What the Dow Corning corporate documents had to say about rupture of breast implants.

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

Dr. O. Gordon Robinson's abstract of a paper entitled "Disruption Rate Of Silicone Gel Prostheses - A Report Of 200 Cases." 200 patients from 02/91 - 10/92 had their silicone gel implants removed. The time from implantation ranged from six months to 25 years. Robinson found that 104 or 52% had one or both implants ruptured, 43 or 21.5% had severe bleed, and 147 or 73.5% had "distortion" - rupture plus severe bleed. Based on this data, Robinson projected future rupture rates using the Kaplan-Meier survival curve, and concluded that in 20 years, only 3.4% of the patients will have both prostheses still intact. He states, "Gel filled mammary prostheses wear out and in a certain predictable time frame. Based on this study, patients can be advised with a certain degree of accuracy as to the probable condition of their prostheses."

CITE: No Bates Number, Exhibit 3 to Robinson Deposition. WITNESS: Robinson DISPOSITION: Not admitted in Toole (II) v. Baxter Healthcare.

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

Dr. O. Golden Robinson presents a paper entitled "Breast Implant Removal Or Exchange: which updated his prior study of 200 patients. He has seen an additional 100 patients and presents nine charts of statistics. Chart 2 lists "symptoms" of patients including burning and pain, numbness and tingling in extremities, joint and muscle pain, joint and muscle dysfunction, enlarged liver, flu symptoms, loss of appetite, swelling, arthritis symptoms, fibrocystic disease, deformity, kidney failure, vision problems, chronic fatigue, lupus, rash, insomnia, and hair loss. Of the 300 patients, 154 had a ruptured prosthesis, and 214 had a "disrupted" prostheses, i.e. loss of integrity of the silicone shell or severe silicone bleed where silicone "strings out at least 12 inches from intact capsule." (p.1).

CITE: No Bates Number, Exhibit 4 to Robinson Deposition. WITNESS: Robinson DISPOSITION: Not admitted in Toole (II) v. Baxter Healthcare.  Dow Corning Trial Exhibit List Abstracts

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

Dr. O. Gordon Robinson's charts on the age of prostheses a significant number of implants ruptured 6-16 years post-implantation, ( observations at surgery 36.9% of his 73 patients were symptomatic), follow-up (most did not show any change in symptoms during follow-up), symptomatic (patient relates to prostheses-arthritic profile, refer, and "No Closed Capsulotomies"), asymptomatic (patient happy), and questions ("Do mammary prostheses last forever? What contributes to the silicone envelope wearing out? ... How do you tell if an implant is ruptured? ...."

CITE: No Bates Number, Exhibit 9 to Robinson Deposition. WITNESS: Robinson DISPOSITION: Not admitted in Toole (II) v. Baxter Healthcare.  Dow Corning Trial Exhibit List Abstracts

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

Draft of Dr. O. Gordon Robinson's paper entitled, "Breast Implant Removal Or Exchange." This is a draft of document number 22.

CITE: No Bates Number, Exhibit 10 to Robinson Deposition. WITNESS: Robinson. DEPOSITION: Not admitted in Toole (II) v. Baxter Healthcare.  Dow Corning Trial Exhibit List Abstracts

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

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

CITE: KKH 1654.  Dow Corning Trial Exhibit List Abstracts

Document #115
04/13/70
KNOWLEDGE OF GEL BLEED
KNOWLEDGE OF SYSTEMIC DISEASE
MISCELLANEOUS - COMPLICATIONS
RUPTURE
TISSUE REACTION

Olson memo to Boone with copies to Hunter, Hobbs, Koning, Radzius and Stark regarding "Inflatable Mammary Toxicology." He responds to Boone's memo stating, "The stability of dextran solutions in an implant situation over the long haul, particularly if there is diffusion of body fluids across the membrane would be difficult to accurately assess without biological data generated under use conditions. It is important to know these things prior to marketing. With my cursory knowledge of the problem I would tend to feel that such a device might cause some patients and Dow Corning some degree of grief. I would think that a rather extensive clinical investigation is indicated in order to assess benefit versus risk for Dow Corning."

CITE: KMM 146382-146384.  Dow Corning Trial Exhibit List Abstracts

Document #118
05/06/70
RUPTURE
SHELL STRENGTH - THICKNESS

J.K. Boone, Dow Corning , handwritten note to F. Stark regarding inflatable mammary development assurance. Boone writes:

"The bags for the inflatable mammary prostheses are taken directly from the production of the standard seamless mammary. It is expected that gel filled bags are softened by the gel somewhat, giving an ultimately softer bag with somewhat higher elongation. Thickness of the bags varies with the size and width, but it is ordinarily between 0/010" and 0.020" with the average being about 0/017.

Several individual prostheses were subjected to severe testing (after filling and tube removal). They were slammed repeatedly against a smooth wall. Valves functioned well, bags can be broken under stress without the valves leaking.

To date, 153 of these devices have been submitted to quality assurance, and 18 of these have been rejected for a variety of reason. Leakage through the valve has not been a problem.

It is very difficult to project the eventual clinical failure rate for this device at this time. I would estimate failures less than 1% on devices successfully implanted, another failure rate should be expected for devices damaged during surgery. These will be immediately detectable as these devices are filled. This will cause professional irritation but little liability. Patients are being cautioned that these devices may break or leak at some later date.... The device now marketed (gel filled) has certainly not been complication free but to date it has not caused us severe liability problems. Over the long haul, I would guess that we might be sued about as often for hard, painful breasts as for 'shrinking' ones."

Dow Corning Trial Exhibit List Abstracts

Document #126
03/09/71
COHESIVENESS - LIQUID COMPONENT OF GEL
RUPTURE
TISSUE REACTION

Morgan, Dow Corning, memo to Koning, regarding a complaint made by Dr. Condie concerning the composition of the silicone gel in a ruptured implant. The patient developed a reoccurring infection and staph infection four months post-op with fluid "oozing from the wound." The memo states "the prosthesis was practically empty of gel and what gel was there was extremely fluid and oozed out of the prosthesis and the surrounding tissue.... It appears to me that we have had a gel breakdown but I did not discuss this in any way with Dr. Condie." (emphasis added)

CITE: KMM 423343 - 423344. DUPLICATE: KKA 152366 - 152367; CO 82 - 83. NOTE: Dow Corning was using V. Mueller as its sales agent.  Dow Corning Trial Exhibit List Abstracts

Document #139
10/17/72
COHESIVENESS - LIQUID COMPONENT OF GEL
RUPTURE
SHELL STRENGTH - THICKNESS

Dr. Gregory letter to Rathjen regarding an implant he ruptured unknowingly during surgery. Three months after implantation, the patient experienced redness on her breast and perforation of the skin with the implant protruding outside and "Gel dripping out of the hole." He says that this "may be a blessing in disguise, because perhaps we have all been trying to make too soft and too fragile an envelope. I do not believe that the old envelope would have perforated as easily as this one did with the mosquito hemostat. Perhaps the viscosity of the Gel may have to be reconsidered in view of this particular type complication."

CITE: KMM 54876 - 54877, Exhibit 9 to Harris County Rathjen Deposition, and Exhibit to MDL Rathjen Deposition. DUPLICATE: B 949 - 950.  Dow Corning Trial Exhibit List Abstracts

Document #149
05/02/73
SHELL STRENGTH - THICKNESS
RUPTURE

Gary Corbeill, Reliability Engineer for Dow Corning, analyzes a Silastic Round implant returned by Drs. Terino and Sengleman to Bill Mantle, who in turn sent them to Art Rathjen. Corbeill states that, "Due to their thin 'skin' these mammaries are delicate and will rupture when subjected to undue pressure." (emphasis added).

CITE: CR 160 - 161. NOTE: Bill Mantle is the sales representative for the Los Angeles area.  Dow Corning Trial Exhibit List Abstracts

Document #178
01/13/75
SHELL STRENGTH - THICKNESS
COHESIVENESS - LIQUID COMPONENT OF GEL
RUPTURE

Brashier, Dow Corning, memo to Salisbury and VerVoort regarding a patient of Dr. Goldwyn's who reported a "stringy gooey substance" that was coming out of a woman's breast who had just been implanted. The patient snipped the substance with a scissors. The implants were removed and replaced and the same thing happened.

