Smoke Fire Documents 401

Document #404

07/10/84

KNOWLEDGE OF SYSTEMIC DISEASE

MISCELLANEOUS - COMPLICATIONS

Gregory follow-up of patient no. 50. The patient had minor arthritic changes in her hands.

CITE: B 804 - 805, Exhibit 18 to Harris County Rathjen Deposition, and Exhibit to MDL Rathjen Deposition. Dow Corning Trial Exhibit List Abstracts

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Document #405

08/01/84

Joint Research Agreement For Identification Of Agricultural Chemicals between Dow Corning (signed by Weyenberg) and Dow Chemical (signed by P. Gehring). Dow Chemical produces and sells pesticides, herbicides, insecticides, acaricides, nematocides and fungicides and has developed expertise in perceiving structural-activity relationships in non-organosilicon compounds. Dow Corning has expertise in the synthesis and manufacture of organosilicon compounds referred to as silicones. The parties will work together to “identify commercially salable organosilicon compounds and formulations therof with biological activity as pesticides in the agricultural chemical field...: Dow Corning appoints Dr. John Ryan as its representative: Dow Chemical appoints Dr. Yulan Tong. The Joint Research Program will begin with 1 or more meetings between the designated representatives. Dow Chemical will disclose the type of pesticides it seeks to develop and the kinds of chemical structural groups that DOW believes impart desired agricultural chemical properties. The parties may select compounds for screen tests by Dow Chemical. The designated representatives shall generate a plan for conduct of the Joint Research Program. The information developed under this program shall be kept confidential for 10 years.

CITE: DCC 2001173 - 2001192. Dow Corning Trial Exhibit List Abstracts

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Document #406

08/14/84

KNOWLEDGE OF GEL BLEED

SHELL STRENGTH - THICKNESS

RUPTURE

R. Dumas, Dow Corning, memo to G. Jakubczak and others regarding “Project Report - Complaint Analysis, Plastic Surgery.” Dumas details the number and types of complaints received on mammary implants and notes that the most common complaints for the gel-saline units were of a greasy surface and post-op deflation from pin hole leaks. Upon inspection, it was determined that the pin holes were caused by “burs on the wire screen in the wash area.... Many of the pin hole leaks examined suggested origination from this source.” Dumas states that, “The appearance of some of these units made me sympathize with one surgeon stating that he believed we were soaking the units on (in) Mazola oil before shipping. Since this bleed appears to be inherent in the current design of the product a standard response has been developed to answer (sic) this type of complaint.” (emphasis added). NOTE: design defect.

The most typical complaint for the Silastic II is post-op suture or rupture during insertion. “The tear propagation (sic) noted with the ruptures was found to be of a much less degree compared with the standard gel product.... There is an indication that there may be more susceptibility to rupturing during insertion than that found with the standard gel unit.”

Dumas noted that most of the complaints concerning the standard gel mammaries (sic) were of the “ease of tear propagation (sic). In addition non-uniformity of the envelope was noted along most tears examined, suggesting thickness variation to be a contributing factor to the rupture.” NOTE: manufacturing defect. Dumas’ overall recommendations are that Dow Corning needs to develop a more uniform envelope thickness on all products, reduce bleed characteristics, and increase stress resistance in the Silastic II.

Dumas also documents the practice of sending returned implants to TS&D from the Medical Plant in mail envelopes via the plant mail. “Many of the units arrived in a smashed condition making analysis extremely difficult. Imagine trying to analyze a mammary flattened like a pancake inside a gel soaked mail envelope.”

CITE: KKA 119771 - 119774. Dow Corning Trial Exhibit List Abstracts

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Document # 407

08/27/84

KNOWLEDGE OF SYSTEMIC DISEASE

MISCELLANEOUS - COMPLICATIONS

Operative report of a Gregory patient indicates a “tingling numbness which radiates up and down both legs. The point of onset varies each time; it may start in the groin, thigh or calf region but always involves both legs” She was diagnosed with aortofemoral stenosis.

