Document #227

04/00/76 ACKNOWLEDGEMENT OF NEED FOR TESTING

A study entitled "Mammary Capsular Contraction (A Situation Analysis 1976)" by P.A. Walters of Health & Human Services. Eldon Frisch, Dow Corning, receives the report. Walters recommends the following:

"Concentrate the initial research effort in the one area Dow Corning knows best, i.e. materials. Do not terminate any existing clinical programs with respect to data generation on mammary capsule contracture. However, I would recommend postponing Dow Corning's involvement in any new clinical program(s) until some very basic research questions are answered. I realize that rejecting some clinical proposals is very difficult because of the political and economic implications, but participating also carries some very high risks. There is a 50/50 chance that the data may be bad data, i.e., damaging by implicating a product.... Remember, a product which is implicated with bad data requires additional expenditures of time, personnel and money to generate defensive research. There are several data gaps which should be investigated before any long-term clinical involvements are undertaken."

Walters recommends further studies on gel bleed and elastomer formulation. (emphasis added).

CITE: KMM 4113 -4129, Exhibit 77 to Harris County Rathjen Deposition. DUPLICATE: M 290021 - 290037.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

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

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

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

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

04/13/76 KNOWLEDGE OF GEL BLEED

Milt Hinsch, Dow Corning, discussed how the market place is telling Dow Corning that improvements can be made to the current production line including to the envelope, gel, and design of the prosthesis. One suggested improvement would be that the gel should be a no bleed gel with very low viscosity, "Doctors are now being sensitized to the oiliness of our current prosthesis...." Hinsch wants Dow Corning to place its name and product size on the mammary in case it needs to be removed and replaced for any reason. "This is a consideration which will become more important as time goes on."

CITE: M 160007 - 160008. DUPLICATE: GEG 4343; M 160079 - 160080; KKH 2632.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

04/14/76 KNOWLEDGE OF GEL BLEED ACKNOWLEDGEMENT OF NEED FOR TESTING

Eldon Frisch, Dow Corning, responds to Milt Hinsch's memo on Greg Bicket's questions on gel bleed. "The material which bleed from a mammary implant is a polydimethylsiloxane, or more appropriately a silicone fluid. It comes from within the gel.... Since the gel starts as a fluid, these materials are also fluids, and they tend to migrate about in the gel, eventually dissolving in the envelope and passing through it.... We have no scientific data to indicate whether or not the presence of the fluid polydimethylsiloxane which bleeds through the envelope increases or decreases the problems of capsular contracture." He questions whether Dow Corning's field inventories are getting too old, allowing "the bleed (to become) more evident." Frisch also talks about injected silicone fluid studies which showed absorption of the silicone fluid into the body. "We have no scientific evidence to indicate whether or not the presence of the fluid polydimethylsiloxane which bleeds through the envelope increases or decreases the problems of capsular contracture."

CITE: M 190259 - 190261, Exhibit 13 to California Braley Deposition (used by Dow Corning), Exhibit to Petraitis Deposition, Exhibit to MDL Rathjen Deposition. DUPLICATE: KKH 1561 - 1565; GEG 4023 -4025; M5700445 - 570047, KMM 3828 - 3830; GEG 4246 - 4250.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

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

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

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

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

04/20/76 SHELL STRENGTH - THICKNESS RUPTURE

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

CITE: KMM 219977.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

04/22/76

Kelley, Dow Corning, memo to Hinsch with copies to C. Lentz, Criger, Leach, Meads, Becker, Petraitis, Bey and Rathjen regarding "Milt Hinsch Memo of April 13 - Attached "Gel Filled Mammaries Of The Future.'" Kelley notes that the attached memo from Hinsch documents specific marketplace requirements for the mammary prosthesis line.

CITE: KKH 2633

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

05/04/76 KNOWLEDGE OF GEL BLEED GEL MIGRATION TISSUE REACTION

Greg Bicket, Dow Corning, reports that he met with Dr. Richard Phares regarding the Silastic Mammary Prosthesis. He is "interested in reports of freshly healed augmentations failing to adhere with subsequent loss of implant. (Phares) experienced this, and was upset to hear others reports of this at the Southeastern meeting. Apparently, the theory is that the opposing faces of the wound are closed, and in ten to fifteen days no appreciable healing has taken place. The suture lines then break down, and the implants are not retained. 'Greasy implants" sliding into the pocket, providing a release agent against healing, were postulated to be the cause."

