Implant Veterans of Toxic Exposure

Document #151
06/00/73
COHESIVENESS - LIQUID COMPONENT OF GEL
ACKNOWLEDGEMENT OF NEED FOR TESTING
GEL MIGRATION

Dow Corning Bioscience Research Laboratory "Research Project Description: entitled "Bioscience Research Support Project - Systemic Migration Of Prosthetic Gel In The Rhesus Monkey." This cooperative project between Dow Corning's Medical Products Business and Dr. Gerow will "to examine the efficacy of using the gel as an injection or implantation for mammary augmentation. This project is designed to examine the potential of gel components to migrate systemically from the site of instillation." (DCC 16001066) "The gel is a complex mixture of which the low molecular weight fraction (up to 1% w/w of the gel; 330 Fluid) is assumed to offer the greatest potential for migration. Present data acquired in rats indicate that such low molecular weight components tend to appear in depot fat and lymph nodes and that maximum tissue concentrations are attained shortly after instillation.... The relative contribution of the various routes of elimination may include the lung, kidneys and liver based on the elimination of orally administered permethylated cyclic tetramer...." (DCC 16001066)

None of the data to be gathered will allow definition of the structural types that may migrate. The 330 Fluid fraction components of the gel "are the most likely candidates ... (so) it may be advisable to repeat the study with a gel formulation containing a minimum of low molecular weight linear and cyclic siloxanes."
CITE: DCC 16001066 - 16001068, Exhibit to Bennett Deposition. WITNESS: Bennett (Authenticated in Bennett, Vol. II, p. 546: 12-23). DISPOSITION: Admitted in Toole (II) v. Baxter Healthcare.

Document #152
06/00/73
ACKNOWLEDGEMENT OF NEED FOR TESTING
GEL MIGRATION

Dow Corning Bioscience Research Laboratory "Research Project Description" entitled "Metabolism of Organosilicon Compounds." The objective is to "study systematically the absorption, distribution, storage, metabolism and elimination of those organosilicon structures forming the bases of silicon chemistry as exploited by Dow Corning." (DCC 016001081) "There have been no systematic explorations of the metabolism of classes of organoxilicone compounds. Such explorations are necessary for their predictive value in selecting and developing efficacious biological applications.... A few of the current projects now requiring an understanding of metabolic potential include:

1. In vivio disposition of low molecular wt. linear/cyclic permethylated and hydroxylated siloxanes in the breast prosthetic gel. (DCC Compounds to be evaluated in the rhesus monkey include cyclic and linear D3 through D5.

CITE: DCC 16001081 - 16001083, Exhibit to Bennett Deposition. WITNESS: Bennett (Authenticated in Bennett Depo., Vol. I p. 254-257). DISPOSITION: Admitted in Toole (II) v. Baxter Healthcare.

Document #153
06/00/73
ACKNOWLEDGEMENT OF NEED FOR TESTING
KNOWLEDGE OF SYSTEMIC DISEASE

Dow Corning Bioscience Research Laboratory "Research Project Description" entitled "Silicon Adjuvants." The objective is to "investigate the action of silicon compounds on the humoral and cellular immune response." (DCC 16001092) "Substances which are non-immunogenic or only slightly immunogenic can often be made strongly immunogenic by simultaneous administration with adjuvants." (Id.) Because of the drawbacks with presently known adjuvants, research will determine if the cellular or humoral response can be selectively enhanced through the use of organosilicon compounds.

CITE: DCC 16001092 - 16001093, Exhibit to Bennett Deposition (used by plaintiffs and as Exhibit 83 by Dow Corning), Exhibit to Boley Deposition, Exhibit to Isquith Deposition, and Exhibit to MDL LeVier Deposition. WITNESS: Bennett (Authenticated in Boley, Vol. I p. 141-143 and 153: 19 - 154:12). DEPOSITION: Admitted in Toole (II) v. Baxter Healthcare.

Document #154
06/09/73
KNOWLEDGE OF LIQUID SILICONE DANGERS
MISCELLANEOUS
MISCELLANEOUS - SALES

Telephone call report by Braley with Dr. F. McDowell with copies to Rathjen, Stark and Bennett regarding Bromley Freeman's paper on the use of free gel implantation. "I explained Dow Corning's great concern with this situation and that we had finally gone to outside counsel in Washington for advice. The situation is serious enough that we are going to considerable length to notify all persons that the breast implant is not to be cut open. The outside counsel has felt that the FDA could interpret this used as a drug being furnished in a very elaborate package, and could thus eliminate all beast implants of any kind."

Dr. McDowell suggested getting an injunction against the FDA concerning the injection program. Braley explained the "impossibility" of this and said that DC does not have sufficient information to give to the FDA yet.
CITE: KMM 112207 - 112208, Exhibit to MDL Rathjen Deposition.

Document #155
06/16/73
ACKNOWLEDGEMENT OF NEED FOR TESTING
COHESIVENESS - LIQUID COMPONENT OF GEL
KNOWLEDGE OF SYSTEMIC DISEASE

Dow Corning bioscience Research Laboratory "Research Project Description" entitled "Exploratory Hapten Modification." The objective is to "determine the antigenic (haptenic as well as conjugate) capability of organosilicones of various molecular weights and to explore their potential use as biological tracers." (KMM 546454) Among the organosilicon compounds to be examined for determination if they function as conjugates or complete immunogens are dimethylpolysiloxanes. Research in this area will most certainly advance our knowledge of the chemical reactions of organosilicone compounds to biological chemicals.... The development of specific antibody in response to organosilicon determinant groups would provide us with an exquisitely sensitive biological tracer for detecting distribution and storage of organosilicones in the body." (KMM 546455)

CITE: KMM 546454 - 546465, Exhibit to Bennett Deposition, Exhibit to Isquith Deposition, Exhibit to Boley Deposition, Exhibit to LeVier Deposition, and Exhibit to Lake Deposition. This document also has Bates Numbers KMM 491081A - 491083A on it. WITNESS: Bennett (Authenticated in Isquith, Vol. II, p. 378:21 - 379;16). DEPOSITION; Admitted in Toole (II) v. Baxter Healthcare.

Document #156
6/19/73
KNOWLEDGE OF LIQUID SILICONE DANGERS

Joe Radqius, Dow Corning Food and Drug Counsel, memo to numerous Dow Corning employees regarding "misuse of the Silastic Mammary Prosthesis." Radzius states that, "we are now aware of isolated instances where physicians are purchasing the Mammary Prosthesis and removing the gel from it for subsequent implantation." (Kmm24296 - 242499). He recommends a warning be put on the data sheets and information brochures. "If the matter is not given our immediate attention, and if the practice continues, Dow Corning may have no alternative but to remove the product from the market because of potential liability."

CITE: KMM 242496 - 242499, Exhibit to Mantle Deposition, Exhibit 92 to Harris County Rathjen Deposition, Exhibit to MDL Rathjen Deposition, and Exhibit to Venn Deposition. DUPLICATE: OOM 880025 - 880027.

Document #157
08/00/73
SHELL STRENGTH - THICKNESS
Dow Corning mammary envelopes are in short supply. There are high losses at the dipping machines for tears and poor release from the mandrels. The reject rate at the dipper is in the range of 50%.
CITE: KMM 220138 - 220147.

Document #158
08/01/73
GEL MIGRATION
KNOWLEDGE OF GEL BLEED
SHELL STRENGTH - THICKNESS

Study by Alcott titled "Physical Comparison Between Camp External Mammary Prosthesis and Dow Corning Silastic External Mammary Prosthesis." The Camp "Symmetry", external mammary prosthesis was found to be a tough, somewhat unyielding prosthesis. A good fabrication system is used with good results. No migration of silicone oils through the envelope is likely since the envelope is not a silicone rubber. The envelope may resist body fluid and odors better than silicone rubber. Camp's advertisement is quite misleading since it implies that the same materials are used in implants.
CITE: KMM 354646 - 354651, Exhibit to Tyler Deposition.

Document #159
09/18/73
FRAUD/MISREPRESENTATION
CONCEALING FROM FDA

Art Rathjen, Dow Corning, memo to numerous Dow Corning employees regarding "Precise Choice of Words/Accurate Written Reports When Returning Unusable Or/Remove Mammary Implants To Quality Assurance." Rathjen discusses recent trip reports which used the word "reject" when referring to a physician's use of the Silastic. Other words or phrases sales person use which Rathjen does not like include "faulty product," "faulty," and "defective." Words like this "are imprecise and could be damaging to Dow Corning if they are used incorrectly when repeating a condition or a set of circumstances.... If a patient elects to file a lawsuit against the surgeon or Dow Corning, the patient's lawyers have a right to review our written files. Our files must be disclosed and the attorneys are entitled to use our records as evidence to try and prove their case against us." (emphasis in original).
CITE: KMM 243010 - 243015, Exhibit to MDL Rathjen Deposition, Exhibit 4 to Hinsch Deposition, Exhibit to Mantle Deposition, and Exhibit 62 to Harris Country Rathjen Deposition. DUPLICATE: M 880016 - 880018; DCC24000537 - 24000542; OOM 880016 - 880018.

Document #160
10/00/73
ACKNOWLEDGEMENT OF NEED FOR TESTING
KNOWLEDGE OF SYSTEMIC DISEASE
MISCELLANEOUS - COMPLICATIONS
MISCELLANEOUS - ORGANIZATIONAL SURVEY
TESTING
TISSUE REACTION

Publication by Rowlett, Nichols, Bailey and Dion titled "Silicones -Can They Further Improve The Quality of Life?," Dow Corning News, Vol. 15, No. 4, Sept. - Oct. 1973. Includes a description of the Bioscience Facility, the History of Bioscience activity at Dow Corning. States that 2,6-cis can alter their behavior of the pituitary, the master gland that chemically controls the function of all the other glands in the body. Describes Bioscience research as opportunity-oriented or for developing profit making products.
CITE: DCC 282001118-282001149, Exhibit to Bennett Deposition, Exhibit to Petraitis Deposition, Exhibit to Tyler Deposition, Exhibit to Boley Deposition, and Exhibit 1 to Randonovich Deposition. DUPLICATE: LAK 1 - 11.

Document
10/08/73
(NOT LISTED ON PLAINTIFF'S EXHIBIT LIST)

Memo from Lake and Ng, Dow Corning, to Isquith and Bennett regarding "Experimental Activities in the Virus and Cell Biology Section of Microbiology 1973-1974." The laboratory is now functional to analyze metabolism of cell cultures, cytogenetics, serology, ultracentrifugation, chromatography, electrophoresis, and fluorescent, phase and light microscopy. "The broad focus of our mission is to circumscribe those areas in the total realm of virus and cell biology where organosilicon entities manifest exploitable biological activity. Antimetabolite, virucidal, antiviral, interference inducing, or cytostatic activities are being sought." (LAK 12) Anticipated areas of research include:

A. Endogenous Si and exogenously applied silicates: The notion that endogenous Si and trace quantities of Si play a role in atherosclerosis, connective tissue structure and function, mammalian cell aging, and lymphocyte transformation has prompted interest in this area. (LAK 14)

Research will also be conducted on new agonists and chemotherapeutic agents with selected groups of organosilicon compounds. Activities that will be monitored include viral interference induction (interferon), antiviral activity against 4 RNA and 4 DNA viruses, modification of cell growth kinetics and modification of cultural characteristics. Also, the authors seek to establish a method to measure the response and processing of fluids resins and silastic materials in macrophages. (LAK 14)
CITE: LAK 12 - 15, Exhibit to Bennett Deposition, Exhibit to Lake Deposition, and Exhibit 1 to Radonovich Deposition. WITNESS: Bennett (Authenticated in Lake, Vol. 11, p. 306:19-23). DISPOSITION Not introduced in Toole (II) v. Baxter Healthcare.

Document #161
12/04/73
MISCELLANEOUS - SALES

Art Rathjen memo to numerous Dow Corning Employees informing them of an "Album For Clinical Photographs, Silastic Mammary Prostheses." This album is later used by sales persons.

CITE: DCC 24000523 - 24000524, Exhibit 23 to Harris County Rathjen Deposition, Exhibit to MDL Rathjen Deposition. NOTE: See 12/13/73. DUPLICATE: DCC 266000237.

Document #162
12/13/73
MISCELLANEOUS - SALES

Maurice Popple memo to Art Rathjen, both of Dow Corning, stating, "Art, I am in receipt of your pornographic picture album and think it's a great idea. As you are aware, salesmen spend long weeks away from home and such an album is a comfort to take along. I am awaiting with adrenalized anticipation the next batch of photos... Anyhow, I have always considered myself a leg man so I don't claim any special expertise (sic) in the subject area." CITE: KMM 46084, Exhibit 24 to Harris County Rathjen Deposition, Exhibit to MDL Rathjen Deposition. NOTE: See 12/04/73. DUPLICATE: DCC 24000967.

