SMOKE - FIRE DOCUMENTS 201 - 250
 
Document #201
08/12/75
 
KNOWLEDGE OF GEL BLEED
MISCELLANEOUS - COMPLICATIONS
TISSUE REACTION
 
Dr. Upton (Cronin”s associate) letter to Rathjen regarding capsular contracture.  Dr. Wilflingseder and Dr. Laub have been able to demonstrate small particles of free silicone inciting inflammatory reactions in adjacent soft tissue. They have noted the same phenomenon. “Although the etiology of the problem is multifaceted, I am sure, we still wonder if the surface of the silicone polymer plays a significant role.”

CITE: DCD 173003034, Exhibit 27 to MDL Rathjen Deposition (used by plaintiffsand Dow Corning), Exhibit 120 to Harris County Rathjen Deposition. DUPLICATE: M190146. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
 
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Document #202
08/28/75
 
TESTING
 
Tony Abbott, Dow Corning, memo to Bey and numerous other employees regarding “Mammary Gel Biocompatability.” Abbott states that he now has a test procedure (Tissue Cell Culture) for evaluating biocompatability of products on a lot to lot basis. Each lot of mammary gel consists of several drums of materials. “Test results show that there is a difference in the biocompatability of the gel on a drum to drum basis.” Abbott also recommends a permanent solution to the problem with the butyl carbitol acetate solvent as a catalyst. Wil Larson is working on this.
 
CITE M 170101 - 170103. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
 
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09/03/75
(NOT LISTED ON PLAINTIFF’S EXHIBIT LIST)
(this document is between #202 & #203)
 
Memo from Art Rathjen, Dow Corning, to Drs. Anderson, Ashley, Barrett, Blocksma, Dingman, Dufourmoutel, Edgerton, Epstein, Giannestine, Goulian, Murray, Orentreich, Rees, Smith, Stark and Vinnik regarding “News Release - Silicone Fluid Injection.” “Because of legal complications, any inquiries from the media should be referred to Silas Braley or Joseph Radzius at Dow Corning.” Rathjen encloses a Dow Corning news release stating that it has filed a New Drug Application with the FDA requesting approval to market silicone fluid for injections.
 
CITE: M 350161 - 350163, Exhibit 29 to Harris County Rathjen Deposition. Dow
Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
 
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Document #203
09/10/75
 
KNOWLEDGE OF LIQUID SILICONE DANGERS
 
Silas Braley, Dow Corning, Summarizes a phone call with Dr. Charles Vinnik in response to the press release. Braley states that Dr. Vinnik: “wanted to know what we were doing about preventing this use so that all of the incapable people don’t get a hold of it for this kind of use.... He said that the Moss subcommittee in Congress is all poised waiting for Vinnick’s (sic) statement to jump on an investigation of the silicone fluid injection story. He has been keeping a lid on this all along.... He said he felt that the information we have had given to us by the investigators is faulty. That his information is much greater and much better and shows that volumes of silicones under high pressure can cause all kinds of things that we do not have in our study. He said that the longest we had was four years in monkeys and even that showed fat necrosis. He explained fat necrosis as being identical with the situations he has seen in the patients that he has treated in Lass Vegas.  (emphasis added).
 
CITE: DCC 240000054. DUPLICATE: KKM 3364. Dow Corning Trial Exhibit ListAbstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
 
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Document #204
09/29/75
 
MISCELLANEOUS - COMPLICATIONS
SILICA
TISSUE REACTION
 
Letter to Rathjen from Dr. Laud regarding Dr. Wilflingseder’s discovery, and publication, of silicon dioxide (silica) in breast capsule specimens and “I was able to tell him what I had learned at Dow Corning.”
CITE KMM 29957. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
 
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Document #205
10/06/75
 
TESTING
 
Abbott, Dow Corning, reports on “biocompatibility Evaluation Of Mammary Gel.” “The problem with biocompatibility is the butyl carbitol acetate solvent in the catalyst.... There are localized high concentrations of BDA in the gel.  Evaluation of the compatibility of the solvent with the gel has shown that BCA does not mix in the formulation at a very desirable rate.” Also, “Visual observations of uncured gel shows the presence of globules or highly contracted pockets of the solvent.... The permanent solution to the problem involves the replacement of the present solvent with a different solvent or a different catalyst system.”
CITE: KMM 39105 - 39121. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
 
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Document #206
10/30/75
 
COHESIVENESS - LIQUID COMPONENT OF GEL
GEL MIGRATION
KNOWLEDGE OF SYSTEMIC DISEASE
TESTING
 
Dow Corning Bioscience Research Report No. 4509 by Lake and Radonovich entitled “Action of Polydimethylsiloxanes on the Reticuloendothelial System of Mice:
 
Basic Cellular Interactions and Structure Activity.” The abstract for this report states that:
“Because of their hydrophobic character, dimethylpolysiloxanes of various viscosities are known to distribute to the reticuloendothelial system (RES) in association with phagocytes. The site, magnitude, specificity and time course of murine RES response to high doses of various dimethylpolysiloxane fluids has been studied to characterize the basic cellular interaction and immunological consequences of dimethylsiloxane administration. Type I interferon production and clearance of colloidal carbon were used to assess RES function. Linear 3,4 and cyclic 4,5 dimethylpolysiloxanes when given parenterally to mice caused a transient response in lymphoreticular tissues with a maximum at 48 hours. This response was found to involve phagocytic cells (macrophages) such that augmented amounts of Type I endotoxin-induced interferon are made. Carbon clearance by the RES is also depressed with the same time course as this hyper-reactivity to interferon induction. Hexamethyldisiloxane and dimethysiloxanes greater than 5 siloxy units do not cause these changes, but do cause a characteristic eosinophilia at an intraperitoneal inoculation site.
 