Further, "The second area of concern was the reported actions of migrating gel/fluid of other manufacturers' gel. Giant cells, granulomae, and siliconomae were reported in and around the locations where the migrating gel/fluid was said to have come to rest." Phares proposes a dog study.

CITE" M 600009 - 600010, Exhibit to MDL Rathjen Deposition, and Exhibit 79 to Harris County Rathjen Deposition. DUPLICATE: F 713 - 714; KMM 380053; DCC 80010141 - 80010142. NOTE: Dow Corning never followed through with a dog study. See 06/08/76 entry.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

05/11/76 SHELL STRENGTH - THICKNESS SHELL DEGRADATION

Neal Langley and Jon Swanson, Dow Corning, report on the "Effects Of Subcutaneous Implantation, Through Two Years, On The Physical Properties Of Medical Grade Tough Rubber (MDF-0198)." MDF-0198 is a "new high performance medical grade elastomer for orthopedic (sic) devices.... Questions to be answered were: do physical properties change during implantation; are body fluid absorbed into the elastomer; and is PDMS leached into the body during the two year subcutaneous implantation period?" Langley and Swanson state that there was little change in tensile strength, tear resistance and ultimate elongation. "Maximum loss of PDMS into the body ranged from 0 to 0.7% of the sample weight after 32 weeks and from 0 to 1.3% after two years.... This degradation may become important over longer periods." There were significant changes in the flaw propagation life after implantation, a 10% decrease in tensile strength and flaw propagation life, a 20% decrease in elongation and a 5% increase in modulus. "Differences to be noted between this study and service conditions include the absence of flexing during implantation, and any differences between the subcutaneous environment in dogs Vs the various locations in the human body where the devices are in service."

CITE: T 21431 - 21444. DUPLICATE: KKH 68344 - 68357; DCC 204001179 -204001192.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

05/17/76 ACKNOWLEDGEMENT OF NEED FOR TESTING

Art Rathjen, Dow Corning, memo to Bey and C. Lentz regarding a capsular contracture study proposed by Dr. James Penoff. "We are engulfed in qualified speculation - nothing to date is truly quantitative or qualitative; therefore, Dr. Penoff's suggestions for a course of action merit some serious consideration." (emphasis added). Phase I of the proposed study includes:

A. Is there something in the implant that migrates out or off the mammary prosthesis? yes or no!

B. Does it continue for the life of the implant or is it limited or controlled for a period of time?

C. Does it come from the gel or envelope or both?

D. What is it?

E. Considering the evolution of the mammary prosthesis, have changes in both the gel and envelope altered the degree or changed what might migrate through or off the prosthesis?

Phase II would be pre-clinical implant testing to determine whether components of the envelope and gel migrate. Phase III is human implantation.

CITE: F 715 - 716, Exhibit to MDL Rathjen Deposition, and Exhibit 78 to Harris County Rathjen Deposition DUPLICATE: FDA 31438 - 31439; M 210001 - 210002.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

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.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

06/02/76 SHELL STRENGTH - THICKNESS RUPTURE

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

CITE: CR 3172 - 3173.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

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

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

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

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

06/08/76 ACKNOWLEDGEMENT OF NEED FOR TESTING

Art Rathjen memo to Al Bey, C. Lentz and others, all of Dow Corning, regarding "G. Bicket Trip Report No. 504, May 4, 1976, i.e., Dr. Phares, St. Petersburg, Florida." Rathjen states:

"I have proposed again and again that we must begin an in-depth study of our gel, envelope, and bleed phenomenon. Capsule contracture isn't the only problem. Time is going to run out on us if we do not get underway. Believe me when I tell you that the A.S.P.R.S. is also going to begin their own investigation. A committee will be organized, and they will come to the manufacturers asking questions. It would certainly be to our advantage to be ready for them. (emphasis added).

