What Dow Corning has to say about Fraud and Reckless/Conscience Disregard
Concealing from FDA/Fraud

Document #1
00/00/00
CONCEALING FROM FDA
FRAUD/MISREPRESENTATION
MISCELLANEOUS - RECKLESS/CONSCIEOUS DISREGARD

"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 biodurability 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.

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 

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 

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

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 the FDA. An antagonistic approach toward the 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.

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.

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.

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)

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 

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

Document #144
00/00/73
TESTING
FRAUD,MISREPRESENTATION 

Robertson and Braley, Dow Corning, author "Toxicological Studies, Quality Control, And Efficacy Of The Silastic Mammary Prosthesis," relying on the 1970 dog study. They use a chart to illustrate complications and claim that the findings are the results at the end of the two-year study, when the chart is actually the findings at six months.
CITE: T 3003 - 3006

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; DCC24000537 - 24000542; OOM 880016 - 880018. 

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

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."
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.

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.

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.

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.

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 

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. 

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).

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 Maneri’s 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."
CITE: KMM 333230 - 333234, Exhibit to Petraitis Deposition, and Exhibit to MDL Rathjen Deposition.

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."
CITE: F 633. DUPLICATE: KMM 264592. NOTE: Del Petraitis later worked for McGhan Nusel.

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.

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.’s 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.

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

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%.

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

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

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.

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 doesn’t 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.

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.

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."
CITE: KMM 261745 - 261746.

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

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

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 #359
06/30/82
CONCEALING FROM FDA

FDA: Dow corning submits its response to the FDA concerning the proposed reclassification of silicone breast implants.
CITE: KMM 275488 - 275512

Document #365
11/05/82
FRAUD/MISREPRESENTATION

L. Smith, Dow Corning, memo regarding implementation of a complaint system "Direct Response" program. She states that the reviewer should "not say anything on the form that you do not want the complainant to know." There will be a separate form to write on which will not be provided to the complainant.
CITE: KKA 236497

Document #368
01/26/83
TISSUE REACTION
KNOWLEDGE OF SYSTEMIC DISEASE
GEL MIGRATION
RUPTURE
TESTING
CONCEALING FROM FDA

Dr. Nirmal Mishra, staff toxicologist at the FDA, presents the FDA's reasons for this recommendation which include: gel migration, granulomatous foreign body reaction, loading of the reticuloendothelium system, unknown subsequent disposition in the body with little epidemiologic or experimental data on effects.
CITEP KMM 120705 - 120729, Exhibit 3 to Harris County Rathjen Deposition. DUPLICATE; M 100083 - 100143

Document #380
09/23/83
FRAUD/MISREPRESENTATION
ACKNOWLEDGEMENT OF NEED FOR TESTING
TESTING

Jim Matherly, Dow Corning Wright, memo to Jim Cooper and Jerry Zoarmp. Regarding Biological Testing of Gel For Implants Matherly states that: 

"Within the past two months, we have received inquiries relating to a broken gel testicle and a broken mammary, as well as from Cox-Uphoff and Ruthton Corporation. To our embarrassment, we were unable to provide more than tissue culture and heavy metals analysis. Furthermore, our product literature on these gels imply that safety testing to qualify them as implant materials does exist and can be obtained readily from Dow Corning."

Matherly notes an added rationale for the safety of the implants is the assumption the gel is contained in an envelope. "This supposes that ruptures do not occur or are removed quickly... (but) experience has shown this later statement to not be accurate...." Matherly concludes "Only inferential data exists to substantiate the long-term safety of these gels for human implant applications." He also points out the "data produced by IBT is ... generally suspect in the industry due to their poor laboratory practices."
CITE: m 170037 - 170038. DUPLICATE: F 854 - 855: m 430215 - 430216: F 838 - 855: KMM 483548 - 483549: KKA 4 - 5; KMM 27693 - 27694; KMM 361961 - 361962: KMM 329306 - 329309: KMM 380521 - 380522.

Document #383
10/05/83
FRAUD/MISREPRESENTATION

Bruce Reuter, Dow Corning, memo to the Territory Managers and Sales Representatives regarding Natural Y breast implants. Reuter lists Natural Y's claims about polyurethane implants and cites to medical publications which disprove their claims. Reuter criticizes Natural Y for not having supporting references for its claims. He states that, "The contracture free claim is a joke! We have had reports of infection, pre-operative rupturing and contracture from around the country." Additionally, Reuter states, "Have you felt a Natural Y prosthesis. There is no envelope around the gel, just an easy peel off foam coating. The FDA is going to move mammaries from Class II to Class III because of the concerns with gel bleed and here is a mammary that is a gel bleed time bomb."
CITE: KKH 56082 - 56087. DUPLICATE: D4503

Document #385
12/13/83
CONCEALING FROM FDA
TISSUE REACTION
KNOWLEDGE OF GEL BLEED

FDA: "The FDA inspects Dow Corning's Hemlock plan and lists numerous violations in the complaint reporting system. The investigator notes that Complaint MD 1081 dated 04/21/81 showed a "giant cell reaction with imbedded silicone particles." Dow Corning failed to follow-up this complaint and get more information. Also, there were numerous complaints about implants being "greasy" and Dow Corning had failed to respond to them. Other violations included production records, oven records, "dirt & debris on top of packaged sterile mammaries," and other problems with sterility in the dipping room and manufacturing process.
CITE: FDA 17098 - 17137

Document #395
04/26/84
DOCUMENT DESTRUCTION
FRAUD/MISREPRESENTATION
TISSUE REACTION

Handwritten note to Jakubczak, Dow Corning, that Wessel called regarding Dr. Barker. "Please call Dr. Barker re two sentences Jim thinks should be deleted to reduce product liability. 1. Chronic inflammatory cells caused by gel. 2. Gel causes contracture. Jim feels above does not reflect the truth."
CITE: M 500016. NOTE: "Dr. Barker was writing an article about capsular contracture with silicone breast implants.

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.

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

Document #440
07/08/86
SHELL STRENGTH - THICKNESS
RUPTURE
FRAUD/MISREPRESENTATION

Clauss in Valbonne, memo to Matherly and others at Dow Corning concerning Dr. Muller's five ruptured implants. Dr. Muller would like answers to the cause of the ruptures, the potential consequences of a rupture, the statistics for ruptures, and whether Dow Corning recommends that patients be followed up to check implant integrity. Clauss states that he understands the response "must be carefully prepared on the legal point of view."
CITE: M 460180. DUPLICATE: M 460196.

Document #447
00/00/87
FRAUD/MISREPRESENTATION

Dow Corning advertisement: "Silastic Mammary Prostheses." The advertisement states: "When you use the Silastic Mammary Prosthesis, you know all possible precautions have been taken:" 

"At least 207 tests-from raw materials to finished product-all for your professional protection." 

"19 years of clinical experience." 

"A half of a million mammary implants since 1962." 

"FDA registered and inspected manufacturing facilities." 

"And, if our prosthesis costs a few dollars more, think of it as your malproduct insurance."