CITE: B 1017 - 1019, Exhibit 10 to Harris County Rathjen Deposition, and Exhibit to MDL Rathjen Deposition. Dow Corning Trial Exhibit List Abstracts

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Document #408

09/24/84

SHELL STRENGTH - THICKNESS

SHELL DEGRADATION

Dr. Muller sends a letter to Dow Corning Valbonne regarding a rupture in situ. When he performed the explantation, he found only gel and no envelope. “In our opinion, this result is very critical.” He requests information from Dow Corning.

CITE: M 460195. NOTE: Dow Corning does not respond to the substance of Dr. Muller’s inquiry for three years when, after considerable letter writing, Jakubczak answers him in a letter dated 08/13/87. Dow Corning Trial Exhibit List Abstracts

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Document #409

10/22/84

KNOWLEDGE OF SYSTEMIC DISEASE

TESTING

Devries and Siddiqui, Dow Corning, report the results of the “Acute Oral Toxicity Study of Diphenylmethylsilanol In “Rats, “TX-84-0110-03. Signs of toxicity exhibited by rats include lethargy, tremors, slight ataxia and coma which terminated in death. The authors conclude that diphenylmethylsilanol is “slightly toxic” when ingested on an acute basis targeting the central nervous system.

CITE: T 29120 - 29165. DUPLICATE: CGS 1321 - 1322. NOTE: Refers to complaint CGS 1306 -1319. Dow Corning Trial Exhibit List Abstracts

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Document 410

12/07/84

KNOWLEDGE OF SYSTEMIC DISEASE TISSUE REACTION

Veresh, Dow Corning, report on the “Ninety-Day Implant Study of Dow Corning Q7-2218 Silicone Gel System.” The pathologist noticed the presence of “a mild to moderate eosinophil infiltrate in the intramuscular and subcutaneous Q7-2218 implant sites in Rabbit #1564 at 30 days, and a trace eosinophil infiltrate at an intramuscular Q7-22l8 site in Rabbit #1570 at 90 days. Dr. Geil noted that the presence of eosinophil in a tissue response is considered indicative of an allergic response.”

CITE: T 39610 - 39704. Dow Corning Trial Exhibit List Abstracts

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Document #411

01/02/85

ACKNOWLEDGEMENT OF NEED FOR TESTING

FRAUD/MISREPRESENTATION

KNOWLEDGE OF SYSTEMIC DISEASE

TESTING

Frye memo to C. Lentz regarding “1984 accomplishments.” There is inconclusive daphnia data/D4 data. Frye also notes the “concerted year-end efforts to respond to the ITC recommendations for further testing of D4 for environmental fate and ecological impact. We might also include our efforts to head off publication of VanDerPost’s silanol nonsense in a highly respected journal. It should at least qualify as ‘fire prevention’ effort where I would also classify our correspondence relating to Shin Etsu Hondotai’s allegations of cyclosiloxane insecticidal (sic) properties and the Hutzinger et al manuscript alleging absorption and bio-transformation of a series of cyclic and linear oligomeric methylsiloxanes. Our Kyoto presentation was also an attempt to prevent silicones in aquatic sediments from being improperly categorized as ecologically threatening materials.”

CITE: FRY 364 - 366, Exhibit 2 to Ryan Deposition. Dow Corning Trial Exhibit List Abstracts

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Document #412

01/08/85

J. Cooper, Dow Corning, memo to C. Lentz, R. Rylee, H. Steinberg and K. Yerrick concerning “Biosafety Testing Concerns.” There is an apparent shift by the FDA to require animal lifetime, device carcinogenic potential testing for all new implant applications.

If we operate from the premise that lifetime carcinogen testing is required, our only approved materials are HP Elastomers, the mammary shell material (MDF0077) and MDX44515 (a peroxide catalyzed elastomer) all of which were tested in rats for two years.

Most of our claims to date have been based on a two-year dog study (five materials). However, a dog study must continue for seven years to qualify as lifetime testing. The materials used in the two-year dog test would not be approved under the lifetime test criteria. These include Adhesive A, MDF 0372 Tubing, MDF 0355 Foam Elastomer and MDF 0382 Elastomers.... Heaven forbid, is it possible the FDA will require such testing for each combination of materials for each application? This must be vigorously opposed. (emphasis added). Cooper also urges Dow Corning to conduct a study of the effects of the human immune system of silicone gels, fluids, and elastomer particles.