CITE: F 712, Exhibit to MDL Rathjen Deposition, and Exhibit 79 to Harris County Rathjen Deposition. DUPLICATE: M 600011; GEG 003999; KMM 242518; DCC 80061401; M 600008.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

06/10/76 COHESIVENESS - LIQUID COMPONENT OF GEL GEL MIGRATION KNOWLEDGE OF GEL BLEED

Study by Brill titled "Development Of A Low Oiling Gel For The External Breast Prosthesis." The resulting gel caused substantially less swell of the silicone rubber envelope and gave a low rate of migration of silicone material through the envelope compared to existing silicon gels formed from low viscosity fluids and plasticizers. It was also shown that gels and fluids based on methyltrifluoropropyl polymer as well as silicone organic copolymers could produce a very low order of elastomeric swell and bleed with polydimethylsiloxane envelope rubber.

CITE: KKH 63280 - 63299, Exhibit to Petraitis Deposition, and Exhibit to MDL Rathjen Deposition.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

06/11/76 MISCELLANEOUS

W. Larson and Y. Peters, both of Dow Corning Corporation, issue an internal Dow Corning report entitled "Medical Products, Technical Service and Development". The authors report that:

"The mammary gel, MDDF0193, often develops a yellow color which detracts from the appearance of the prosthesis. The cause of this problem has been traced back to the catalyst, XY173. Four catalysts were evaluated on the basis of color, XY173. Four catalysts were evaluated on the basis of color, XY173, XF95504, PtII and MDDFoo69. The color intensity of the gels was found to decrease in the following order: XY173 >XF95504 >PtII > MDF0069.

The results indicated that the easiest solution to the problem was to switch to MDF0069."

CITE: KMM 8596 - 8605. NOTE: The first page states that this document is Dow Corning Proprietary and that neither this document nor the information contained in it may be reproduced except in TIS, nor distributed outside the company without permission from the Director of Technical Service and Development.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

06/25/76 SHELL STRENGTH - THICKNESS RUPTURE

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

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

CITE: CR 3272.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

07/07/76 FRAUD/MISREPRESENTATION GEL MIGRATION

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

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

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

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

CITE: KMM 354956 - 354957.l

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

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.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

07/14/76 DOCUMENT DESTRUCTION TESTING

Milt Hinsch, Dow Corning, memo to Rathjen, Kelley, Leach, Lentz, Bey, Bennett, Hoyt, Mantle, and Nelson regarding "The Milt Hinsch Grant." Hinsch turned down a request for funding by Dr. Tanski which Rathjen supported and then agreed to fund a similar study by Drs. Horton and Rasato. Rathjen has suggested that Drs. Horton and Rasato had gone "shopping" for funding and were turned down by Heyer-Schulte already. Hinsch responds that it was a marketing sponsored decision to support Horton and Rasato because they are product champions. In response to Rathjen's question about what to do with the data Horton and Rasato generate, Hinsch states, "Question number 9 about what will we do with the data depends upon the data which is generated, Art. It may turn out that we will take the paper on which this data is printed, roll it up and light pipes and cigars with it." (emphasis added).

CITE: M 190344 - 190345, Exhibit to MDL Rathjen Deposition, and Exhibit 82 to Harris county Rathjen Deposition.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

07/15/76 KNOWLEDGE OF SYSTEMIC DISEASE

Pulley memo to LeVier regarding "Patent Memo 4240 - Insecticidal Activity of Silicone Oils and Emulsions." The subject patent is being placed in our inactive files in the Patent Department. Note: The referenced patent memo is not attached.

CITE: DCC 281041374 (Temporary Dow Corning Bates Number 16359 - 16379), Exhibit to Bennett Deposition, Exhibit to Isquith Deposition, Exhibit to Lake Deposition, Exhibit to LeVier Deposition.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

07/23/76 CONCEALING FROM FDA FRAUD/MISREPRESENTATION

FDA: A hearing is held by the FDA Panel on Review of General and Plastic Surgery Devices. On the issue of breast implants, J. Radqius, Dow Corning, states that he has evidence that doctors may be altering the breast implants by injecting an antibiotic into the prosthesis which is gradually released through the membrane of the implant.