CITE: M 700030. DUPLICATE: M 370055.

Document #453
02/23/87
ACKNOWLEDGEMENT OF NEED FOR TESTING
COHESIVENESS - LIQUID COMPONENT OF GEL
CONCEALING FROM FDA
FRAUD/MISREPRESENTATION
GEL MIGRATION
KNOWLEDGE OF SYSTEMIC DISEASE
MISCELLANEOUS - RECKLESS/CONSCIOUS DISREGARD
SHELL DEGRADATION
TESTING
TISSUE REACTION

Robert LeVier, Dow Corning, memo to Hayes, Rylee, Stark, Thiess, Weyenberg, and Yerrick regarding the "Medtox Project Final Report." Seven numbered copies of the Medtox Report were issued to the seven individuals
listed above. The final report replaces the 12/31/86 interim report. Levier asks each of the recipients to "Please discard the interim report dated December 31, 1986. (KMM 298339).

The purpose of the Medtox project was to formulate a consolidated understanding of all internally funded safety studies of silicone material relevant to the Health Care Business and to relate the findings to current safety issues as presented in the literature, by the physician community and in litigation. LeVier reviewed four sources of information: the Corporate Toxicology File 1949 - present, the DC 360 Fluid NDA 2702 file 1974, the Medical Research Report File 1980 - present, and the Corporate Mainframe Reference List 1957 - present. The report will generate a database for Dow Corning to search and will be available to the Legal Department. The first and earliest report LeVier noted was a 1949 publication. He also located and identified in the appendix 110 reports. The studies through 1963 were primarily related to antifoam compounds and emulsions used in antigas formulations. Thereafter, the studies were conducted to qualify materials. "Studies in the 1980 - 1986 period are primarily directed toward requalification of materials that have been in use for some time." 

Levier concludes that the reaction at the implantation site is an acute inflammation progressing to chronic inflammation characteristic of a mild foreign body response and that there is no evidence of systemic toxicity.

LeVier does note, however, that:  

Two studies indicate that PDMS injected S.Q. or I.P. in very large quantities (5 to 62 ml/animal) in mice and rats is disseminated broadly and polymer is microscopically visible as deposits in tissue. It is likely that these deposits are the end-stage result of phagocytic transport and aggregation of polymer.... 

Several teratology studies in rats and rabbits have shown a positive but low incidence of skeletal defects and increased fetal resorptions.

 LeVier acknowledges that silicone fluid and silicone elastomers can be found in macrophages and multinucleated giant cells. "The greater incidence of macrophages and giant cells is more characteristic of a chronic inflammatory state than usually seen around elastomer implants in the absence of abrasion particles." He notes that the silicone fluid migrates and is transported to regional lymph nodes. Further, LeVier concludes that:

The implantation site reaction to silicone gel, particularly in the form of a fabricated mammary prosthesis, is similar to that produced by fluid polymer. In the case of free silicone gel the distribution compared to fluid polymer resides in the cohesiveness of the gel.... In the case of free gel, progressive gel subdivision by connective tissue septa is superimposed on encapsulation of the entire gel mass.

 The analyses of the internal studies indicates that there are notable deficiencies among the reports. LeVier classifies these as "Nuisance Issues" and "Substantive Issues." The nuisance issues include that the study designs are outdated, the studies are of limited utility, the variety of systemic histopathologic findings is broad, and the majority of the studies were conducted by IBT and FDRL. "Both of these companies are known to have falsified data in the time period relevant to the studies conducted for Dow Corning." He does not think it likely that any of Dow Corning's studies were falsified, but he does not state the basis for this belief. 

Regarding the substantive issues, LeVier states: 

There are two specific deficiencies of importance that tend to limit the utility of the long-term studies in particular. 

1. The histopathology of the reticuleondothelial system (RES) including liver, spleen, lungs, lymph nodes and bone marrow was not examined carefully or systematically in any long-term study. Therefore, little information is available from these studies with regard to migration of implanted materials nor with regard to target tissue effects. Such an examination is rarely part of a formal toxicity study but the absence of such an evaluation is often cited as a criticism. 

 2. None of the studies incorporate a critical assessment of physiologic effects induced by the local inflammatory reaction. Nor is the nature of the local reaction assessed in detail. Thus, no information is available with regard to effects on the immune system, for example. 

In discussing the limitations of the prior studies, LeVier admits that there are no studies in which the inflammatory reactions were described and classified according to "criteria employed by researchers expert in the study of inflammation nor have any studies been designed to detect the range of systemic effects that could attend a chronic inflammatory state.... Presently, there are insufficient data to effectively understand cause and effect relationships or to defend silicones against the broadening claims of HAD stimulation.:

In discussing what corrective measures should be taken. LeVier recommends that Dow Corning should not replicate any of the studies that were flawed and outdated. He states: 

Replication of existing studies for the sole purpose of correcting nuisance problems would be very costly and would consume several years before results could be available. Some problems such as too few animal per group and too many implants per animal could be corrected but it is improbable that the spectrum of unrelated pathologic events could be materially influenced. It is such pathologic events that are used to claim systemic toxicity caused by silicone implants. The course of action (corrective measure) that is recommended is to develop sound arguments in support of the validity of existing studies. 

(emphasis added). LeVier also discusses the immunopotentiation of silicone and notes that "if immunopotentiation is prolonged in response to PDMS, then the probability may be increased that silicone has an adjuvant like effect of sufficient duration to promote development of auto-antibodies in susceptible individuals."
CITE: KMM 298296 - 298339. NOTE? The interim Medtox report is dated 12/31/86. NOTE: Includes LeVier memo sending attached Medtox report to D. Hayes, R. Rylee, F. Stark, G. Thiess, D. Weyenberg and K. Yerrick. 

Document #455
02/24/87
CONCEALING FROM FDA
KNOWLEDGE OF SYSTEMIC DISEASE
FRAID/MISREPRESENTATION

Steinberg, Dow Corning counsel, submits information to the FDA regarding the Two-Year Gel Implant Study of Dow Corning 360 Fluid and the findings of malignant lymphoma.
CITE: KMM 491863 - 491912

Document 458
04/10/87
TESTING
FRAUD/MISREPRESENTATION
MISCELLANEOUS - PRODUCT LABELLING

I.G. Hignite, Dow Corning, records the minutes of the "Health Care Businesses Board Meeting Minutes - 04/07 - 08/87" The Board decided to proceed on Talmadge Holmes' proposal to acquire 1,250 case histories from Dr. Ben Gregory. Dow Corning plans to computerize the data and publish a paper on the findings. Also, LeVier presented the results of his Medtox final report which showed that "there can be acute to chronic inflammation and mild foreign bold reaction" from silicone breast implants. He claims there was no indication of systemic reaction. The immunotoxicology testing is now to begin in September 1987. LeVier noted that Dow Corning has "not been able to define how to design experiments that measure antibody formation from silicones." Also, the Health Care Board reported that legal counsel recommended that Dow Corning settle the Stern case because of "incomplete information on our implant package inserts...." Dow Corning recommends a review of all other package inserts to bring them up to date.
CITE: F 817 - 822

