SMOKE - FIRE DOCUMENTS 351 - 400
 
Document #351
04/22/82
KNOWLEDGE OF LIQUID SILICONE DANGERS
TISSUE REACTION
RUPTURE
GEL MIGRATION
MISCELLANEOUS - PRODUCT LABELLING
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; KMM354986- 354990. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
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Document #352
05/10/82
ACKNOWLEDGEMENT OF NEED FOR TESTING
KNOWLEDGE OF SYSTEMIC DISEASE
J. Cooper, Dow Corning, memo stating that the Two-Year Implant Study of Q7-2167 and Q7-2168 was flawed and useless. Cooper states that, “Prior to completion of the study and interpretation of the results IBT (Industrial Bio-Test Laboratories) was cited by the FDA for poor clinical/laboratory practices including loss of records and falsification of data. The corporation was subsequently dissolved.” In addition, “the data were considered highly suspect because of abnormally high disease rates among all of the test animal groups—including the saline injected and untouched groups.... We have since had opinions from several external pathologists and veterinarians that the colony was disease ridden and the entire exercise was badly flawed and useless. We have concluded this study has resulted in no usable information and that no conclusions can be drawn from it. We are now back at the same point we were at in 1975 except that we have expended $200M in the study and its subsequent evaluation/condemnation.” (emphasis added).
 
CITE: F 814 - 815. DUPLICATE: m 170070 - 170071: M 430209 - 430210; KMM 361951 - 361952; KMM 339375 - 339378. NOTE: Dow Corning has no long-term studies and, even though they admit that “we still need the two year study...,” Dow Corning does not begin another such study until 1988. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
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Document #353
05/14/82
TISSUE REACTION
KNOWLEDGE OF SYSTEMIC DISEASE
Dr. Robert Parsons, Professor of Surgery at the University of Chicago, writes a letter to Gene Jakubczak at Dow Corning informing them of their research on implanted silicone prostheses. “our data suggest strongly that the fibrosis and capsular contracture seen clinically maybe (sic) an immunologically mediated phenomenon.” (emphasis added). Dr. Parsons states that macrophages aggregate and adhere to the surface and actively erode the silicone envelope after implantation: macrophages ingest and process silicone; macrophag-lymphocyte communication occurs by intracellular bridging in the lymph nodes and have identified silicone containing microvacuoles in both the macrophages and lymphocyte ends of the bridges; and significant inhibition of macrophage migration by silicone sensitized lymphocytes in vitro has been shown. Dr.  Parsons, Dr. Heggers and their research assistant, Nir Kossovsky, suggest that their work may enable them to develop a method of screening patients for “hypersensitivity to silicone” before they are implanted.  The research team found that the body’s reaction to silicone created giant cells called macrophages that erode the silicone envelope and can migrate to the lymph nodes. Dr. Parsons believes that the body’s immune reaction could be causing such problems as capsular contracture. Requests for finding from Dow Corning for further research to better understand this immune response were denied by the company.
 
CITE: F 748 - 749. DUPLICATE: FDA 19612 - 19613: KMM 447084 - 447085; Staff Report prepared by the Human Resources and Intergovernmental Subcommittee of the Committee on Government Operations, December, 1992, p. 15. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
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Document #354
05/17/82
FRAUD/MISREPRESENTATION
CONCEALING FROM FDA
Dow Corning submits its portion of the industry-coordinated response to the proposed reclassification to HIMA. Dow Corning’s portion consists of a discussion of the long-term effect of silicone breast implants.
 
CITE: MCG 5454 -5462. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
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Document #355
10/19/82
TISSUE REACTION
KNOWLEDGE OF SYSTEMIC DISEASE
Eldon Frisch, Dow Corning, responds to Richard Swett, M.D., concerning an allergy-type reaction to Silastic brand implants made from medical grade silicone. Frisch states: “Clinically, the implants have been used in several million patients with very few reports of suspected inflammatory or allergic reactions. In the past, with one recent exception, when the reactions were evaluated by patch testing, by subdermal implantation of a small specimen, or by cell culture studies of the implant the reactions have universally been negative.”
Frisch notes another report of a potential allergic reaction to silicone reported by George Francis, M.D. (emphasis added).
 
CITE: M 480031 - 480032. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
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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.
 