CITE: This document also has the Bates numbers KMM 489852A - 4900119A (This document also has Bates numbers KMM 545507 - 545555, 547162, 545556 - 545557, 547163 - 547164, and 545558 - 545671 on it.) DULICATE: FDA 160 - 161 (Pages 150 and 151 only).

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

08/02/76 ACKNOWLEDGEMENT OF NEED FOR TESTING KNOWLEDGE OF SYSTEMIC DISEASE

Hobbs, Dow Corning, memo to Atwell, Bey, LeVier, Radzius, Ryan, Smith, Stark, Gamon, Lentz, Maneri, Tyler, Wehrly, and Weyenberg regarding "2,6-cis Toxicity." Hobbs states:

"A six month chronic toxicity study conducted on 2,6-cis has demonstrated possible relationship between the appearance of mammary tumors in the (word is cut off) and the feeding of the chemical. This possibility may have implications which involve products other than 2,6-cis. There are three major questions we must answer concerning this possible effect:

1. Is the occurrence of mammary tumors an absolute response in the rat when fed 2,6-cis?

2. Do any of our products contain 2,6-cis?

3. Is the production of these tumors a result of the estrogenic activity of 2,6-cis or is it related to certain low molecular weight silicone compounds?

CITE: KMM 482556 - 482557, Exhibit to Tyler Deposition, Exhibit to Ryan Deposition. NOTE: The right hand side of the page is cut off.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

08/03/76 KNOWLEDGE OF SYSTEMIC DISEASE

Pulley, Dow Corning, memo to LeVier concerning the inactivation of Patent Memorandum 4320. Because LeVier represents "that the project which supported the subject disclosure in on the shelf and that Dow Corning would probably not reactivate work in this area in the near future," the patent memo is inactivated, to be reactivated "whenever you consider it appropriate."

CITE; DCC 281061472, Exhibit to Bennett Deposition, Exhibit to Isquith Deposition, Exhibit to Lake Deposition, and Exhibit to LeVier Deposition. NOTE; Refer to entry dated 01/31/75. This was listed on Plaintiffs' Exhibit List in Carter as "No Bates Number."

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

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.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

08/23/76 GEL MIGRATION KNOWLEDGE OF SYSTEMIC DISEASE RUPTURE

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

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

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

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.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

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.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

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.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

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.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

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

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

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

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

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. (emphasis added).

CITE: CRM 200 - 203.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

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.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

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.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

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. (emphasis added).

CITE: KKH1719. DUPLICATE: GEG 4009.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

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. (emphasis added).

CITE: GEG 4009.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

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

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

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

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

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.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

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).

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

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." (emphasis added).

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.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

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.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

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" (emphasis added).

CITE: M 240368

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

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." (emphasis added).

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.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

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.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

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

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

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

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

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

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

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

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

CITE: KMM 333230 - 333234, Exhibit to Petraitis Deposition, and Exhibit to MDL Rathjen Deposition.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

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." (emphasis added).

CITE: M 190441 - 190443, Exhibit to Harris County Tyler Deposition.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

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

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

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." (emphasis added).

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

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

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. (emphasis added).

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.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

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.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

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.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

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.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

05/26/77 RUPTURE SHELL STRENGTH - THICKNESS

Complaint analysis prepared by Woodard and forwarded to Rathjen.

CITE: M 460026 - 460028 and M 570200 - 570203, Exhibit to MKL Rathjen Deposition.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

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.

08/12/77 TISSUE REACTION SHELL STRENGTH - THICKNESS RUPTURE

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

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

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

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.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

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.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

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.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

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.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

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.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

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. (emphasis added).

CITE: KMM 333267. DUPLICATE: KMM 149564 - 149566.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

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

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

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

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

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.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

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.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

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

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

CITE: KMM 255487 - 255488

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

Log of a telephone conversation between Dr. Glazer and A. Rathjen, Dow

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

CITE: KMM 194463 - 194466, Exhibit to Oppelt Deposition, and Exhibit to MDL Rathjen Deposition.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

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.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

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.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

12/15/77 SHELL STRENGTH - THICKNESS RUPTURE

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

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

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

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).