Document #163
01/22/74
ACKNOWLEDGEMENT OF NEED FOR TESTING
COHESIVENESS - LIQUID COMPONENT OF GEL
MISCELLANEOUS - COMPLICATIONS
STERILIZATION/CONTAMINATION
TESTING
TISSUE REACTION

Abbott memo to Stark with copies to Bennett, Larson, Rathjen and Robertson regarding "Summary of Gel Review Meeting, January 16, 1974." All of the gel samples except X-30885 showed a reaction when implanted in rabbits at Huntingdon, suggesting that some gel samples may not be properly cured and "will, therefore, show a reaction." Also, he recovered the volatiles from the gel which consisted of cyclic pentamer and constituents larger than pentamer. Many gel samples tested are "highly contaminated with bacteria. Also the samples that gave a reaction at IBT were found to be contaminated. The number of organisms is so high that the antibiotics in the tissue culture medium will not control them There is a possibility that the organisms involved are resistant to the antibiotics which are in the medium. In a recent study in our laboratory, it was found that S. auras (gram positive) can survive in mammary gel for approx. 120 days. Because of this data, we would like to isolate and identify the bacterial that are present in the gel."
CITE: T 21169 - 221172, Exhibit to Harris Country LeVier Deposition and Exhibit to MDL Rathgen Deposition.

Document #164
01/23/74
KNOWLEDGE OF SYSTEMIC DISEASE
TESTING

Boley and LeVeir memo regarding organosilicon immunopotentiators. Forty-eight silicon-containing compounds were examined in guinea pigs for their ability to enhance serum antibody levels. Nine of the compounds showing high enhancing activity were further evaluated in a rat model. Of the nine, four prolonged and enhanced serum antibody levels.
CITE" DCC 281061454 - 281061486 (Temporary Dow Corning Bates Numbers 16362 - 16377), Exhibit to Bennett Deposition, Exhibit to Lake Deposition, Exhibit to LeVier Deposition, and Exhibit to Isquith Deposition.

Document #165
02/18/74
SHELL STRENGTH - THICKNESS

Tom Talcott, Dow Corning, memo to Boone, Stark, Ringey, Hoyt, Houle, Polmanteer, and Brodhagen regarding "Control of the Aesthetic Character of our Soft Contour Mammary Prosthesis." Talcott states:

Some of us have felt for some time that we need to do much better on envelope thickness control for the round prosthesis. Gel control maybe also, but this is another separate subject. Envelope thickness control appears even more important in the soft contour product line. This is because of the general shape of the product. The envelope if too thin can be extended and/or sag, allowing the peak of the projection to be grossly underfilled. There are also some severe irregularities in the tooling for this product line that contribute to the problem in certain sizes.

CITE: KKM 21110

Document
03/00/74
(NOT ON PLAINTIFF'S EXHIBIT LIST)

Handwritten document produced by Dow Corning synopsizing three classified Dow Corning reports: 1) Lake, Isquith and Bennett report "Status of Biological Testing of Sila-adamantoner compounds, Dow Corning Internal Report 4234"; 2) Lake, Schultz, Radonovich, Dittenber and Kociba report "Joint Research Contract Report, February 197_, Evaluation of the Syrian hamster fibroblast system for direct and host-mediated carcinogen bioassays"; and 3) Lake, Radonovich and Boley's 1975 report "Immunopotentiating activity of dimethylpolysiloxanes and phenylmethylpolysiloxanes. In preparation for submission to Infection & Immunity." The note states that patent memos have been submitted on antigen modification, immunopotentiators, and silicone substitutes for tissue culture.
CITE: LAK 133.

Document #166
04/10/74
SHELL STRENGTH - THICKNESS

J.L. Boone, Dow Corning, memo to Hoyt, Talcott, Emmons, Polmanteer and Ringey regarding production analysis for 1973-74. He chronicles problems during 1973 consisting of gel shipments, gel yellowing and platinum level adjustments, extraordinary high tear losses, reject rates as high as 50% in some months, contamination with "lemon-scented I.P.A.," and irregular thickness in envelopes which cause a loss of 10,000 bags and a 10% breakage rate. During 1974, Dow Corning experienced "extraordinarily high reject rates" with yields of approximately 20-35% of the actual output. Reject losses were heavy at every step and particularly at dipping and placing.

Boone states that the fixation patch on the envelope "covered up air bubbles and other flaws that will reject the NFP style." Manufacture of the NFP mammary requires considerably more skill and diligence. This is a "permanent problem inherent in the design...."
CITE: KMM 220138 - 220147

Document #167
06/11/74
KNOWLEDGE OF LIQUID SILICONE DANGERS
TESTING

Memo from Hobbs, Dow Corning, to Needleman about a study of DC 200 fluid injected intravenously in rabbits. Seventeen of the twenty eight rabbits tested died during the study probably due to lung, liver and kidney congestion.

CITE: FDA 27196

Document #168
06/28/74
KNOWLEDGE OF SYSTEMIC DISEASE
MISCELLANEOUS - COMPLICATIONS
TESTING

United States Patent No. 3,821,373 for "Organosilicon Compositions In Methods Of Treatment Involving Increasing The Dopamine Content Of The Brain" granted to Donald R. Bennett and Robert R. Levier of Dow Corning. The patent is for the method by which the dopamine content of the brain is increased by administering 2,6-cis. The purpose of this is to alleviate some of the symptoms caused by Parkinsonism, manganese poisoning, and similar diseases.
CITE: DCC 281001098 - 281001100, Exhibit 3 to Isquith Deposition, Exhibit 70 to Bennett Deposition (used by Dow Corning). and Exhibit to LeVier Deposition.

Document #169
08/20/74
MISCELLANEOUS - COMPLICATIONS
TESTING
TISSUE REACTION

Patent No. 3,830,912 for a method for decreasing the reproductive function of mammals by Bennett and McHard, A method for altering the reproductivity function of mammals by administering a pharmacologically effective amount to certain organosilicon compounds. As a means of illustration, one can orally or parenterally administer from 1.0 gn. To 5000 mg. per kilogram of body weight or an organosilicon compound thereby rendering the subject infertile.
CITE: DCC 281061389 - 281061395, Exhibit 71 to Bennett Deposition (used by Dow Corning).

Document #170
08/21/74
MISCELLANEOUS - ORGANIZATIONAL SURVEY

Bennett memo to Tyler regarding technology generation and patents. Crises primarily initiate needed technological change in biological affairs rather than long range planning. Bioscience Research has a better credibility and interface with outside biological businesses that it often has within Dow Corning. Consensus between Dow Corning Legal and Federal Regulatory Agencies regarding all biomedically-related activities and products should exist rather than the current practices such as guarded "win-no lose" or compromise mechanisms.
CITE: LAK 62 - 64, Exhibit to Bennett Deposition and Exhibit to Tyler Deposition.

Document #171
09/23/74
KNOWLEDGE OF LIQUID SILICONE DANGERS

Frisch, Dow Corning, letter to James McDonough, Department of the Army, regarding his letter of 09/12/74. Frisch states, "I want to emphasize that we do not recommend implantation of the gel except when fabricated in devices with intact silicone elastomer capsule."
CITE: DCC 240000861 - 240000862.

Document #172
09/30/74
MISCELLANEOUS
TESTING

Bennett memo to Bennett, Hobbs, Larson, Radzius and Stark regarding the product safety committee meeting. Handwritten note to complete gel chg. (Mam) and the Lake transformation screen.
CITE: DCC 281061484.

Document #173
09/30/74
MISCELLANEOUS - COMPLICATIONS

Bioscience Research Quarterly Status Report - July 1 - September 30, 1974. There are reports on 2,6-cis and KABI; Microbiology's work on biodegradation, the environmental effect on soil microflora, antimicrobial surface treatment, nonabsorbable antimicrobials, development of carcinogen bioassay - "Dow Chemical has yet to indicate the extent to which they will support this project," antigen modification, and modulation of interferon response - "Four compounds ... (Me2Si0)4 (and others) have been shown by W. Boley to have immune adjuvant activity and are also being examined for their ability to potentiate IF induction." (LAK 56). Under Plant Sciences, there are reports on antitranspirants, large tree transplanting, cherry cracking, hormonal - siloxqane diols could retard opening of flower and leaf buds, insecticide - "previous information on spider-mite, mealy-bugs and aphids has been confirmed and extended. Additional work has been done on mosquito larvae, tomato hornworm and potato beetle, for all of which DC 200 fluid is effective, and on white fly and ladybird larvae, which are not harmed by the fluid." (LAK 58). Under Environmental, there is a report on the Idaho project - silicon analysis of foliage, soil and water samples: and the Salzburg Road project - spills of silicone fluids on soil to look at plant damage, effects on flowering and effect on percent coverage of the plant species.

CITE : LAK 53 - 59, Exhibit to Blocksma Deposition (used by Dow Corning), Exhibit to Bennett Deposition, Exhibit to Isquith Deposition, Exhibit to Weyenberg Deposition, Exhibit 9 to Harris County Gehring Deposition, Exhibit to Tyler Deposition, Exhibit to Ryan Deposition, Exhibit 5 to Lake Deposition (used by Dow Corning), and Exhibit to LeVier Deposition. WITNESS: Bennett (Authenticated in Bennett, Vol III, p. 749-750). DISPOSITION: Not introduced in Toole (II) v. Baxter Healthcare.

Document #174
10/02/74
KNOWLEDGE OF SYSTEMIC DISEASE
TESTING

Dow Corning Bioscience Research Report No. 4319 by Boley and LeVier, Dow Corning, entitled "Immunological Enhancing Activity Of Organosilicon Compounds And Non-Functional Fluids." Forty-nine (49) silicon-containing compounds were examined in guinea pigs to screen for "potential adjuvant activity." Nine compounds showing "good antibody producing activity" were evaluated for their ability to enhance serum antibody levels. Four compounds including (Me2Si0)4 showed good adjuvant activity. Dow Corning plans future work to evaluate these four compounds for their ability to enhance the antibody response to viral, bacterial and soluble proteins antigens.

Organosilicon compounds can stimulate the immune response. No information is currently available about the mechanism of action of these compounds.
CITE: T 21287 - 21304, Exhibit to Dillon Deposition, Exhibit to Frye Deposition, Exhibit to Bennett Deposition, Exhibit 14 to Edwards Deposition, Exhibit to Isquith Deposition, Exhibit to Harris County Klykken Deposition, Exhibit to LeVier Deposition, Exhibit to Lynch Deposition, Exhibit to Lake Deposition, Exhibit to D. McGhan Deposition, Exhibit to Palensky Deposition, Exhibit to Weyenberg Deposition, Exhibit to Compton Deposition, Exhibit 3 to Harris County LeVier Deposition, Exhibit 18 to Zimmer Deposition, Exhibit to Boley Deposition, Exhibit 1 to Harris County Boley Deposition; Exhibit to Hudson Deposition, Exhibit 23 to Harris County Rich Deposition, Exhibit to Harris County Burda Deposition, Exhibit to Frisch Deposition (used by Dow Corning), Exhibit to Oppelt Deposition Exhibit to Peters Deposition, Exhibit 10 to California Braley Deposition; Exhibit 1 to Dallas Espinoza Deposition, Exhibit to Radonovich Deposition, and Exhibit to Harris County Tyler Deposition. DUPLICATE: This was originally listed as P 14028 - 14046 on the exhibit list; DCC 80061481 - 80061530: F 86 - 103; DCC 281001575 - 281001589. WITNESS; Bennett (Authenticated in Boley, Vol. I, p. 155:4-24). DISPOSITION: Admitted in Toole (II) v. Baxter Healthcare.

Document (Not Listed)
(Note: this is not numbered but is between 174 & 175)
10/21/74
(NOT ON PLAINTIFF'S EXHIBIT LIST)

Memo from G. Robertson, Dow Corning, to Bennett, Bennett, Hobbs, Radzius and Stark with copies to Brodhagen and Larson regarding "Minutes of Product Safety Committee Meeting, October 11, 1974." They discussed proposed changes for mammary gel including using 360 fluid rather than 330 fluid (DCC 267380231).
CITE: DCC 267380231 - 267380234 (page 2 is missing). NOTE: This document also has Bates Numbers QDC 118693 - 118696 and MM 220066 - 220069 on it. WITNESS: Bennett (Authenticated in Bennett, Vol. IV, p. 954-968). DISPOSITION: Admitted in Toole (II) v. Baxter Healthcare.