A consistent hypothesis for this observed increase in early interferon production is that dimethylsiloxanes in the 305 size range are sub-lethally surface active in macrophages of the RES. Like lead acetate and mineral oil-surfactant mixtures, which are known to augment early interferon production, low molecular weight dimethylsiloxanes decrease the phagocytic capacity of macrophages. Because endotoxin is not cleared (phagocytosed) or detoxified, the viable but phagocytically impaired macrophages undergo a prolonged and more complete interaction with endotoxin. (OOT 42327)”
 
CITE: OOT 42325 - 42352, Exhibit 1 to Radonovich Deposition (abstract only), Exhibit 23 to Harris County Hayes Deposition, Exhibit to Harris County Tyler Deposition, Exhibit 11 to Zimmer Deposition, Exhibit to Lake Deposition, Exhibit to Isquith Deposition, and Exhibit 23 to Harris County Rich Deposition.
DUPLICATE: DCC 281001636 - 281001662; DCC 281061445 - 281061450. WITNESS:
Radonovich.  DISPOSITION: Admitted in Toole (II) v. Baxter Healthcare. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
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Document #207
11/03/75
 
MISCELLANEOUS - COMPLICATIONS
TISSUE REACTION
 
Letter to Rathjen from Dr. Laub regarding the Toronto meeting. “Dr. Bob Briggs from New Jersey has seen several patients from the original study (mostly Orentreich patients) who have had intractable swelling. ... This case is similar to the ones reported at a meeting in Mexico City several years ago by physicians from Buenos Aires. ... I have followed patients myself in this are ‘suffering’ from the same condition. ...”
 
CITE: KKM 31788, Exhibit to MDL Rathjen Deposition. Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
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Document (no number) dated 11/7/75 (this document is between #207 & #208)
11/07/75
 
(NOT LISTED ON PLAINTIFF’S EXHIBIT LIST)
Memo from Larson, Dow Corning, to Talcott with copies to Bey, Rathjen, and Kelley regarding “Capsule Formation & Mammary Implants.” Larson states that Stark commented in a staff meeting that “implanted silica causes the formation of a very heavy tough capsule.... Possibly we could minimize capsule formation around the mammary prosthesis if they were over coated with a pure silicone polymer.... These are the basis for the concept that maybe some exposed silica on the very surface of the envelope rubber can cause excessive capsule formation and that this might be minimized if the capsule were formed and interfaced against pure silicone polymer.” On M 190174 there is a handwritten note from Talcott to Ron Kelley: “I’d like more proof of silica at interface causing problems.”
 
CITE: m 190174 - 190175. NOTE: M 190175 is a duplicate of M 190174 but it has different marginalia on it. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
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Document #208
11/18/75
 
MISCELLANEOUS - COMPLICATIONS
MISCELLANEOUS - RECKLESS/CONSCIOUS DISREGARD TESTING
 
Memo to Boone, Leach, Meads, Polmanteer & Talcott from Bey regarding capsule contracture studies. “Our TS&D budget situation for 1976 is simply this, we have considerably less discretionary spending money for 1976 than we had in 1975. I can’t see any way we can support these proposals in 1976. I suggest we discourage the proposals as much as possible....”
 
CITE: M 190186, Exhibit to MDL Rathjen Deposition. Dow Corning Trial ExhibitList Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
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Document #209
12/10/75
 
KNOWLEDGE OF LIQUID SILICONE DANGERS
 
Telephone call report by Silas Braley regarding a call with Richard Samuels about a grand jury investigation being done on Hal Ellison for doing injections of silicone fluid. Ellison had been receiving Dow Corning fluid through a company called Silaco. Braley states that, “I told Mr. Samuels that we had been fighting, the breast injections since we had heard about them and were trying to get the information across to people. We find now that people are very confused about breast injections vs. breast implants and I explained that the latter are both ethical and legal and that the problems of injections do not apply. I asked for his help in differentiating between these two procedures so that those women who have had surgical augmentation will not worry when they read about the horrors of injections.” (emphasis added). The call report notes that additional phone calls from Mr. Samuels occurred throughout the morning. Joe Radzius, Dow Corning legal counsel, advised Braley that Dow Corning’s position “from here on in” was “no comment.”
 
CITE: KKM 3537 - 3538 Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
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Document #210
12/12/75
 
KNOWLEDGE OF GEL BLEED
 
T. Talcott, Dow Corning, memo about a telephone call from Dr. Frank Gerow. Gerow attended a meeting in Phoenix recently and reported that “the general tone to him was something is coming through the envelope to the tissue.” Gerow concluded that Dow Corning needed a “100% tied up gel now.” Talcott writes that he’s inclined to agree that something’s coming through the envelope. “Could it be miscellaneous contamination during our manufacturing process? Do we need an audit of the process?’
 
CITE: F 636, Exhibit to Frisch Deposition, Exhibit to MDL Rathjen Deposition, and Exhibit 64 to Harris County Rathjen Deposition. DUPLICATE: M 170143;
M190203; FDA 32914; DCC 242031351 - 242031352. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
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Document #211
12/12/75
 
TESTING
 
Franklin and Annelin, Dow Corning, report on “Subcutaneous Implants Of Developmental Prosthetic Gels In Monkeys And Rats: Examination Of Tissue Deposition And Urinary, Fecal, And Respiratory Elimination Routes.” “In the rats, dosed with the new production gel, only the axillary lymph showed an increase in total silicon; a similar increase in hexane extractable silicon was not observed.: In the monkeys, “the low cross-linker formulation moved along tissue planes and formed only a very thin capsule.”
 
CITE: KMM 140087 - 140104, Exhibit to Frisch Deposition, Exhibit 42 to Hinsch Deposition (used by Dow Corning), Exhibit to LeVier Deposition, Exhibit 45 to Harris County Peters Deposition, Exhibit 115 to Harris County Rathjen Deposition, Exhibit 88 to Harris County Talcott Deposition, Exhibit 92 to Bennett Deposition (used by Dow Corning), Exhibit 15 to MDL Rathjen Deposition (used by Dow Corning), and Exhibit to Isquith Deposition.
 