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Document #357
06/03/82
MISCELLANEOUS - LOBBYING
TESTING
Letter to Goldwyn from Rathjen regarding the unacceptable situation with the clinical investigators, “I am missing annual follow-up reports (see protocol), photographs, injection reports, etc. With a very few investigators, the lack of attention to the protocol is absolutely unacceptable. ... The FDA doesn’t want to hear excuses why investigators’ records are incomplete or why there is an apparent lack of control or attention to detail. ... This impression concerning the conduct and results could conceivably carry over into other device areas, i.e., the breast prosthesis reclassification.” Strongly worded letter.
 
CITE: DCC 106006096 - 106006099, Exhibit to MDL Rathjen Deposition.   Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
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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
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
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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. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
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Document #360
07/13/82
KNOWLEDGE OF GEL BLEED
Duel, Dow Corning, memo to Jakubczak regarding comments, questions and recommendations on the letter from Dr. Schmidt. Among Duel’s comments are shells are very oily, we lubricate the valves with silicone, H.P. shells have visually more bleed, all gel-saline units bleed, and our distributors are well educated but poorly informed.
CITE: M 250033 - 250034. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
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Document #361
08/11/82
ACKNOWLEDGEMENT OF NEED FOR TESTING
Gene Jakubczak, Dow Corning, memo to Jim Wessel and Jerry Marlar on the two year rat implant studies using mammary prosthesis silicone gels. He supports the acquisition of implant data on Q7-2167 and Q7-2168 gels. Further, he “recommend(s) that systemic fate of the material or extract should be stud(ied) as well as the metabolic fate.... The study should be expanded to make sure that we know what happens to gel bleed or gel and what is its metabolic fate.” (emphasis added).
 
CITE: M 250033 - 250034. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
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Document #362
09/01/82
SHELL STRENGTH - THICKNESS
Tom Brown, Dow Corning, memo to Milt Hinsch about the staggering reject rate with the larger size Silastic II mammaries. Dow Corning changes from a 3.2 cm patch to a 4.5 cm patch to “compensate for the inherently less responsive and elastic character of the Flourosilicone-coated envelope.
 
CITE: d 2226. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
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Document #363
09/13/82
 
COHESIVENESS - LIQUID COMPONENT OF GEL
 
McMahon and Sweet, Dow Corning, memo to Cooper and Metevia regarding “Progress Report On The Mammary Gel Cohesion Project.” Sample implants were taken from the plant and a gel cohesion test was performed. “The data generated showed that 23% failed the gel cohesion test.” They observe that “inconsistency within a lot could mean mechanical breakdown of gel or a shift of the cross-link network.” Also, they state, “First of all, we found that the catalyzed gel was approximately 75% non-reactive fluid....” Using gel with the additional factors enter in “although the extent of importance is not understood. The mammary envelope is an addition cured elastomer and ... any unsaturated vinyl groups at the envelope/gel interface can react with active hydrogen from the gel cross-linker. If this occurs then part of the cross-linking network is disturbed.”
CITE: KKA 245424 - 245426 Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged and Confidential
 
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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
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
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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. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
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Document #366
12/17/82
TESTING
Letter to Dr. Goldwyn from Rathjen regarding receipt of clinical data, “the quality of documentation is self explanatory. Absolutely unacceptable! I suspect the validity! ... There is no room for friendships here. He has embarrassed you and me, he has disregarded the Protocol, ignored the reputation of his colleagues and the A.S.P.R.S.”
 
CITE: DCC 106003897, Exhibit to MDL Rathjen Deposition. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
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Document #367
00/00/83
SILICA
Researcher N. Kossovsky studies the surface morphology of explanted mammary prostheses and reports that the surface was covered with embedded spheres and surrounded by pits. Kossovsky suggests these surface anomalies may be the result of the “grazing” of silica filler particles from the envelope of the prosthesis by phagocytic cells.
CITE: M 790186 - 790193. Dow Corning trial Exhibit List Abstracts
PENDLETOM/PSC Attorney Work Product/Privileged & Confidential
 