CITE: M 570188 – 570189  Dow Corning Trial Exhibit List Abstracts

Document #196
05/23/75
COHESIVENESS - LIQUID COMPONENT OF GEL
RUPTURE REPLACEMENT

Minutes of the meeting of the Dow Corning Mammary Task Force. Countdown to product introduction, "1 week, 8 days, 192 hours, 11,520 minutes." The Task Force discussed the economic reasons for getting the contours on the market by 10/01/75. Also, "Marketing wanted to use a sealed bottle of gel as a sales aid to show the flowability and cohesiveness of the responsive gel. However, Talcott and Larson discouraged (this) because the gel may not retain constant properties with continued manipulation such as this. The aesthetics of doing this would probably not show our product in a good light." The Task Force decides on "aggressive marketing tactics" including rebates, consignment, back-up units-singles for immediate rupture - replacement, and price breaks for big users.

CITE: F 599 - 601, Exhibit 45 to Harris County Rathjen Deposition, and Exhibit to MDL Rathjen Deposition. DUPLICATE: M 540087 - 540089.  Dow Corning Trial Exhibit List Abstracts

Document #212
12/12/75
SHELL STRENGTH - THICKNESS
RUPTURE
ACKNOWLEDGEMENT OF NEED FOR TESTING

Rathjen, Dow Corning, memo to various Dow employees regarding Breast Symposium in Phoenix, Arizona on November 23-26, 1975. Reports that Dow has lost the number one position as "the innovator." He states:

"Surgery was performed by members of the faculty, put on tape, edited and viewed during the three day course. Each manufacturer donated implants for this use. Dr. Eugene Courtiss and Dr. Robert Winslow used our prostheses. In both instances the doctors broke an implant during their surgery. Fortunately these were edited from the tape; but ours were the only ones to break, and they really let us know about it. The Medical Products Business should consider a full scale research program to fully evaluate the current status of our gel (chemistry, toxicology) and to begin a concentrated program to develop a dry gel (dry to touch, cohesive, non-adhesive with absolutely no bleed). I would also like to see the development of a radio-opaque envelope which would allow the examination of an implant "in situ" if and when capsular contracture is suspected. How contracture develops by observing an implant "in situ" could contribute to a better design of an implant. (emphasis added).

CITE: M 190200 - 190202, Exhibit to Mantle Deposition, Exhibit 80 to Harris County Rathjen Deposition, and Exhibit to MDL Rathjen Deposition.  Dow Corning Trial Exhibit List Abstracts

Document #215
01/15/76
RUPTURE
SHELL STRENGTH - THICKNESS

Tom Talcott memo to Kelley and Rathjen, Dow Corning, discusses the recent Phoenix Breast Symposium in which Dow Corning introduced its new mammary. During the taped implantation surgery, two of Dow Corning's implants ruptured/broke. Talcott expresses dismay that at Dow Corning the consensus was that the envelope was "good enough" despite finding:

"gross thin spots and flaws in the form of significant bubbles.... The allowable flaws are written into our current specifications.... When will we learn at Dow Corning that making a product "just good enough' almost always leads to products that are 'not quite good enough'? It is unfortunate that the thinner dispersion, four dip method proved by Bartolo and Vallender in early 1974 appeared too expensive to plant personnel to even try, although a much higher acceptance rate would be obtained. I sincerely hope this experience will convince us to support programs for 'high quality' rather than 'just enough quality' in the future. (emphasis added).

CITE: F 534, Exhibit 65 to Harris County Rathjen Deposition. Exhibit to MDL Rathjen Deposition. DUPLICATE: DCC 8003157; M 600007; KMM 140185; KMM 380078.  Dow Corning Trial Exhibit List Abstracts 

Document #219
03/03/76
TISSUE REACTION
RUPTURE

Dr. Terino presents a paper on "Technique and Results of 50 Breast Capsule releases" at the California Society of Plastic Surgeons. He reports a 36.5% rate of contracture. Also, a Dow Corning implant was removed 10 years post-op. "Upon opening the capsule bilaterally there was a thick sticky layer of silicone outside the envelope. On taking the implants out bilaterally there was no perforation from the envelope whatsoever, but there was clearly silicone on the outside. And pathology showed extensive foreign body giant cell granulomas."

CITE: M 290302 - 290306.

Document #228
04/05/76
MISCELLANEOUS - COMPLICATIONS
MISCELLANEOUS - PRODUCT LABELING
RUPTURE - CLOSED CAPSULOTOMY
TISSUE REACTION

FDA: The FDA, after receiving information that some persons had experienced serious problems with silicone mammary and testicular implants, met with Dow Corning to inspect their files. Mr. Radzius, Dow Corning's Food and Drug counsel, and Milt Hinsch, Product Supervisor, Dow Corning, claim to John Nicholson, FDA, that current data shows approximately 18% of mammaries implanted will cause a contracture problem. Of this 18%, somewhat less than 10% will require corrective surgery or other techniques. Hinsch also states that a new technique of manually breaking the capsule has recently been developed and shows promise as a solution to contracture. Hinsch also stated that it has always been a policy of Dow Corning to include "adverse reactions" as part of its labeling but, recently, competitors have been using this statement in the literature as a tool to convince surgeons not to use Dow Corning's products.

CITE: FDA 17180 - 17182. NOTE: HINSCH was aware that the contracture data was much higher than 18%, i.e., see Dr. Terino's paper presented 03/76.  Dow Corning Trial Exhibit List Abstracts

Document #231
04/19/76
COHESIVENESS - LIQUID COMPONENT OF GEL
MISCELLANEOUS - SALES
RUPTURE
TESTING

Robertson memo to Blackmore, Coyne, Fredricksen, Pryor, Trischler, Doolittle, Flora, Hauser, McLellan and Murray regarding a discussion with Donald McGhan on 04/14/76. McGhan is now receiving Dow Corning silicone. For the gel uses McGhan prefers the GE product which has a lower level of low molecular weight components. McGhan mammary implants are also more consistent than Heyer-Schulte's because of the mandrel molding technique used - the madrels are polyester and cast individually.

CITE: MMM 1445 - 1450, Exhibit 6 to D. McGhan Deposition, Exhibit to Horgan Deposition, Exhibit 43 to Harris County D. McGhan Deposition, and Exhibit 68 to Harris County Coyne Deposition. DUPLICATE: MMM 666-671.  Dow Corning Trial Exhibit List Abstracts

Document #232
04/20/76
SHELL STRENGTH - THICKNESS
RUPTURE

Milt Hinsch, Dow Corning, memo to Brodhagen, et al., regarding demonstration implants used at the "Aesthetic Show in Atlanta on April 11-15, 1976. He writes, "Of these 23 (demonstration implants), 5 had large bubbles in the gel, 1 broke when picked up, and 3 others developed bubbles in the gel around the patch area during the show. We were unable to show the entire line as planned."

CITE: KMM 219977.  Dow Corning Trial Exhibit List Abstracts

Document #238
06/02/76
SHELL STRENGTH - THICKNESS
RUPTURE

Mazelin, a Dow Corning sales representative, files Complaint Report F76023 for a rupture of a Silastic Round mammary implant. Dr. Kellett, the implanting physician, noted that this was the second rupture in the past few weeks. He "feels 'thinner' envelope weakens it (the implant) significantly."

CITE: CR 3172 - 3173.  Dow Corning Trial Exhibit List Abstracts

Document #239
06/07/76
GEL MIGRATION
MISCELLANEOUS - COMPLICATIONS
RUPTURE
TISSUE REACTION

Braley, Dow Corning, telephone report concerning a conversation with Dr. Nicholas Georgiade. Dr. Georgiade's patient developed a mediastinal node enlargement and lung lesions and suspects gel migration from a ruptured implant. He notes that the patient's husband is a "smart ass" trial lawyer and wants to know how to handle this. He wants a letter from Dow Corning so that he has "enough information to counteract any feelers that this lawyer may put out."