Document #470
12/15/87
DOCUMENT DESTRUCTION
FRAUD/MISREPRESENTATION

Note from Winton, Dow Corning, regarding conversation he had with Don Linkert about the falsification of cure oven charts. He quotes Linkert as saying that they had gotten low on inventory and there was pressure to get product out the door. Winton claims that Linkert told him that there was some discussion about the problem and the QA department's hassling over atypical situations such as oven cycles. Winton quotes Linkert as saying that he was aware that a second chart could be run with nothing in the oven and substitute that chart for the original. Winton claims that Linkert responded to this suggestion by saying: "do what you have to, but I don't want to know about it." Mike Mitchell was fired earlier in the year for falsification of documents.
CITE: DCC 80062087 - 80062088. DUPLICATE: DCC 17015132

Document #473
01/00/88
KNOWLEDGE OF SYSTEMIC DISEASE
FRAUD/MISREPRESENTATION

Hayes, Dow Corning, writes Dear Doctor letter regarding immunological reactions to silicone. He encloses a position paper. The position paper criticizes the research done by the Japanese by claiming that fluids used were often adulterated and by claiming that the adjuvant concept is broadly misunderstood. The paper gives a brief description of the research that has been done on the problem and then states:

Unfortunately, all animal studies reported to date have been founded upon incomplete experimental designs, and interpretations and speculations that extend well beyond the support that can be provided by the data.
CITE: KMM 122710 - 122712. DUPLICATE: MD 145633 - 145635

Document #476
02/04/88
DOCUMENT DESTRUCTION
FRAUD/MISREPRESENTATION
CONCEALING FROM FDA

Harvey Steinberg, in-house legal counsel for Dow Corning, memo to the File regarding the "GMP Records Review." This document is the basis for Griffin Bell's finding in his October 12, 1992 report that Dow Corning falsified oven temperature charts, and has a typed note at the top: "Attachment I, APPROVED FOR PUBLIC DISSEMINATION ON OCTOBER 12, 1992." Steinberg writes that"  

In late Fall, 1987, Sandy Brondstetter, a sister of a mammary area employee, advised her supervisor,

Ken Montague, that dummy over (sic) cure charts were being made in the mammary area. Brondstetter and Montague investigated and found, under a desk blotter in the mammary area, an actual chart evidencing an interim oven shutdown for a lot where a chart for a cycle not exhibiting any such shutdown had been submitted with the lot history record....On December 1, at a meeting with T. Bartolo, Boone and Winter were advised that Bartolo were completely unaware of any problems with the cure ovens that would lead to anybody even having a need to be concerned about charts, at least since the new controllers and recorders were installed in late 1986 or early 1987. He admitted that with the old equipment there were a number of problems with the recorders with the result that a substantial number of problems with the recorders with the result that a substantial number of the curing charts evidenced atypical curing cycles and required management review and clearance. Bartolo admitted that he had personally prepared mocked-up charts to submit in place of the actual charts where, based on his technical knowledge of the limits of the cure cycle, he could conclude that the product had actually been cured a fully sufficient amount of time even if outside of the SOP/specs for the product. His knowledge of cure cycle was based upon his co-authoring the TS&D reports documenting that intermediate interruptions do not interfere with the proper cure of the silicone materials where the total cycle time, at the specified cycle temperature, is achieved. He repeated that, to the best of his knowledge, this practice stopped with the installation of the new equipment. 

*** The investigation reasonably established that the cure ovens would kick off in the middle of a cycle an average of about once a week (four times a month) whereas an actual review of the mammary charts showed only 3 out of 104 lots as anything other than a perfect. non-interrupted cycle. Of those 3, none represented a substantial intermittent downtime (e.g. overnight) as did the chart discovered hiding under the desk blotter. A subsequent review of an additional 84 mammary chart turned up only 2 less than perfect samples. In contrast, a review of cured non-mammary silicones showed about 20% of cure runs evidencing over shutdowns, a number consistent with the once-a-week expectation. 

The memo also states that Les Schnoll reviewed the lot history records for 1985-1987 and that all lots passed the test evidencing proper gel cure. Schnoll also reviewed the complaint trends and found no unusual events or activities. " Based on the above, it was concluded that all product fully met quality standards and the issue was merely a personnel and documentation concern." Dow Corning suspended for 30 days all implicated individuals and supervisors and gave them stern warnings and lectures on the importance of documentation.
CITE: DCC 105000001 - 105000003

Document #480
05/11/88
TESTING DOCUMENT DESTRUCTION
FRAUD/MISREPRESENTATION

Eldon Frisch, Dow Corning, memo to Bauer regarding "Animal Implant Reactions To Breast Prostheses." He encloses the 11/29/68 study in dogs conducted by Food and Drug Research Laboratories which he has redacted
Frisch states:

 A large number of materials were tested in this single study. Thus, when information pertinent to all materials and all animals is considered the report is rather confusing, difficult to interpret, and can easily be misrepresented to a jury as happened in the Stern case. Accordingly, all data not pertinent to the four dogs who received SILASTIC 372 elastomer (the envelope material) and the miniature breast implants and the control animals have been removed. Data were deleted by covering the copy with paper or tape, and nothing has been added.

CITE: KMM 200817 - 200862

Document #484
08/09/88
TESTING
CONCEALING FROM FDA
KNOWLDEDGE OF SYSTEMIC DISEASE

FDA: M. Stratmeyer, Acting Chief, Health Sciences Branch of FDA to Director, office of Science and Technology, memo with attached report regarding analysis of Dow Corning data on carcinogenicity of silicone gels. "As you will see, the conclusion of this report is that silicone can cause cancer in rats; there is no direct proof that silicone causes cancers in humans; however, there is considerable reason to suspect that silicone can do so." The FDA Reviewer finds that patients were studied for an average of 6.2 years which is "probably too short to detect breast cancer... considering that the latency period for foreign body carcinogenesis in humans appears to be in the range of 20-30 years."
CITE" M 780055. DUPLICATE: FDA 29449 - 29457.