CITE: M 170062 - 170065. DUPLICATE: F 751 - 754; KKA 160337 - 160341. NOTE: In l985, Dow Corning is complaining about the FDA requirements which they can not meet.

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Document #413

01/29/85

ACKNOWLEDGEMENT OF NEED FOR TESTING

A.J. Isquith, Dow Corning, memo to W.F. Boley with recommendations for Dow Corning Q7-2159A gel basic genetic toxicology screening. “It is important to recognize that the tests outlined are capable of measuring genetic potential of chemical toxicity. The tests would not detect cancer potential due to hormonal imbalance (example, effect of estrogen or 2,6-cis diphenylhexamethylcyclotetrasiloxane) or cancer caused by chronic tissue destruction related to the geometry or physical state of an implanted material (solid state carcinogenicity).”

CITE: F 853, Exhibit 12 to Isquith Deposition, Exhibit to Harris County Boley Deposition, and Exhibit 19 to Harris County Zahalsky Deposition. DUPLICATE: M 170040 - 170041; M 580052. NOTE: See 03/07/85 entry. Dow Corning Trial Exhibit List Abstracts

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Document #414

02/19/85

ACKNOWLEDGEMENT OF NEED FOR TESTING

KNOWLEDGE OF SYSTEMIC DISEASE

Boley, Malczewski and Cooper of Dow Corning Health Care Group Research submit a Project Proposal titled “Investigation of the Effects of Silicone Fluids, Gels and Particles on the Immune System.” Proposed is an immunotoxicology program involving “a series of animal tests and in vitro tests designed to assess the risk of adverse immunological sequela associated with the presence of silicone materials in the human.” The authors note that silicone materials are causally linked to three different immunology-related disease states. First, a direct immunological sensitizations to implanted silicone material involving an immediate systemic response which is not correctable by explantation. Finally, the presence of silicone material in the lymphatic system may suppress the immune response to pathogenic organisms and tumor cells. Animal studies suggest that silicone materials modify the immune system both by eliciting a specific immune response and by nonspecifically enhancing or suppressing the immune system. Further, many recent clinical reports in the medical literature suggest that silicone materials elicit or modify the immune system. More sensitive testing methods by some researchers finding an immune response to silicone materials may explain conflicting reports by others who do not. Accordingly, proposed is a comprehensive screen of the immunotoxicity potential of silicone fluids, gels and particles. More than five series of sensitive in vitro tests will access nonspecific suppressing or enhancement of individual immune cell populations, as well as evaluate cell-mediated and antibody-mediated immune response to specific antigenic stimulation. Test will also evaluate the ability of animals to resist proliferation of pathogenic bacteria and tumor cells. Different species of animals will be used in the implantation studies to account for interspecies variations. Expected benefits from this testing include:

1. An assessment of the real risk potential for an immunological response to silicones.

2. An awareness of immunological problems that may erupt so that they can be engineered around if possible.

3. Five or six publications in literature to defuse the current wave of negativism toward silicones.

4. Possible ability to evaluate suspected human silicone sensitivity cases.

5. Data available for defense in lawsuits. NOTE: handwritten entry states “or prove guilty.”

The authors estimate a recourse requirement of “6 effort years...expended over a 3 year period,” and that “Health Care Group Research currently has adequate people skills and resources to conduct this work.

CITE: KMM 386643 - 386659, Exhibit to LeVier Deposition, Exhibit 21 to Harris County Hayes Deposition, Exhibit to Boley Deposition, Exhibit 12 to Popoff Deposition, and Exhibit to Isquith Deposition. Dow Corning Trial Exhibit List Abstracts

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Document #415

03/07/85

ACKNOWLEDGEMENT OF NEED FOR TESTING

KNOWLEDGE OF SYSTEMIC DISEASE

B. Boley, Dow Corning, responds to A. Isquith’s memo of 01/29/85 on “Genetic Toxicology Screen of Dow Corning Q7-2159A Gel.” Boley states, “There is currently no valid carcinogenic test data on the silicone mammary gel Q7-2159A. I recognize that short term in vivo and in vitro mutagenicity tests are no substitute for a 2-year animal carcinogen study.... I feel the Health Care Business has an obligation to do what it can to assess the carcinogenic potential of this material.... Without this testing, I think we have excessive personal and corporate liability exposure.” (emphasis added”.