DUPLICATE: P 17497 - 17515. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
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Document #212
12/12/75
 
SHELL STRENGTH - THICKNESS
RUPTURE
ACKNOWLEDGEMENT OF NEED FOR TESTING
 
Rathjen, Dow Corning, memo to various Dow employees regarding Breast Symposium in Phoenix, Arizona on November 23-26, 1975. Reports that Dow has lost the number one position as “the innovator.” He states:
“Surgery was performed by members of the faculty, put on tape, edited and viewed during the three day course. Each manufacturer donated implants for this use.  Dr. Eugene Courtiss and Dr. Robert Winslow used our prostheses. In both instances the doctors broke an implant during their surgery. Fortunately these were edited from the tape; but ours were the only ones to break, and they really let us know about it. The Medical Products Business should consider a full scale research program to fully evaluate the current status of our gel (chemistry, toxicology) and to begin a concentrated program to develop a dry gel (dry to touch, cohesive, non-adhesive with absolutely no bleed). I would also like to see the development of a radio-opaque envelope which would allow the examination of an implant “in situ” if and when capsular contracture is suspected. How contracture develops by observing an implant “in situ” could contribute to a better design of an implant. (emphasis added).
 
CITE; M 190200 - 190202, Exhibit to Mantle Deposition, Exhibit 80 to Harris County Rathjen Deposition, and Exhibit to MDL Rathjen Deposition. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
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Document #213
00/00/76
 
FRAUD/MISREPRESENTATION
 
Dow Corning brochure, “Facts You Should Know About Your New Look,” Which contains the following question and answer: “How long will the implants last?  Based on laboratory findings and human experiences to date, a gel-filled breast implant should last for a lifetime.” (emphasis added).
CITE: M 650012 - 650019, Exhibit to Harris Country Jakubczak Deposition, 27 to Harris County Peters Deposition (used by Dow Corning), Exhibit to MDL Rathjen Deposition, and Exhibit 77 to Harris County Rathjen Deposition.
 
NOTE: From 1963-73, Dow Corning only “warned” of fluid accumulation and foreign body reactions in its product inserts. From 10/74 - 09/76, Dow Corning added to its product inserts the following for the Silastic implant: capsular contracture/firmness, pain or discomfort from surgery, ptotic breasts, additional surgeries/implantations, and the risks associated with surgery. See PSC World of Warnings for Dow Corning and Dow Corning Wright. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
 
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Document #214
01/07/76
 
FRAUD/MISREPRESENTATION
KNOWLEDGE OF LIQUID SILICONE DANGERS
MISCELLANEOUS - COMPLICATIONS
STERILIZATION/CONTAMINATION
TISSUE REACTION
 
Testimony of Joseph Radzius to the California legislature regarding silicone injections. He states that DC’s study “absolutely contraindicates injection of the fluid in the mammary area.”
 
CITE: M 350149 -350155, Exhibit 33 to Harris County Rathjen Deposition, and Exhibit to MDL Rathjen Deposition, NOTE: The document also has the Bates Numbers DCD 173002728 -173002734 on it. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
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Document #215
01/15/76
 
SHELL STRENGTH - THICKNESS
 
Tom Talcott memo to Kelley and Rathjen, Dow Corning, discusses the recent Phoenix Breast Symposium in which Dow Corning introduced its new mammary. During the taped implantation surgery, two of Dow Corning’s implants ruptured/broke.  Talcott expresses dismay that at Dow Corning the consensus was that the envelope was “good enough” despite finding:“gross thin spots and flaws in the form of significant bubbles.... The allowable flaws are written into our current specifications.... When will we learn at Dow Corning that making a product “just good enough’ almost always leads to products that are ‘not quite good enough’? It is unfortunate that the thinner dispersion, four dip method proved by Bartolo and Vallender in early 1974 appeared too expensive to plant personnel to even try, although a much higher acceptance rate would be obtained. I sincerely hope this experience will convince us to support programs for ‘high quality’ rather than ‘just enough quality’ in the future.  (emphasis added).
 
CITE: F 534, Exhibit 65 to Harris County Rathjen Deposition. Exhibit to MDL Rathjen Deposition. DUPLICATE: DCC 8003157; M 600007; KMM 140185; KMM 380078. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
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Document #216
01/22/76
 
TESTING
 
Dow Corning stated a Two-Year Implant Study with Q7-2159A and MDF-0193 at Industrial Bio-Test Laboratories (IBT).
 
CITE: Referenced in KMM 390371. NOTE: See 02/03/78 entry. Dow Corning Trial Exhibit List Abstracts
PENDLTON/PSC Attorney Work Product/Privileged & Confidential
 
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Document #217
01/23/76
 
ACKNOWLEDGEMENT OF NEED FOR TESTING
 
Art Rathjen, Dow Corning, memo to numerous Dow Corning employees (Mammary Task Force) regarding “Research/Testing - Mammary Gel/Envelope.” Rathjen states, “I have suggested verbally and in writing that we better get going on a basic long range project relative to gel, its formulation, toxicology, etc. over and above what is now underway. The same goes for the envelope. The complaint report from Dr. Horowitz Manchester, Conn., is just one more flag.” (emphasis added).  
 
CITE: F 809, Exhibit to MDL Rathjen Deposition, and Exhibit 76 to Harris County Rathjen Deposition. DUPLICATE: M 170171: M 580066: KKA 152383: DCC 17016569: KKA88865: KMM 447050. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
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Document #218
02/16/76
 
Rathjen, Dow Corning, memo to the IND 2702 clinical investigators - Ashley, Blocksma, Dingman, Edgerton, Goulian, Murray, Orentreich and Rees - regarding “Proposed California Legislation To Control Injection Of Silicone Fluid.” Dr.  Ashley disagrees with regulating injections and states that breast injection should be a contraindication to the use of liquid silicone.
 
CITE: M 350147 - 350148, Exhibit 33 to Harris County Rathjen Deposition. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
 
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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.
 
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Document 220
03/17/76
 
TISSUE REACTION
KNOWLEDGE OF GEL BLEED
 
Art Rathjen, Dow Corning, memo to numerous Dow Corning employees regarding a paper presented by Dr. Edward Terino at the California Society of Plastic Surgeons on 03/03/76. The paper discussed a Dow Corning Silastic implant removed 10 years post-op. Silicone was found on the outside of the implant and “pathology showed extensive foreign body giant cell granulomas.... This event, as described by Dr. Terino, cannot be ignored. An attempt must be made to get an answer or explain this phenomenon before the manuscript is submitted to the Journal for publication. If we don’t, everyone of the 350 member audience, the Journal readers, and the lawyers may interpret this as proof that our gel causes problems.”
CITE; F 833 - 834, Exhibit 36 to California Braley Deposition, Exhibit 66 to Harris County Rathjen Deposition, and Exhibit to MDL Rathjen Deposition.
 