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

01/20/78 SHELL STRENGTH - THICKNESS RUPTURE

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

CITE: KMM 333270. DUPLICATE: KMM 261276 - 261277.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

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.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

03/02/78 SHELL STRENGTH - THICKNESS RUPTURE

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

CITE: F 729 - 730. DUPLICATE: M 570150 - 570151; KMM 3919 - 3920.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

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.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

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." (emphasis added).

CITE: F 744 - 746. DUPLICATE: M 3320004 - 320005.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

04/10/78 STERILIZATION/CONTAMINATION

Dow Corning Complaint Report 20602 notes a "hair inside package."

CITE: CRM 296 - 300. DUPLICATE: KKH 33333.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

04/17/78 SHELL STRENGTH - THICKNESS RUPTURE

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

CITE KMM 333262 - 333264, Exhibit to MDL Rathjen Deposition.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

05/17/78 GEL MIGRATION TESTING TISSUE REACTION

Lentz, Chandler and LeVier, Dow Corning, report on the "Biological Evaluation Of An Implantable Silicone Gel: Summary Of Acute And Chronic Studies." They write:

"The majority of subcutaneous implant sites at three and six months showed subdivision of the gel mass by bands of fibrous connective tissue. The current data does not support use of this gel by direct instillation. While no deleterious effects were noted, the long term localization of the gel is uncertain as is the endpoint 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 mass of gel implanted, and whether a similar fragmentation occurs in humans."

CITE: KMM 174130 - 174159, Exhibit 33 to Harris County Peters Deposition, Exhibit 30 Rathjen Deposition (used by Dow Corning), Exhibit to Harris County Tyler Deposition, Exhibit to Weyenberg Deposition, and Exhibit to Ryan Deposition. DUPLICATE: KMM 453860 - 453893; DCC 80061699 - 80061732; DCC 281002010 - 281002045. 

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

06/00/78 KNOWLEDGE OF GEL BLEED MISCELLANEOUS - COMPLICATIONS TISSUE REACTION

Donald E. Barker, M.D., Marvin I Retsky, M.D. and Sherill Schultz, R.N., report in the Plastic and Reconstructive Surgery Journal that, "Modern silicone bag-gel breast implants leak silicone gel through the bag, the amount leaked varies from one implant to another and is not constant for any type or brand, and the silicone will be found in fibrous thickening and various degrees of inflammation will be found in capsules surrounding the implants...."

CITE: M 260116 - 2601121, Exhibit 44 to Harris County Duel Deposition (used by Dow Corning), Exhibit 37 to Frisch Deposition (used by Dow Corning), Exhibit to D. McGhan Deposition, Exhibit to Oppelt Deposition, Exhibit 2B to Harris County Talcott Deposition (used by Dow Corning), Exhibit 2 (and 125) to Harris county Rathjen Deposition, and Exhibit to Steward Deposition. DUPLICATE: D 3583 - 3585, M 260269 - 260275.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

09/06/78 SILICA

The Department of Health, Education and Welfare issues a pathology report on monkeys exposed by inhalation to Amorphous Silica-F (99.5% of its particles are less than one micron in size). Noting that "the abundance of vacuoles containing fine bands of connective tissue is significant in view of previous reports that amorphous silica is innocuous," the report concludes that the "effects of particulates containing silica ... should be a cause for concern."

CITE: KMM 313106 - 313110.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

10/18/78 FRAUD/MISREPRESENTATION KNOWLEDGE OF LIQUID SILICONE DANGERS MISCELLANEOUS - COMPLICATIONS MISCELLANEIOUS - RECKLESS/CONSCIOUS DISREGARD TISSUE REACTION

Swanson memo to Ludington, Hargreaves, Maneri, Layne, Tyler, "Reed, Griffin, Klauser, Bott, Dion, Seeberger and Schumack regarding Zemker & Associates communications clinic. A prepared question of Mr. Layne states that Dow Corning's marketing strategy apparently dictates that the responsibility stops with the doctor. But according to MS. Magazine there is a 60% complication rate. The question asks that many people have trouble understanding that since Dow spends a few million dollars promoting the safe sealants and defoamers to the end user why doesn't it spend a red cent to give thousands of young women the true facts about implants and at the same time warn them about silicone breast injections. The question goes on to ask if Dow doesn't feel some ethical and moral responsibility to do more than you are doing.

