISSUE REACTION

KNOWLEDGE OF SYSTEMIC DISEASE

Eldon Frisch, Dow Corning, responds to Richard Swett, M.D., concerning an

allergy-type reaction to Silastic brand implants made from medical grade

silicone. Frisch states:

"Clinically, the implants have been used in several million patients with

very few reports of suspected inflammatory or allergic reactions. In the

past, with one recent exception, when the reactions were evaluated by patch

testing, by subdermal implantation of a small specimen, or by cell culture

studies of the implant the reactions have universally been negative."

Frisch notes another report of a potential allergic reaction to silicone

reported by George Francis, M.D. (emphasis added).

CITE: M 480031 - 480032. Dow Corning Trial Exhibit List Abstracts

PENDLETON/PSC Attorney Work Product/Privileged & Confidential


Document #356

05/20/82

CONCEALING FROM FDA

515(B): Two meetings take place in Washington D.C.: one in the morning for

manufacturers and HIMA, and afternoon meeting for manufacturers, ASPRS and HIMA, and afternoon meeting for manufacturers, ASPRSS and HIMA. 3M, Dow Corning, Medical Engineering Corporation, ASPRS, HIMA, and the AMA attend the meetings. Harvey Steinberg, Dow Corning's FDA Counsel, Tells group that reclassification is important to Dow because from the industry standpoint "$$ have to be diverted, generated for PMA. (This) effects how co.'s practice - sites, plant

improvements ..., effects how management allocates resources. Very significant

cost factors enter in." (MCG 5427 - 5431). He also states that "Risks 40 yrs.

down the road cannot be determined." Betty Lock Wiles, Surgitek, writes a memo

to Surgitek personnel about the May 20 meeting and states that the manufacturers

"reviewed the cost, time, and liability affect of Class III."

CITE: MCG 5427 - 5431. DUPLICATE: MED 11222.


Document #357

06/03/82

MISCELLANEOUS - LOBBYING

TESTING

Letter to Goldwyn from Rathjen regarding the unacceptable situation with the

clinical investigators, "I am missing annual follow-up reports (see protocol),

photographs, injection reports, etc. With a very few investigators, the lack of

attention to the protocol is absolutely unacceptable. ... The FDA doesn't want

to hear excuses why investigators' records are incomplete or why there is an

apparent lack of control or attention to detail. ... This impression concerning

the conduct and results could conceivably carry over into other device areas,

i.e., the breast prosthesis reclassification." Strongly worded letter.

CITE: DCC 106006096 - 106006099, Exhibit to MDL Rathjen Deposition. Dow

Corning Trial Exhibit List Abstracts