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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.
CITE: KMM 120705 - 120729, Exhibit 3 to Harris County Rathjen Deposition. DUPLICATE; M 100083 - 100143. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
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Document #369
02/02/83
KNOWLEDGE OF LIQUID SILICONE DANGERS
KNOWLEDGE OF SYSTEMIC DISEASE
Stark, Dow Corning, memo to Marlar, Rathjen, Steinberg, Jakubczak, Weyenberg, Lentz and Hobbs reporting that “the number and type of abnormalities noted with the 360 fluid studies in rabbits, i.e., classic cyclops condition of the eyes, clubbing of extremities, ankles bent in the wrong direction, were all indications of potential birth defects related to silicones: and the “this issue is of paramount importance. It has relevancy to the safety of all silicone applications and must be resolved ASAP.: (emphasis added).
CITE: DCC 17042386 - 17042387, Exhibit to California Lentz Deposition, Exhibit 93 to Bennett Deposition, and Exhibit to MDL Rathjen Deposition. DUPLICATE: KKA 22785 - 22786. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
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Document #370
02/03/83
KNOWLEDGE OF GEL BLEED
MISCELLANEOUS - PRODUCT LABELING
G. Jakubczak, Dow Corning, memo to Milt Hinsch regarding revisions to the package insert for the Silastic implant. Jakubczak suggests routing all comments on inserts to Jim Matherly, Chick Burda, Harvey Steinberg and Marcia Marsh since this is a “very high potential liability product.” Jakubczak suggest adding language on silicone bleed - “Silicone bleed from a gel filled mammary has been identified in surrounding tissue.”
CITE: KMM 301297 - 301301. NOTE: Need to cross check the final package insert to see if Jakubczak’s suggestions were incorporated. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
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Document #371
02/17/83
TESTING
Hobbs, Dow Corning, memo to Lentz stating that data produced 15 years ago would likely produce adverse publicity because the data does produce doubt, the laboratories producing the data can easily be criticized relative to their performance standards and the studies involved would likely not withstand validation. (emphasis added)
CITE: DCC 204005659 - 204005660. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
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Document #372
04/01/83
KNOWLEDGE OF SYSTEMIC DISEASE
MISCELLANEOUS - COMPLICATIONS
Gregory patient no. 29 follow-up. The patient developed rheumatoid arthritis in the back and shoulders and has an over active thyroid.
CITE: B 1453 - 1454, Exhibit 14 to Harris County Rathjen Deposition, Exhibit to MKL Rathjen Deposition. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
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Document #373
04/05/83
DOCUMENT DESTRUCTION
C. Burda, Dow Corning, memo to J. Matherly regarding the “severe status of record keeping by TSS&D” on Slapstic II Lot History Records. Burda states, “Tim Pinto and I encountered a serious problem of HX master records being incomplete and/or missing.” When “Attempting to determine the number of Silastic II implants distributed by Dow Corning the following conditions have been encountered. Master HX records have not been properly prepared and recorded.  Many ... are not available for lots processed by the plant. Supportive records and/or references are often not provided.” There is also a four page listing of irregularities found in at least 56 lot history and device master records including the reject cause tally does not reconcile with the quantity rejected, incomplete and missing information in the records, sizes combined in a single lot, and implants unaccounted for. “The HX master record is (a) suitable document for device manufacturing work. But it has not been used properly. As the records indicate people using it do not use it as a serious GMP type document. The management of the HX system is totally missing as written by failure to check and approve each lot. Furthermore it appears no audit was ever performed to check if HX lots were ever completed and records returned.... There are no exceptions for failure to comply to good manufacturing processes.” (emphasis added).
CITE; D 4924 - 4929. NOTE: Dow Corning has cited to lot history records in responding to inquiries from the FDA and Physicians about problems with implant shells. Specifically, Dow Corning Claims that the lot history records show that there was no problem with the particular lot in question. See, e.g., 06/21/82
entry. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
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Document #374
04/20/83
COHESIVENESS - LIQUID COMPONENT OF GEL
Gene Jakubczak and Tom Brown of Dow Corning recommend rejection of loose gel HH0223099 (Drums 1,2) (Used in Silastic II Mammaries) as “unsuitable for sale.” The lot of gel passed all lot acceptance requirements but it was atypical gel.  The recommendation is based upon their observations that the gel “appeared sloppy,” that some Slapsti II units “failed catastrophically,” and others failed ASTM cohesivity tests. “Gel fell en masse from envelopes.... Gel appeared to ‘flow’ and when manual attempt to squeeze from envelope was made, no tendency to spring back into the envelope was noted upon release.’ (emphasis added).  Further, “On the basis of the risk which would be posed to a patient having one of these units implanted, prudence requires their rejection. The ease with which gel may be displaced from the shell (as evidenced in the hang test) is sufficient cause for concern.” (emphasis added).
 