CITE: DCC 80021587 - 80021589, Exhibit to Tyler Deposition.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

00/00/79 RUPTURE - CLOSED CAPSULOTOMY SHELL STRENGTH - THICKNESS

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

CITE: M 660189 - 660204, Exhibit to MDL Rathjen Deposition.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

00/19/79 KNOWLEDGE OF SYSTEMIC DISEASE GEL MIGRATION

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

CITE: M 460274.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

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

Dow Corning minutes of a PMG (Product Marketing Group) meeting with R. Rylee, G. Jakubcvzak, A. Rathjen, M. Nelson, A. Bey and others. Three areas of importance concerning the inflatable mammary prosthesis were discussed - ethical/morality, legal, and business. The 1972 study was presented which showed there was a deficiency in the envelope. Jakubczak reported failures in the clinicals were the result of pinholes of undetermined origin. (NOTE: This is inconsistent with Rathjen's prior memos.) Rathjen outlined his ethical concerns that "no matter when the product fails, it is the fact that it did fail...." There was discussion whether Dow Corning should stay in the market with the inflatable, do clinicals on the HP envelope, or market the HP. Marketing claimed that the field results showed there was no problem. Rathjen, however, stated that his clinical experience showed there was a "definite serious problem." (NOTE: See Rathjen's memos throughout 1977 and 1978). Bey, in Dow's Marketing Department, proposes that they put the HP on the market but increase envelope thickness to 7 mils. The HP will replace what's on the market but there will be "no recall."

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

CITE: KMM 261081 - 261085, Exhibit to MDL Rathjen Deposition.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

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

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

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

CITE: MCG 8487 -8489, Exhibit to Coyne Deposition, Exhibit to Grosh Deposition, Exhibit to Oppelt Deposition, Exhibit to Schreiber Deposition, and Exhibit to Petraitis Deposition.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

04/04/79 KNOWLEDGE OF GEL BLEED GEL MIGRATION

Gene Jakubczak, Dow Corning, memo responding to Bill Overton's, sales representative in Texas, memo to Milt Hinsch discussing gel bleed and the effect of therapeutic radiation. Jakubczak begins by stating, "I remain intrigued that what appears to be obvious TS&D activities continue to be sent to the marketing function. Is this by design? Is it due to lack of response from TS&D? Do sales personnel understand TS&D functions? Do sales personnel understand who to contact? Enough!!"

In response to question of mammary bleed, Jacubczak states that Dow Corning's "fluid injection program ... does give some guidance on what happens when polydimethylsiloxane is injected in-vivo. Dow Corning does have data from its industrial sales effort on polydimethylsiloxane fluids. The buildup in organs is reviewed however, I do not know what it says.... If you detect reluctance on DC's part to provide data bear in mind that most surgeons (obviously not all) do not deal well with scientific accuracy as it impacts on data interpretation." (emphasis added).

With regard to Overton's question on what material is bleeding, Jacubczak states that, "The material referred to as bleed represents the soluble fraction of the prosthesis gel component. Bleed is silicone (polydimethylsiloxane polymer)...." In addition, "Silicone bleed has been shown to move out and away from the gel prosthesis. Insufficient information exists to say how much and where it travels and accumulates, if it does, much less what are its affects. Dow Corning again from the industrial sales side, does have data on polydimethylsiloxane fluid and its bio path and the effects in the body." (emphasis added).

Finally, in response to whether there is any difficulty with x-ray and mammography exams of women with breast implants, "experience will usually overcome difficulties.' Also, Jakubvczak will review the effect of therapeutic radiation on implants.