Document #175
11/22/74
ACKNOWLEDGEMENT OF NEED FOR TESTING
MISCELLANEOUS

Stark memo to Frisch, Rathjen & Talcott with copies to Hoyt and Nelson regarding "Capsular Contracture Studies." Stark writes, "THE WELL IS DRY! we cannot give financial support for more studies of capsular contracture in '74 and '75 ... I think our future role in these studies should be to provide input on the technology of silicones and to provide samples of materials."
CITE: M 190131, Exhibit to MDL Rathjen Deposition.

Document #176
11/26/74
KNOWLEDGE OF LIQUID SILICONE DANGERS
TISSUE REACTION

Silas Braley, Dow Corning, telephone call report of his conversation with Dr. Charles Vinnik. Braley states:

" Dr. Vinnik then launched into a very extended discussion of how terrible he thinks the silicone fluid injections are and the fact that it is going to mean the financial ruin of Dow Corning if we ever get it approved by the FDA. He said that he had just treated the wife of a doctor from Saginaw who had obtained pure #360 medical fluid directly from a friend at Dow Corning in the days before it was restricted. She had exactly the same typical inflammatory and foreign body reaction that the patients he had seen from Kleifgen and Dr. Haines in Las Vegas. He said he has seen some good results in the face and thinks this is put in in (sic) tiny amounts and in a highly vascular area, but to put it into other areas of the body, he feels is catastrophic. He said he is going to do everything he can to prevent this from ever becoming cleared until further work has been done. He has gone to Senator Cannon and to the FDA commissioner to protest the clearance of the IND. He states that he will offer himself as an expert witness against anybody who chooses to use it in the future.

CITE: DCC 240000051, Exhibit 35 to California Braley Deposition.

Document #177
00/00/75
KNOWLEDGE OF SYSTEMIC DISEASE
TESTING

Abstract of Lake, Radonovich and Boley report entitled "Potentiation of Endotoxin Induced Interferon In Mice Treated With Octamethylcyclotetrasiloxane." D4 increases serum interferon levels in mice induced with bacterial endotoxin, apparently potentiating production of "early" interferon induced by endotoxin but not viral-induced "late" or "virus-type" interferon. Forty-eight hours after intraperitoneal inoculation, mice exhibit weight loss, decreased spleen/liver weight ratio, decreased in vivo carbon clearance and peritonial monocytosis.

CITE: LAK 65 - 66A, Exhibit to Bennett Deposition, Exhibit to Lake Deposition, Exhibit to LeVier Deposition, and Exhibit 1 to Radonovich Deposition. NOTE: See entry dated 10/30/75.DUPLICATE: DCC 281061469 - 281061470. WITNESS: Radonovich. DISPOSITION; Admitted in Toole (II) v. Baxter Healthcare.

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

Brashier, Dow Corning, memo to Salisbury and VerVoort regarding a patient of Dr. Goldwyn's who reported a "stringy gooey substance" that was coming out of a woman's breast who had just been implanted. The patient snipped the substance with a scissors. The implants were removed and replaced and the same thing happened.
CITE: M 570188 - 570189

Document #179
01/22/75
KNOWLEDGE OF SYSTEMIC DISEASE
TESTING

Study by Lake, Radonovich and Boley with abstract titled "Potentiation of Endotoxin Induced Interferon in Mice Treated With Octamethylcyclotetrasiloxane." D4 has been found to increase serum interferon levels in mice induced with E. coli endotoxin. Because spleen cells but not peritoneal exudate cells from D4 treated mice continue to produce augmented amounts of endotoxin-induced IF upon removal and incubation in vitro, a direct interaction between IF producing lymphoreticular organs and D4 is being considered.
CITE: LAK 67, Exhibit to Radonovich Deposition, and Exhibit to Boley Deposition.

Document #180
(Note: this is all that is listed for #180)

01/22/75
DUPLICATE OF DOCUMENT # 177 (see above).

Document #181 & 182
(Note: #181 (ALSO LISTED AS #182)
01/22/75
TESTING
MISCELLANEOUS - SALES

Hoyt, Dow Corning, memo to Rathjen with copies to Salisbury, Talbot, Thompson, Houle, Meads, Leach, Polmanteer, Boone and Nelson regarding "Mammary Prosthesis Task Force." He announces that a Dow Corning Task Force has been organized to further development of the Silastic Mammary prosthesis, Low Profile Round and Contour, with "flo gel" and which will be packaged in a new sterile container. Permanent members of this committee include: A. Rathjen (Chair), D. Houle, T. Salisbury, J. Thompson, and T. Talcott. Active consultants include: T. Abbott, G. Robertson, W. Larson, and Z. Bennett. The deadline for product introduction is 06/01/75. There is a 90-day gel implantation test scheduled with Biometric. Although there was no planned gel testing at Dow Corning's Biomedical facility, this was requested by Robertson.

Hoyt writes that:

"I can't emphasize enough the urgency and importance of this project for the business in 1975.The basic assignment is to insure rapid commercialization of a new mammary prosthesis product line, incorporating new shapes, sterile pack, and responsive gel. The low profile round - targeted for June 1 introduction/ low profile contour - by September. The many variables connected with this particular program make it a challenging management assignment but we can and must make it happen. How this assignment is handled in detail is up to the Task Group. We are primarily interested in the final result.... Because of our market position and tight corporate business situation as we progress into 1975 we really cannot accept any delays in getting the product onto the market. The big mammary prosthesis sales months will be May, June, and July in which approximately 36% of our total business sales will be made. Missing one of those months would have a dramatic impact. We could, and might be able to accept trade-offs, but certainly not delays.... I would like to emphasize that this task and the assignment of all members has received total Business and PMG support."

CITE: F535 -540, Exhibits 35, 37 and 94 to Harris County Rathjen Deposition, Exhibit to MDL Rathjen Deposition. NOTE: In a rush to get the product to market, Dow Corning cut the 90-day study short by 10 days. See 04/25/75 entry, which is the result of the 80-day study. DUPLICATE: M 630061 - 630061; M 540001 - 540006.

Document #183
01/28/75
KNOWLEDGE OF GEL BLEED

Art Rathjen memo to numerous Dow Corning employees regarding "Gel Bleed - New Gel In Mammary Prostheses Scheduled For June 1 Introduction." Rathjen writes that, "there is only a two week period before the new 'flo-gel' is scheduled to be formulated and filling begins. A question has not yet been answered is whether or not there is an excessive bleed of the gel through the envelope.... We must address ourselves to this question immediately.... The stakes are too high if a wrong decision is made."
CITE: F 541, Exhibit 38 to Harris County Rathjen Deposition, Exhibit to MDL Rathjen Deposition.DUPLICATE: KMM 260794; KMM 19824; FDA 19671 - 19672; M 150001.

Document #184
01/31/75
KNOWLEDGE OF SYSTEMIC DISEASE TESTING

Patent Memorandum Number 4320 by Boley, Lake and LeVier entitled "Organosilicon Immunopotentiators" is received by Dow Corning's Patent Department on this date. The memorandum essentially outlines findings that various organosilicon fluids potentiate the formation of humoral antibody, modulate cell mediated immunity and promote the induction of interferon by stimulation of the immune system." The document also includes a memo dated 08/03/76 from J.I. Pulley to LeVier noting that this patent memorandum has been inactivated and "that Dow Corning would probably not reactivate work in this area in the near future." Another memo dated 07/15/76 from Pulley to LeVier notes that "Dow Corning is no longer actively involved in this (the use of silicone fluids as immunopotentiators)...."

Another document is a "Patent Memorandum" by Boley and LeVier with the suggested title of "Immunological Enhancing Activities of Organosilicon compounds and Non-Functional Fluids" which was renamed to "Organosilicon Immunopotentiators." Nine of 48 silicon-containing compounds showed a "strong immunological enhancing" effect. Boley and LeVier wanted to explore possible applications of these compounds including for potentiation of veterinarian vaccines and in the "production of high quality and expensive experimental antibodies."

Some of these compounds were tested for their ability to augment or potentiate endotoxin induction of IF. Dow Corning 200 fluid and D4 "show a significant potentiation of endotoxin induced IF." (DCC 281061466).

There is also a one page abstract of the Lake, Radonovich and Boley report on "Potentiation Of Endotoxin Induced Interferon In Mice Treated With Octamethylcyclotetrasiloxane." Interferon appears to be involved in the Immune response to bacterial, viral and protozoal infections. Substances able to modulate the interferon response may be useful in the control of many infectious diseases and cancer. This report describes the immunopotentiating activity of some structurally defined linear and cyclic polydimethylsiloxane fluids which have been found to mimic the potentiating effects of mineral oil adjuvants (Boley and Levier Dow Corning Report 4319, 1974).
CITE: DCC 281061451 - 281061468 (Temporary Dow Corning Bates Number 16359 - 16379), Exhibit to Bennett Deposition, Exhibit to Isquith Deposition, Exhibit to Lake Deposition, and Exhibit to LeVier Deposition.

Document #185
02/03/75
KNOWLEDGE OF SYSTEMIC DISEASE
TESTING

Patent department memo to Boley, LeVier and Lake regarding organosilicon immunopotentiators patent memo assigned #4320.
CITE: DCC 281061471 (Temporary Dow Corning Bates Number 16379), Exhibit to Lake Deposition, and Exhibit to LeVier Deposition.

Document #186
02/13/75
SHELL STRENGTH - THICKNESS

J. Thompson, Cow Corning, memo to A. Rathjen that the new low profile round envelopes are being dipped on the automatic dippers at a rate of 1,000 bags per day, but, "PROBLEM: NO SPECIFICATION EXISTS TO Q.C. THESE BAGS!!! WHERE IS IT?
CITE: F 552 - 553, Exhibit to MDL Rathjen Deposition.

Document 187
02/14/75
SHELL STRENGTH - THICKNESS

Dow Corning's Mammary Task Force meets. The minutes of the meeting report that Dow Corning is "15 weeks, 170 days, 2,568 hours (and) 154,080 minutes" from the 06/01/75 deadline. Will Larson reported gel migration in monkeys with the new gel. A "major point of contention" is that, "No specification exists on the acceptable thickness for the low profile round envelope." TS&D and Production have differing opinions on what is acceptable. There has also been a breakdown in the special fabrication program, evidencing that acceptable envelope fabrication was a problem. "RIGHT NOW I (Rathjen) CONSIDER THIS THE MAJOR PROBLEM CONFRONTING THE TASK FORCE. I RECOMMEND THAT FILLING WILL NOT COMMENCE UNTIL THERE IS AN AGREEMENT BETWEEN MARKETING, TS&D AND PRODUCTION AS TO WHAT IS AN ACCEPTABLE ENVELOPE! (emphasis in original).

CITE: F 549 -551, Exhibit 40 to Harris County Rathjen Deposition, and Exhibit to MDL Rathjen Deposition. DUPLICATE: KMM 446914 - 446916: M540023 - 540025. NOTE: Why does Marketing decide what is an acceptable envelope?

Document #188
02/19/75
MISCELLANEOUS

Hommel memo to Rathjen with copies to Hagerman, Salisbury and Leach regarding "Revision of the "Facts About Your New Look" Pamphlet." Rathjen volunteered to compile information to revise the Facts About Your New Look brochure. Hommel encloses "a series of questions which were submitted during a survey (by Karen Lott) among a number of the ladies working in the advertising agency in Grand Rapids. I think there is merit to giving due thought to these questions while working toward the revision of the booklet."
CITE: M 400001, Exhibit 84 to Harris County Rathjen Deposition, and Exhibit to MDL Rathjen Deposition.

Document #189
02/25/75
COHESIVENESS - LIQUID COMPONENT OF GEL
KNOWLEDGE OF GEL BLEED
TISSUE REACTION

Nawash memo to Salisbury, both of Dow Corning, regarding low molecular weight gel diffusion. He writes:

"The reactivity between free low molecular weight silicones and the subcutaneous tissue seems to be of increasing concern among plastic surgeons. It is thought that the soft gel used by Heyer-Schulte in the mammary implant is obtained by mixing low viscosity silicone fluid in the regular gel. It is also thought that the low molecular weight components of the fluid eventually diffuse through the rubber envelope of the breast implant and elicit the untoward reaction which is occasionally observed and results in an undesirable, relatively thick fibrous capsule. I do not know the actual method used by Heyer-Schulte to obtain their soft gel: nor do I know the process we developed for making our own soft gel.

However, If I may, I strongly recommend that we take measures to insure against the presence of unwarranted free low molecular weight fluids in our now soft breast implant."

CITE: M 190133, Exhibit to Nawash Deposition, and Exhibit to MDL Rathjen Deposition.

Document #190
04/25/75
TESTING

Biometric Final Report to Dow Corning on "Implantation Study in Rabbits with Four (4) Mannary Gels." This is a report of an 80 day test using the new flo gel or responsive gel - X7-2159A in rabbits. Results showed the "presence of mild, subacute granulomatous inflammatory lesions...."
CITE: t 3740 - 3755, Exhibit to Peters Deposition, Exhibit 87 to Harris County Talcott Deposition, and Exhibit to MDL Rathjen Deposition. DUPLICATE: P 16689 - 16694. NOTE: The 01/22/75 minutes of the first Mammary Task Force states that this was supposed to be a 90-day test. See also 03/08/75 entry, with interim report of the 90-day test.