DUPLICATE: M 190247 - 190248; M 250038 - 250041; KMM242493 - 242494; DCC 240000437 - 240000438. See 03/03/76, 03/19/76 and 03/26/76 entries. The implants were from lot number H0209. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
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Document #221
03/19/76
 
KNOWLEDGE OF LIQUID SILICONE DANGERS
CONCEALING FROM FDA
 
Dow Corning’s New Drug Application submitted pursuant to Section 505(b) of the FDA Act, for the preparation Dymasyl (dimethylpolysiloxane) Fluid is not approved. The FDA reviewed the application and found that the information presented is inadequate. The application fails to report adequate animal studies in support of the safety of the drug.
 
Presently reported carcinogenic studies in animals are inadequate to determine the carcinogenic potential of dimethicone. It is recommended that new studies be initiated in accordance with our current guidelines for testing of products for carcinogenic potential.
 
The FDA also found that Dow Corning’s application failed to report the clinical studies in full detail, that there was no long-term data or patient follow-up, that manufacturing instructions are ambiguous, that sterility tests were not submitted, and that information on laboratory tests was not submitted. As a result of this, the FDA has closed Dow Corning’s NDA file. The Director, J.  Richard Crout, states, “(T)he only potentially acceptable indications for use of dimethicone, on a benefit/risk basis, are for the major facial defects and severe acne scars. We regard the benefit/risk ratio of dimethicone for minor cosmetic uses as unacceptable.” (emphasis added).
 
CITE: DCC 106006714 - 106006719, Exhibit 29 to California Braley Deposition, and Exhibit to MDL Rathjen Deposition. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
 
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Document #222
03/19/76
 
ACKNOWLEDGEMENT OF NEED FOR TESTING
GEL MIGRATION
KNOWLEDGE OF GEL BLEED
 
Art Rathjen, Dow Corning, reports on the “backlash” from Dr. Terino’s paper to the California Society of Plastic Surgeons. Dr. Barker approached Rathjen after Dr. Terino’s presentation and stated he was also studying capsular contracture.  “He (Dr. Baker) also subscribes to the possibility that the migration of fluid or low moleculars through the envelope which causes the greasy feel to the envelope may be contributing to the contracture.... Nevertheless, the question remains in his mind, as it does in a number of other plastic surgeons around the country “Dr. Baker wants to take Dow Corning’s Silastic implants in a centrifuge to collect what is forced through the envelope. The quantity of what comes through should then be implanted in animals in a very small quantity to see what kind of tissue reaction develops. Rathjen thinks that it would be in the best interest of Dow Corning if they were to “take the initiative” and attempt to do something of a similar basis first. He states in this internal memo: I think it would be embarrassing for Dow Corning and for any of our research expertise if we find that this type of testing has to be left to a doctor in this field. If he were to come up with something detrimental, I think we ought to be prepared for it. (emphasis added).
 
CITE: M 160001 - 160002, Exhibit to MDL Rathjen Deposition, Exhibit 67 to Harris County Rathjen Deposition. DUPLICATE: M 190249 - 190250; DCC 17031054. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Work Product/Privileged & Confidential
 
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Document #223
03/19/76
 
SILICA
 
Hinsch, Dow Corning , memo to Criger, Hoyt and Leach with copies to Bey, Petraitis, Larson and Rathjen) regarding a conversation with Dr. William Jervis.  Dr. Jervis claims that “silica (a component of the bag and gel of a mammary prosthesis) is an irritant. Tom also said (according to the doctor) that the silica in the silicone can be released from its entrapped state by over-curing and that the bag of a gel implant was more over-cured than that of inflatables.  Tom admitted that some inflatables also probably had some of this silica on them. Tom speculated to me later that a final polymer coating might help retain the silica if that is in fact what is happening.” (emphasis added).
 
CITE: KMM 74769, Exhibit to Frisch Deposition, Exhibit 49 to Hinsch Deposition (used by Dow Corning), and Exhibit to MDL Rathjen Deposition. DUPLICATE: M 190251; KMM 120458. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
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Document #224
03/22/76
 
KNOWLEDGE OF GEL BLEED
GEL MIGRATION
 
Handwritten note to Milt Hinsch from Greg Bicket, both of Dow Corning, discussing the bleed question and Dr. Terino’s presentation. Bicket notes that many persons are asking questions about, “What is that stuff on the outside of DC’s implant.... Do you want that bleeding into your patient’s body ... will it cause capsule contracture. We say they all do it; McGhan must be cleaning their implant very carefully.” He lists 8 questions including whether the gel migrates and, if so, to what parts of the body and with what effects. Bicket feels “uncomfortable” since he can’t answer all of the questions. He notes that McGhan is raising these questions with doctors.
 
CITE: M 160026 - 160027, Exhibit to Petraitis Deposition, and Exhibit to MDL Rathjen Deposition. DUPLICATE: GEG 4026 - 4027; M 190255 - 190256, KMM 3831 - 3832. NOTE: This date is approximate and is based on the date on the top of the page from the ASPRS meeting on 03/22/76. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
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Document #225
03/26/76
 
KNOWLEDGE OF GEL BLEED
FRAUD/MISREPRESENTATION
 
Art Rathjen, Dow Corning, letter to Dr. Terino with blind carbon copies to numerous Dow Corning employees. Despite Rathjen’s knowledge that gel bleeds through the envelope, Rathjen tells Dr. Terino that this is “physically impossible” from a polymer chemistry standpoint. He attempts to cast doubt on Dr. Terino’s claims that the substance on the outside of the Dow Corning implant Dr. Terino examined was silicone gel, particularly since the implant was not torn or ruptured. Rathjen suggests that Terino shouldn’t publish his paper stating, “I truly think it would be to the best interest of all concerned if we try to get some answers before there is any further dissemination of information which might be erroneous....(Rathjen) would like to ... help solve the mystery, if that is possible, before your presentation is submitted for publication.” He requests that Dr. Terino send him any explanted Dow Corning prostheses with “a strange color or a questionable envelope surface or seem to have a change in the normal physical qualities.”
 