CITE: F 726 - 727. DUPLICATE: DCC 800441416 - 80041417. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
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Document #375
05/03/83
COHESIVENESS - LIQUID COMPONENT OF GEL
Dr. Vinnik writes to Robert Rylee, Dow Corning Wright, regarding a Dow Corning silicone gel implant “which does not appear to conform to your own minimal specifications with respect to gel cohesion.” The attached Operative Report notes “THE GEL ON BOTH SIDES APPEARED TO BE DEFECTIVE, BEING EXCESSIVELY THIN AND RUNNY.” (emphasis in original).
 
CITE: KMM 3885 - 3891 Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
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Document #376
07/20/83
ACKNOWLEDGEMENT OF NEED FOR TESTING
KNOWLEDGE OF SYSTEMIC DISEASE
C. Lentz, Dow Corning, memo to D. Weyenberg discussing staffing needs to conduct toxicological studies. He writes, “The work we do has a wide range of urgency connected with it. On one end of the range is the work that must be done now and on the other end is work which needs to be done some time but can be put off for now ...until it reaches the ‘must be done now’ stage.” Lentze states that Dow Corning’s current mode is that the toxicology department is understaffed or “inadequately’ staffed, that they are “borrowing” pathology and veterinary skills from Dow Chemical and that Dow Corning has “no resources available to do long term studies or fundamental information type studies.” Lentz urges Dow Corning to immediately hire two people to meet Dow Corning’s “here and now obligations.” A long term (2 year) state of the art study on the health effects, including carcinogenic potential of implanted silicone gel “must be done. Dow Corning no longer has the option of not doing or delaying the study.’ Lentz adds, “Commencement of a gel implant study is overdue and at this time we would not be able to convincingly demonstrate due diligence in pursuing knowledge.”
One of the recipients of the memo, Forrest Stark, writes a handwritten note back to Lentz at the top of M 420069: “Bringing appropriate professionals in house has my wholehearted support. I still think that a reorganized TOX within HES could give us efficiencies.” (emphasis added).
 
CITE: M 420068 - 420072, Exhibit to Harris County Boley Deposition, Exhibit 7 to Zimmer Deposition, Exhibit to Rylan Deposition, and Exhibit 19 to Harris County Zahalsky Deposition. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
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Document #377
08/09/83
ACKNOWLEGEMENT OF NEED FOR TESTING
KNOWLEDGE OF SYSTEMIC DISEASE
TESTING
TISSUE REACTION
Memo to Rathjen from Isquith regarding Immunological Research Proposal, “It has long concerned me that our knowledge in this area is virtually nil and should not be. ... Knowledge from such a study ... could be a tremendous asset in better understanding tissue reaction to silicone implants.”
 
CITE: KMM 205513 , Exhibit to Isquith Deposition and Exhibit 65 to MDL Rathjen Deposition. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
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Document #378
08/25/83
ACKNOWLEDGEMENT OF NEED FOR TESTING
Weyenberg, Dow Corning, memo to C. Lentz. J. Cooper, Rylee, Stark, Steinberg, and Ziarno regarding a toxicity evaluation of silicone gel.  “Will you please take the leadership in the preparation of a definitive proposal for a chronic tox study on gel implants? Please consider the options of a study conducted within our TOX Department versus and externally funded study. The proposal should include the options and your recommendations on scope, expense (including APS) and timing for the study—A proposal which can be used by the Health Care Group and the RDES function for decisions on funding this project.
CITE: M 420067. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
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Document #379
09/15/83
ACKNOWLEDGEMENT OF NEED FOR TESTING
Boley, Dow Corning, memo to J. Matherly regarding “Biological Safety Testing Of Gel For Implants.” He states the “only gel to my knowledge that has had long-term implant testing performed on it” is X-3-0885 (Sylgard 51). “Gel Q7-2218 only has tissue cell culture data available for it. Therefore, if we are to continue to sell this material as “medical Grade,” immediate action should be taken to bring it into compliance with the business definition of Medical Grade.”
“It is my opinion the Q7-2167/2168, Q7-2150/2146, and X-3-0885 are similar enough in formulation such that testing performed on one gel is applicable to the other two... we have no valid long-term implant data to substantiate the safety of gels for long-term implant use.... Only inferential data exists to substantiate the long-term safety of these gels for human implant applications.  (emphasis added).
CITE: F 838 - 839. duplicate: M 170034 - 170036; M 580061; KMM 380518 - 380520; KMM 140198: KMM 386581: KMM 483550 - 483552; KFD 1655 - 1658: KKA 1. NOTE: In 1983, Dow Corning is till complaining of no long term testing and no real safety data. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
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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.” (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
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
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Document #381
09/26/83
ACKNOWLEDGEMENT OF NEED FOR TESTING
MISCELLANEOUS - PRODUCT LABELING
TESTING
TISSUE REACTION
Boley, Dow Corning, memo to Marlar, Rylee, Wessel, Cooper, Rathjen and Hobbs with copies to Lentz, Stark and Steinberg regarding “Repeat of Dr. Heggers Published Procedures Claiming Antigenicity Of Silicone Gel.” Boley wanted to repeat the study with an outside laboratory but the estimated cost of $20,000 was too much. He states: So Economically, I find it difficult to justify expending much time and money on this matter. For the present, I believe it may be adequate to begin updating our product data sheets to read “low-sensitization” or “minimal sensitization” rather than “non-sensitizing.” The issue of sensitization of silicone polymers will eventually be resolved by the medical community with or without our help. Therefore, perhaps the appropriate course is to wait. In any event, the sensitization potential of silicones will be extremely low or non-existent and therefore, should have little economic impact on Dow Corning.”
 