CITE: M 250053, Exhibit 35 to Hinsch Deposition (used by Dow Corning), Exhibit 87 to Harris county Rathjen Deposition, Exhibit 39 to California Braley Deposition, Exhibit to MDL Rathjen Deposition. NOTE: for Rathjen's response, see M 250050 - 250052 dated 07/12/76  Dow Corning Trial Exhibit List Abstracts

Document #243
06/25/76
SHELL STRENGTH - THICKNESS
RUPTURE

John Gallagher, Dow Corning, memo to Bob Becker regarding the "large increase in rupture returns in the past month...." Gallagher states that:

"All the doctors claim that the ruptures are happening from 90% of the prosthesis with the creases and large air bubbles. I had a discussion with Milt Hinsch today and he told me he has had three telephone calls, one from Tom Mazelin, one from Greg Whittaker, and one from Jim Reisma (sic - Reitsma), all having the same problem - an excessive amount of ruptures. I wanted to bring this to your attention because I have one customer that has had a return of thirty ruptures in the last three months.... We have enough problems with competition without worrying about ruptures constantly.

CITE: CR 3272.  Dow Corning Trial Exhibit List Abstracts

Document #252
08/23/76
GEL MIGRATION
KNOWLEDGE OF SYSTEMIC DISEASE
RUPTURE

Jim Rudy, President of Heyer-Schulte sends a "Dear Doctor" letter regarding "the possible and known problems and complications" of breast implants. It is noted that subtle processes of degradation should be expected to occur, and that the knowledge associated with long-term implantation is imperfect. If the implant is torn the gel will migrate and that is why Heyer-Schulte placed warnings in data sheets in May 1975. Doctors and patients should expect some patients to exhibit adverse response to silicone implants.

CITE: M 190413 - 190417, Exhibit 159 to Harris County Powell Deposition, Exhibit to Harris County LeVier Deposition, Exhibit to Nawash Deposition, and Exhibit 140 to Harris County Rathjen Deposition.   DUPLICATE: GEG 004050 - 004054; KMM 262028 - 262032; BAX 36899 - 36903. WITNESS: Rudy Exhibit 34; Hyans Exhibit 24. DISPOSITION: Admitted in Toole (II) v. Baxter Healthcare.  Dow Corning Trial Exhibit List Abstracts

Document #256
09/22/76
GEL MIGRATION
RUPTURE/DEAR DOCTOR RESPONSE
TISSUE REACTION

Milt Hinsch memo to the Dow Corning sales force concerning Dow Corning's response to Heyer-Schulte's "Dear Doctor" letter discussing problems and complications of gel-filled mammary prosthesis. Hinsch claims that Dow Corning's implants are considered "non-active in the body" and he "would not expect shape or softness to change appreciably." Also, Dow Continues "to test 100% for cohesive gel during production" and "their gel offers the softest possible feel while retaining cohesiveness." Hinsch states that, "there are no cases of Dow Corning gel migration. Conversely, in documented cases where the envelope was ruptured, the gel did not migrate." He claims that all materials are subjected to "extremely sensitive" tests for tissue reaction and must show no tissue reaction to be accepted. Hinsch states that Dow Corning does not plan a written response to the " "Dear Doctor" letter.

CITE: M 240432 - 240433, Exhibit 8 to Hinsch Deposition (plaintiffs), Exhibit 44 to Hinsch Deposition (Dow Corning), Exhibit to Peters Deposition, Exhibit to Harris County Rudy Deposition, Exhibit 97 to Harris County Rathjen Deposition, Exhibit 2D to Harris County Talcott Deposition, Exhibit 113 to Burda Deposition, and Exhibit to MDL Rathjen Deposition. DUPLICATE: GEG 4048 - 4049; M 880029 - 880030; OOM 880029 -880030.  Dow Corning Trial Exhibit List Abstracts

Document #257
10/01/76
KNOWLEDGE OF GEL BLEED
KNOWLEDGE OF LIQUID SILICONE DANGERS
KNOWLEDGE OF SYSTEMIC DISEASE
RUPTURE
STERILIZATION/CONTAMINATION
TISSUE REACTION

Donald Barker, M.D., presents a paper, "Reactions to Silicone Implants in the Guinea Pig," to the Scientific Session of the American Society of Plastic and Reconstructive Nurses.

CITE: GEG 4000 - 40006. NOTE: Paper was published in the Aesthetic Plastic Surgery in 1978, authored by Barker and Sherrill Lee Schultz, R.N.  Dow Corning Trial Exhibit List Abstracts

Document #263
11/02/76
KNOWLEDGE OF LIQUID SILICONE DANGERS
TISSUE REACTION
RUPTURE

Dr. Charles Vinnik writes to Art Rathjen, Dow Corning, about a histologic response to a patient whose breast implant ruptured. Dr. Vinnik states that "microscopically it appeared to resemble the reaction (sic) seen around silicone injected breasts." He also notes that the response to silicone materials in humans is "a very variable thing...." (emphasis added)

CITE: KKH 6944 - 6945, Exhibit 47 to MDL Rathjen Deposition (used by Dow Corning). Dow Corning Trial Exhibit List Abstracts

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. (emphasis added)."

CITE: KMM 333230 - 333234, Exhibit to Petraitis Deposition, and Exhibit to MDL Rathjen Deposition.  Dow Corning Trial Exhibit List Abstracts

Document #279
05/26/77
RUPTURE
SHELL STRENGTH - THICKNESS

Complaint analysis prepared by Woodard and forwarded to Rathjen.

CITE: M 460026 - 460028 and M 570200 - 570203, Exhibit to MKL Rathjen Deposition.  Dow Corning Trial Exhibit List Abstracts

Document #280
06/16/77
SHELL STRENGTH - THICKNESS
RUPTURE - CLOSED CAPSULOTOMY

A.H. Rathjen, Dow Corning, reports a telephone call from Dr. Ben T. Gregory regarding two incidents of ruptured mammaries immediately upon attempting to "pop a capsule," i.e., performing a closed capsulotomy. Upon explantation, Dr. Gregory found a quantity of loose gel. The doctor called to let the company know that, "He does not subscribe to those in his profession who claim that--under no circumstances when you 'pop a capsule' will you break and implant."

CITE: M 570125, Exhibit 13 to Harris County Rathjen Deposition. DUPLICATE: M 240322; KKH 001616.

Document #281
08/12/77
TISSUE REACTION
SHELL STRENGTH - THICKNESS
RUPTURE

Eldon Frisch, Dow Corning, memo to Virg Metevia regarding Dr. Julius Henry-Cohen's article on capsular contracture. Frisch states, "during discussions with John Madden, M.D., we had reached a conclusion that probably most cases which develop thick fibrous capsules do so because of trauma to the fibrous capsule which creates local tissue damage and minute ruptures in the capsule without producing a major rupture which leads to complete loss of capsule integrity.... Damage to fibrous tissue is generally painful, and associated with rupturing of small blood vessels leading to small hematomas and an increase in the inflammatory process." Frisch also states that ruptures most likely occur because "during certain activities such as love making, vigorous hugging, strenuous physical exercise," and that "physicians can completely rupture a fibrous tissue capsule by externally squeezing the implant." (emphasis added).

CITE: OOM 320474 - 320476. NOTE: Dow Corning was not warning in its product inserts of rupture or recommending that doctors not perform closed capsulotomies. Dow Corning Trial Exhibit List Abstracts

Document #283
08/31/77
RUPTURE
TISSUE REACTION

Dow Corning Telephone call report noting a person who developed severe bilateral nfections seven days post-op. She entered the hospital with a temperature of 105 degrees in a "life threatening situation. Upon opening up the chest cavity, the doctor found large quantities of puss. ... In an effort to forestall a potential lawsuit, I told the doctor that I would recommend free replacement of these prostheses -- even though no rupture upon removal.

CITE: KHH 35213.  Dow Corning Trial Exhibit List Abstract

Document
09/29/77
SHELL STRENGTH - THICKNESS
RUPTURE

Petraitis, Dow Corning, memo to Roush and Becker setting forth "The Reasons For Proceeding With An Inflatable Introduction." Petraitis notes that the clinical evaluations "indicated a high incidence of deflations: but claims that most were caused by small pinholes in the envelope. He assumes he can improve the envelope to prevent these pinholes by making it thicker. Petraitis concludes, "I feel that any risk associated with marketing the inflatable made from the improved envelope without additional clinicals is certainly worth taking.... The decision to delay introduction is equivalent to eliminating the product forever."