CITE; M 250018 - 250019, Exhibit to MDL Rathjen Deposition, and Exhibit 68 to Harris Country Rathjen Deposition. DUPLICATE; DCC 240000435 -240000436; M 570126 · 570127. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
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Document #226
03/31/76
 
ACKNOWLEDGEMENT OF NEED FOR TESTING
SHELL DEGRADATION
 
Art Rathjen, Dow Corning, memo to Overton, Bey, Bennett, Harlow, Hinsch, Lewis, Stark, and VerVoort regarding “Your Request For Information, i.e., Radiation Treatments Of The Breast Following Implantation - Dr. John Lindsay.” He states: “I want to re-affirm again that Dow Corning personnel cannot become involved in medical judgments relative to patient care.... The following information is conjecture. Depending on the amount of x-ray or gamma radiation, one could expect the gel to stiffen with no major change to the physical properties of the envelope. It can be suggested that some chemical reaction might take place with the prosthesis, but we absolutely do not know what affect such a reaction would have on tissue or systemically. It is also an assumption that the implant would act as a screen for the tissue against the posterior side of the implant.  Obviously, the screening effect would be in relationship to the thickness and/or density of the implant.... (In) no way do I agree that this be used to endorse or suggest the safety and efficacy of radiation therapy following augmentation using our SILASTIC Mammary Prosthesis. (emphasis added)
 
CITE: KMM 29699, Exhibit to MDL Rathjen Deposition. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
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Document #227
04/00/76
 
ACKNOWLEDGEMENT OF NEED FOR TESTING
 
A study entitled “Mammary Capsular Contraction (A Situation Analysis 1976)” by P.A. Walters of Health & Human Services. Eldon Frisch, Dow Corning, receives the report. Walters recommends the following:
“Concentrate the initial research effort in the one area Dow Corning knows best, i.e. materials. Do not terminate any existing clinical programs with respect to data generation on mammary capsule contracture. However, I would recommend postponing Dow Corning’s involvement in any new clinical program(s) until some very basic research questions are answered. I realize that rejecting some clinical proposals is very difficult because of the political and economic implications, but participating also carries some very high risks. There is a 50/50 chance that the data may be bad data, i.e., damaging by implicating a product.... Remember, a product which is implicated with bad data requires additional expenditures of time, personnel and money to generate defensive research. There are several data gaps which should be investigated before any long-term clinical involvements are undertaken. ”Walters recommends further studies on gel bleed and elastomer formulation.(emphasis added).
 
CITE: KMM 4113 -4129, Exhibit 77 to Harris County Rathjen Deposition. DUPLICATE: M 290021 - 290037. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
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Document #228
04/05/76
 
MISCELLANEOUS - COMPLICATIONS
MISCELLANEOUS - PRODUCT LABELING
RUPTURE - CLOSED CAPSULOTOMY
TISSUE REACTION
 
FDA: The FDA, after receiving information that some persons had experienced serious problems with silicone mammary and testicular implants, met with Dow Corning to inspect their files. Mr. Radzius, Dow Corning’s Food and Drug counsel, and Milt Hinsch, Product Supervisor, Dow Corning, claim to John Nicholson, FDA, that current data shows approximately 18% of mammaries implanted will cause a contracture problem. Of this 18%, somewhat less than 10% will require corrective surgery or other techniques. Hinsch also states that a new technique of manually breaking the capsule has recently been developed and shows promise as a solution to contracture. Hinsch also stated that it has always been a policy of Dow Corning to include “adverse reactions” as part of its labeling but, recently, competitors have been using this statement in the literature as a tool to convince surgeons not to use Dow Corning’s products.
 
CITE: FDA 17180 - 17182. NOTE: HINSCH was aware that the contracture data was much higher than 18%, i.e., see Dr. Terino’s paper presented 03/76. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
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Document #229
04/13/76
 
KNOWLEDGE OF GEL BLEED
 
Milt Hinsch, Dow Corning, discussed how the market place is telling Dow Corning that improvements can be made to the current production line including to the envelope, gel, and design of the prosthesis. One suggested improvement would be that the gel should be a no bleed gel with very low viscosity, “Doctors are now being sensitized to the oiliness of our current prosthesis....” Hinsch wants Dow Corning to place its name and product size on the mammary in case it needs to be removed and replaced for any reason. “This is a consideration which will become more important as time goes on.”
CITE: M 160007 - 160008. DUPLICATE: GEG 4343; M 160079 - 160080; KKH 2632. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
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Document #230
04/14/76
 
KNOWLEDGE OF GEL BLEED
ACKNOWLEDGEMENT OF NEED FOR TESTING
 
Eldon Frisch, Dow Corning, responds to Milt Hinsch’s memo on Greg Bicket’s questions on gel bleed. “The material which bleed from a mammary implant is a polydimethylsiloxane, or more appropriately a silicone fluid. It comes from within the gel.... Since the gel starts as a fluid, these materials are also fluids, and they tend to migrate about in the gel, eventually dissolving in the envelope and passing through it.... We have no scientific data to indicate whether or not the presence of the fluid polydimethylsiloxane which bleeds through the envelope increases or decreases the problems of capsular contracture.” He questions whether Dow Corning’s field inventories are getting too old, allowing “the bleed (to become) more evident.” Frisch also talks about injected silicone fluid studies which showed absorption of the silicone fluid into the body. “We have no scientific evidence to indicate whether or not the presence of the fluid polydimethylsiloxane which bleeds through the envelope increases or decreases the problems of capsular contracture.” 
 