CITE: KMM 337395. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
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Document #382
09/30/83
COHESIVENESS - LIQUID COMPONENT OF GEL
TESTING
KNOWLEDGE OF GEL BLEED
Dow Corning “Investigation of Q7-2167/2168 Formulation Parameters Which Might Influence Gel Cohesivity And Bleed” by Joan McMahon, Randall Sweet, and Virgil Metevia. They discuss that in mid-1982, Dow Corning Wright’s TS&D requested the Medical materials Department of Dow Corning to address issues of gel cohesivity and bleed with Q7-2159A (the gel used in Silastic and Silastic II), which is the catalyzed version of Q7-2167/2168 gel.
Thirty (30) mammaries were taken from inventory and tested. 23.3% (7 of 30) failed the cohesivity test. Mammaries within the same lot passed while others in the same lot failed this test. Some has excessive bleed and some did not. There was little area where the gel would be cohesive and still fall in the specification range of 75-300. Data showed the specification could be brought to 50-150 and still likely pass the ASTM F703-81 gel cohesivity test. The responsiveness of 50 penetrations was not considered to be objectionable. Gel bleed is already known to be a problem.
CITE: KKA 121630 - 121669. DUPLICATE: KKA 88488 - 88495; KMM 270149 -270162; KMM 173990.
 
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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 Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential .
 
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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
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
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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. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product /Privileged & Confidential
 
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Document #386
12/27/83
MISCELLANEOUS - COMPLICATIONS
MISCELLANEOUS - PRODUCT LABELING
TISSUE REACTION
Lentz memo to Marlar with copies to Boley, Cooper, Hobbs, Rathjen, Rylee, Steinberg and Wessel regarding Marlar’s 11/21 memo about “plans to change the silicone gel product literature to indicate some degree of sensitization.... I would like you to delay a final action on this plan until a group representing a broader product responsibility in the corporation has had a chance to discuss the subject and reach a conclusion. I believe this is essential because the major component of gel is polydimethylsiloxane. This material is used in a very broad spectrum of products and consequently a variety of human exposure does occur. For example, PDMS is used in a variety of personal care products, such as skin lotions. If your literature suggests silicone gel causes some degree of sensitization, there is significant potential for implicating other PDMS products.”
CITE: KMM 336678 Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
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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
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
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Document #388
02/16/84
ACKNOWLEDGEMENT OF NEED FOR TESTING
KNOWLEDGE OF SYSTEMIC DISEASE
TESTING
Holmes, Dow Corning, memo to Rathjen regarding “S.H. Miller Study Protocol.” Holmes states: “It seems almost inconceivable that we do not know more about the human immunological response to silicone at this point....” He states that the study is “certainly needed” and that Dow Corning should support it.
 