CITE: KMM 149569 - 146570, Exhibit to Petraitis Deposition, and Exhibitto MDL Rathjen Deposition.  Dow Corning Trial Exhibit List Abstracts

Document #287
10/03/77
ACKNOWLEDGEMENT OF NEED FOR TESTING
RUPTURE
MISCELLANEOUS - RECKLESS/CONSCIOUS DISREGARD
FRAUD/MISREPRSENTATION

Rathjen, Dow Corning, memo to PMG and MPPBB (Medical Products Business Board) reiterating his objection to marketing the inflatable prosthesis when there are doubts about its efficacy. He notes, "This suggestion was turned down because some members of this business thought the product would indeed stand up. Well, it hasn't!" Rathjen believes the product's efficacy should be determined after clinical trials and not merely "on the bench...." He believes it is a "moral issue ... whether Dow Corning was really, truly being honest and straightforward with our customers?" He recommends the product be tested further on 50 patients over the next four to five months and hard facts be developed before introduction as surgeons believe a ten percent deflation rate is absolutely unthinkable. (emphasis added).

CITE: KMM 333259 - 333261, Exhibit to Oppelt Deposition, and Exhibit to MDL Rathjen Deposition. DUPLICATE: OOM 321512 - 321514. NOTE: The deflation rate with the inflatables over a nine month period was 12%.  Dow Corning Trial Exhibit List Abstracts

Document #290
10/26/77
ACKNOWLEDGEMENT OF NEED FOR TESTING
RUPTURE
MISCELLANEOUS - RECKLESS/CONSCIOUS DISREGARD

Log of a telephone conversation in which Rathjen, Dow Corning, tells Dr. G. Perrin he is unhappy with the marketing department's decision to introduce an inflatable mammary that had a 14 percent deflation rate when tested. He says he was concerned about the decision and feels "there is an ethical matter involved here." Dr. Perrin replies "if you are too hasty (sic), things backfire on you. Both of us know that...." (emphasis added).

CITE: KMM 255487 - 255488

Document #291
10/26/77
ACKNOWLEDGEMENT OF NEED FOR TESTING
RUPTURE
MISCELLANEOUS - RECKLESS/CONSCIOUS DISREGARD

Log of a telephone conversation between Dr. Glazer and A. Rathjen, Dow Corning. Dr. Glazer says he is surprised they were putting the inflatable mammary implant on the market without all of the data being collected and feel such a move is premature. Rathjen agreed and stated, "There is no two ways about that, but it hasn't been tested...." Rathjen feels that he has "been muscled and I am mad because here we said we were going to stop and retrench and they insisted the thing keep going." Rathjen states that he is prepared to resign because his "reputation is on the line as it relates to the silicone injection fluid...." (emphasis added).

CITE: KMM 194463 - 194466, Exhibit to Oppelt Deposition, and Exhibit to MDL Rathjen Deposition. Dow Corning Trial Exhibit List Abstracts

Document #294
12/15/77
SHELL STRENGTH - THICKNESS
RUPTURE

Frank Lewis, Dow Corning, Memo to Milt Hinsch regarding the "inordinate rate" of ruptures occurring with mammary implants. Lewis lists four doctors who are experiencing "abnormal percentage(s) of ruptures." Dr. Don Davis of Lansing, Michigan with 14%, Dr. Fusilero of Lorain, Ohio with 32%, Dr. James Scarcella of Lakewood, Ohio with 12% and Dr. Richard Straith of Detroit, Michigan with 11%. Lewis states, "I am sure some of these were the fault of the doctor, but that alone could not account for such a high percentage of ruptures. These doctors have on the average ten years of experience in this procedure."

CITE: M 240328 - 240329. NOTE: A handwritten comment is at the bottom of the memorandum and reads, "A detailed study of mammary rupture frequency is being made and should be completed by 1/31/78 for the year 1977. Data to be made available from Midland Marketing." DUPLICATE: F 731 - 732; M 570147 - 570148; M 460300 - 460301; KMM 351899; KKH 1631 - 1632; KHH 67459 - 67460; KKA 88982. NOTE: No such studies have been located.

Dow Corning Trial Exhibit List Abstracts

Document #296
01/20/78
SHELL STRENGTH - THICKNESS
RUPTURE

Rathjen, Dow Corning, memo to various members of the Marketing Department - Nelson, Hoyt, Bey and Hinsch - and to members from Dow Corning's in-house Legal Department - Steinberg and Lewis. Rathjen reports that the current deflation rate for the inflatable clinicals from January to August 1977 is 22%. Several patients had bilateral deflations.

CITE: KMM 333270. DUPLICATE: KMM 261276 - 261277.  Dow Corning Trial Exhibit List Abstracts

Document #298
03/02/78
SHELL STRENGTH - THICKNESS
RUPTURE

Dow Corning salesman, Frank Lewis, informs Milt Hinsch that he has experienced an "excessive number of ruptures" in the Detroit area. Numerous doctors report an increase in ruptures and are commenting, "Noticing a difference in the envelope."

CITE: F 729 - 730. DUPLICATE: M 570150 - 570151; KMM 3919 - 3920.  Dow Corning Trial Exhibit List

Document #302
04/17/78
SHELL STRENGTH - THICKNESS
RUPTURE

Rathjen, Dow Corning, memo to Gant regarding the deflation problems of the Varifil Mammary Prosthesis. Some clinicians report deflation rates as high as 8 out of 13 patients. Rathjen states "the most important factor for all of us to keep in proper perspective is that a mammary implant, with very few exceptions, is expected to function and remain in the human body for the lifetime of the patient.... Therefore, in no way can we even remotely think that a mammary prosthesis that has functioned for six months and failed is any worse than one that has functioned for a year or 18 months, and then deflated. When a product stays inflated for four months and then deflates overnight, we can't blame the doctor." (emphasis added).

CITE KMM 333262 - 333264, Exhibit to MDL Rathjen Deposition.  Dow Corning Trial Exhibit List Abstracts

Document #307
00/00/79
RUPTURE - CLOSED CAPSULOTOMY
SHELL STRENGTH - THICKNESS

A brochure entitled "Suggested Surgical Procedures for Silastic Mammary Prostheses" states that "an alternative to surgical release of a tight capsule is the closed compression technique for rupturing a contracted capsule around a breast implant." (emphasis added).

CITE: M 660189 - 660204, Exhibit to MDL Rathjen Deposition.  Dow Corning Trial Exhibit List Abstracts

Document #308
00/19/79
KNOWLEDGE OF SYSTEMIC DISEASE
GEL MIGRATION
RUPTURE

Handwritten letter advising that the gel represents a potential rupture or immunogenic problem and a mild inflammatory problem which is probably beneficial since this will stimulate encapsulation of the gel and help minimize gel migration. Gel will probably eventually be found in the regional lymph nodes. (emphasis added).

CITE: M 460274.  Dow Corning Trial Exhibit List Abstracts

Document #309
02/13/79
SHELL STRENGTH - THICKNESS
RUPTURE
MISCELLANEOUS - RECKLESS/CONSCIOUS DISREGARD

Dow Corning minutes of a PMG (Product Marketing Group) meeting with R. Rylee, G. Jakubcvzak, A. Rathjen, M. Nelson, A. Bey and others. Three areas of importance concerning the inflatable mammary prosthesis were discussed- ethical/morality, legal, and business. The 1972 study was presented which showed there was a deficiency in the envelope.

Jakubczak reported failures in the clinicals were the result of pinholes of undetermined origin. (NOTE: This is inconsistent with Rathjen's prior memos.) Rathjen outlined his ethical concerns that "no matter when the product fails, it is the fact that it did fail...." There was discussion whether Dow Corning should stay in the market with the inflatable, do clinicals on the HP envelope, or market the HP. Marketing claimed that the field results showed there was no problem. Rathjen, however, stated that his clinical experience showed there was a "definite serious problem." (NOTE: See Rathjen's memos throughout 1977 and 1978). Bey, in Dow's Marketing Department, proposes that they put the HP on the market but increase envelope thickness to 7 mils. The HP will replace what's on the market but there will be "no recall."

Rylee questions two different sets of data from marketing and clinical and whether "Dow Corning is selling quality. The notes reflect: "1. Do we stay on the market with the existing product? (lack of clear existing data); 2. Do we introduce it without clinical trials?... A subjective decision." Dow then reviews the damages to patients: "Damages - minimal with deflation (saline) much more with gel migration." They again reaffirm there will be no recall, that the HP will be phased in, and Dow Corning will do limited clinical evaluations.