Boley authorizes tests such as the Ames Test, InVitro Forward Mutation Test, In Vitro Chromosome Aberration Test, and In Vitro Transformation Assay Test. According to Isquith’s memo of 01/29/85, this is the “minimal testing” that would meet the FDA guidelines.

CITE” M 170039, Exhibit to Harris Country LeVier Deposition, Exhibit to Peters Deposition, Exhibit to Boley Deposition, Exhibit to Isquith Deposition, and Exhibit 20 to Harris County Zahalsky Deposition. DUPLICATE: F 851; M 580051; DCC 17016611 - 17016613. NOTE: see 01/29/85 entry. Dow Corning Trial Exhibit List Abstracts

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Document #416

03/12/85

TESTING

GEL MIGRATION

Dow Corning Health Care Group Research Report 150 by Boley and Bejarano entitled “Fate of Q7-2159A Gel Injected Sub-dermally In Rats: Macro Observations.” Fibrous tissue can infiltrate Q7-2159A gel and partition it into many smaller masses. The disappearance of 50% of the gel from the injection site is of concern. Whether the gel migrated or was trapped in capsular tissue is unknown.

CITE: DCC 800311717 - 800311729, Exhibit 9 to Bejarano Deposition, Exhibit to Frisch Deposition, and Exhibit 32 to Zimmer Deposition. DUPLICATE: F 160 - 175; KMM 297691 - 297705. Dow Corning Trial Exhibit List Abstracts

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Document #417

03/26/85

SHELL STRENGTH - THICKNESS

RUPTURE

MISCELLANEOUS - PRODUCT LABELLING

Dow Corning receives a complaint report MD2402 for an implant that ruptured necessitating removal. Dow Corning states, “Gel mammary rupture not covered by labeling.”

CITE: CO 3106 - 3112 Dow Corning Trial Exhibit List Abstracts

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Document #418

04/10/85

ACKNOWLEDGEMENT OF NEED FOR TESTING

KNOWLEDGE OF SYSTEMIC DISEASE

R. Steele, Dow Corning, memo to G. Hignite regarding subjects discussed at a Health Care Business Board Meeting, Steele notes that the mission of the Health Care Business Board is on “internal profitability issues.” One subject dealt with a presentation made by Bill Boley to the Executive Committee about a research study of the effects of silicone on the immune system. “The benefits of such a program would be to test for the real potential of immunological response to silicones.... Hopefully, we can diffuse any negativism that might exist toward silicone through publication of this data. This study would also give us the basis for an ability to potentially evaluate the sensitivity of individuals to silicone materials. Finally, the data would be available for defense in litigation proceedings.”

CITE: F 842 - 846. Dow Corning Trial Exhibit List Abstracts

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Document #419

04/11/85

ACKNOWLEDGEMENT OF NEED FOR TESTING

KNOWLEDGE OF SYSTEMIC DISEASE

TESTING

Boley, Dow Corning, Memo to Hobbs, Lentz and Cooper regarding “HCB” Research Immunotoxicology Program.” Boley states that the Health Care Business has approved research on immunotoxicology. Handwritten notes indicate that Al Munson, University of Virginia, is involved.

CITE: KMM 386642, Exhibit to LeVier Deposition, Exhibit to Boley Deposition, Exhibit 5 to Harris County Burchiel Deposition, and Exhibit to Isquith Deposition. Dow Corning Trial Exhibit List Abstracts

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Document #420

04/30/85

GEL MIGRATION

TISSUE REACTION

Krystyna Pasyk, M.D., University of Michigan, writes a report to Dow Corning concerning pathological analysis of three slides of lymph nodes from women’s tissues who were implanted with silicone breast implants. “All three slides show similar microscopic changes - hyperplasia of the lymph node sinuses with infiltration of foamy histiocytes and foreign-body reaction most probably to silicone.”