Document #191
04/25/75
MISCELLANEOUS

Boone memo to Talcott, Hoyt, Leach & Salisbury with copies to Rathjen and others regarding the scale up of the new low profile contours and setting of specifications. "I am not prepared to repeat the acrimonious exercises that were encountered during the scale-up and specification setting of the low profile round envelopes. That scale-up was accomplished with the Production Department assuming fundamental responsibility for arriving at optimums after considerable trial and error with eventual prototyping and specification recommendations being done by this department. I am willing to repeat this work with the low profile contour product line because we are certainly the best qualified to do the work. If, however, there are any doubts as to the quality or intensity of our desire to produce the thinnest product manufacturable, I will be happy to relinquish this scale-up responsibility to any other group prepared to man and supervise the equipment on a three-shift basis for the first several weeks of production. This scale-up should lead to procedures, spec recommendations, supporting data, and prototypes illustrating limits of acceptability for all sizes."
CITE: KMM 220579, Exhibit to MDL Rathjen Deposition

Document #192
05/01/75
FRAUD/MISREPRESENTATION
KNOWLEDGE OF GEL BLEED
MISCELLANEOUS - SALES

Boone memo to Hoyt, Leach & Salisbury with copies to Larson, Talcott, Peters, Brodhagen, Rathjen and Ringey regarding "Oily Effect on New Mammaries." They have observed that the new mammaries tend "to bleed noticeably after the product is massaged and handled. We are relatively confident that the doctor will not see any appreciable bleed on the product as it is removed from the package. The salesman, however, will experience bleed on his detail samples, particularly the day after they have been squeezed. It would be advisable for the salesman to understand this and clean his detail samples prior to demonstrating to the customer."
CITE: KMM 220570, Exhibit to MDL Rathjen Deposition

Document #193
05/13/75
KNOWLEDGE OF GEL BLEED

Tom Talcott, Dow Corning, memo to Larson, Dow Corning Mammary Task Force and other Dow Corning colleagues, regarding silicone gel bleed from implants. He states, "We are hearing complaints from the field about the demonstration samples they are receiving. The general claim is that the units bleed profusely after they have been flexed vigorously. This may tie into the soaking to wash off excess gel which was occurring in the early stages of production or the time interval between fill and cure.... Please run appropriate testing when you receive these samples to determine if a bleed rate problem exists."
CITE: F 743, Exhibit 43 to Harris County Rathjen Deposition, and Exhibit 12 to MDL Rathjen Deposition (used by Dow Corning). DULICATE: M 16003; M570062; FDA 19586; Staff Report prepared by the Human Resources and Intergovernmental Subcommittee of the Committee on Government Operations, December, 1992, p. 17.

Document #194
05/16/75
KNOWLEDGE OF GEL BLEED

Minutes of the meeting of the Dow Corning Mammary Task Force. Countdown to product introduction is "2 weeks, 16 days, 384 hours, 23,040 minutes." Rathjen began by reading a memo which officially turned the round and low profile rounds "back to its jurisdiction." The minutes do not say what this jurisdiction is. On the issue of gel bleed, "A range of solutions is possible - from reformulating the gel to eliminating salesmen's abuse of the product during demonstrations. It seems to be a function of the porosity of the envelope; the lower molecular weight gel passes through the pores more easily, especially after stretching and pulling."
CITE: F 590 - 596, Exhibit to MDL Rathjen Deposition, and Exhibit 44 to Harris County Rathjen Deposition. DUPLICATE: KMM 446988 - 446991: M540064 - 540070.

Document #195
05/16/75
KNOWLEDGE OF GEL BLEED

Tom Salisbury memo to Dow Corning sales force regarding the "Oily Phenomenon With New Mammary Prostheses." Salisbury writes that, "It has been observed that the new mammaries (sic) with responsive gel have a tendency to appear oily after being manipulated. ... You should make plans to change demonstration samples often. Also, be sure samples are clean and dry before customer detailing. Two easy ways to clean demonstration samples while traveling, 1) wash with soap & water in nearest washroom, dry with hand towels, 2) carry a small bottle of IPA and rag."
CITE: F 635, Exhibit 2 to Hinsch Deposition, Exhibit 63 to Harris County Rathjen Deposition, Exhibit to Nawash Deposition, and Exhibit to MDL Rathjen Deposition. DUPLICATE: M 540071; KKA 152381; KKH 868: KMM446993: KMM 148337: KMM 518441: DCC 80061333 - 80061334.

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

Minutes of the meeting of the Dow Corning Mammary Task Force. Countdown to product introduction, "1 week, 8 days, 192 hours, 11,520 minutes." The Task Force discussed the economic reasons for getting the contours on the market by 10/01/75. Also, "Marketing wanted to use a sealed bottle of gel as a sales aid to show the flowability and cohesiveness of the responsive gel. However, Talcott and Larson discouraged (this) because the gel may not retain constant properties with continued manipulation such as this. The aesthetics of doing this would probably not show our product in a good light." The Task Force decides on "aggressive marketing tactics" including rebates, consignment, back-up units-singles for immediate rupture - replacement, and price breaks for big users.
CITE: F 599 - 601, Exhibit 45 to Harris County Rathjen Deposition, and Exhibit to MDL Rathjen Deposition. DUPLICATE: M 540087 - 540089.

Document #197
06/01/75
COHESIVENESS - LIQUID COMPONENT OF GEL
SHELL DEGRADATION
SHELL STRENGTH - THICKNESS
TESTING

Study titled "New responsive Gel - '"Effect on Mammary Envelope Physical Properties" by James Vallender, cc to Rathjen. Conclusion, "the new gel seems to cause slightly weaker envelope in ultimate properties but appears to cause slightly less weakening on aging. The difference in effect on physicals by new and old gel is considered insignificant."

The study was approved by Matherly and Stark.
CITE: OOT 41627 - 41629, Exhibit to Peters Deposition, Exhibit 112 to Harris County Rathjen Deposition, Exhibit 129 to Burda Deposition (used by Dow Corning), and Exhibit to MDL Rathjen Deposition. DUPLICATE: F 630

Document #198
06/30/75
KNOWLEDGE OF SYSTEMIC DISEASE
MISCELLANEOUS - COMPLICATIONS
TESTING
TISSUE REACTION

Study sent to Dowell by Lince, Pruitt, Neagele, Kenaga, Moss, Hymas Goring, Bjork, Coulter, Johnson, Osborne, Getzendaner, Meulder, Seymour, Sheldon, Barrons, Hinman, Laskowski, Gray, Hunter, Hanson, Little, Kurihara, Hamaker, Meikle, Regoli, Magana, Dalman, Edumura, Geronimo, Turner, Ferguson, Simon, Scott, MacDougal, Shaver, Fears and Regan regarding the rapidity of German roach knock-down with fospirate formulated on dri-die.

Dow Chemical U.S.A. Ag-Organics Research in Walnut Creek, California report by F.H. Dowell on "Rapidity of German Roach Knock-Down With Fospirate Formulated On Dri-Die." The report was distributed to numerous departments within Dow Chemical including Ag-Org. Information Center (M. Lince), Ag-Org. R&D Planning (name illegible), U.S. Area R&D Dir. M.E. Pruitt, Ag-Organics Dept. Manager RD Naegele, Ag-Organics R&D Director R.E, Hefner, Ag-Org. Regist. D. McCollister and E. Kenaga, Ag-Org. Chemistry Dir. R.D. Moss, Ag-Org. An. Health Devel. T.A. Hymas, Plant Sci. R&D Dir. C.A.I. Goring, Ag-Org Areas Pestic. Coord. L.L. Coulter, Corp. Prod. Dept. R.B. Johnson, Ag-Org. Synthesis Res. Mgr. D.W. Osborne, Ag-Org. Residue/Metab. M.E. Getzendaner, Ag-Org. Formulations K.G. Seymour, Ag-Org. Prod. Bus. Mgr. H.W. Sheldon, Ag-Org. R&D Tech. Advisor K.C. Barrons, Chem. Biol. Res. C.W. Hinman, Ag-Org. Environ. Studies D.A. Laskowski, Prod. Plan. Team R&D Spec. H.E. Gray, Res. Mgr. Field R&D R.C. Hunter: persons in the Ag-Org. department at the Walnut Creek lab; and to people in international locations.

The 2% fospirate + Dri-Die Formulation appears to combine flushing action, residual rapid knock-down and indefinite slow residual action, all highly desirable properties in a roach control formulation. Dri-Die (micronized silica gel) is widely used for cockroach control.
CITE: TDCH 345 - 356, Exhibit to Bennett Deposition, Exhibit to Ryan Deposition, and Exhibit to Hinman Deposition

Document #199
07/15/75
MISCELLANEOUS - COMPLICATIONS
TISSUE REACTION

Letter to Dr. Fleming from M. Popple, bcc to Rathjen, regarding patient with excessive capsule contraction after mammaplasty.
CITE: m 470064 - 470065, Exhibit to MDL Rathjen Deposition

Document #200
08/12/75
ACKNOWLEDGEMENT OF NEED FOR TSTING
KNOWLEDGE OF LIQUID SILICONE DANGERS
MISCELLANEOUS
TESTING

Dow Corning submits New Drug Application (NDA) for DYMASYL(R) Brand Injectable Silicone for Soft Tissue Augmentation. The NDA 2702. Ancillary to the filing of the New Drug Application, Dow Corning will pursue activities to elicit data relative to safety and efficacy on a long-term basis.
CITE: M 410001 - 410003, Exhibit 25 to Harris County Rathjen Deposition.

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 plaintiffs and Dow Corning), Exhibit 120 to Harris County Rathjen Deposition. DUPLICATE: M 190146.

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.

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.

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.

CITE: DCC 240000054. DUPLICATE: KKM 3364.

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

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.

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.

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.

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.

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.

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

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.

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.

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.

Document #213
00/00/76
FRAUD/MISREPRESENTATION

Dow Corning brochure, "Facts You Should Know About Your New Look," Which contains the following question and answer: "How long will the implants last? Based on laboratory findings and human experiences to date, a gel-filled breast implant should last for a lifetime."
CITE: M 650012 - 650019, Exhibit to Harris Country Jakubczak Deposition, 27 to Harris County Peters Deposition (used by Dow Corning), Exhibit to MDL Rathjen Deposition, and Exhibit 77 to Harris County Rathjen Deposition. NOTE: From 1963-73, Dow Corning only "warned" of fluid accumulation and foreign body reactions in its product inserts. From 10/74 - 09/76, Dow Corning added to its product inserts the following for the Silastic implant: capsular contracture/firmness, pain or discomfort from surgery, ptotic breasts, additional surgeries/implantations, and the risks associated with surgery. See PSC World of Warnings for Dow Corning and Dow Corning Wright.

Document #214
01/07/76
FRAUD/MISREPRESENTATION
KNOWLEDGE OF LIQUID SILICONE DANGERS
MISCELLANEOUS - COMPLICATIONS
STERILIZATION/CONTAMINATION
TISSUE REACTION

Testimony of Joseph Radzius to the California legislature regarding silicone injections. He states that DC's study "absolutely contraindicates injection of the fluid in the mammary area."

CITE: M 350149 -350155, Exhibit 33 to Harris County Rathjen Deposition, and Exhibit to MDL Rathjen Deposition, NOTE: The document also has the Bates Numbers DCD 173002728 -173002734 on it.

Document #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.
CITE: F 534, Exhibit 65 to Harris County Rathjen Deposition. Exhibit to MDL Rathjen Deposition. DUPLICATE: DCC 8003157; M 600007; KMM 140185; KMM 380078.

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.

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."
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.

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 xontraindication to the use of liquid silicone.
CITE: M 350147 - 350148, Exhibit 33 to Harris County Rathjen Deposition.

Document #219
03/03/76
TISSUE REACTION
RUPTURE

Dr. Terino presents a paper on "Technique and Results of 50 Breast Capsule releases" at the California Society of Plastic Surgeons. He reports a 36.5% rate of contracture. Also, a Dow Corning implant was removed 10 years post-op. "Upon opening the capsule bilaterally there was a thick sticky layer of silicone outside the envelope. On taking the implants out bilaterally there was no perforation from the envelope whatsoever, but there was clearly silicone on the outside. And pathology showed extensive foreign body giant cell granulomas."
CITE: M 290302 - 290306.

Document 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.