CITE: KMM 261081 - 261085, Exhibit to MDL Rathjen Deposition.  Dow Corning Trial Exhibit List Abstracts

Document #310
02/27/79
GEL MIGRATION
KNOWLEDGE OF GEL BLEED
RUPTURE
SHELL STRENGTH - THICKNESS

Del Petraitis memo to Bill Oppelt, both of whom are former Dow Corning employees who are now at McGhan Medical. Petraitis is critical of Dow Corning's inflatable shells because of their method of dipping which results in significant differences in thickness, making the shells "very susceptible to aneurysm formation."

With gel-filled implants, the shell thicknesses are less. Also, he states that Dow Corning's gel "achieves its responsiveness by utilizing a large quantity of non-functional polymer in the gel formation.... This free polymer is not chemically cross-linked and is only mechanically trapped in the gel matrix. As a result, it is free to migrate through the shell and makes the entire implant much more prone to the 'bleed' phenomenon."

CITE: MCG 8487 -8489, Exhibit to Coyne Deposition, Exhibit to Grosh Deposition, Exhibit to Oppelt Deposition, Exhibit to Schreiber Deposition, and Exhibit to Petraitis Deposition. Dow Corning Trial Exhibit List Abstracts

Document #312
06/29/77RUPTURE
SHELL STRENGTH - THICKNESS

Vaz da Silva, Dow Corning, memo to Venn and Beyruth regarding ruptures. She states, "Our sales could be bigger if these ruptures didn't happen. As I have already said, our Plastic Surgeons are afraid of using our Mammary Prosthesis and with complete reason. At first I was thinking that was (the) fault of the surgeons but now, I really don't think this." A handwritten note at the top of the document from Venn to Bob Becker states, "I think her comments are self explanatory. Hope we begin seeing more uniform envelopes and non-reinforced patches soon."

CITE: CR 4006 - 4007.  Dow Corning Trial Exhibit List Abstracts

Document #315
11/07/79
SHELL STRENGTH - THICKNESS
RUPTURE
COHESIVENESS - LIQUID COMPONENT OF GEL
GEL MIGRATION
TISSUE REACTION

Operative report from Dr. Vinnik's patient. Patient reported being involved in a "very trivial accident, when she struck her right breast against the 'monkey bars' while playing with her child in a playground." During explantation for the ruptured prostheses, Dr. Vinnik noted that the gel ran "down the patient's chest, onto the operating table and onto the floor.... This procedure is performed because of medical necessity as a ruptured breast implant can produce serious medical problems.... Free silicone gel, particularly when it is non-cohesive as (sic - has) been known to migrate through the local area, and produces severe granulomatous response." (emphasis added).

CITE: KMM 423161. NOTE: See KMM 423155 - 423156.  Dow Corning Trial Exhibit List Abstracts

Document #316
11/08/79
SHELL STRENGTH - THICKNESS
RUPTURE

Dr. Vinnik's cover letter to G. Jakubczak, Dow Corning, sending him the 11/07/79 operative report about a broken implant. He states, "The implant ... was definitely defective and decidedly not up to the proper standards.... I am very distressed about this apparent breakdown in quality control, as I have removed many broken Dow Corning products....

(Dow Corning) should have a recall ... of some sort to the physician."

CITE: KMM 423153 - 423154.  Dow Corning Trial Exhibit List Abstracts

Document #319
01/22/80
KNOWLEDGE OF SYSTEMIC DISEASE
RUPTURE

Joseph Connelly, M.D., writes to Dow Corning Wright about a patient whose Silastic implant ruptured when she was involved in car accident. The implants were removed shortly thereafter because the patient experienced draining fluid from the implant through the skin. The patient's family doctor performed tests "which he says are suggestive of chronic lupus erythematosus." He wants to know if Dow Corning has any information whether the silicone implants can cause lupus. (emphasis added).

CITE: CM 1133 -1134. He writes a second letter on 04/01/80 because Dow Corning did not respond to the first letter. For Dow Corning's response, see 04/23/l80 entry.  Dow Corning Trial Exhibit List Abstracts

Document #321
04/14/80
RUPTURE
SHELL STRENGTH - THICKNESS

Memo from W. Lynch and W. Stich to the Medical Engineering Corporation Field Force. They discuss Dow Corning's new shell material for their inflatable implant and claim that this new shell has twice the tear resistance of their former material. "Regrettably one of the characteristics of silicone rubber is that it has a very low tear strength. Even if Dow Corning has made a shell with twice the tear strength of what they presently have, the new value will still be low compared to other materials, such as Saran Wrap." (emphasis added)

CITE: MEA 22 - 25. DUPLICATE: MEC 7835 - 7838: MEC 9278 - 9180,  Dow Corning Trial Exhibit List Abstracts

Document #322
04/23/80
KNOWLEDGE OF SYSTEMIC DISEASE

Dow Corning responds to Joseph Connelly, M.D., concerning his inquiry about a patient who developed lupus erythematosus following a rupture of a Silastic mammary implant. William Boley, senior Group Leader for the Health Care Group Research, responds:

"Dow Corning has performed extensive safety testing, in animals, on the silicone materials from which SILASTIC breast implants are made. I have also reviewed our product complaint files. Your inquiry appears to be the first Dow Corning has received asking whether a silicone breast implant could be a causative agent for chronic lupus erythematosus.

The data Dow Corning has suggest that it would be highly improbable that your patient's symptom of chronic lupus erythematosus could be attributed to the silicone breast implants."

CITE: CM 1135. NOTE: See 01/22/80 entry. Dow Corning Trial Exhibit List Abstracts

Document #328
07/22/80
COHESIVENESS - LIQUID COMPONENT OF GEL
RUPTURE
ACKNOWLEDGEMENT OF NEED FOR TESTING

Dr. Vinnik writes to Jakubczak, Dow Corning, regarding a "defective Dow Corning prosthesis." The patient reported a sudden onset of pain, changing consistency of the implant, and changing configuration of the left breast. Vinnik states:

"At surgery, you will note the Operative Report findings of an apparently defective gel in terms of both consistency, cohesiveness, and possibly color.... What we need to have accomplished is a thorough evaluation as to why this implant had a late failure. Was the problem inherent in the bag? Were there variabilities of thickness of shell, less than those of design tolerances? Why is this gel not cohesive as it should be? This is the second implant that we have removed which has been non-cohesive, and has shown spontaneous rupture for no apparent reason.... We need to consider whether or not a recall of all patients bearing this Lot number should be made. I think it may be wise to at least alert physicians that there may be a problem with this particular lot number.

CITE: KKH 53276 - 53277. Dow Corning Trial Exhibit List Abstracts

Document # 337
07/22/81
MISCELLANEOUS - RECKLESS/CONSCIOUS DESREGARD
RUPTURE

Hinsch, Dow Corning, memo to Jakubczak, Kelly, Burda, Jack Smith, Marlar, and Wessel regarding a marked decline in sales of the Varifil inflatable. "For 1980, we had approximately $10,000 in prelitigation expenses for Varifil mammary deflations. Y-T-D through July, 1981, we have approximately $16,000 in prelitigation expenses. With a decline in sales and an increase in prelitigation expenses, we should review our position with this product again."

CITE: KMM 78011 – 78039 Dow Corning Trial Exhibit List Abstract

Document #339
09/16/81
TISSUE REACTION
RUPTURE
SHELL STRENGTH - THICKNESS
MISCELLANEOUS - RECKLESS/CONSCIOUS DESREGARD

C. Burda, Dow Corning, handwritten notes regarding the Varifil prosthesis, "Probably most vulnerable in product line w/regards to efficacy and litigation. Potential for class action suit. Product did not have clinical testing. Rathjen recommended that product not be put into market. Charged w/writing protocol but technical people did not follow... Poor field performance led to 78 decision to go to Failure to Varify causes: 1. contracture, 2. infection, 3. rupture (good or imperfect products both may fail). Varifil may have small pinhole & fluid will leak out. Also may actually split...." (emphasis added).

CITE: KMM 78006 - 78007. Dow Corning Trial Exhibit List Abstracts

Document #340
09/16/81
SHELL STRENGTH - THICKNESS
RUPTURE
SHELL DEGRADATION

Dr. Vinnik letter to Bob Rylee, President of Dow Corning Wright. He states, "I am considerably worried about the failure rate of gel implants, and this correlates with the research that has been done by Mr. Garth W. Hastings of England on the matter of shell fatigue." Dr. Vinnik reports a second patient experienced shell fatigue also.