Document #494
09/08/89
CONCEALING FROM FDA
FRAUD/MISREPRESENTATION
MISCELLANEOUS - RECKLESS/CONSCIOUS DISREGARD

Patricia Lang, a consulting toxicologist, writes to Birdsall, Dow Corning, with copies to Stark, Ovsenik, Frith and Benson enclosing her assessment of Dow Corning's toxicology laboratory and its efforts to comply with Good Laboratory Practices (GLP). Lang states: 

"In the last two weeks it has become apparent that though some actions are being implemented to bring HES into compliance, the general feeling within the lab is one of chaos. This can be explained, at least in part, by the fact that there is no management with a full understanding of laboratory function to give direction, and get things implemented. Until now, the three consultants you hired, Charles Frith, Barry Benson and myself, have been trying to take the place of management, with very limited success. The only real progress to date has been in educating some of the personnel in general theory behind Good Laboratory Practice regulations. This does not mean that these people are trained, just educated to some degree.... With the pressures put on the already-too-few people to generate SOP's in the past two weeks (especially the ones for Zybion), I was hearing many comments indicating that these documents will be generated haphazardly, without respect to whether they are accurate or not. Because the department has so much breadth and so little depth, there are not natural double-check systems to assure that either bad science or poorly thought out procedures (let alone poorly written sets of instructions) do not get put into place.... Since there is so much work to be done to bring the lab into compliance, any SOP's which get approved in the new system, will have to be followed for a long time before anyone has time to rewrite them. They should be correct and complete the first time." (DCC 80112044)

Under the "Personnel" section, Lang notes that:  

"The consultants you hired were TRYING to take the place of a manager of toxicology. Because they were not part of the group, and only had the ear of Brian Hobbs (who apparently was given the authority to make decisions which should not have been his to make), they were not able to do the job that is needed to be done. As stated several months ago, IT IS ESSENTIAL THAT A GOOD MANAGER OF TOXICOLOGY BE HIRED IMMEDIATELY. The Dow Corning management style is not conducive to running even an adequate toxicology laboratory." (DCC 80112045) She goes on to note that Dow Corning's toxicology department has serious problems working its Xybion computer system, that it hasn't been maintained and that inexperienced persons are operating it. (Id.) Further, she notes many problems with formulation of policies on scientific issues: 

"At the present time, the WRONG people are making decisions (in some cases the WRONG decisions) which impact upon the science being performed. The policies which I am addressing include, BUT ARE NOT LIMITED TO, use of Room Log Books for entry of study information, secondary review of raw data or calculations, assurance of room conditions (light cycle, temperature and humidity), health check by veterinarian prior to study assignment, proper anesthetization procedures for animals, training procedures for various tasks (as necropsy, weighing organs, ect.), supervision of weekend activity, and authority of study directors to assure proper study conduct. This list is far from complete." (DCC 80112045 - 80112046) Lang notes that the pathology procedures need a "complete overhaul."

She states"  

"Documentation is extremely poor at present, and no one in HES fully understands the requirements in this area.... A plan must be written to bring this group up to industry standard as soon as possible. Just getting this department into compliance will take several months...." (DCC 80112046)

CITE: DCC 80112043 - 80112071, Exhibit to Isquith Deposition (used by Dow Corning)

Document #496
12/04/89
CONCEALING FROM FDA
ACKNOWLEDGEMENT OF NEED FOR TESTING
KNOWLEDGE OF SYSTEMIC DISEASE

515(B): Dr. Jack Fisher (ASPRS) informs "All Members of BIRAC, Old and New" about progress report since ASPRS convention in San Francisco. He notes four concerns of the PSEF Board of Directors and those of BIRAC: 1) that manufacturers had written the RFP and they thought Colton was going to do this; 2) concerned that all southern California bidders would be excluded; 3) concerned that one manufacturer stated that it would only fund two issues from a longer list that PSEF wanted studies; and 4) concerned and "disappointed that the study does not address the connective tissue issue.... Based on our very best clinical judgment and scientific understanding, we believe that CT disease issue will forever loom until we meet it head on." (emphasis added). PSEF is also deeply concerned about the reporting requirements - the potential delays in notification of study results. PSEF believes "these restrictions to be an infringement of academic freedom and a potential embarrassment to foundation (PSEF)."
CITE: KKA 43763 - 43769A 

Document #500
02/19/90
CONCEALING FROM FDA

515(b) Lois Duel writes to other manufacturers suggesting that the epidemiology studies be funded only by manufacturers, and that ASPRS be excluded. She claims the basis for this position is the "need to preserve the confidential nature of the study content as its supports PMA submissions by sponsoring manufacturers." Duel further suggests that ASPRS and PSEF play a modified role such as PR efforts.
CITE: MEX 28736 - 28738

Document #501
07/331/90
KNOWLEDGE OF LIQUID SILICONE DANGERS
CONCEALING FROM FDA
ACKNOWLEDGEMENT OF NEED FOR TESTING

Dow Corning's "Summary of Pre-clinical Testing Relevant To The Keratosis Project And Indications For Additional Studies." There is no testing of extracts, hemolysis, mutagenicity for 360 Fluid (although the author notes that this should have been done since "such testing is brief and inexpensive"), skin irritation for DC 360 Fluid, Sensitization, 90-Day implantation study of 360 Fluid, and no long term studies. The author also reviews the chronic exposure toxicology files and states: 

"A series of five studies (1968-1976) in the rat and dog involve the injection of relatively large volumes of DC 360 Fluid, 350 cs at subcutaneous, sublantar and intramuscular sites for periods of one to two years. These studies provide evidence of a limited local inflammatory reaction and instances of fatty necrosis at the injection sites. These findings are expected. Unfortunately, none of these studies conform to GLP regulations and, more seriously, none of the wet tissues, blocks or slide preparations have been retained. There is another series of reports of fluid injection experiments conducted by Dr. Ashley and by Dr. Rees (1964-1972). These latter studies are of virtually no utility. They suffer from the same deficiencies as the other long-term studies and, in addition, no protocols or in-life data can be retrieved. 

On at least two occasions the FDA has indicated that existing chronic data are insufficient to support the use of PDMS in small volume injection applications. Most recently (April, 1988), the FDA informed Ortho Pharmaceutical that a rat carcinogenicity study must be completed before initiating clinical trials related to the treatment of facial wrinkles with injected PDMS. The bottom line is that there are no specific long-term pre-clinical safety studies conforming to GLP's to support development of a product to treat keratosis. 

A 2-year study in the rat has not yet been requested. Such a study cannot be started in HES until about April 1991. The objective of a life-time rat study is to assess the long-term local reaction as well as systemic toxicity including carcinogenicity."

With regard to special testing on polymer distribution, nine in vivo distribution studies of PDMS have been conducted between 1956 - 1985. "All of the animal studies tend to show a low level ubiquitous distribution with the highest concentrations found in lymphatic tissue."

With regard to immunotoxicity, the author states: 

"A study was done in 1974 to look at the immune adjuvant activity of a number of organosilicone compounds and polymers including several viscosities of DC 200 Fluid.... This is not a well-structured nor GLP-conforming study but it is unlikely that a repeat will be needed."

With regard to teratology and reproductive effects studies, the author claims that there are no adverse effects from PDMS on reproductive capacity in the rat or primate. The summary also lists a cost estimate for conducting additional studies and a list of the present studies in the Toxicology Files.
CITE: KMM 407282 - 407282.