CITE: T 31093 - 31108. Dow Corning Trial Exhibit List Abstracts

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Document 421

06/04/85

MISCELLANEOUS - PRODUCT LABELLING

Art Rathjen, Dow Corning, Memo to Duel, Jakubczak, Rigas and Wessel regarding the “Revised SILASTIC II Product Insert.” Attached is Rathjen’s handwritten changes and comments to the product insert. Rathjen states in the cover memo:

It isn’t a matter of semantics, it’s a matter of being articulate, precise. In the Health Care Businesses, there probably isn’t a more important or meaningful document than this one currently under revision. I think it is important enough that each sentence should be studied and analyzed as it relates to the sentence proceeding it and the one following it. Some sentences are way too long. They ramble. There is an overdose of repetition. Some subjects are out of order or sequence. I wouldn’t have spent the time nor the effort on this revision if I didn’t feel it was important. (emphasis added).

CITE: KMM 232474 - 232480, Exhibit to MDL Rathjen Deposition. Dow Corning Trial Exhibit List Abstracts

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Document #422

06/30/85

Boley memo to Cooper, Lentz.

CITE: KMM 386490 - 386491. (TO BE SUPPLEMENTED). Dow Corning Trial Exhibit List Abstracts

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Document #423

07/17/85

ACKNOWLEDGEMENT OF NEED FOR TESTING

“A complaint from Dr. Muller is handled through Dow Corning Valbonne. Wilfried, a sales representative, inquires why no one has responded to Dr. Muller’s prior complaints and inquires. “Prof. Muller is seriously considering publishing those bad results which probably is one of the least desirable things which should happen to us here in Germany. It once more underlines the necessity to give a scientific watertight answer to problems if and when they occur. I do regard this case as serious as it could potentially damage our image here in the market and moreover could potentially do us further harm.”

CITE: M 460190. Dow Corning Trial Exhibit List Abstracts

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Document #424

07/30/85

ACKNOWLEDGEMENT OF NEED FOR TESTING

KNOWLEDGE OF SYSTEMIC DISEASE

Boley, Dow Corning, memo to Cooper, Lentz, Rylee, Weyenberg, Yerrick, DeVries, Hobbs, and Siddiqui regarding “Summary of Meeting with IIT Research Institute to Discuss Immunotoxicology Testing of Silicone Materials.” He identifies seven issues which Dow Corning must decide including “The major business issue of whether Dow Corning should commit to immunotoxicology testing of silicone materials.” (underlined portion -emphasis in original). IIT Research Institute proposes to research adjuvant disease, immune sensitization, and immune suppression. Boley is “convinced that immunological testing of at least some silicone materials used for medical applications is appropriate.” (emphasis added).

CITE: KMM 386490 - 386491. Dow Corning Trial Exhibit List Abstracts

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Document #425

08/08/85

ACKNOWLEDGEMENT OF NEED FOR TESTING

KNOWLEDGE OF SYSTEMIC DISEASE

MISCELLANEOUS - COMPLICATIONS

TESTING

TISSUE REACTION

Dow Corning Study titled “Thirty-Day Implant Study of Dow Corning Q7-2218 Silicone Gel System” by Bejarano. He states: Mild encapsulation of the gel by fibrous tissue was evident in nine of the ten test animals by unaided visual observation. Fibrous tissue encapsulation of the U.S.P. polyethylene control sites was not evident. Microscopic evaluation of tissue sections of the intramuscular implant sites revealed a greater cellular response to the Q7-2218 gel than to the U.S.P. polyethylene control. In addition, increased numbers of eosinophiles were evident at the Q7-2218 gel implant site.

The presence of eosinophiles at the Q7 2218 gel implant site suggests the possibility of immunological sensitization to a component of the gel formulation. Additional studies are required to either substantiate or disprove the possible sensitization potential of this silicone gel.

CITE: T 31514 - 31571, Exhibit to Boley Deposition and Exhibit to Isquith Deposition. DUPLICATE: KKH 40082 - 40139.