CITE: KMM 205503, Exhibit to MDL Rathjen Deposition. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
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Document #389
02/29/84
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
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
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Document #390
03/14/84
COHESIVENESS - LIQUID COMPONENT OF GEL
TISSUE REACTION
Dr. Charles Vinnik, Dow Corning, letter to Gene Jakubczak, Dow Corning, regarding an implant which had lost its shell integrity. “(T)he patient did have a silicone reaction exterior to the intact capsule....” He states that Dow Corning’s gel was “greatly inferior” to other manufacturer’s gel because of its “looser consistency.” Bruce Reuter, Dow Corning’s National Sales Manager, writes at the top of the letter, “I think we should cut Dr. V. loose!” (emphasis added).
CITE: DCC 242051086 - 242051087. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
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Document #391
03/30/84
TESTING
Abstract of Dow Corning study of “Tissue Cell Biocompatability of Dow Corning 200 Fluid, 65 cs” states that, “The test material was evaluated for cytopathic effect by placing the material in direct contact with a confluent monolayer of human embryonic cells.... A distinct cytopathic effect was observed by the test material in both initial and retesting of the samples.”
CITE: 38813 - 38821. DUPLICATE: KKH 59302 - 59320. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
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Document #392
04/16/84
ACKNOWLEDGEMENT OF NEED FOR TESTING
TESTING
Letter to Miller from Rathjen re the March 28th letter covering prospective breast study,. In July, patients will receive an examination for their 12 year follow-up.
 
CITE: KMM 205496 - 205497, Exhibit to MDL Rathjen Deposition. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
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Document #393
04/18/84
TESTING
GEL MIGRATION
Linda Veresh, Dow Corning, “Final Report on Dow Corning 382 Elastomer, skin sensitization test; the original report is dated 1982. Two of the guinea pigs died with no cause determined but the implants had migrated and whitish lesions and granular particles were found on the lung, ventricles of the heart, spleen and liver. In addition, hemorrhagic spots were found on the cerebrum.
CITE: T 11768 - 11817 Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
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Document #394
04/23/84
DOCUMENT DESTRUCTION
COHESIVENESS - LIQUID COMPONENT OF GEL
Reuter, “Dow Corning, memo to Wessel regarding C. Vinnik’s runny gel complaints.  “These escapades are costly! The price tag on this one is greater than $3,000.00 and we settled another claim for $5,000.00 late in 1983. ... P.S. Please read memo then destroy. Do not keep for files.”
CITE: KKH 76226. DUPLICATE: M 490088. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
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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. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
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Document #396
05/09/84
KNOWEDGE OF SYSTEMIC DISEASE
Eldon Frisch, Dow Corning, memo to Bill Boley, Marcia Marsh, and Jim Wessel concerning Baxter Travenol’s presentation at the biomaterials Meeting. The poster presentation demonstrated a cell culture method Baxter developed for assessment of immunotoxicity. Frisch states that Baxter “tested a number of materials, including silicones, and have found that many, if not most, plastics and elastomers elicit an immunotoxicity reaction. ... This may be of interest in the alleged case of human adjuvant disease.” (emphasis added).
CITE: KMM 37828. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
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Document #397
05/21/84
KNOWLEDGE OF SYSTEMIC DISEASE
Frisch, Dow Corning, letter to Dr. John Madden (cc to Boley) regarding a female hydrocephalic patient described in an attached abstract entitled “Evidence For Immune Response to Silastic Implants” by Michael R. Wasserman. The described patient experienced an alleged immune response to silicone elastomer.
 
CITE: DCC 10005769 - 10005770. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
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Document #398
06/84
KNOWLEDGE OF SYSTEMIC DISEASE
MISCELLANEOUS - COMPLICATIONS
Gregory follow-up for patient no. 8. She developed arthritis in 1978, 6 years post-implantation.
 
CITE: B 1084 - 1085, Exhibit 11 to Harris County Rathjen Deposition, Exhibit to MDL Rathjen Deposition. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
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Document #399
07/09/84
KNOWLEDGE OF SYSTEMIC DISEASE
MISCELLANEOUS - COMPLICATIONS
Gregory follow-up of patient no. 48. Five years post-implantation she was diagnosed with idiopathic thrombocytopenia purpura.
 
CITE: B 727 - 750, Texas Exhibit No. 8, Exhibit to Harris County Rathjen Deposition, and Exhibit to MDL Rathjen Deposition. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
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Document #400
07/09/84
KNOWLEDGE OF SYSTEMIC DISEASE
MISCELLANEOUS - COMPLICATIONS
Gregory follow-up of patient no. 26. The patient developed arthritis in her fingers.
 
CITE: B 1401 - 1403, Exhibit 12B to Harris County Rathjen Deposition, and Exhibit to MDL Rathjen Deposition. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
 

TO DOCUMENTS: 401 - 450