Document # 502
08/13/90
CONCEALING FROM FDA
KNOWLEDGE OF SYSTEMIC DISEASE
DOCUMENT DESTRUCTION

FDA: B. Levier, Dow Corning, memo to R. Dieck and L. Duel regarding Statistical Analysis of Neoplasm Data from 2 Year Gel-Implant Study of Q7-2159A and MDF-0193 in rats stating, "but the sum of hepatocellular adenomas and carcinomas is within only one or two tumors of being statistically significant.... Our argument... may still be plausible but it is weakened by these findings... (and) I think it would be imprudent to test this issue with the FDA." A handwritten note at the bottom of the memo states "Please discard this memo after reading
CITE: KMM 451517 - 451525 

Document #503
08/20/90
CONCEALING FROM FDA

Woodbury, Dow Corning, memo to R. Dieck, C. Dillon, L. Duel, R. LeVier, H. Steinberg, regarding comment by Roscoe Moore, FDA, at the 1990 Data users Conferences that manufacturers purposely overestimate device prevalence because it allows them to underestimate complication rates.
CITE: KMM 402702, Exhibit to Dillon Deposition, Exhibit 13 to Woodbury Deposition.

Document #504
09/06/90
DOCUMENT DESTRUCTION
CONCEALING FROM FDA

FDA: W.L. Miller, Dow Corning Wright Marketing, telex to Lutz and Schmitz regarding the MSI Questionnaire during the period of 01/01/90 to 03/27/91. He states that, "The FDA continues to exert tremendous influence on the ways in which we manage our business. As a result, the questionnaire which we developed would be required to be included in the submission package when MSI is presented for P.M.A. review by the FDA. Even if the results of our evaluation are very product/D.C. positive such a document could raise many questions and potentially impact our successful completion of the PMA process. THEREFORE I MUST ASK YOU TO DESTROY ALL COPIES OF THIS DOCUMENT WHICH CURRENTLY EXIST IN YOUR FILES. A NEW DOCUMENT HAS BEEN CREATED, AND HAS ALREADY BEEN SENT TO DUSSELDORF VIA FAX FOR DISTRIBUTION."
CITE: KKE 1315.

Document #505
10/09/90
SHELL STRENGTH - THICKNESS
FRAUD/MISREPRESENTATION

Dr. Flowers sends a letter to Doris Michelson, Dow Corning, regarding complaint Report MW 3416. Dow Corning claimed that a slit developed in the implant "in response to wear and stresses that were greater than the implant's design limits." Dr. Flowers believes it is the same fold flaw phenomenon as that which caused near 100% deflation rates in McGhan implants between 1977 and 1979. He believes the deflation problem is caused by folding, which in turn causes fiber fatigue and later fracture and slits. He blames inadequate pre-market testing and is distressed about Dow Corning's complaint analysis process. He states that, "What alarms me most of all, and that which I find totally unacceptable is the identical 'finding' which contains two fairly lengthy sentences, word for word identical with the earlier patient. This obviously is a company approved 'finding' that is 'rubber stamped' in an effort to decrease company liability and conceal the true significance of the findings."
CITE: KMM 498693 - 498696
Document #507
12/06/90
CONCEALING FROM FDA
KNOWLEDGE OF SYSTEMIC DISEASE

Robert Rylee, Vice President and General Manager of the Health Care Business of Dow Corning, sends a "Dear Doctor" letter. Rylee states that Dow Corning "voluntarily" submitted information to the FDA including a "summary list of 750 bio-safety studies and full reports of more than 30 toxicology studies.... The list included all of our studies; none were withheld." Rylee discusses recent media attention and a 11/27/90 decision by a district court in Washington D.C. ordering Dow Corning to make public this bio-safety data. 

Dow Corning cites the need for confidentiality as the reason it is appealing the district court's order.

Rylee also states that there have been recent reports of immunological responses to silicone breast implants. "Suspected immunological response is a controversial subject because there are so few cases available for study. A review of the global literature indicates that out of more than two million women with silicone mammary implants, only about 40 have been reported to have a form of rheumatic/connective tissue disease. Some form of scleroderma has been reported in 14 implanted women with a latency of about 10 years, and so-called human adjuvant disease HAD) has been reported in 13 implanted women with a latency of about 7 years." He concludes by states that based on Dow Corning's 25 years of experience in silicone breast implants has demonstrated the "reasonable safety and efficacy of these devices."
CITE: M 370276 - 370277, Exhibit to MDL Rathjen Deposition. DUPLICATE: M 690014 - 690014A.

Document #508
12/10/90
FRAUD/MISREPRESENTATION
DOCUMENT DESTRUCTION

Woodbury and Delongchamp, Dow Corning, memo to various Dow Corning employees regarding U.S. breast implant prevalence. The "figure of 2,000,000 women in the U.S. with breast implant does not appear to be supportable or reliable." Woodbury and Delongchamp claim that the prevalence rates are "roughly 250,00 to 800,000. These figures translate to a prevalence rate of about 4 to 8 per 1000 adult white women in the United States."
CITE: KMM 403370, Exhibit 2 to Woodbury Deposition. DUPLICATE: KMM 489617.

Document #509
12/12/90
FRAUD/MISREPRESENTATION
ACKNOWLEDGEMENT OF NEED FOR TESTING
CONCEALING FROM FDA

Dow Corning "Epidemiology Update" on post-surgical complications in breast augmentation notes that internal customer complaints based on Dow Corning Wright data probably "substantially underestimates true incidence rates. The number of complaints reported underestimates the true number. And, product sales, used as a denominator in rate calculations, likely overestimates the number of women who have been implanted."
CITE (KKA 1971: KMM 396712).
CITE: KKA 10971 - 10972, Exhibit to Dillon Deposition, and Exhibit 4 to Woodbury Deposition. DUPLICATE: KMM 396712; KKA 155318 - 155322. NOTE: Regarding the Micro Surfaced Implant (MSI), the report notes the principal outcome of the clinical trial in progress is "excessive capsular contracture."

Document #510
12/12/90
DOCUMENT DESTRUCTION
FRAUD/MISREPRESENTATION

Woodbury and Delongchamp, Dow Corning's Medical Research Services, memo concerning the National Center for Health Statistics, 1988 Device Survey, Attached materials provide findings based on 142 documents from the FDA funded Device Supplement to the National Center for Health Statistics (NCHS) 1988 National Health Interview Survey. Woodbury and Delongchamp conclude that in the U.S. there are 544,000 implanted breast devices and 320,000 women with breast implants (4.2 per 1000 adult white population). Also, 25.9% of the devices had some problems, equaling 30.3% of the women. Within 5 years of implantation, 13% of sampled women had a replacement, with 17% having a replacement by 10 years. Device defect, failure or malfunction was reported for 11% of the women, and defect or malfunction being the reason for replacement in 30% of replaced devices.
CITE: DCC 80011571 - 80011597, Exhibit to Dillon Deposition, Exhibit to LeVier Deposition, Exhibit to Harris County Rylee Deposition, and Exhibit 3 to Woodbury Deposition. DUPLICATE: KMM 333323 - 333349. NOTE: This is the document that Rylee and Thiess are alleged to have requested Dillon and Woodbury to destroy because it would be damaging to Dow Corning.

Document #514
01/16/91
FRAUD/MISREPRESENTATION
DOCUMENT DESTRUCTION

Woodbury, Dow Corning, responds to Yerrick's memo of 01/14/91 stating, "I have just returned from being off sick. I tend to still be skeptical, as a result of other things that I know Bob Rylee has done."
CITE: KMM 486119, Exhibit 9 to Woodbury Deposition.