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Document #426

09/05/85

FRAUD/MISREPRESENTATION

GEL MIGRATION

KNOWLEDGE OF GEL BLEED

MISCELLANEOUS - COMPLICATIONS

MISCELLANEOUS - PREP PROGRAM

RUPTURE

RUPTURE - CLOSED CAPSULOTOMY

SHELL DEGRADATION

TISSUE REACTION

Dr. Garry Brody writes to Rylee, Dow Corning Wright, complimenting him on his “unique plans for replacing broken implants. Not only should this be effective in controlling litigation but it also ought to be an excellent marketing tool.” “Brody is referring to the PREP warranty program Dow Corning recently announced. Attached are Brody’s comments on the patient brochure. He states, “I really do feel it hits the mark with just the right balance between what the manufacturer needs to tell the physician and to transmit to the patient without discussing the medical side of things.”

Brody enclosed sample questions and answers about silicone breast implants. The proposed answers including statements such as: “Reports of serious or life threatening problems directly related to the implant itself are rare.

There is no evidence that there is any relationship between breast implants and cancer.

All silicone materials will shed tiny microscopic amounts of material which are picked up by the body’s scavenger white blood cells and filtered by the lymph glands in the arm pits.

The gel filled implants tend to bleed tiny amounts of gel which travels the same routes. This very minute quantity of silicone that escapes the implant and travels in the body appears to be harmless.

Occasionally, closed capsulotomy can cause bruising, bleeding or even rupture of the implant.”

CITE: KMM 41248 - 41261 Dow Corning Trial Exhibit List Abstracts

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Document #427

09/11/85

COHESIVENESS - LIQUID COMPONENT OF GEL

RUPTURE

MISCELLANEOUS - PRODUCT LABELING

Dr. Charles Vinnik letter to Bruce Reuter, Dow Corning Wright, concerning another implant which had lost shell integrity and the gel was “terribly runny.” He states, “I am forced to believe Gene and Lois’ hypothesis of the physical disruption of the gel by prolonged contact with tissue fluids and fat. Inasmuch as this is not generally known by my colleagues, I feel that your company has both a moral and legal obligation to make this information available through your representatives and in your literature. I am loathe to publish my series of cases as I feel that it may open a Pandora’s Box. I do feel, however that rapid dissemination of this information is very necessary to protect your company and my colleagues.” (emphasis added).

CITE: M 240116 - 240117. DUPLICATE: KMM 4625 -4626; KKH 1086 - 1087;DCC 242051124. Dow Corning Trial Exhibit List Abstracts

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Document #428

09/23/85

ACKNOWLEDGEMENT OF NEED FOR TESTING

GEL MIGRATION

D. Weyenberg memo to J. Cooper, Dow Corning, regarding an “immunomodulation Study.” Weyenberg outlines the objective of the study: What is the potential for silicone gels and fluids intended for disposition in the body, and which migrate and persist indefinitely in the body, to cause or contribute to clinically significant disorders? Where does the material accumulate: Where would theory predict it to accumulate? What might be the impact of certain accumulations? Are there elimination mechanism? Does it migrate from any initially deposited site? The phenomenon of silicone migration within the body is very central to any of these questions, and I am bothered by our apparent lack of knowledge of this phenomenon and the low emphasis on phenomenon in our potential program.

CITE: KMM 369357, Exhibit to Weyenberg Deposition. Dow Corning Trial Exhibit List Abstracts

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Document #429

10/01/85

EMBOLISM

KNOWLEDGE OF GEL BLEED

KNOWLEDGE OF LIQUID SILICONE DANGERS

MISCELLANEOUS - COMPLICATIONS

SHELL DEGRADATION

TISSUE REACTION

In an Infor-Med, Natural Y discusses the recurring problems of painful fibrosis and implant distortion associated with the standard smooth silicone implant. “The dangerous implications of ongoing fibrosis, accompanied by cell anoxia, vascular impairment and pain, have been consistently documented by microbiologists and histologists as being precursive to cancer. Additionally, the hazards of free silicone, well documented in silicone injections, are leading to more granulomas and silicone gorged lymph nodes.” The memo also describes more specific and basic areas of concern: “Smooth surfaced polymers, because of their disruptive effect on cell products, are generally regarding as unsuitable for long term implantation.... Early design smooth silicone breast prostheses—commercially available until the mid 1970’s – were vulnerable to extreme gel bleed and volume loss.... Possibility of embolism.”