Document #221
03/19/76
KNOWLEDGE OF LIQUID SILICONE DANGERS
CONCEALING FROM FDA

Dow Corning's New Drug Application submitted pursuant to Section 505(b) of the FDA Act, for the preparation Dymasyl (dimethylpolysiloxane) Fluid is not approved. The FDA reviewed the application and found that the information presented is inadequate. The application fails to report adequate animal studies in support of the safety of the drug.

Presently reported carcinogenic studies in animals are inadequate to determine the carcinogenic potential of dimethicone. It is recommended that new studies be initiated in accordance with our current guidelines for testing of products for carcinogenic potential.

The FDA also found that Dow Corning's application failed to report the clinical studies in full detail, that there was no long-term data or patient follow-up, that manufacturing instructions are ambiguous, that sterility tests were not submitted, and that information on laboratory tests was not submitted. As a result of this, the FDA has closed Dow Corning's NDA file. The Director, J. Richard Crout, states, "(T)he only potentially acceptable indications for use of dimethicone, on a benefit/risk basis, are for the major facial defects and severe acne scars. We regard the benefit/risk ratio of dimethicone for minor cosmetic uses as unacceptable." (emphasis added).
CITE: DCC 106006714 - 106006719, Exhibit 29 to California Braley Deposition, and Exhibit to MDL Rathjen Deposition.

Document #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.

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."
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.

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.

Document #225
03/26/76
KNOWLEDGE OF GEL BLEED
FRAUD/MISREPRESENTATION

Art Rathjen, Dow Corning, letter to Dr. Terino with blind carbon copies to numerous Dow Corning employees. Despite Rathjen's knowledge that gel bleeds through the envelope, Rathjen tells Dr. Terino that this is "physically impossible" from a polymer chemistry standpoint. He attempts to cast doubt on Dr. Terino's claims that the substance on the outside of the Dow Corning implant Dr. Terino examined was silicone gel, particularly since the implant was not torn or ruptured. Rathjen suggests that Terino shouldn't publish his paper stating, "I truly think it would be to the best interest of all concerned if we try to get some answers before there is any further dissemination of information which might be erroneous....(Rathjen) would like to ... help solve the mystery, if that is possible, before your presentation is submitted for publication."

He requests that Dr. Terino send him any explanted Dow Corning prostheses with "a strange color or a questionable envelope surface or seem to have a change in the normal physical qualities."
CITE; M 250018 - 250019, Exhibit to MDL Rathjen Deposition, and Exhibit 68 to Harris Country Rathjen Deposition. DUPLICATE; DCC 240000435 -240000436; M 570126 - 570127.

Document #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.

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.

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.

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.

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.

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.

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.

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

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.

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.

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.

Document #237
06/00/76
GEL MIGRATION
TESTING
TISSUE REACTION

G. 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.

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.

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

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.
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; M 600008.

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.

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.

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

Document #244
07/07/76
FRAUD/MISREPRESENTATION
GEL MIGRATION

Rathjen, Dow Corning, letter to Nicholas Georgiade responding to expressed concerns regarding gel migration. Rathjen states:

"The first silicone gel-filled mammary prosthesis was implanted in a patient of Dr. Tom Cronin's in 1962, and as of July 1976, she still has them, and her course during the past 14 years has been uneventful. Since that time, mammary implants numbering in the hundreds of thousands have been used for augmentation and reconstruction of the breast.


The percentage of complications has been minimal, and very frankly, gel migration due to breakage of the silicone envelope has not been a problem nor can I recall when a surgeon has questioned us about this, relative to a Dow Corning Product.

We also have test data on the implantation of our materials; and there is, to my knowledge, no indication or proof that phagocytes pick up the material and carry it off. I agree with Si on that Point - the size and consistency of the gel, and even more specifically, our gel used in 1970 does not make it feasible."

CITE: KMM 354956 - 354957.l

Document #245
07/12/76
FRAUD/MISREPRESENTATION
GEL MIGRATION

Rathjen, Dow Corning, letter to Dr. Nicholas Georgiade stating that he has never heard of a problem of gel migration "relative to a Dow Corning product." (emphasis added). He notes that the gel is "very cohesive." Rathjen also claims that Dow Corning does not have any test data or knowledge showing that phagocytes pick up the silicone and carry it through the body, claiming that this is not "feasible."
CITE" M 250050 - 250052, Exhibits 36 and 37 to Hinsch Deposition (used by Dow Corning), Exhibit 40 to California Braley Deposition, Exhibit 63 to MDL Rathjen Deposition (used by plaintiffs and Dow Corning), Exhibit 88 to Harris County Rathjen Deposition, and Exhibit 40 to California Braley Deposition. NOTE: There are numerous instances of gel migration noted in Dow Corning's internal and external tests as well as in letters from physicians. See, e.g., 04/00/67 - GEG 4301 - 4304; 04/01/67 - PSC Medical Articles CDE, J 157 - 166; 04/11/67 - T 38842 - 38866; and 08/02/71 - KMM419744). NOTE: Also see 06/07/76 telephone report, M 250053.

Document #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.

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.

Document #248
07/23/76
CONCEALING FROM FDA
FRAUD/MISREPRESENTATION

FDA: A hearing is held by the FDA Panel on Review of General and Plastic Surgery Devices. On the issue of breast implants, J. Radqius, Dow Corning, states that he has evidence that doctors may be altering the breast implants by injecting an antibiotic into the prosthesis which is gradually released through the membrane of the implant.
CITE: This document also has the Bates numbers KMM 489852A - 4900119A (This document also has Bates numbers KMM 545507 - 545555, 547162, 545556 - 545557, 547163 - 547164, and 545558 - 545671 on it.) DULICATE: FDA 160 -161 (Pages 150 and 151 only).

Document #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.

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."

Document #251
08/12/76
MISCELLANEOUS - COMPLICATIONS

Dr. John Wolfe, Detroit Medical Center, writes to Milt Hinsch of Dow Corning expressing concerns regarding silicone mammary prostheses. Wolfe writes, "I would like to stress to you that the present prostheses composed of silicone are more than an inconvenience but a very serious problem. Very often women who have an augmentation have severe mammary dysplasia. Severe mammary dysplasia is related to a high incidence of developing breast cancer. Prostheses effectively block from view a great amount of the breast tissue on radiographic examination.... We have the situation where implants are being put into breast which are at high risk for developing breast carcinoma and we are seriously impairing our ability to recognize the carcinoma in its early and curable stage."
CITE: COM 361 - 362. DUPLICATE; GEG 4090.

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

Jim Rudy, President of Heyer-Schulte sends a "Dear Doctor" letter regarding "the possible and known problems and complications" of breast implants. It is noted that subtle processes of degradation should be expected to occur, and that the knowledge associated with long-term implantation is imperfect. If the implant is torn the gel will migrate and that is why Heyer-Schulte placed warnings in data sheets in May 1975. Doctors and patients should expect some patients to exhibit adverse response to silicone implants.
CITE: M 190413 - 190417, Exhibit 159 to Harris County Powell Deposition, Exhibit to Harris County LeVier Deposition, Exhibit to Nawash Deposition, and Exhibit 140 to Harris County Rathjen Deposition.

DUPLICATE: GEG 004050 - 004054; KMM 262028 - 262032; BAX 36899 - 36903. WITNESS: Rudy Exhibit 34; Hyans Exhibit 24. DISPOSITION: Admitted in Toole (II) v. Baxter Healthcare.

Document #253
08/24/76
KNOWLEDGE OF SYSTEMIC DISEASE
MISCELLANEOUS
TESTING
TISSUE REACTION

Hobbs memo to Atwell, Bey, LeVier, Radzius, Ryan, A. Smith, F. Stark, A. Gamon, "C. Lentz, R. Maneri, L. Tyler, J. Wehrly and D. Weyenberg regarding "2,6-cis Toxicity Action Meeting - 8/23/76." The parties met on 8/2/76 and discussed and agreed to the following activities: all products having potential for 2,6-cis formation will be identified along with their known uses: existing data will be reviewed to determine estrogenic potency of various low molecular weight organosilicon compounds when compared to 2,6-cis and/or DES: all areas will be identified where 2,6-cis is a known process by-product.
CITE: DCC 281031680 - 281031681, Exhibit to Harris County Tyler Deposition, and Exhibit to LeVier Deposition.

Document #254
09/20/76
GEL MIGRATION

E. Hobbs, Dow Corning, Memo to Milt Hinsch and Charles Lentz providing information on the migration of silicone gels. Experimentation utilizing various animals has not demonstrated migration of Dow Corning mammary gel. However, "Gels having a low consistency due to low levels of cross-linker appear to migrate along tissue planes in much the same manner as large injected doses of silicone fluid." One gel, in a test situation having a low cross-linker material, moved from its original implant site apparently along tissue planes aided by gravity.
CITE: D 972, Exhibit 141 to Harris Country Rathjen Deposition, and Exhibit 2D to Harris County Talcott Deposition. DUPLICATE: M 170104; M 570060; DCC 8200611.

Document #255
09/20/76
KNOWLEDGE OF LIQUID SILICONE DANGERS
TISSUE REACTION

Dr. C. Vinnik writes a letter to Art Rathjen of Dow Corning, copying Dr. Brody of ASPRS. Dr. Vinnik reports on a patient with a breast implant who developed a lump in her left breast. During surgery Vinnik noted that the Heyer-Schulte implant was intact and the lump or mass was eternal to the capsule. Vinnik notes that the pathologist's report showed:

"extensive fibrosis and granuloma formation that I have seen previously with silicone injections.... I do not know what the implications of this problem are, however, one consideration must be that there was extensive reaction within the tissue to the silicone gel with which it was in contact. I believe this is a serious matter and is something that the Standards Committee of the American Society of Plastic and Reconstructive Surgeons should ultimately consider. I might add that the type of reaction described in this case is similar to that of injected silicone gel as reported several years ago by Dr. Boo-Chai of Singapore. You will recall that Dr. Boo-Chai ran a series of breast injections with silicone gel through a dissection subcutaneous pocket with disastrous results.... It certainly goes along with reactions I have seen with silicone gel extrusion by another manufacturer utilizing the General Electric gel." (emphasis added).

CITE: DCC 24000504 - 24000506, Exhibit to MDL Rathjen Deposition. DUPLICATE: M 190364 - 190366; CO 21 - 23; KHH 54148 - 54150.

Document #256
09/22/76
GEL MIGRATION
TISSUE REACTION

Milt Hinsch memo to the Dow Corning sales force concerning Dow Corning's response to Heyer-Schulte's "Dear Doctor" letter discussing problems and complications of gel-filled mammary prosthesis. Hinsch claims that Dow Corning's implants are considered "non-active in the body" and he "would not expect shape or softness to change appreciably." Also, Dow Continues "to test 100% for cohesive gel during production" and "their gel offers the softest possible feel while retaining cohesiveness." Hinsch states that, "there are no cases of Dow Corning gel migration. Conversely, in documented cases where the envelope was ruptured, the gel did not migrate." He claims that all materials are subjected to "extremely sensitive" tests for tissue reaction and must show no tissue reaction to be accepted. Hinsch states that Dow Corning does not plan a written response to the " "Dear Doctor" letter.
CITE: M 240432 - 240433, Exhibit 8 to Hinsch Deposition (plaintiffs), Exhibit 44 to Hinsch Deposition (Dow Corning), Exhibit to Peters Deposition, Exhibit to Harris County Rudy Deposition, Exhibit 97 to Harris County Rathjen Deposition, Exhibit 2D to Harris County Talcott Deposition, Exhibit 113 to Burda Deposition, and Exhibit to MDL Rathjen Deposition. DUPLICATE: GEG 4048 - 4049; M 880029 - 880030; OOM 880029 -880030.

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

Donald Barker, M.D., presents a paper, "Reactions to Silicone Implants in the Guinea Pig," to the Scientific Session of the American Society of Plastic and Reconstructive Nurses.
CITE: GEG 4000 - 40006. NOTE: Paper was published in the Aesthetic Plastic Surgery in 1978, authored by Barker and Sherrill Lee Schultz, R.N.

Document #258
10/09/76
SHELL STRENGTH - THICKNESS

Bill Overton, a Dow Corning sales representative, files Complaint Report L76001 regarding service problems and thick envelopes on Silastic Round mammary implants. In an accompanying memo dated 10/19/76 from Overton to Hinsch, Leach, Darling, Brodhagen, Woodard, Hoyt, Schultz, and VerVoort, Overton states that, "Frankly, I was a little surprised to see such a difference in the comparison (between the new Silastics and the Silastics in Dr. Forrest's inventory).... Dr. Forrest stated he felt the new SILASTIC stock had an envelope about three times as thick, and also stated he would be able to feel the thick envelope in a patient.... I know he was upset more at this point when he sort of threw the implants from his locker onto the floor. If the implants I picked up from Dr. Forrest are typical of mammary product we are making today, I can't help but feel I will loose half of my business in the next six months. I prefer giving a few extra out for breakage than lose $100M in sales.... We cannot afford to make noticeable changes if we expect to retain present market." Dow Corning's Quality Assurance Reliability Engineer noted that the returned implants did exceed envelope thickness specifications and that there was inconsistency in envelope thickness specifications and that there was inconsistency in envelope thickness on the same implant as well as in comparing implants.
CITE: CRM 200 - 203.