CITE: KMM 427907.   Dow Corning Trial Exhibit List Abstracts

Document #341
09/16/81
TISSUE REACTION
RUPTURE
KNOWLEDGE OF SYSTEMIC DISEASE

Dr. Vinnik's operative report to Dow Corning notes a patient who experienced a rupture and found an "irregular nodular mass" in her right breast which "became increasingly fibrotic and dense, raising some concern about malignancy. At surgery, the right breast was found to be totally disrupted with the implant shell incorporated within the gel mass.

Contiguous with the gel mass and separately isolated by capsule, was a roughly 4x6 cm irregular nodular mass which upon excision was an obvious siliconoma." The attached pathology report notes that, "The process ranges from a fibrous rather acellular one through concentrations of lymphocytes and plasma cells to small foreign body type giant cells tending to form granulomas. One section demonstrates an acute necrotizing inflammatory cell reaction."

CITE: F 687 – 689 Dow Corning Trial Exhibit List Abstracts

Document #342
09/23/81
KNOWLEDGE OF LIQUID SILICONE DANGERS
SHELL STRENGTH - THICKNESS
TISSUE REACTION
RUPTURE

Dr. Vinnik writes a second letter to Bob Rylee, President of Dow Corning Wright, regarding a failed silicone gel implant. He writes,

"(T)here is suspicion in my mind that we are dealing once again, with a shell failure. You will see from the enclosed Pathology Report that this patient had considerable silicone reaction to the extruded material. Review of the sections by the same pathologist who has reviewed all of the silicone injection material with me over the past twelve years shows this reaction to be as marked a reaction as we ever saw with the silicone injections. I believe this proves the point that 'pure silicone' can cause severe foreign body reactions in susceptible individuals." (emphasis added).

CITE: F 685 - 686. DUPLICATE: M 780645 - 780646.  Dow Corning Trial Exhibit List Abstracts

Document #347
01/12/82
SHELL STRENGTH - THICKNESS
RUPTURE - CLOSED CAPSULOTOMY

Sue Peters, Dow Corning, memo to Milt Hinsch regarding closed capsulotomies and the Silastic II mammary prosthesis. "Please make it very plain to your sales people that it is incorrect to promote or to imply any benefit of this mammary because of increased strength allowing a closed capsulotomy to be performed. We have no data to support that type of claim or implication."

CITE: D 4897. NOTE: Dow Corning did not warn of the risks of closed capsulotomy with the Silastic II until 1986.  Dow Corning Trial Exhibit List Abstracts

Document #351
04/22/82
KNOWLEDGE OF LIQUID SILICONE DANGERS
TISSUE REACTION
RUPTURE
GEL MIGRATION
MISCELLANEOUS - PRODUCT LABELING

Dr. Vinnik sends a letter regarding his meeting with G. Jakubczak, Bob Rylee and Tom Brown, Dow Corning, in which he details many breast implant problems and his proposed solutions. He recommends changing the patient and physician pamphlets to include warnings on shell fatigue, rupture, and gel migration. He provided Jakubczak with the pathology reports of a patient who showed such "...extensive and violent silicone reactions comparable to the worst of those seen with the old silicone injections."

CITE: KMM 140193 - 140197. duplicate: KMM 243027 - 243031; MM354986- 354990.  Dow Corning Trial Exhibit List Abstracts

Document #358
06/11/82
GEL MIGRATION

Burda, Dow Corning, reports on Complaint Report WM2570 in which the left implant ruptured and "silicone gel migrated down the patient's arm." 

CITE: CO 1417 - 1429.  Dow Corning Trial Exhibit List Abstracts

Document #364
09/23/82
KNOWLEDGE OF LIQUID SILICONE DANGERS
TISSUE REACTION
RUPTURE

Dr. Charles Vinnik letter to Robert Rylee, Dow Corning, regarding a patient who experienced severe reaction to the gel in a ruptured Silastic implant. Dr. Vinnik states, "Review of the sections by the same pathologist who has reviewed all of the silicone injection material with me over the past twelve years shows this reaction to be as marked a reaction as we ever saw with the silicone injections. I believe this proves the point that 'pure silicone' can cause severe foreign body reactions in susceptible individuals." (emphasis added).

CITE: M 780645 - 780649. NOTE: See 12/06/83 entry. M 780641 - 780644, for the second letter written to Rylee regarding this same patient.  Dow Corning Trial Exhibit List Abstracts

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.  Dow Corning Trial Exhibit List Abstracts

Document #380
09/23/83
FRAUD/MISREPRESENTATION
ACKNOWLEDGEMENT OF NEED FOR TESTING
RUPTURE
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." (emphasis added).

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.  Dow Corning Trial Exhibit List Abstracts

Document # 384
12/06/83
COHESIVENESS - LIQUID COMPONENT OF GEL
TISSUE REACTION
RUPTURE
GEL MIGRATION

Dr. Charles Vinnik writes to Robert Rylee, Vice President of Dow Corning Wright, regarding an enclosed pathology report showing that a patient has had a considerable silicone reaction to the mammaries extruded material. Dr. Vinnik states that he will not "assume liability along with Dow Corning for a defect in the silicone gel."

"The silicone gel, as demonstrated to Mr. Reuter and Mr. McGuire, and as seen and commented on by Mr. Matherly, Ms. Duel, Mr. Jakubczak and others at Dow Corning was in fact lacking in cohesion. Various theories were postulated as to why this gel was not cohesive and thus reacted as migratory gel within this patient's body producing considerable inflammation, foreign body reaction and discomfort. Nonetheless, all of these theories are moot as there has never been any representation to the medical public or the lay public that in any way, shape or fashion does the silicone gel change its physical characteristics once implanted in the human body with or without the intact shell.... There would be no requests to you for compensation for this patient's problem were the gel cohesive. If the gel was cohesive, she would have no problem.... I think (this) points up the fact that there should be some type of a liability insurance scheme with impartial analysis which would appropriately compensate people for products which are defective. I keep using the word 'defective' with respect to the silicone gel as there is yet to be any hard scientific evidence to show that what happened in this patient's case is anything other a defect in manufacture....(emphasis added).

CITE: KKA 246750 - 246753. DUPLICATE: KKA 152422 - 152425; M 780641 -780644.  Dow Corning Trial Exhibit List Abstracts

Document #387
02/06/84
KNOWLEDGE OF LIQUID SILICONE DANGERS
TISSUE REACTION
RUPTURE
SILICA

Dr. Charles A. Vinnik writes to Gene Jakubczak of Dow Corning regarding a pathology report from a patient whose implant lost its shell integrity. The pathologist found some silicone material engulfed by macrophages. "The type of reaction seen here is very similar to that in which liquid silicone is ingested by phagocytes converting them to foreign body giant cells and 'foamy macrophages'." (emphasis added). One of the rationales given by Dr. Vinnik for this reaction is, "The factor X within the shell of the implant. the reaction ... sustained is very similar to those which I have seen rarely over the years associated with faulty polymerization of the shell and/or filler. It is possible that the birefringent particles described by the pathologist (was) silica used as the filler material in the implant shell.... These findings have been reported by Wilflingseder and Brown with the silica particles confirmed by scanning electron microscopy." Dr. Vinnik hopes that Dow Corning will do more than its "usual casual, perfunctory and useless analysis...."

CITE: M 490041 - 490045. DUPLICATE: KKA 246784 - 246785.  Dow Corning Trial Exhibit List Abstracts

Document #389
02/29/84
RUPTURE
SHELL STRENGTH - THICKNESS
SHELL DEGRADATION
COHESIVENESS - LIQUID COMPONENT OF GEL

E. Frisch, Dow Corning, memo to R. Dumas, G. Jakubczak, and S. McGuire referring to a visit with Dr. Vinnik. Dr. Vinnik stated that many of Dow Corning's implants were "defective with thin spots causing them to be easily ruptured.... The gel in removed implants has lost its cohesiveness, and suggested that biodegradation may be occurring." Frisch claims it is not Dow Corning's envelopes and gel which are the problem, but that implant manipulation "would probably result in localized stressing of some areas of the implant, particularly if there were a thin spot, or if the stretching were uneven such that it created an aneurysm. The subsequent manipulations would probably stretch these areas resulting in progressive weakening and ultimately rupture...." There is no machine that duplicates this kind of manipulation that is commonly recommended by doctors to prevent capsular contracture.