CITE: MEI 4230 - 4233. Dow Corning Trial Exhibit List Abstracts

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Document #430

10/10/85

GEL MIGRATION

KNOWLEDGE OF GEL BLEED

KNOWLEDGE OF SYSTEMIC DISEASE

TESTING

TISSUE REACTION

Study titled “Characterization of C-U Silicone Elastomer Shells.” The use of plastic embedding significantly enhances our ability to resolve the presence of silicone gel as well as those cells involved in the response. Plastic embedding provides retention of the interface between the fibrous capsule and the foreign body. The silicone gel is removed from the immediate locality and taken to the periphery of the capsule where one can only assume it is then transferred to the reticuloendothelial system as observed with similar materials used in other clinical situations A significant difference in degree of cellularity, number of lymphocytes and cells at the interface is noted when gel implants are compared to the extracted implants. It is my impression that the use of silicone gel prostheses represents a significant risk to the patient. The literature suggests that individuals can develop an allergic and immunologic reaction to silicone gel and oil. It would behoove us to develop in an expeditious fashion a non-permeable silicone shell with subsequent replacement of the gel with another polymer system.

CITE: CUI 300317 - 300414, Exhibit 11 to D. McGhan Deposition, Exhibit to Oppelt MDL and Harris County Depositions, Exhibit 7 to Harris County Pool Deposition, and Exhibit to MDL Pool Deposition. Dow Corning Trial Exhibit List Abstracts

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Document #431

10/10/85

SHELL STRENGTH - THICKNESS

SHELL DEGRADATION

John Conrad, Territorial Manager for Dow Corning Wright, reports that a very loyal customer has switched to using Surgitek products. The reason for the switch is that the doctor, Dr. Mobley, experienced 6-7 post-op loss of shell integrity with Dow Corning implants including one where the “shell has been eaten away by something.” There was no evidence of a shell whatsoever. Conrad requests follow-up by Dow Corning Wright.

CITE: KMM 425114. Dow Corning Trial Exhibit List Abstracts

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Document #432

10/17/85

SHELL STRENGTH - THICKNESS

SHELL DEGRADATION

Clauss, Dow Corning Valbonne, memo to Frisch regarding Dr. Muller. Dr. Muller complained that the envelope has disappeared and suggests that there was a chemical dissolution of the envelope by the gel, that the body metabolized the envelope, or that the envelope migrated. Clauss states that the first and second hypothesis “seems for me, according to our silicone behavior knowledge, the most credible.”

CITE: M 460185. Dow Corning Trial Exhibit List Abstracts

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Document #433

12/04/85

COHESIVENESS - LIQUID COMPONENT OF GEL

KNOWLEDGE OF GEL BLEED

Matherly sends a confidential memo to Jakubczak, Dow Corning, regarding “Dow Complaint MD2579.” In it, he states that, “The claim is really extraordinary in that it alleges that gel volume has been lost while envelope integrity is maintained.” Matherly then suggests “We probably should include a carefully constructed professional statement (from you or Lois) that would discount weight loss from an intact envelope.” He also discusses the investigator’s inability to find any other problem with the prosthesis, “He, I don’t believe, meant to convey the message that I think is obvious here, and which seems to be very dangerous in that it implies something he didn’t observe.” Matherly says he is seeing enough problems in the Complaint Analyses that he is scheduling a meeting in January to review concerns and provide training.

CITE: KKH 38544. Dow Corning Trial Exhibit List Abstracts

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Document #434

12/05/85

SHELL STRENGTH - THICKNESS

RUPTURE

Eldon Frisch, Dow Corning, memo to Thiess and Wessel regarding “Rupture of Gel-Containing Mammary Implants.” Frisch states, “In about 1974, Dow Corning modified the implant in response to competitive pressure by making the envelope thinner and the gel softer and more responsive.” He concludes that “the potential for rupturing implants was quite well known, based upon the information provided by Weiner, Talcott, Bloomenstein, and Vistnes. I have always taken the position that any reasonable person would realize that a gel-containing breast implant is a rather fragile, delicate implant, somewhat analogous to a water-filled balloon....: (emphasis added”.

CITE: DCC 240000969 - 240000970. Dow Corning Trial Exhibit List Abstracts

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