Document #515
01/22/91
CONCEALING FROM FDA
DOCUMENT DESTRUCTION

Lois Duel, Dow Corning, memo to Bailey Lipscomb and others regarding the "January, 1991 Monthly Report." Under the heading of "Technical Communications," Duel notes that she "spent MANY days reviewing, filing and/or trashing retained documents in my files. Major progress was made, but there is more to do."
CITE: KKA 37643 - 37646

Document #516
01/22/91
FRAUD/MISREPRESENTATION
TESTING

515(B): Dr. Cherup sends a letter to ASAPS returning a research grant. She reports that she did not get any cooperation from Dow Corning and Mentor and that they "more or less told me that they did not want their textured silicone implants involved in any studies over which they were unable to have direct control. They explained to me that they had other studies ongoing with other researchers characterizing their implants, but they admitted to me that they had direct control over these studies." She states that she does not want to add to the "the mound of already existing information wrought by studies which are biased as being supported by one company or product or another."
CITE: MD 120461 - 120463

Document #518
01/29/91
COHESIVENESS - LIQUID COMPONENT OF GEL
FRAUD/MISREPRESENTATION
KNOWLEDGE OF GEL BLEED

FDA: Department of Health and Human Services pharmacologist, Hoan My Do Luu, letter to Dow Corning and Dan McGunagle of the Breast Implant Task Force regarding Appendix A and B, supplements to PMA P910039A (Silastic II H.P.) and P910040A (Silastic MSI single lumen silicone gel-filled mammary implants). The letter deals with the summary of extraction data for Dow Corning Silastic shells, gels and patches. Luu states that "the reporting of low amount of cyclics (less than 2% wt) in the summary report is misleading because the company selectively reported only two of the 17 cyclics found in the components' extracts. The firm selectively reported the amount recovered for cyclic tetrameter (D4) and pentameter (D5) as total volatile cycles. Other shortcomings were found in the methodology protocols used such as incomplete extraction in ethanol, ethanol: CH2CL2 and saline, lack of controls and validation of the methodology.... The reporting of no detectable siloxane residues in saline extracts was questionable." See original document for additional questions regarding Dow Corning's reporting.
CITE: FDA 12281 - 12290. NOTE: See entries of 12/20/91, 02/05/92, 02/06/92 and 03/13/92.

Document #519
02/28/91
CONCEALING FROM FDA
DOCUMENT DESTRUCTION

FDA: Eldon Frisch, Dow Corning, memo to Garry Brody, M.D. regarding letters from the FDA on the use of silicone fluid on hypodermic needles. Frisch states; 

"I have found the letters from FDA that have served as a basis for the use of silicone fluid on hypodermic needles and syringes for many years. I have removed all references to Dow Corning just in case these letters somehow find their way back to FDA. I have been asked by some of the individuals at FDA about the basis for silicone fluid being used on syringes and needles, and have never produced these letters. There are some who believe that if FDA cannot identify how it came about that fluids were allowed on syringes and needles then it is difficult for them to rescind the approval." 

(emphasis added). Attached are two documents - a letter from Philip Sheeler, FDA, in which all names of individuals and companies have been redacted, and a second letter from William Jester, FDA, in which all names have also been redacted.
CITE: DCC 17037526 - 17037528

Document #521
03/15/91
FRAUD/MISREPRESENTATION
CONCEALING FROM FDA
KNOWLEDGE OF SYSTEMIC DISEASE

Woodbury, Dow Corning, letter to Gary Brody, M.D., regarding National Health Statistics Survey. Woodbury states:

Factors which may influence the accuracy of prevalence estimates: 

--Primary data collection methodology.
--Statistical design of sampling plan.
--Specific data collection methodology within a given primary data collection method.
--Survey participation bias.
--Completeness or representativeness of data upon which estimates are based.
--Analysis Method.
--Willingness of respondent to disclose information or knowledge and willingness to disclose for a proxy respondent.
--Device replacement rates and frequency of replacement.
--Permanent removal rates.
--Mortality patterns for implanted patients.
--Device inventory and wastage for marketing based estimates.
--Subjective estimates of surgery rates by surgeons within surgeon surveys. 

The letter includes an attachment containing a comments by R. Delongchamp, Dow Corning, stating: 

"The observation of serious disease among women with cosmetic implants is expected simply because all women eventfully die whether or not they have an implant. As the numbers of women with implants increases, this fact makes it inevitable that at least one woman with an implant will succumb to even the rarest of diseases. An assessment that the implant caused the disease is unwarranted." 

The letter also includes attachments presenting survey data.
CITE: KMM 403500 - 403530, Exhibit to Harris County Rylee Deposition, Exhibit 17 to Woodbury Deposition. DUPLICATE: KKA 102860 - 102880.

Document #523
06/04/91
CONCEALING FROM FDA
FRAUD/MISREPRESENTATION
MISCELLANEOUS - PRODUCT LABELING
TESTING

J Curtis sends a telex to L. Duel, Dow Corning, regarding animal study data for the PMA submission, "I was not privileged to its duration and discovered its incompleteness during preparation for the PMA.... Is LeVier's response not a problem for us. Doesn't John Gauger utilize some of the data from these 'incomplete' studies as the basis for product claims in 'labeling' (i.e. product advertising)?"
CITE: KAA 57

Document #525
06/24/91
FRAUD/MISREPRESENTATION
 

Hall, Dow Corning, memo to Gary Anderson, Campbell, Carmichael, Biggs, LeVier, and Jenkins regarding the "DCC Committee." Hall states:  

It has been two weeks since we had the great session with the BOD at which time they pointed out some of the problems we were facing and suggested ways we might get beyond them. This communication is intended to simply summarize where I feel we are.  

The issue of cover-up is going well from a long-term perspective. We are moving rapidly ahead on our press conference, and all things appear to be in place for that with the exception of the University of Michigan study being finalized.... 

The number one issue in my mind is the establishment of networks. I believe we have made no progress in the two weeks. Obviously, this is the largest single issue on our platter because it affects not only the next 2-3 years profitability of DCC, but also ultimately has a big impact on the long-term ethics and believability issues. If we do not win this one, or at least minimize the financial impact that people are able to achieve, you can forget about whether we have done all these other things correctly.... 

It has become obvious to me that what is at risk here is somewhere between $50 million and $500 million. Right now, I think we are losing the time race badly in this critical area, and I believe that the amount of money we are going to lose is increasingly rapidly since we are not going to be in a position to divert the opposing forces into the directions we want soon....

The place we have the biggest hole still missing and two weeks behind from the time we got the word from Keith McKennan (sic), is in this whole arena of getting a patient grass roots movement going.
CITE: KKA 332805 - 32806

Document #530
12/30/91
FRAUD/MISREPRESENTATION

FDA: FDA sends a Warning Letter to Dow Corning Wright instructing them to take immediate action to eliminate dissemination of false and/or misleading information concerning the safety of breast implants. Examples of false statements made regarding the following subjects are: 

1) Implant Safety - "Scientific data and research show that breast implants are 100% safe.... After thirty years of study conducted with patients, there have never been health problems with implants or silicone.... Breast implants are safe." 