Document #259
10/13/76
KNOWLEDGE OF LIQUID SILICONE DANGERS
MISCELLANEOUS - COMPLICATIONS
TISSUE REACTION

Report of 10/12/76 phone call from Dr. Colocho to Rathjen regarding 6 of Dr. Colocho's patients with palpable nodes in the axillary area, and Dr. Colocho's "very real concern" regarding possible gel bleed.
CITE: KKM 42792, Exhibit of Rathjen Deposition.

Document #260
10/15/76
KNOWLEDGE OF LIQUID SILICONE DANGERS
MISCELLANEOUS - COMPLICATIONS
TISSUE REACTION

Letter to Dr. Colocho from Rathjen submitting questions regarding Dr. Colocho's 6 implant patients with palpable nodes.
CITE: M 190376 - 190378, Exhibit 32 to MDL "Rathjen Deposition (used by Dow Corning), and Exhibit 69 to Harris County Rathjen Deposition. DUPLICATE: M 240009 - 240011.

Document #261
10/23/76
GEL MIGRATION

Art Rathjen, Senior Clinical Research Specialist for Dow Corning, writes to Kurt Wagner, M.D. about a problem with gel migration, "Obviously, whether it is a Dow Corning implant or a competitors' the fact that this phenomenon would exist is disturbing enough. We have always been conscious of this possibility: therefore, you certainly caught me off guard when you first reported that the gel from one of our implants had indeed migrated to the groin." Rathjen claims that Dow Corning did not supply any materials to competitors for the manufacture of mammary implants until the first quarter of 1976. General Electric supplied the materials.
CITE: KKH1719. DUPLICATE: GEG 4009

Document #262 (Possible)
10/31/76 (NOT LISTED ON PLAINTIFF'S EXHIBIT LIST)

Art Rathjen, Senior Clinical Research Specialist for Dow Corning, writes to Kurt Wagner, M.D. about a problem with gel migration. "Obviously, whether it is a "Dow Corning implant or a competitors', the fact that this phenomenon would exist is disturbing enough. We have always been conscious of this possibility; therefore, you certainly caught me off guard when you first reported that the gel from one of our implants had indeed migrated to the groin. " Rathjen claims that Dow Corning did not supply any materials to competitors for the manufacture of mammary implant until the first quarter of 1976. General Electric supplied the materials.
CITE: GEG 4009.

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

Dr. Charles Vinnik writes to Art Rathjen, Dow Corning, about a histologic response to a patient whose breast implant ruptured. Dr. Vinnik states that "microscopically it appeared to resemble the reaction (sic) seen around silicone injected breasts." He also notes that the response to silicone materials in humans is "a very variable thing...." (emphasis added) CITE: KKH 6944 - 6945, Exhibit 47 to MDL Rathjen Deposition (used by Dow Corning).

Document #264
12/07/76
TISSUE REACTION

Guillermo Colocho. M.D., of New Mexico, letter to Art Rathjen, Dow Corning, enclosing tissue specimens of patients who experienced problems with implants. Patient number 1 had a small nodule in the right breast three years post-op. Following biopsy, pathological diagnosis revealed lymphoid hyperplasia. Patient number 2 developed multiple tender nodules and lumps in her breast five months post-op. Following bilateral biopsies, pathological diagnosis revealed bilateral lymphoid hyperplasia.
CITE: M 240013 - 240014, Exhibit 32 to MDL Rathjen Deposition (used by Dow Corning), and Exhibit 69 to Harris County Rathjen Deposition.

Document #265
01/04/77
KNOWLEDGE OF SYSTEMIC DISEASE
MISCELLANEOUS - COMPLICATIONS
TISSUE REACTION

Patent No. 4,001,403 for a method for reducing the reproductive function of mammals by Bennett and McHard. A method for altering the reproductive function of mammals by administering a pharmacologically effective amount of certain fluoroalkyl-substituted organosilicon compounds. As a means of illustration, one can orally or parenterally administer from 1.00 mg. to 100 mg. per kilogram of body weight of an organosilicon compound thereby rendering the subject (either a male or female mammal) infertile.
CITE; DCC 281061 - 281061408, Exhibit 73 to Bennett Deposition (used by Dow Corning).

Document #266
01/10/77
ACKNOWLEDGEMENT OF NEED FOR TESTING
KNOWLEDGE OF GEL BLEED

Becker, Dow Corning, memo to C. Lentz regarding silicone found in tissue. He writes, "The question of bleed and contracture is indeed of concern by our competitors and the physician. There is no question in my mind that Dow Corning's leadership position is expected to provide answers to the questions. I am very surprised to find that we do not have any data on Si levels in tissue or the distribution and fate of trace levels of polymer in the body."
CITE: F 810, Exhibit to California C. Lentz Deposition, Exhibit to Harris County LeVier Deposition, Exhibit 70 to Harris County Rathjen Deposition, and Exhibit to MDL Rathjen Deposition. DUPLICATE: KMM 260614; M 170124; KMM 380071

Document #267
10/18/77
KNOWLEDGE OF GEL BLEED
MISCELLANEOUS - COMPLICATIONS
MISCELLANEOUS - SALES

Rathjen, Dow Corning, memo to Bey, Hoyt, Hutchison, Lentz, and Nelson regarding "observations Relative To Dow Corning's Future In The Mammary Implant And External Breast Markets." Rathjen states; "In my opinion, we, Dow Corning, are no longer the recognized leaders or innovators in either segment; and our present position will continue to decline unless specific measure are taken now to turn things around.... I am powerless to change anything, and my sphere of influence in this business continues to diminish: hopefully, I still have the privilege to express opinions even if they are not shared by all."
CITE: KMM 12998 - 13000 and 13004, Exhibit to MDL Rathjen Deposition, and Exhibit 83 to Harris County Rathjen Deposition. DUPLICATE: m 190101.

Document #268
02/10/77
TISSUE REACTION
KNOWLEDGE OF SYSTEMIC DISEASE

Will Larson, Dow Corning, memo to Art Rathjen, Becker, Bennett, Bey, Kelley and Lewis concerning an allergic reaction in a patient of Dr. Vanduyn. The patient was implanted with a Silastic Mammary Prosthesis, No Fixation Patch. One month following implantation, the patient contracted the flu. Shortly thereafter, the implant "broke through" the healed incision and the implants were removed. The augmentation was redone and, within days after the surgery, the implants again "broke through." Dr. Vanduyn suggested a possible allergic reaction and asked if there were any similar reports. Larson told him, "I was unaware of any allergic reaction to silicones".
CITE: M 240368

Document #269
02/17/77
KNOWLEDGE OF GEL BLEED
ACKNOWLEDGEMENT OF NEED FOR TESTING

Larson, Dow Corning, memo to Bennett, Hoyt and Rathjen regarding mammary bleed. "The permeability of silicone elastomers is a well known phenomena.... Permeation in this case is ... toxicologically unknown.... It is of great concern because of what can be made of the unknown...." Also, "We would also anticipate bleed may be a function of heretofore unmeasured factors, e.g. manipulation and stress.... Dow Corning's product development direction has been an attempt to strike a balance between: 1)What we factually know about bleed. 2)What gel and envelope polymer intermediates can be produced. 3)What toxicological data we have on materials. (and) 4What is a marketable product.... In conclusion, any physiological effect or consequence of this permeation remains speculative. What can be done and what should be done is an open topic of discussion."
CITE: OOM 320448 - 320449, Exhibit to MDL Rathjen Deposition, and Exhibit 71 to Harris County Rathjen Deposition. DUPLICATE: KMM 176928; KKH 2263: M 150002 - 150003: M 190423 - 190424.

Document #270
02/25/77
ACKNOWLEDGEMENT OF NEED FOR TESTING
SHELL STRENGTH - THICKNESS

Rathjen, Dow Corning, memo to Hoyt, C.Lentz, and Nelson stating, for the record, his objection to the Product Marketing Group's ("PMG") decision to market the Silastic Inflatable Mammary Prosthesis. Rathjen believes a six month review of clinical experience with the implant is necessary before a meaningful assessment could be made regarding the efficacy of the implant. At the time, Dow Corning was only six weeks into a clinical trial on the inflatable. He cites Bob Becker who reported to the PMG that, based on his investigation of the envelope production, he believed the quality of the inflatable envelope now was no better than when Dow Corning made it in 1971-72, when the inflatable line failed.
CITE: KMM 3333245 - 333426, Exhibit to Oppelt Deposition, and Exhibit to MDL Rathjen Deposition.

Document #271
03/11/77
FRAUD/MISREPRESENTATION
MISCELLANEOUS - RECKLESS/CONSCIOUS DISREGARD
RUPTURE

"Thoughts relative to Meeting - March 10 - Inflatable - Telephone Conversation with Mel Nelson - March 11." Dow Corning held a meeting on March 10 with Hoyt, Meads, Bennett, LeVier, Leach, Petraitis, Radzius, Hinsch, Criger, Steele, Rathjen, and Lewis. The author is unidentified but believe it is Rathjen. The author states:

"I sat there and listened to the various opinions that were offered and it became evident to me that actually it was a matter of having everybody stroke one another hoping that a consensus of opinion would be developed that would allow a positive decision on the distribution and sales question with nobody taking firm responsibility for a final decision. In the meeting, when it got around to the legal aspects of product liability, Joe Radzius read the memo that had been delivered by Norm Lewis which stated that our liability was wide open and if we did have any problem that Dow Corning would have a very difficult time defending its position and the recommended course of action by Steve Giadard, Harry Dingman, and Norm Lewis was that we not accelerate the calendar (sic) or time relative to our distribution and sales of the product. The ultimate decision of this meeting was of course that they would continue on there (sic) course for a projected May 1 distribution and sales limited area and therefore, they were willing to take a chance over and above the recommendations of the legal department.

I continued to hold my position that I did not feel that it was prudent for Dow Corning to consider an early distribution and that we should wait until at least a six month period when the (sic) clinical evaluation data would be in and evaluated and therefore, I was certainly in the minority when Hoyt put it all to a vote at the end of the meeting.

Between Thursday, the 10th of the March and Friday, the 11th of March, I had occasion to think about this and I felt that I still couldn't live with this decision and therefore, at approximately 8:15 on Friday, March 11th, I called Hemlock and spoke with Mel Nelson. In doing so I told him I was concerned because the meeting yesterday was the fourth meeting on this same subject and it (sic) indicated to me that people were still uneasy and not entirely committed and to have such indecision requiring these repeated meetings to go over the same subject indicated a shakiness (sic) on the part of the parties concerned. I told Mel that I actually really felt that the people in that conference room on Thursday afternoon really wanted to be stroked. There was safety in numbers. I asked him who the person would be that one individually would be held accountable if this project were to get underway and things were to go to hell in a bushel basket, I did not get an answer to that and of course I think that Mel felt that ultimately he would be the one that had to make an accounting for this. But I find it hard to believe that he would allow himself to succumb to the pressures of several of the members of the Marketing Department and possibly Ron Kelley of TS&D, simply for the sake for getting 500 inflatable mammary prostheses out in 1977, which would only amount (to) $70,000. I think that the disregard for a plan and our disregard for the ethics of clinical testing and product reliability for (sic) to sale isn't worth jeopardizing for the sake of this small amount of money.

My second point to Mel on the phone was that I truly believe that this decision , as fostered by John Hoyt and Chuck Leach, is a violation of Ray Maneri's Codes of Business Conduct. I think the Marketing Department Planned very poorly and I think the PMG has not been very realistic in pushing forward in this and therefore, a decision to go ahead with an early marketing date violates Maneris Codes of Business conduct in the U.S. area that was circulated by all Dow Corning employees. Ray has very emphatically stated in his little pamphlet (sic) that Dow Corning "Dow Corning will strive to assure product efficacy, assure that its products are of the highest practical quality and that product characteristics and potential hazards are made clearly known to the user." If they go with an early market introduction date, they have violated that statement in the code. Further on in the same pamphlet, it states "the product sold by Dow Corning will be thoroughly tested to determine their effect on the environment." Here again I feel that an early distribution would violate that part of the code. I made both of these points to Mel Nelson and pointing out that we were succumbing to Marketing pressure. I also brought up the subject of a problem we had years ago when the Marketing Department and Gordon McIntyre elected to distribute all the (sic) silicone foley catheter in the southern California area prior to any conclusive testing relative to safety and efficacy. That decision turned out to be a real fiasco (sic) in several months we had telephone calls and letters and telegrams from hospitals and Urologist and nurses from southern California relating incidents of balloon failure, balloons coming off the end of the catheter, etc. and immediately we had to cease and while we retrieve (sic) all of these catheters, our legal council (sic), Joe Radzius was down in Washington trying to keep the lid (sic on this thing so it would not become an official recall. This meeting on Thursday, bothered me because Joe was back in that meeting offering Legal Council (sic) which was opposite what had been voiced by Steve Gaidard and Harry Dingman and Norm Lewis in the memo that was left for Joe to discuss. All three of these people including the chief legal council (sic) for the corporation, Steve Giadard stated that there (sic) recommendation that we not go with an early market distribution, Joe on the other hand (stated) that he felt that the risk was worth it. I felt his contribution at the best (sic) biased because he had already made it known to the Corporation that he is resigning and so whatever he said would have little effect anything that would transpire past March 31, when he officially leaves the employment of Dow Corning.