CITE: M 190259 - 190261, Exhibit 13 to California Braley Deposition (used by Dow Corning), Exhibit to Petraitis Deposition, Exhibit to MDL Rathjen Deposition.  DUPLICATE: KKH 1561 - 1565; GEG 4023 -4025; M5700445 - 570047, KMM 3828 - 3830; GEG 4246 - 4250. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
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Document #231
04/19/76
 
COHESIVENESS - LIQUID COMPONENT OF GEL
MISCELLANEOUS - SALES
RUPTURE
TESTING
 
Robertson memo to Blackmore, Coyne, Fredricksen, Pryor, Trischler, Doolittle, Flora, Hauser, McLellan and Murray regarding a discussion with Donald McGhan on 04/14/76. McGhan is now receiving Dow Corning silicone. For the gel uses McGhan prefers the GE product which has a lower level of low molecular weight components. McGhan mammary implants are also more consistent than Heyer-Schulte’s because of the mandrel molding technique used - the madrels are polyester and cast individually.
 
CITE: MMM 1445 - 1450, Exhibit 6 to D. McGhan Deposition, Exhibit to Horgan Deposition, Exhibit 43 to Harris County D. McGhan Deposition, and Exhibit 68 to Harris County Coyne Deposition. DUPLICATE: MMM 666 -671. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
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Document #232
04/20/76
 
SHELL STRENGTH - THICKNESS
RUPTURE
 
Milt Hinsch, Dow Corning, memo to Brodhagen, et al., regarding demonstration implants used at the “Aesthetic Show in Atlanta on April 11-15, 1976. He writes, “Of these 23 (demonstration implants), 5 had large bubbles in the gel, 1 broke when picked up, and 3 others developed bubbles in the gel around the patch area during the show. We were unable to show the entire line as planned.”
CITE: KMM 219977. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
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Document #233
04/22/76
 
Kelley, Dow Corning, memo to Hinsch with copies to C. Lentz, Criger, Leach, Meads, Becker, Petraitis, Bey and Rathjen regarding “Milt Hinsch Memo of April 13 - Attached “Gel Filled Mammaries Of The Future.’” Kelley notes that the attached memo from Hinsch documents specific marketplace requirements for the mammary prosthesis line.
 
CITE: KKH 2633 Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
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Document #234
05/04/76
 
KNOWLEDGE OF GEL BLEED
GEL MIGRATION
TISSUE REACTION
 
Greg Bicket, Dow Corning, reports that he met with Dr. Richard Phares regarding the Silastic Mammary Prosthesis. He is “interested in reports of freshly healed augmentations failing to adhere with subsequent loss of implant. (Phares) experienced this, and was upset to hear others reports of this at the Southeastern meeting. Apparently, the theory is that the opposing faces of the wound are closed, and in ten to fifteen days no appreciable healing has taken place. The suture lines then break down, and the implants are not retained.  ‘Greasy implants” sliding into the pocket, providing a release agent against healing, were postulated to be the cause.”
 
Further, “The second area of concern was the reported actions of migrating gel/fluid of other manufacturers’ gel. Giant cells, granulomae, and siliconomae were reported in and around the locations where the migrating gel/fluid was said to have come to rest.” Phares proposes a dog study.
 
CITE” M 600009 - 600010, Exhibit to MDL Rathjen Deposition, and Exhibit 79 to Harris County Rathjen Deposition. DUPLICATE: F 713 - 714; KMM 380053; DCC 80010141 - 80010142. NOTE: Dow Corning never followed through with a dog study. See 06/08/76 entry. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
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Document #235
05/11/76
 
SHELL STRENGTH - THICKNESS
SHELL DEGRADATION
 
Neal Langley and Jon Swanson, Dow Corning, report on the “Effects Of Subcutaneous Implantation, Through Two Years, On The Physical Properties Of Medical Grade Tough Rubber (MDF-0198).” MDF-0198 is a “new high performance medical grade elastomer for orthopedic (sic) devices.... Questions to be answered were: do physical properties change during implantation; are body fluid absorbed into the elastomer; and is PDMS leached into the body during the two year subcutaneous implantation period?” Langley and Swanson state that there was little change in tensile strength, tear resistance and ultimate elongation.  “Maximum loss of PDMS into the body ranged from 0 to 0.7% of the sample weight after 32 weeks and from 0 to 1.3% after two years.... This degradation may become important over longer periods.” There were significant changes in the flaw propagation life after implantation, a 10% decrease in tensile strength and flaw propagation life, a 20% decrease in elongation and a 5% increase in modulus. “Differences to be noted between this study and service conditions include the absence of flexing during implantation, and any differences between the subcutaneous environment in dogs Vs the various locations in the human body where the devices are in service.”
 
CITE: T 21431 - 21444. DUPLICATE: KKH 68344 - 68357; DCC 204001179 -204001192. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
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Document #236
05/17/76
 
ACKNOWLEDGEMENT OF NEED FOR TESTING
 
Art Rathjen, Dow Corning, memo to Bey and C. Lentz regarding a capsular contracture study proposed by Dr. James Penoff. “We are engulfed in qualified speculation - nothing to date is truly quantitative or qualitative; therefore, Dr. Penoff’s suggestions for a course of action merit some serious consideration.” (emphasis added). Phase I of the proposed study includes:
 
A.     Is there something in the implant that migrates out or off the mammary prosthesis? yes or no!
B.    Does it continue for the life of the implant or is it limited or controlled for a period of time?
C.    Does it come from the gel or envelope or both?
D.    What is it?
E.    Considering the evolution of the mammary prosthesis, have changes in both the gel and envelope altered the degree or changed what might migrate through or off the prosthesis?
Phase II would be pre-clinical implant testing to determine whether components of the envelope and gel migrate. Phase III is human implantation.
 
CITE: F 715 - 716, Exhibit to MDL Rathjen Deposition, and Exhibit 78 to Harris County Rathjen Deposition DUPLICATE: FDA 31438 - 31439; M 210001 - 210002. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
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Document #237
06/00/76
 
GEL MIGRATION
TESTING
TISSUE REACTION
 
Frugard’s Dow Corning trip report from Heyer-Schulte’s library. Includes 08/06/76 memo from J. Erhardt to T. Talcott regarding confidentiality agreement with Dow Corning requiring all information being confidential for a period of ten years from the date of disclosure of delivery. Frugard’s trip report was sent to S. Koorajian and is dated 07/14/76. Frugard reports that there are both positive and negative aspects of his trip to Dow Corning.  On the positive side, he feels that he was successful in bringing back a comprehensive summary of all of Dow Corning’s animal data; or at least “all that I was given access to”. The negative aspect is that the data does not answer the key questions concerning migration and its consequences. Many of the experiments were not well controlled. The animal studies indicate no significant pathological findings and, in cases were there were, they were attributed to experimental procedures.
 