CITE: KMM 259750 - 259751. DUPLICATE: DCC 80030963 - 80030966.  Dow Corning Trial Exhibit List Abstracts

Document #406
08/14/84
KNOWLEDGE OF GEL BLEED
SHELL STRENGTH - THICKNESS
RUPTURE

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

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

Dumas noted that most of the complaints concerning the standard gel mammaries (sic) were of the "ease of tear propagation (sic). In addition non-uniformity of the envelope was noted along most tears examined, suggesting thickness variation to be a contributing factor to the rupture." NOTE: manufacturing defect.

Dumas' overall recommendations are that Dow Corning needs to develop a more uniform envelope thickness on all products, reduce bleed characteristics, and increase stress resistance in the Silastic II.

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

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

Document #408
09/24/84
RUPTURE
SHELL STRENGTH - THICKNESS
SHELL DEGRADATION

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

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

Dow Corning Trial Exhibit List Abstracts

Document #417
03/26/85
SHELL STRENGTH - THICKNESS
RUPTURE
MISCELLANEOUS - PRODUCT LABELING

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

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

Document #426
09/05/85
FRAUD/MISREPRESENTATION
GEL MIGRATION
KNOWLEDGE OF GEL BLEED
MISCELLANEOUS - COMPLICATIONS
MISCELLANEOUS - PREP PROGRAM
RUPTURE
RUPTURE - CLOSED CAPSULOTOMY
SHELL DEGRADATION
TISSUE REACTION

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

Brody enclosed sample questions and answers about silicone breast implants. The proposed answers including statements such as:

"Reports of serious or life threatening problems directly related to the implant itself are rare.

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

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

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

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

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

Document #427
09/11/85
COHESIVENESS - LIQUID COMPONENT OF GEL
RUPTURE
MISCELLANEOUS - PRODUCT LABELING

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

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

Document #434
12/05/85
SHELL STRENGTH - THICKNESS
RUPTURE

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

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

Document #437
04/18/86
RUTURE
SHELL STRENGTH - THICKNESS
TISSUE REACTION
ACKNOWLEDGEMENT OF NEED FOR TESTING
KNOWLEDGE OF LIQUID SILICONE DANGERS

W. Boley, Dow Corning, memo to J. Vallender, J. Cooper, and G. Jakubczak, responding to a ruptured mammary implant complaint from Drs. Weiss and Cohen. Boley states that he is a toxicologist and is not competent to give medical advice. Responding to the finding of granuloma with "entrapped globules of silicone," Boley states that:

The extent and duration of this response to silicone gel has not been well characterized.... The assumption can be make that the gel will behave similarly to the fluid. Animal tests on PDMS (polydimethylsiloxane) fluid suggest that the granuloma response should be self-limiting and resolve with time. However, it was recently stated to me by one experienced clinician that he did not believe this response would resolve itself in humans. I think the answer to the question is, that at this time we do not know what the clinical sequel (sic) will be. (emphasis added)

CITE: KMM 202743. DUPLICATE: DCC 204000522.  Dow Corning Trial Exhibit List Abstracts

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.  Dow Corning Trial Exhibit List Abstracts

Document # 441
08/06/86
RUPTURE - CLOSED CAPSULOTOMY
SHELL DEGRADATION
TISSUE REACTION

Outline of issues and answers regarding breast implant contracture in which the occurrence of capsular contracture is termed "logical, rational, predictable, and entirely explainable." It is noted that, since fibrous tissue is merely scar tissue, "fibrous tissue encapsulation cannot be prevented, even with the 'best' biomaterial." Treatment can include daily manipulation, open or closed capsulotomy, initial placement of implant beneath pectoralis muscle, use of certain bioreactive materials, placement of implant in an oversized surgical pocket, and partial deflation of implant when capsule has matured. Three theories for prevention are identified: use of biodegradable covering (such as porous polyurethane), use of a porous coating, and use of shape retaining implants.

CITE: KKA 16168 - 16174.  Dow Corning Trial Exhibit List Abstracts

Document #444
11/05/86
SHELL STRENGTH - THICKNESS
COHESIVENESS - LIQUID COMPONENT OF GEL
RUPTURE

Dr. Charles Vinnik writes to Gene Jacubczak, Dow Corning, regarding the gel implant failures Dr. Vinnik has seen and "whether or not the gel changes within a patient or we are just dealing with a variation in the spectrum of gel cohesiveness used during the manufacturing process." He also notes that during routine mammography screening, he is discovering a loss of implant shell integrity "far more frequently in the general population than has been anticipated...."

CITE: DCC 242051156.  Dow Corning Trial Exhibit List Abstracts

Document#445
11/11/86
KNOWLEDGE OF LIQUID SILICONE DANGERS
RUPTURE
TESTING
TISSUE REACTION

M. Bejarano and W. Boley, Dow Corning, perform an internal study on "Dow Corning Q7-2159A Gel Injected Subcutaneously Into Rats" which concluded that the gel caused an increasing inflammatory response and tissue in-growth into the gel, "partitioning it into numerous smaller masses.... It is reasonable to assume that a similar response may occur in humans." This test resulted from the concern over the fate of gel if the prosthesis ruptured. (emphasis added).

CITE: KMM 270273 - 270283. DUPLICATE: KMM 278641 - 278650.

Document #449
01/16/87
COHESIVENESS - LIQUID COMPONENT OF GEL
RUPTURE
GEL MIGRATION

Dr. Charles Vinnik writes to Bruce Reuter, having expressed all of the following thoughts to you, Bob Rylee and Gene Jakubczak for years now.

I feel like a broken record, having expressed all of the following thoughts to you, Bob Rylee and Gene Jakubczak for years now.

Bruce, you will recall that when you first started working for Dow Corning you observed surgery with me and observed an implant being exchanged. The original silastic implant that was removed from the patient that you observed had gel which literally ran to the floor. We all observed it--it was far from cohesive, having the consistency of approximately 50 weight motor oil. Preceding that incident, and subsequent to that incident, there have been numerous implants which I have returned to the company ... all delineating the problems that I have been having with the gel.... I have begged that the returned products be compared with the original lot samples ... to determine if there is indeed any change in the gel. It is amazing to me that apparently nobody has done this very simple test. (emphasis added).

Vinnik also complained about the lack of meaningful analysis given to complaints and returned implants. "What really has burned me is the fact that on many of these reports when I received them, there are gratuitous self serving statements wherein the evaluator obviously speculates that somehow or other the patient has, at my direction, abused the implant." Dr. Vinnik questions the cohesivity of the gel in recent implants stating,

"Imagine my disappointment and shock when I found the gels were not what they were represented to be." He recommends a "thicker more cohesive silicone gel ... a much softer gel" be used than what is used in the SILASTIC II.

Loss of shell integrity is also an increasing problem on older prosthesis. "Loss of shell integrity is discovered on mammography when in fact it is clinically not evident.... I am hesitant, particularly with the poor quality of cohesion of some of the silicone gels that we have encountered to allow patients that I discovered to have lost implant shell integrity to keep those implants in place.... I do not want to have the responsibility of problems with respect to migratory gel on my hands as was the case with the many, many cases that McGhan accumulated.... It is amazing to me that apparently nobody has done this very simple test.

CITE: F 674 - 678. DUPLICATE: DCC 80031352 - 80031354.

Document #465
08/13/87
SHELL STRENGTH - THICKNESS
RUPTURE - CLOSED CAPSULOTOMY
ACKNOWLEDGEMENT OF NEED FOR TESTING
KNOWLEDGE OF SYSTEMIC DISEASE
GEL MIGRATION
TISSUE REACTION

Jakubczak, Dow Corning, sends Dr. Muller a lengthy response to his questions about implant rupture. He states that a hypothetical cause of rupture which may be possible but about which he does not have direct knowledge of is "Excessive force created when closed capsulotomy is being performed." Also, in the event of an implant rupture, gel can migrate and complications include "enlarged lymph nodes, scar formation, inflammation, granulomatous foreign body reaction, presence of foamy histiocytes, silicone mastopathy, nodule formation, or other difficulties.... The long term physiological effects of uncontained gel are not completely known."