I mentioned to Mel that I felt that the strength of the position by the Marketing Department, namely Hoyt, Leqach, Hinsch also pivoted on their having to save face within the last week they had a general sales meeting down in Houston and I come to find that they did announce to the sales force that the inflatable was coming and it would be offered for limited distribution. Now here some of these problems are being posed to them and would require their having to go back to the sales force and tell them that there (sic) initial decision was incorrect and retract all that they have said and therefore their credibility as being challenged I think that it wasn't in the best interest of this corporation to go down and tell the salesmen in the first place we are going to have a product, while it was still under test.

I think that we are indeed putting Dow Corning's name and reputation on the line for a measly (sic) $70,000 and there is not (sic) guarantee that there would be sale of pairs between May 1 and the end of the year. Finally I said to Mel Nelson that for the last several years we have (been) under strict criticism (sic) by the American society of Plastic and Reconstructive Surgeons because of our position with the silicone injection program. When we first got involved with the A.S.P.R.S. with the silicone symposium, we were accused as a Corporation of disregarding safety and efficacy data to jam our product through so that we could recoup (sic) some of our investment dollars and we were looked at as a large corporation who disregarded safety and efficacy standards to make money. I had to defend Dow Corning's position in this regard at the California Plastic and Reconstructive Society meeting last year because the same accusation was made that we were more interested in profit and dollars then (sic) we were in ethics and good testing. I told Mel that one of our current clinical evaluators for the inflatable was Dr. Verner Lindgren who is Vice-President elect of the A.S.P.R.S. and also Fred Grazer who, both of these men being very active in Society matters. I would find it hard (to) believe and in fact I would find it a very difficult thing to do, to go and have to tell these men that now that they are testing the product, that Dow Corning has taken upon themselves to market this product. Therefore I wanted a written statement from the Business stating the rational and the decision behind this move and that I would use that statement when these investigators were to be informed of Dow Corning's decision. Mel Nelson pointed out that the Business as a whole and the Business Board hadn't even gotten that far to consider what the ramifications would be and what the impact would be on these investigators were to be informed of Dow Corning's decision. Mel Nelson pointed out that the Business as a whole and the Business Board hadn't even gotten that far to consider what the ramifications would be and what the impact would be on these investigators and that this would be something that would have to be looked at in great detail. While I find this whole matter very disconcerting (sic), I personally am very uneasy about the whole thing. I find it hard to believe that after so many difficult experiences in the past that management for the Medical Products Business would be so narrow -- in their vision that they are going to go out and promote a product that has not been tested. It is my sincere hope that there will be a reversal to this decision."
CITE: KMM 333230 - 333234, Exhibit to Petraitis Deposition, and Exhibit to MDL Rathjen Deposition.

Document #272
03/16/77
GEL MIGRATION

Dr. Swanson calls Eldon Frisch, Dow Corning, noting that he had written to Zeke Bennett urging that Dow Corning undertake appropriate studies to determine the potential migration of silicone elastomer particles throughout the body. Dr. Niebauer, San Francisco, is presenting a paper and speech about silicone particle migration in monkeys, particularly in the liver. also, Dr. Rose from the Massachusetts Institute of Technology will propose his theory on silicone elastomer degradation by interaction with lipids at the upcoming Biomaterials Meeting. Frisch suggests that Dow Corning attend these meetings and publish their own position that "biodegradation does not occur." He also suggests an animal study at the University of Michigan because they are "open to suggestions."
CITE: M 190441 - 190443, Exhibit to Harris County Tyler Deposition.

Document #273
03/22/77
MISCELLANEIOUS - COMPLICATIONS
TISSUE REACTIONS

Complaint report from Dr. Tony Emmett filed by Green. Report states that Dr. Emmett has removed implants after a cancer was found in the breasts. This is one of several such cases sighted by Emmett. The cancer cells have seemed to follow the capsule.
CITE: COM 4331 - 433

Document #274
03/28/77
FRAUD/MISREPRESENTATION
KNOWLEDGE OF GEL BLEED

Dow Corning employee, D. Petraitis, memo regarding bleed studies for Dr. Barker. There is serious concern whether any gel bleed data should be released to the public because "any general release of this data could be misinterpreted or misconstrued, and could result in severe repercussions in the public sector." (emphasis added). Also, "The bleed measurement may not be representative of actual in vivo results.... I still believe that Dow Corning should convey the impression that we are indeed working in this area."
CITE: F 633. DUPLICATE: KMM 264592. NOTE: Del Petraitis later worked for McGhan Nusel.

Document 275
03/31/77
TISSUE REACTION
FRAUD/MISREPRESENTATION
KNOWLEDGE OF GEL BLEED

Leach, Dow Corning, memo to Bob Levier regarding "Contracture Phenomenon." Leach refers to recommendations made by Pat Walters on contracture and states that Dow Corning has taken no significant action on any of Walter's recommendations, except for a "half-hearted" low priority program at Northwestern University. He reports that he is losing customers because doctors believe Dow Corning implants bleed more than others. Leach writes:

Several of our customers looking to us as leaders in the industry, asked me what we were doing. I assured them, with crossed fingers, that Dow Corning too had an active 'contracture/gel migration' study underway. This apparently satisfied them for the moment, but one of these days they will be asking us for the results of our studies....l I am not sure where this unrest is leading but suspect that our PMG, as the steward of Dow Corning's implantable products, should not be to (sic) comfortable with our current lack of focus and coordinated leadership relating to this entire issue. I suggest that this question be addressed at our next PMG Meeting and clear definition given as to what answers we can reasonably be expected to have, and what steps need to be taken to fill whatever gaps that may exist in our needed storeroom of knowledge. In my opinion, the black clouds are ominous and should be given more attention.

CITE: F 717 - 718 (Handwritten note, "R-grand push. Where does Ron Kelley stand w/summarizing available data? John.")' M 190439 - 190440 (Handwritten note, "Chuck, excellent memo. We must not be complacent as in past. Unlikely other co.s research will favor us. Are we going to do something? Dick.") Exhibit to MDL Rathjen Deposition. DUPLICATE: F 683 - 684; GEG 4028 - 4029; KMM 140266 - 140267.

Document #276
04/13/77
SHELL STRENGTH - THICKNESS

Petraitis, Dow Corning, memo to LeVeir, Rathjen, et al. about returned inflatable implants. One of the implants had a pinhole leak which Petraitis believed was not caused by procedures. Concerned about the problem Petraitis recommends a halt to the current program plan as he is convinced the current envelope is "questionable." Cycle testing had raised doubts regarding the envelope, confirmed subsequently by the pinhole leak problem. He recommends Dow Corning officially halt all additional clinical implantation, continue close monitoring of those patients with inflatable implants to develop a data base, emphasize improved envelope production and take a conservative, responsible attitude before gearing up again. Finally, he strongly recommends Dow Corning not take any assumptions regarding their envelope quality improvements until they have some definite history.
CITE: KMM 333250, Exhibit 9 to Hinsch Deposition, and Exhibit to Petraitis Deposition.

Document #277
05/03/77
FRAUD/MISREPRESENTATION
SHELL STRENGTH - THICKNESS
STERILIZATION/CONTAMINATION

Hinsch, Dow Corning, memo to Kelley, Metevia and Petraitis regarding a conversation he had with Jim Cox. The topic of conversation was Cox-Uphoff's method of manufacturing mammary prostheses. Hinsch first states that at Cox-Uphoff, when raw materials are received, they undergo additional filtering because they are not as clean as they would like to have them. Secondly, Hinsch comments on Cox's vulcanization times. Jim Cox suspects that he and the people on the West Coast vulcanize their gel implants longer than Dow Corning. Cox's comments lead Hinsch to believe that there is some correlation between his longer vulcanization time and the lack of oily feel on the prosthesis. The third and final comment concerned manufacturing double lumen implants. "Jim conceives that he can 'dump' gel implants which are not ideally manufactured by using them in these Double Lumen Prostheses.... This is something we should keep in mind should we eventually move into the area of double lumen type of implants."
CITE: OOM 320455.

Document #278
05/16/77
MISCELLANEOUS - LOBBYING
MISCELLANEOUS - ORGANIZATIONAL SURVEY

Helmer memo to Sanders regarding Breast Implant Manufacturers Association, California meeting.

515(B): First meeting of manufacturers called by Dick Compton of McGhan because he "desired that an association be formed of the manufacturers of breast implants." Al Cohen requested a study be jointly funded by manufacturers on the issue of constrictive capsules. Tom Talcott of Heyer-Schulte tells Jerry Helmer of Surgitek that Heyer-Schulte is not in favor of a trade association research program. Other manufacturers are not in favor of trade association for joint research either and inform Dr. Jack Fisher, ASPRS, they would instead support a workshop to discuss issues with plastic surgeons.

CITE: MEM 415 - 417, Exhibit to Lynch Deposition, Exhibit to D. McGhan Deposition, Exhibit to Sanders Deposition, and Exhibit to Compton Deposition.

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

Complaint analysis prepared by Woodard and forwarded to Rathjen.
CITE: M 460026 - 460028 and M 570200 - 570203, Exhibit to MKL Rathjen Deposition.

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

A.H. Rathjen, Dow Corning, reports a telephone call from Dr. Ben T. Gregory regarding two incidents of ruptured mammaries immediately upon attempting to "pop a capsule," i.e., performing a closed capsulotomy. Upon explantation, Dr. Gregory found a quantity of loose gel. The doctor called to let the company know that, "He does not subscribe to those in his profession who claim that--under no circumstances when you 'pop a capsule' will you break and implant."
CITE: M 570125, Exhibit 13 to Harris County Rathjen Deposition. DUPLICATE: M 240322; KKH 001616.

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

Eldon Frisch, Dow Corning, memo to Virg Metevia regarding Dr. Julius Henry-Cohen's article on capsular contracture. Frisch states, "during discussions with John Madden, M.D., we had reached a conclusion that probably most cases which develop thick fibrous capsules do so because of trauma to the fibrous capsule which creates local tissue damage and minute ruptures in the capsule without producing a major rupture which leads to complete loss of capsule integrity.... Damage to fibrous tissue is generally painful, and associated with rupturing of small blood vessels leading to small hematomas and an increase in the inflammatory process." Frisch also states that ruptures most likely occur because "during certain activities such as love making, vigorous hugging, strenuous physical exercise," and that "physicians can completely rupture a fibrous tissue capsule by externally squeezing the implant."
CITE: OOM 320474 - 320476. NOTE: Dow Corning was not warning in its product inserts of rupture or recommending that doctors not perform closed capsulotomies.

Document #282
08/24/77
KNOWLEDGE OF GEL BLEED
COHESIVENESS - LIQUID COMPONENT OF GEL

John R. Hilliard, Dow Corning, writes to Bob Gruber of Surgical Appliances Industries Inc., regarding a new gel to consider as an alternative to the current gel. The new gel, X7-2339, bleeds only 60% more than the current gel, Z7-2339, while the pre-1976 gel bleeds almost 600% more than the current gel.
CITE: M 250044.

Document #283
08/31/77
TISSUE REACTION

Dow Corning Telephone call report noting a person who developed severe bilateral infections seven days post-op. She entered the hospital with a temperature of 105 degrees in a "life threatening situation. Upon opening up the chest cavity, the doctor found large quantities of puss. ... In an effort to forestall a potential lawsuit, I told the doctor that I would recommend free replacement of these prostheses -- even though no rupture upon removal.
CITE: KHH 35213.

Document #284
09/07/77
TISSUE REACTION
KNOWLEDGE OF SYSTEMIC DESEASE

Dr. Ashley sends Art Rathjen, Dow Corning, a letter and medical records of a silicone injection patient who developed a mass the size of an orange and experienced reddening, hardness and itching at the injection site on the thigh. The pathology report notes there was a "chronic inflammation reaction."
CITE: KMM 418633 - 418656, Exhibit to MDL Rathjen Deposition.
DUPLICATE: I 6182 - 6190.