2) Gel Bleed - "a minute amount of gel, less than half a teaspoon, which doesn't go anywhere."

3) Rupture - "...results from a traumatic incident... such as being hit in the chest with a two by four.... It (rupture) has happened less than 1% in 2 million women."

4) Migration - "It is not possible for the silicone to go to the internal organs because it is not specifically possible for the silicone to get into your spleen, kidneys, etc."

5) Autoimmune disease - "It must be a genetic glitch... Silicone breast implants have never been linked to autoimmune or connective tissue disease in any studies ever done."

6) Cancer - "There is no increase in breast cancer from implants, if anything it is less."

7) Capsular Contracture Complications. - "But remember, you can have complications when you have a baby, yet people do it all the time."

CITE: M 780626 - 780628. DUPLICATE: KKA 39985 - 29987; FDA 16233; FDA 50509 - 50512; DCC 242061180 - 242061182; DCC 242010055 -242010057; DCC 242051629 -242051631: M 780626 - 780628: DCC 17006751 -17006753; DCC 242031792 - 242031794

Document # 532
01/27/92
TESTING
FRAUD/MISREPRESENTATION
KNOWLEDGE OF LIQUID SILICONE DANGERS

M. Zimmer memo to the "substantial Risk Evaluation Committee" regarding his conclusions reached after reviewing some of the previous teratology studies on Dow Corning silicones. His conclusions differ from the conclusions reached in the initial reports. 

In some studies, after reevaluation of the data, it has been determined that the original interpretation of the data was incorrect. 

First, he notes increased skeletal defects which "may be due to a direct effect of the test material. This conclusion differs from that on the report...." Second, "an increase in dead fetuses and a decrease in live births were seen at all doses of 360 fluid.... This conclusion differs from that in the report.... The finding of dead fetuses in the treated groups were related to treatment." Third, "There is evidence of material toxicity based on maternal body weights" in albino rats. "The study demonstrates material effect at 1000 mg/kg but has no fetotoxic or teratologic effect at any dose." 

Zimmer also notes that the conclusions in File No. 1059-5 that polydimethylsilozane does not cause adverse reproductive teratologic and mutagenic effects is incorrect. (emphasis added).
CITE" KMM 452794 - 452802.

Document #533
02/11/92
FRAUD/MISREPRESENTATION
KNOWLEDGE OF SYSTEMIC DISEASE
MISCELLANEOUS - COMPLICATIONS
MISCELLANEOUS - LOBBYING

Zellner, Lutz, McClintick, Rothhaar and Clary, Dow Corning, memo to Parr, Yerrick and Anderson regarding D4 issue definition and actions. The authors present an overall communication plan that is split into two phases. Phase I is to disseminate the most recent information regarding the orally administered, range-finding study on rabbits. Phase II is to assure a state of DC preparedness to effectively meet any/all future D4-related events and provide a mechanism for periodically updating customers regarding D4 study plans and results. The authors enclose a schedule for each phase.
CITE: DCC 260000852 - 260000854, Exhibit 43 to Zimmer Deposition.

Document #534
02/12/92
DOCUMENT DESTRUCTION
CONCEALING FROM FDA

Greg Thiess, Dow Corning, memo to Jim Jenkins regarding Dillon's memo regarding document destruction. Thiess does not want memo released publicly to the FDA for a number of reason. He states: 

"First, it is difficult to understand how Dillon's complaint could be relevant in any way to the FDA's investigation or its further inquiries, primarily because the document R. Rylee sought to be withdrawn or destroyed as inaccurate was not, in fact, withdrawn or destroyed. The request initiated by Rylee and transmitted by me was, simply stated, refused.... 

Second, I do not wish for my character to once again be drawn into question by the release of such an irrelevant document, particularly where the facts of the incident (in my opinion) showed that I was the victim of an apparent long simmering dispute between Messrs. Rylee and Dillon and a childish unwillingness or refusal of them to communicate about needed epidemiological studies, creation of internal documents, etc. Moreover, if the unfounded allegation of Dillon is released, how am I to answer the charge without, in effect, releasing confidential communications to me by a representative (Rylee) of my client, made to another representative of my client (Dillon)?

Third, I remain as concerned today as after the Committee meeting that the Committee never actually reached a decision about the supposed improper conduct. As I said at the meeting of my conduct, or that of R. Rylee for that matter, did not breach any DCC code of conduct or any applicable rule of professional conduct for lawyers."
CITE: DCC 80021872, Exhibit to Dillon Deposition, Exhibit to Reed Deposition, and Exhibit 15 to Woodbury Deposition.

Document #536
02/24/92
CONCEALING FROM FDA
FRAUD/MISREPRESENTATION
KNOWLEDGE OF SYSTEMIC DISEASE
MISCELLANEOUS - COMPLICATIONS
TESTING 

Joan Hatfield, Dow Corning Australia, fax attaching several documents, notably:

a. Dow Corning 02/10/92 press release announcing the release of "15 reports of scientific studies and 94 internal, non-scientific company documents.' In the release, Rylee admits implants are not risk-free. Tylee quotes Dr. Calman of the United Kingdom Department of Health stating: "There is little evidence on links between silicone gel implants and autoimmune disease."

b. McKennon 02/11/92 letter expressing regret that the "10 or so most painful memos" to be used against Dow were taken out of context, "to discredit Dow Corning," often without concern for any responsive documents or memos. Also, McKennon feels that "many of Dow Corning's critics are applying 1990's standards to 1970's memos and studies." McKennon also states that he has been assured that all of the information known to Dow Corning which might be relevant to their deliberations has already been provided to the FDA.

CITE: DCC 267010007 - 267010014

Document #537
03/02/92
CONCEALING FROM FDA
FRAUD/MISREPRESENTATION
KNOWLEDGE OF GEL BLEED
MISCELLANEOUS - COMPLICATIONS
RUPTURE
SHELL DEGRADATION
SHELL STRENGTH - THICKNESS
STERILIZATION/CONTAMINATION
TESTING
TISSUE REACTION

FDA: FDA inspects Dow Corning Wright's plant from January 13 to March 2 and finds various examples of MDR reportable silicone breast implant complaints that were not reported to the Food and Drug Administration.