Jakubczak states that Dow Corning has been tracking the rate of ruptures since the gel-filled implants were introduced to the market. "The rate (Of rupture) is less than ).1% for gel filled product. The gel-saline product is slightly less than that for gel product. The SILASTIC II mammary implant, to the best of our knowledge, is in the ballpark or slightly less. For the specific time period of the last 1970's our data indicates that the rate of rupture was the same."

CITE: M 460204. DUPLICATE: KKH 75863 - 75871. NOTE: Jakubczak did have direct knowledge of ruptures occurring with closed capsulotomies. Also, Dow Corning did not track rupture rates like he represents in this letter.  Dow Corning Trial Exhibit List Abstracts

Document #475
02/01/88
ACKNOWLEDGEMENT OF NEED FOR TESTING
RUPTURE
SHELL STRENGTH - THICKNESS

Letter from Franklin Wilder, The Hartford, to Greg Thiess, Senior Managing Attorney at Dow Corning, about a woman who struck her breast when slipping at a grocery store, allegedly causing one or both implants to rupture. Wilder questions, "Is there a standard for rupture force? The reason for this question is that it is foreseeable that a woman may hit her breast, or suffer some trauma and this force imparted to the implant. (sic) Has Dow Corning performed any studies along these lines?" (emphasis added).

CITE: KKM 42522. Note: See 02/04/88 response Dow Corning Trial Exhibit List Abstracts

Document #477
02/04/88
ACKNOWLEDGEMENT OF NEED FOR TESTING
RUPTURE
SHELL STRENGTH - THICKNESS

Greg Thiess, Senior Managing Attorney at Dow Corning, Letter to Frank Wilder, The Hartford, about a breast implant case filed against Dow Corning. Thiess states, "With respect to your question concerning any Dow Corning studies on the force that a mammary implant could withstand once placed inside of the female breast, Dow Corning has done no such studies." (emphasis added).

CITE: KMM 42521. Note: See 02/01/88 entry.  Dow Corning Trial Exhibit List Abstracts

Document #526
09/13/91
KNOWLEDGE OF GEL BLEED
RUPTURE
SHELL DEGRADATION
SHELL STRENGTH - THICKNESS
TESTING
TISSUE REACTION

FDA: Letter from the FDA to B. Lipscomb, Director of Clinical and Regulatory Affairs for Dow Corning Wright. Dow Corning Wright submitted 229 studies to the FDA in its PMA for the Silastic II Mammary Implant H.P. and the MSI Mammary Implant H.P. but the FDA states, "we believe that the PMA lacks information needed to show that there is reasonable assurance that the device is safe and effective for its intended use." The FDA then lists "major deficiencies" in the PMA including lack of specific data on rupture testing, tear resistance testing, abrasion resistance, gel bleed performance testing, pharmacokinetic/biodegradation studies, mutagenicity testing, manufacturing information, and clinical and non-clinical investigations.

CITE: m 780258 - 780265. DUPLICATE: M 780092 - 780100: M 780101 -780103; KKA 178597 - 178604.  Dow Corning Trial Exhibit List Abstracts

Document #529
12/20/91
COHESIVENESS - LIQUID COMPONENT OF GEL
KNOWLEDGE OF GEL BLEED
RUPTURE
SHELL STRENGTH - THICKNESS
TESTING

FDA: Lawrence Coyne, Material Research Engineer for the FDA, provides an in-depth review of Gel Bleed and Mechanical Testing submitted in Dow Corning's 12/13/91 Amendment (Volume 1) concerning Single and Double Lumen Silastic II and Silastic MSI Breast Prostheses, PMAs P910039A and P910040A. One notable deficiency in the testing is "the absence of any reported values for the total energy to rupture." Also:

a. Tensile Strength Testing

Coyne's "examination of the raw data for ultimate elongation reveals that a number of inordinately low elongation values were simply disregarded in calculating average values of this property." As such, Dow Corning's calculations were artificially high, within ASTM F703 guideline; however, inclusion of all data would have brought the mean average down to "a clearly unacceptably small and highly fluctuating value." Coyne attributes the low values to poor manufacturing quality control leading to "chemical differences within the shells."

b. Patch/Valve Tensile Testing

Significantly lower values of ultimate elongation and tensile strength in the patch material and the shell material in the vicinity of the patch would appear to indicate the higher probability of device rupture in these areas.

Finally, Coyne finds Dow Corning's gel bleed study unacceptable, as it "does not include any chemical or molecular weight characterization of the gel bleed products.... Also, contrary to what might be expected, the bleed rates were higher in terms of a weight basis for the firm gel as opposed to the soft or responsive gel."

CITE: FDA 12423 - 12431.  Dow Corning Trial Exhibit List Abstracts

Document #530
12/30/91
FRAUD/MISREPRESENTATION
DEFINITIONS

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.  Dow Corning Trial Exhibit List Abstracts

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.  Dow Corning Trial Exhibit List Abstracts

Document #540
03/13/92
COHESIVENESS - LIQUID COMPONENT OF GEL
KNOWLEDGE OF GEL BLEED
RUPTURE
SHELL STRENGTH - THICKNESS
TESTING

FDA: The FDA cites deficiencies in Dow Corning, Mentor and McGhan's PMA test data on chemical extraction studies, in-vitro gel cohesivity, valve competence, joint integrity, tear resistance, and tensile strength. Include internal FDA memos dated 03/13/92 and 03/18/92 from Lawrence Coyne explaining in detail the reasons for the PMA denials.

CITE: FDA 12567 - 12607. NOTE/ FDA 12519 - 12535 may be an attachment to this document.  Dow Corning Trial Exhibit List Abstracts

Document #541
02/13/92
COHESIVENESS - LIQUID COMPONENT OF GEL
KNOWLEDGE OF GEL BLEED
RUPTURE
SHELL STRENGTH - THICKNESS
TESTING

FDA: The FDA, in a summary of safety and effectiveness data, cites deficiencies in Dow Corning's, Mentor's, and McGhan's PMA test data on chemical extraction studies, in-vitro gel cohesivity, valve competence, joint integrity, tear resistance, and tensile strength.

CITE: FDA 12519 - 12535. NOTE: May be an attachment to FDA 12567 -12607.  Dow Corning Trial Exhibit List Abstracts

Document #547
09/07/92
ACKNOWLEDGEMENT OF NEED FOR TESTING
KNOWLEDGE OF SYSTEMIC DISEASE

Dow Corning lists "Clinical Immunology Proposals...and finds worthy of serious consideration:

1. Barrett Noones's silicone as an antigen and =/-presence of specific antibodies; specific T-cell stimulation; Dow Corning states that this "becomes important in the light of the recent Goldblum article";

2. Walter Peter's cytokines in implanted individuals. He has already started screening individuals and Myron Harrison, Dow Corning, has asked him to combine this clinical study with Laurence Rubin's proposal on serologies on implanted women to look for markers of autoimmune disease.

3. James Sanger's proposal to study the presence or absence of humoral antibodies contiguous to implants or in case of rupture.

4. Kimber White's (study on the potential immunogenicity of silicone elastomers and elicitation of humoral or cell-mediated responses.

5. Daniel Ladin's and David Fivenson's study hyupothesis that T cell activation occurs at the site of capsular formation and that peripheral blood lymphocytes have the same oligocloanality.

6. Howard Smith's study on indiciduals who are being explanted and claims to be seeing differences in some biomarkers levels.

7. Marianne Frieri"s clinical immunology focusing on cytokine and growth factor assessment in breast implant patients.

8. Robert Winchester's and Jane Morse's characterization on the clinical features, auto-antibody profile, lymphocyte phenotypes, and HLA groups of women who are symptomatic post implant.

9. Nemecek Young's clinical research with emphasis on immunology and genetics.

10. Sudha Agarwal's and Marc Liang's study on immune response to silicone implants.

11. John Varga's clinical studies.

12. Jeffrey Brown's rupture detection via MRI.

13. M.A. Atassi's clinical immunology and animal studies of the immune system.

CITE: DCC 267011492 - 267011512.  Dow Corning Trial Exhibit List Abstracts

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 Conyers, 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.  Dow Corning Trial Exhibit List Abstracts

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 theirown 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.  Dow Corning Trial Exhibit List Abstracts
Also from the Dow Docs are these subjects