Frugard concludes that: “due to the fact that there was no apparent difference in reaction to any of the gels, the inflammatory response must be considered to depend solely on tissue injury and not upon gel migration. This conclusion is tenuous at best considering there were no controls. Perhaps all gels were reactive.... Gel migrates into the capsule.... Unfortunately, the data collected in this study does not answer questions concerning migration, even though that was the main objective. I regret the fact that Dow Corning’s data was lacking in quality and left many questions unanswered.”
CITE MD 114416 - 114428. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
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Document #238
06/02/76
 
SHELL STRENGTH - THICKNESS
RUPTURE
 
Mazelin, a Dow Corning sales representative, files Complaint Report F76023 for a rupture of a Silastic Round mammary implant. Dr. Kellett, the implanting physician, noted that this was the second rupture in the past few weeks. He “feels ‘thinner’ envelope weakens it (the implant) significantly.”
CITE: CR 3172 - 3173. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
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Document #239
06/07/76
 
GEL MIGRATION
MISCELLANEOUS - COMPLICATIONS
RUPTURE
TISSUE REACTION
 
Braley, Dow Corning, telephone report concerning a conversation with Dr.  Nicholas Georgiade. Dr. Georgiade’s patient developed a mediastinal node enlargement and lung lesions and suspects gel migration from a ruptured implant.  He notes that the patient’s husband is a “smart ass” trial lawyer and wants to know how to handle this. He wants a letter from Dow Corning so that he has “enough information to counteract any feelers that this lawyer may put out.”
CITE: M 250053, Exhibit 35 to Hinsch Deposition (used by Dow Corning), Exhibit 87 to Harris county Rathjen Deposition, Exhibit 39 to California Braley Deposition, Exhibit to MDL Rathjen Deposition. NOTE: for Rathjen’s response, see M 250050 - 250052 dated 07/12/76 Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
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Document #240
06/08/76
 
ACKNOWLEDGEMENT OF NEED FOR TESTING
 
Art Rathjen memo to Al Bey, C. Lentz and others, all of Dow Corning, regarding
“G. Bicket Trip Report No. 504, May 4, 1976, i.e., Dr. Phares, St. Petersburg,
Florida.” Rathjen states: “I have proposed again and again that we must begin an in-depth study of our gel, envelope, and bleed phenomenon. Capsule contracture isn’t the only problem.  Time is going to run out on us if we do not get underway. Believe me when I tell you that the A.S.P.R.S. is also going to begin their own investigation. A committee will be organized, and they will come to the manufacturers asking questions. It would certainly be to our advantage to be ready for them.  (emphasis added).
 
CITE: F 712, Exhibit to MDL Rathjen Deposition, and Exhibit 79 to Harris County Rathjen Deposition. DUPLICATE: M 600011; GEG 003999; KMM 242518; DCC 80061401; M600008. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
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Document #241
06/10/76
 
COHESIVENESS - LIQUID COMPONENT OF GEL
GEL MIGRATION
KNOWLEDGE OF GEL BLEED
 
Study by Brill titled “Development Of A Low Oiling Gel For The External Breast Prosthesis.” The resulting gel caused substantially less swell of the silicone rubber envelope and gave a low rate of migration of silicone material through the envelope compared to existing silicon gels formed from low viscosity fluids and plasticizers. It was also shown that gels and fluids based on methyltrifluoropropyl polymer as well as silicone organic copolymers could produce a very low order of elastomeric swell and bleed with polydimethylsiloxane envelope rubber.
 
CITE: KKH 63280 - 63299, Exhibit to Petraitis Deposition, and Exhibit to MDL Rathjen Deposition. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
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Document #242
06/11/76
 
MISCELLANEOUS
 
W. Larson and Y. Peters, both of Dow Corning Corporation, issue an internal Dow Corning report entitled “Medical Products, Technical Service and Development”.
 
The authors report that: “The mammary gel, MDDF0193, often develops a yellow color which detracts from the appearance of the prosthesis. The cause of this problem has been traced back to the catalyst, XY173. Four catalysts were evaluated on the basis of color, XY173. Four catalysts were evaluated on the basis of color, XY173, XF95504, PtII and MDDFoo69. The color intensity of the gels was found to decrease in the following order: XY173 >XF95504 >PtII > MDF0069.
 
The results indicated that the easiest solution to the problem was to switch to MDF0069.”
CITE: KMM 8596 - 8605. NOTE: The first page states that this document is Dow Corning Proprietary and that neither this document nor the information contained in it may be reproduced except in TIS, nor distributed outside the company without permission from the Director of Technical Service and Development. Dow Corning Trial Exhibit List Abstract
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
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Document #243
06/25/76
 
SHELL STRENGTH - THICKNESS
RUPTURE
 
John Gallagher, Dow Corning, memo to Bob Becker regarding the “large increase in rupture returns in the past month....” Gallagher states that: “All the doctors claim that the ruptures are happening from 90% of the prosthesis with the creases and large air bubbles. I had a discussion with Milt Hinsch today and he told me he has had three telephone calls, one from Tom Mazelin, one from Greg Whittaker, and one from Jim Reisma (sic - Reitsma), all having the same problem - an excessive amount of ruptures. I wanted to bring this to your attention because I have one customer that has had a return of thirty ruptures in the last three months.... We have enough problems with competition without worrying about ruptures constantly.
 
CITE: CR 3272. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
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Document #244
07/07/76
 
FRAUD/MISREPRESENTATION
GEL MIGRATION
 
Rathjen, Dow Corning, letter to Nicholas Georgiade responding to expressed concerns regarding gel migration. Rathjen states: “The first silicone gel-filled mammary prosthesis was implanted in a patient of Dr. Tom Cronin’s in 1962, and as of July 1976, she still has them, and her course during the past 14 years has been uneventful. Since that time, mammary implants numbering in the hundreds of thousands have been used for augmentation and reconstruction of the breast.
 