Document #285
09/07/77
TISSUE REACTION
KNOWLEDGE OF SYSTEMIC DISEASE

Dr. Ashley sends Art Rathjen, Dow Corning, a letter and medical records of a silicone injection patient who developed a mass the size of an orange and experienced reddening, hardness and itching at the injection sit on the thigh. The pathology report notes there was a "chronic inflammation reaction."

CITE: KMM 418633 - 418656, Exhibit to MDL Rathjen Deposition. DUPLICATE: I 6182 - 6190.

Document
09/29/77
SHELL STRENGTH - THICKNESS
RUPTURE

Petraitis, Dow Corning, memo to Roush and Becker setting forth "The Reasons For Proceeding With An Inflatable Introduction." Petraitis notes that the clinical evaluations "indicated a high incidence of deflations: but claims that most were caused by small pinholes in the envelope. He assumes he can improve the envelope to prevent these pinholes by making it thicker. Petraitis concludes, "I feel that any risk associated with marketing the inflatable made from the improved envelope without additional clinicals is certainly worth taking.... The decision to delay introduction is equivalent to eliminating the product forever."
CITE: KMM 149569 - 146570, Exhibit to Petraitis Deposition, and Exhibit to MDL Rathjen Deposition.

Document #286
09/30/77
ACKNOWLEDGEMENT OF NEED FOR TESTING
MISCELLANEOUS - RECKLESS/CONSCIOUS DISREGARD

Roush, Dow Corning, memo to the Medical Business Board announcing that the Implants PMG has decided to introduce the inflatable mammary prosthesis at the Plastic Surgery Show on October 30, l977. There is a risk being assumed in doing this since the product has not been clinically tested. The PMG believes, however, that the risk of the Product not performing is much smaller than the risk of losing market share. Dow Corning was concerned with a permanent loss in market share unless it moved quickly.
CITE: KMM 333267. DUPLICATE: KMM 149564 - 149566.

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

Rathjen, Dow Corning, memo to PMG and MPPBB (Medical Products Business Board) reiterating his objection to marketing the inflatable prosthesis when there are doubts about its efficacy. He notes, "This suggestion was turned down because some members of this business thought the product would indeed stand up. Well, it hasn't!" Rathjen believes the product's efficacy should be determined after clinical trials and not merely "on the bench...." He believes it is a "moral issue... whether Dow Corning was really, truly being honest and straightforward with our customers?" He recommends the product be tested further on 50 patients over the next four to five months and hard facts be developed before introduction as surgeons believe a ten percent deflation rate is absolutely unthinkable. (emphasis added).
CITE: KMM 333259 - 333261, Exhibit to Oppelt Deposition, and Exhibit to MDL Rathjen Deposition. DUPLICATE: OOM 321512 - 321514. NOTE: The deflation rate with the inflatables over a nine month period was 12%.

Document #288
10/06/77
KNOWLEDGE OF SYSTEMIC DISEASE
STERILIZATION/CONTAMINATION
TISSUE REACTION

Hobbs memo to Atwell, Bey, Lentz, LeVier, Owen, Pearce, Ryan, A. Smith, F. Stark, J. Campbell, S. Guittard, L. Tyler and D. Weyenberg regarding "Minutes from 2,6-cis meeting of 9/20/77." Certain unvulcanized food grade elastomers contain 250-450 ppm 2,6-cis, 996 resin contains approximately 50 ppm, and DC 550 fluid using the new process contains 1-5 ppm. The verbal results of the genetic tests on 2,6-cis show positive results and "indicate aggressive action is necessary to evaluate the potential hazard of this impurity." Hobbs states that he has obtained technical and legal opinions from Joe Raddzius and Dr. Steve Carson.
CITE: DCC 281031108, Exhibit to Tyler Deposition, and Exhibit to LeVier Deposition.

Document #289
10/20/77
COHESIVENESS - LIQUID COMPONENT OF GEL
FRAUD/MISREPRESENTATION
STERILIZATION/CONTAMINATION

Peters, Dow Corning, memo to Chandler with copies to Lentz Wendel and Rathjen regarding mammary gel review, part II. The molecular weight given for the gels are much lower than actual since the gels have a significant amount of branching and are polydispersed. X7-2151 would be the better gel for implantation since for a given penetration it has a high molecular weight distribution. The report also lists trace metal amounts for various gels.
CITE KMM 453922 - 453928.

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

Log of a telephone conversation in which Rathjen, Dow Corning, tells Dr. G. Perrin he is unhappy with the marketing department's decision to introduce an inflatable mammary that had a 14 percent deflation rate when tested. He says he was concerned about the decision and feels "there is an ethical matter involved here." Dr. Perrin replies "if you are too hasty (sic), things backfire on you. Both of us know that...."
CITE: KMM 255487 - 255488

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

Log of a telephone conversation between Dr. Glazer and A. Rathjen, Dow Corning. Dr. Glazer says he is surprised they were putting the inflatable mammary implant on the market without all of the data being collected and feel such a move is premature. Rathjen agreed and stated, "There is no two ways about that, but it hasn't been tested...." Rathjen feels that he has "been muscled and I am mad because here we said we were going to stop and retrench and they insisted the thing keep going." Rathjen states that he is prepared to resign because his "reputation is on the line as it relates to the silicone injection fluid...."
CITE: KMM 194463 - 194466, Exhibit to Oppelt Deposition, and Exhibit to MDL Rathjen Deposition.

Document #292
11/10/77
GEL MIGRATION

Dr. Jerrold Abraham responds to Eldon Frisch's letter of 10/21/77. He states, "I am quite disappointed by your letter of October 21, 1977. It seems you remain unwilling to accept the fact that I am able to identify the silicone material in the tissues and to separate it from contamination from dust, glass, etc.... The FDA has expressed interest in supporting some limited studies, but they will not of course, support studies designed to improve your implantable devices. They must limit their support to studies testing available devices already on the market."

"I must have examined human tissue from patients with implants and find no difficulty in identifying the silicone material migrating from prostheses in joints." (emphasis added). Dr. Abraham goes on to request an opportunity to review animal specimens from earlier studies and informs Frisch of improved detection techniques. "This latter technique has provided additional confirmation that the material we are looking at is indeed the polydimethylsiloxane rubber. I urge you to reconsider and to aid in this study of your long term animal implantation experiments."
CITE: OOM 320482 - 320483.

Document #293
12/07/77
FRAUD/MISREPRESENTATION

Jim Bolland, Dow Corning, responds to Woodard analysis of Arm No. 0964 and "Complaint Forms And Their Resolution." He indicates that the complaint procedure does not seem like it designed to give doctors qualitative information regarding their complaint. "If the idea of returning defect material to you is to cover ourselves from the liability point of view then perhaps we should know this and we will be careful not to tell the doctor that he can expect a full report when his complaint is being investigated."
CITE: COM 494.

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

Frank Lewis, Dow Corning, Memo to Milt Hinsch regarding the "inordinate rate" of ruptures occurring with mammary implants. Lewis lists four doctors who are experiencing "abnormal percentage(s) of ruptures." Dr. Don Davis of Lansing, Michigan with 14%, Dr. Fusilero of Lorain, Ohio with 32%, Dr. James Scarcella of Lakewood, Ohio with 12% and Dr. Richard Straith of Detroit, Michigan with 11%. Lewis states, "I am sure some of these were the fault of the doctor, but that alone could not account for such a high percentage of ruptures. These doctors have on the average ten years of experience in this procedure."
CITE: M 240328 - 240329. NOTE: A handwritten comment is at the bottom of the memorandum and reads, "A detailed study of mammary rupture frequency is being made and should be completed by 1/31/78 for the year 1977. Data to be made available from Midland Marketing." DUPLICATE: F 731 - 732; M 570147 - 570148; M 460300 - 460301; KMM 351899; KKH 1631 - 1632; KHH 67459 - 67460; KKA 88982. NOTE: No such studies have been located.

Document #295
00/00/78
COHESIVENESS - LIQUID COMPONENT OF GEL
KNOWLEDGE OF SYSTEMIC DISEASE
MISCELLANEOUS - COMPLICATIONS
TESTING
TISSUE REACTION

Publication by LeVier, Chandler and Wendell titled "The Pharmacology of Silanes and Siloxanes, Biochemistry of Silicon and Related Problems." pages 473-514. The salient features of silicon chemistry that may be considered of interest to life scientists have been reviewed while the biochemistry of silicon compounds has received only brief comment because this subject remains largely unexplored. Indeed, so little is known that we continue to categorize structures only on the basis of intended use with some consideration for bioavailability and a few emerging trends relating activity to structure and reactivity. This approach at least allows a clear division of though between popular silicones known for their lack of bioactivity and the less well known reactive silicon compounds.
CITE: DCC 281061312 - 281061353; Exhibit 64 to Bennett Deposition (used by Dow Corning).

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

Rathjen, Dow Corning, memo to various members of the Marketing Department - Nelson, Hoyt, Bey and Hinsch - and to members from Dow Corning's in-house Legal Department - Steinberg and Lewis. Rathjen reports that the current deflation rate for the inflatable clinicals from January to August 1977 is 22%. Several patients had bilateral deflations.
CITE: KMM 333270. DUPLICATE: KMM 261276 - 261277.

Document #297
02/28/78
FRAUD/MISREPRESENTATION
MISCELLANEOUS - COMPLICATIONS
TISSUE REACTION

Tyler memo to Campbell, C. Lentz, John Ryan, Weyenberg, Gergle, Hartlein and Maneri regarding "Adventitious 2,6-cis." "I am concerned lest Dow Corning employees generate an unwarranted number of documents containing adventitious 2,6-cis.. I see no reason for any documents not authorized or reviewed by C. Lentz or L. Tyler. Even the verbal communications can be very simple. We know of no health problems associated with the extremely low levels of adventitious 2,6-cis in hundreds of Dow Corning products. However, there could be a 'business' risk associated with adventitious 2,6-cis. Because of (the business risk) we are proceeding to eliminate adventitious 2,6-cis from almost all Dow Corning products." There is a handwritten note to copy to Stark and LeVier.
CITE: DCC 281031106, Exhibit to "Weyenberg Deposition, Exhibit to Harris County LeVier Deposition, Exhibit 9 to Harris County Tyler Deposition, Exhibit to MDL Tyler Deposition, Exhibit to Ryan Deposition, and Exhibit to LeVier Deposition.

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

Dow Corning salesman, Frank Lewis, informs Milt Hinsch that he has experienced an "excessive number of ruptures" in the Detroit area. Numerous doctors report an increase in ruptures and are commenting, "Noticing a difference in the envelope."
CITE: F 729 - 730. DUPLICATE: M 570150 - 570151; KMM 3919 - 3920.

Document #299
03/10/78
ACKNOWLEDGEMENT OF NEED FOR TESTING
KNOWLEDGE OF LIQUID SILICONE DANGERS
TESTING
TISSUE REACTION

Study titled "Biological Evaluation of an Implantable Silicone Gel: Summary of Acute and Chronic Studies" by Lentz, Chandler and LeVier. The authors report:

"The current data do not support the use of X7-2151 gel by direct instillation. While no deleterious effects were noted, the long term localization of the gel is uncertain as is the end point of the tissue reaction. To permit use of this gel by instillation, future studies should address the questions of whether the reaction stops short of complete dispersal of the gel, whether gel fragments are carried to remote sites and if so the fate of this material, whether this reaction is dependent upon the ways of gel injected, and whether a similar fragmentation occurs in humans."
CITE: DCD 154000246 - 154000266, Exhibit to Weyenberg Deposition. DUPLICATE: KMM 174130 - 174159l

Document #300
03/16/78
ACKNOWLEDGEMENT OF NEED FOR TESTING
KNOWLEDGE OF SYSTEMIC DISEASE

Bob LeVier, Dow Corning, memo to Bey and Nelson (both are in the Marketing Department) proposing development of the implantable gel implant. He writes, "The 180-day rabbit gel implantation study led to two conclusions based on the data:

l. The evidence for progressive subdivisions of gel is sufficient to warrant the conclusion that a hypothesis favoring efficacy in mammary augmentation and/or mammary reconstruction cannot be supported without further experimentation.

2. The evidence for the presence of small isolates of gel surrounded by potentially phagocytic cells is sufficient to raise a theoretical question concerning dissemination of gel or its components.

LeVier states that animal studies are needed on these issues and on questions relating to gel subdivision "by connective tissue and gel-associated systemic toxicity," He has designed a study which will provide the "minimally required information ... (in) the shortest practical time course for completion and at as low a cost as possible." CITE: F 744 - 746. DUPLICATE: M 3320004 - 320005.