Examples include leaking mammary envelopes, ruptured mammary implants, implant deflations, capsular contracture complaints, inflammatory reactions, infections, gel bleed, an inadequate program in place for monitoring and controlling the levels of microbial and particulate matter in the controlled rooms, improper validation of the envelope curing oven, inadequate calibration program and MDR reports not filed in a timely manner.
CITE: M 780802 - 780813

Document #538
03/09/92
COHESIVENESS - LIQUID COMPONENT OF GEL
FRAUD/MISREPRESENTATION
KNOWLEDGE OF GEL BLEED
KNOWLEDGE OF SYSTEMIC DISEASE
TISSUE REACTION

Lutz, Dow Corning, memo to Clary, McClintick, Klykken, Rigas, Roghhaar and Zellner regarding position statement on gel bleed and D4 - review and comments. Comments regarding bleed include bleed of silicone fluid is commonly associated with mammary implants and has long been recognized by surgeons as a characteristic of silicone gel-filled breast implants. The amount of bleed is largely dependent on the molecular weight of the silicone material. The comments regarding D4 include that it is contained in minute quantities in the silicone gel-filled mammary implant and Dow Corning and other manufacturers believe D4 is safe for use in its intended applications and in no way affects the safety of silicone mammary implants.
CITE: KMM 452997 - 453002, Exhibit 44 to Zimmer Deposition.

Document #544
06/24/92
CONCEALING FROM FDA
FRAUD/MISREPRESENTATION
MISCELLANEOUS - RECKLESS/CONSCIOUS DISREGARD
TESTING

McGunagle memo to Johnson and Kalins regarding the significance of Dow Corning studies omitted from their PMA's.
CITE: FDA 30537 - 30539, Exhibit to LeVier Deposition, Exhibit 21 to McKennon Deposition, Exhibit 10 to Harris County LeVier Deposition, and Exhibit to Issquith Deposition.

Document #545
06/24/92
CONCEALING FROM FDA
FRAUD/MISREPRESENTATION
MISCELLANEOUS - RECKLESS/CONSCIOUS DISREGARD
TESTING

FDA: Daniel S. McGunagle, Task Leader for the FDA’s Breast Prosthesis PMA Review Team, memo stating that studies were omitted from Dow Corning's PMA. Dow Corning's PMA does not contain information significant to the determination of the safety and effectiveness of breast implants. McGunagle lists eleven specific studies that Dow Corning had failed to Mention or submit. These provide a factual basis for the FDA's concern regarding silicone-filled breast implants. Further, he notes that:  

"The content of the withheld documents can be said to show a pattern. Intelligent people, familiar with this material, and anxious to obtain agency approval would recognize that these studies would draw more inquiry and justify further investigation into the safety of these devices. It is reasonable to assume that such people would not want this to happen and, being in a position to control the content of the PMAs, would leave these studies out to improve the chances for PMA approval."

CITE: FDA 51245 - 51247

Document #549
12/31/92
ACKNOWLEDGEMENT OF NEED FOR TESTING
CONCEALING FROM FDA
FRAUD/MISREPRESENTATION
GEL MIGRATION
KNOWLEDGE OF GEL BLEED
KNOWLEDGE OF LIQUID SILICONE DANGERS
KNOWLEDGE OF SYSTEMIC DISEASE
MISCELLANEOUS
MISCELLANEOUS - LOBBYING
RUPTURE
TESTING
TISSUE REACTION

The Committee on Government Operations (John Coyners, Chairman, Henry Waxman, et al.) writes a report which includes a scathing critique of the FDA's failed regulation of silicone breast implants while ignoring their own scientists recommendations and the manufacturers' failure to do any long term safety studies. Silicone breast implants should have been banned due to lack of safety evidence in all manufacturers PMA's. The article covers all areas of this issue.
CITE: PSSC Medical Articles CD, J 3968 - 4022

Document #554
04/21/93
CONCEALING FROM FDA

Jim Jenkins, general counsel to Dow Corning, letter to Dr. Charles Vinnik agreeing to indemnify him whenever you are named as a defendant in lawsuits related to Dow Corning's silicone gel-filled breast implants, except for claims of malpractice arising from surgery.... We are extending this indemnification to you because of the historical role you have played with respect to our products. In turn, you have agreed to cooperate and work together with us in defending this litigation."
CITE: DCC 80071933 - 80071934, Exhibit to Duel Deposition, Exhibit 116 to Burda Deposition, and Exhibit to MDL Rathjen Deposition.

Document #558
11/24/93
CONCEALING FROM FDA
FRAUD/MISREPRESENTATION
MISCELLANEOUS - RECKLESS/CONSCIOUS DISREGARD
TESTING

Study by Busey titled "Audit Report For Dow Corning Corporation Project Number 7088 - A Life-time Implant Study With Dow Corning Q7-2159A In Rats." The raw data did not appear to have been reviewed in a timely fashion. Deficiencies were detected in the accountability and identification of the animals on study. Raw data was deleted for no apparent reason. Records for the receipt, distribution and archiving of the control article were not present or were incomplete. Records for the transfer of samples, namely blood samples, within the laboratory were not present. Some of the maintenance records for the balances used on this study were not present. The printed protocol and its amendments were incomplete with regard to identifying personnel assigned to the study, specifically the current study director and pathologist.
CITE: DCC 411000615 - 411000765, Exhibit 10 to Bey Deposition, Exhibit 45 to Zimmer Deposition.

Document #559
01/25/94
CONCEALING FROM FDA
FRAUD/MISREPRESENTATION
MISCELLANEOUS - RECKLESS/CONSCIOUS DISREGARD
TESTING

Study by Busey titled "Audit report For Dow Corning corporation Master Schedule Number M8616-0 EPL Project Number 287-005-Biodurability And Tissue Compatibility Of Optimized 55- and 70- durometer H.P. Elastomers." 

No data were present documenting how or where the control samples of each test material were selected and stored control samples were inconsistently used. Some samples were not tested within 48 hours of implant retrieval as specified by the protocol. The test material receipt log does not document the receipt of the DeMattia Bars. There are no precise test article accountability records. There were several inconsistencies among the daily observations, veterinary records and material removed records concerning the loss and re-implantation of implants. The animal daily observation records indicate that daily observations were not recorded after 9/16/87 as specified by the protocol. No dogs were sacrificed at the 6 month interval. There were no environmental records. There were no raw data documenting the histologic preparation of the capsule tissue collected at necropsy. No raw data were present documenting the collection or preparation of the tissue samples for transmission electron microscopy. CITE: DCC 411000580 - 411000614, Exhibit 11 to Bey Deposition, Exhibit 46 to Zimmer Deposition.

Document #562
08/15/94
CONCEALING FROM FDA
FRAUD/MISREPRESENTATION
TESTING

Dow Corning study titled "A Chronic Implant Study in Rats with Dow Corning Q7-2423 and Q7-2551 Elastomers: Audit of Pathology Materials" by Experimental Pathology Laboratories, Inc. The report states: 

"The results of the initial slide/block comparison of 20% of the animals revealed several identification discrepancies between the slides and blocks and several slides with missing blocks." 

"This audit revealed several discrepancies in the conduct of the histology phase of the study." 

"The detailed findings from the audit of the blocks and slides and supporting documentation are presented in Appendix A. In addition to the cutting of duplicate slides, a variety of other discrepancies were noted in the identification and histologic preparation of the slides on this study.
CITE: DCC 411000769 - 411000965, Exhibit 4 to Bey Deposition

What Dow Corning had to say on other subjects.