The percentage of complications has been minimal, and very frankly, gel migration due to breakage of the silicone envelope has not been a problem nor can I recall when a surgeon has questioned us about this, relative to a Dow Corning Product.
 
We also have test data on the implantation of our materials; and there is, to my knowledge, no indication or proof that phagocytes pick up the material and carry it off. I agree with Si on that Point - the size and consistency of the gel, and even more specifically, our gel used in 1970 does not make it feasible.”
CITE: KMM 354956 - 354957.l Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
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Document #245
07/12/76
 
FRAUD/MISREPRESENTATION
GEL MIGRATION
 
Rathjen, Dow Corning, letter to Dr. Nicholas Georgiade stating that he has never heard of a problem of gel migration “relative to a Dow Corning product.” (emphasis added). He notes that the gel is “very cohesive.” Rathjen also claims that Dow Corning does not have any test data or knowledge showing that phagocytes pick up the silicone and carry it through the body, claiming that this is not “feasible.”
CITE” M 250050 - 250052, Exhibits 36 and 37 to Hinsch Deposition (used by Dow Corning), Exhibit 40 to California Braley Deposition, Exhibit 63 to MDL Rathjen Deposition (used by plaintiffs and Dow Corning), Exhibit 88 to Harris County Rathjen Deposition, and Exhibit 40 to California Braley Deposition. NOTE: There are numerous instances of gel migration noted in Dow Corning’s internal and external tests as well as in letters from physicians. See, e.g., 04/00/67 - GEG 4301 - 4304; 04/01/67 - PSC Medical Articles CDE, J 157 - 166; 04/11/67 - T38842 - 38866; and 08/02/71 - KMM419744). NOTE: Also see 06/07/76 telephone
report, M 250053. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
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Document #246
07/14/76
 
DOCUMENT DESTRUCTION
TESTING
 
Milt Hinsch, Dow Corning, memo to Rathjen, Kelley, Leach, Lentz, Bey, Bennett, Hoyt, Mantle, and Nelson regarding “The Milt Hinsch Grant.” Hinsch turned down a request for funding by Dr. Tanski which Rathjen supported and then agreed to fund a similar study by Drs. Horton and Rasato. Rathjen has suggested that Drs.  Horton and Rasato had gone “shopping” for funding and were turned down by Heyer-Schulte already. Hinsch responds that it was a marketing sponsored decision to support Horton and Rasato because they are product champions. In response to Rathjen’s question about what to do with the data Horton and Rasato generate, Hinsch states, “Question number 9 about what will we do with the data depends upon the data which is generated, Art. It may turn out that we will take the paper on which this data is printed, roll it up and light pipes and cigars with it.” (emphasis added).
 
CITE: M 190344 - 190345, Exhibit to MDL Rathjen Deposition, and Exhibit 82 to Harris county Rathjen Deposition. Dow Corning Trial List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
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Document #247
07/15/76
 
KNOWLEDGE OF SYSTEMIC DISEASE
 
Pulley memo to LeVier regarding “Patent Memo 4240 - Insecticidal Activity of Silicone Oils and Emulsions.” The subject patent is being placed in our inactive files in the Patent Department. Note: The referenced patent memo is not attached.
 
CITE: DCC 281041374 (Temporary Dow Corning Bates Number 16359 - 16379), Exhibit to Bennett Deposition, Exhibit to Isquith Deposition, Exhibit to Lake Deposition, Exhibit to LeVier Deposition. Dow Corning Trial Exhibit List Abstracts
Pendleton/PCS Attorney Work Product/Privileged & Confidential
 
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Document #248
07/23/76
 
CONCEALING FROM FDA
FRAUD/MISREPRESENTATION
 
FDA: A hearing is held by the FDA Panel on Review of General and Plastic Surgery Devices. On the issue of breast implants, J. Radqius, Dow Corning, states that he has evidence that doctors may be altering the breast implants by injecting an antibiotic into the prosthesis which is gradually released through the membrane of the implant.
 
CITE: This document also has the Bates numbers KMM 489852A - 4900119A (This document also has Bates numbers KMM 545507 - 545555, 547162, 545556 - 545557, 547163 - 547164, and 545558 - 545671 on it.) DULICATE: FDA 160 - 161 (Pages 150 and 151 only). Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
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Document #249
08/02/76
 
ACKNOWLEDGEMENT OF NEED FOR TESTING
KNOWLEDGE OF SYSTEMIC DISEASE
 
Hobbs, Dow Corning, memo to Atwell, Bey, LeVier, Radzius, Ryan, Smith, Stark, Gamon, Lentz, Maneri, Tyler, Wehrly, and Weyenberg regarding “2,6-cis Toxicity.” 
 
Hobbs states: “A six month chronic toxicity study conducted on 2,6-cis has demonstrated possible relationship between the appearance of mammary tumors in the (word is cut off) and the feeding of the chemical. This possibility may have implications which involve products other than 2,6-cis. There are three major questions we must answer concerning this possible effect:
 
1.     Is the occurrence of mammary tumors an absolute response in the rat when fed 2,6-cis?
2.     Do any of our products contain 2,6-cis?
3.     Is the production of these tumors a result of the estrogenic activity of 2,6-cis or is it related to certain low molecular weight silicone compounds?
 
CITE: KMM 482556 - 482557, Exhibit to Tyler Deposition, Exhibit to Ryan Deposition. NOTE: The right hand side of the page is cut off. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
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Document #250
08/03/76
 
KNOWLEDGE OF SYSTEMIC DISEASE
 
Pulley, Dow Corning, memo to LeVier concerning the inactivation of Patent Memorandum 4320. Because LeVier represents “that the project which supported the subject disclosure in on the shelf and that Dow Corning would probably not reactivate work in this area in the near future,” the patent memo is inactivated, to be reactivated “whenever you consider it appropriate.” CITE; DCC 281061472, Exhibit to Bennett Deposition, Exhibit to Isquith Deposition, Exhibit to Lake Deposition, and Exhibit to LeVier Deposition. 
 
NOTE; Refer to entry dated 01/31/75. This was listed on Plaintiffs’ Exhibit List in Carter as “No Bates Number.” Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
 
 
TO DOCUMENTS: 251 - 300