CITE: M 250045 - 250047.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

06/29/77 RUPTURE SHELL STRENGTH - THICKNESS

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

CITE: CR 4006 - 4007.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

07/03/79 KNOWLEDGE OF SYSTEMIC DISEASE MISCELLANEOUS - COMPLICATIONS TESTING TISSUE REACTION

Study by Spielvogel, Robinson and Hanneman titled "Metabolism of Cis and Trans 2,6 Diphenylhexamethylcyclotetrasiloxane In The Rhesus Monkey, Rat and Man," by Speilvogel, R.J. Robinson and Hanneman. A copy was sent to John Ryan, Bey, Frye, Hobbs, C. Lentz, Boley, Nelson, Rylee, Stark, Tyler, Weyenberg and others.

CITE: DCC 281002046 - 281002085 (Temporary Dow Corning Bates Number 3781-3820), Exhibit 6 to Isquith Deposition.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

09/28/79 SHELL STRENGTH - THICKNESS MISCELLANEOUS - RECKLESS/CONSCIOUS DISREGARD

Dr. Gordon Robinson Jr. letter to A. Rathjen, Dow Corning, stating he had to replace 13 out of 16 inflatable mammaries that were part of the clinical trial since they deflated. He states, "I feel like the handwriting is on the wall. This was a bad adventure." (emphasis added).

CITE: KMM 256659 - 256660, Exhibit to MDL Rathjen Deposition.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

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

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

CITE: KMM 423161. NOTE: See KMM 423155 - 423156.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

11/08/79 SHELL STRENGTH - THICKNESS RUPTURE

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

CITE: KMM 423153 - 423154.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

11/13/79 KNOWLEDGE OF LIQUID SILICONE DANGERS MISCELLANEOUS - COMPLICATIONS TISSUE REACTIONS

Letter to Dr. Goldwyn from Dr. Murray, with a copy to Rathjen, regarding patient who received 4 silicone injections, 4 years earlier, who was having pain and lesions in her face near and adjacent to sites of injection; microscopic report revealed epidermal inclusion cyst without any evidence of silicone fluid. Murray will follow "with great interest because one wonders if some of the long term results with liquid silicone may be undesirable."

CITE: DCC 106003480 - 106003481, Exhibit to MDL Rathjen Deposition

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

00/00/80 ACKNOWLEDGEMENT OF NEED FOR TESTING TESTING

Hunter handwritten notes regarding 2, 6-cis project new ventures milestones for 1980. He notes that Dow Corning used Dow Chemical's laboratory and its subsidiary, Lepetit, to conduct testing on 2,-cis.

CITE: DCC 281031798.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

01/22/80 KNOWLEDGE OF SYSTEMIC DISEASE

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

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

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

03/14/80 KNOWLEDGE OF GEL BLEED

Milt Hinsch, Dow Corning, memo to Bartolo, Gant, Peters, Jakubczak, Haas, and Smith stating that, "We are now saying (seeing) extremely greasy lots of Gel Saline Mammary implants. The H.P. envelope accentuates gel bleed." (emphasis in original).

CITE: KMM 518831.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

04/14/80 RUPTURE SHELL STRENGTH - THICKNESS

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

CITE: MEA 22 - 25. DUPLICATE: MEC 7835 - 7838: MEC 9278 - 9180,

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

04/23/80 KNOWLEDGE OF SYSTEMIC DISEASE

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

"Dow Corning has performed extensive safety testing, in animals, on the silicone materials from which SILASTIC breast implants are made. I have also reviewed our product complaint files. Your inquiry appears to be the first Dow Corning has received asking whether a silicone breast implant could be a causative agent for chronic lupus erythematosus. The data Dow Corning has suggest that it would be highly improbable that your patient's symptom of chronic lupus erythematosus could be attributed to the silicone breast implants."

CITE: CM 1135. NOTE: See 01/22/80 entry.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

04/29/80 KNOWLEDGE OF GEL BLEED MISCELLANEOUS - RECKLESS/CONSCIOUS DISREGARD

B. Schnabel, a Dow Corning salesman, writes Milt Hensch regarding a complaint from a customer, F. Grazier, M.D. The doctor is complaining about excessive gel bleed and a "greasy" feel to the envelopes. "The lot number involved is H129700. It has been brought to my attention that this particular lot was put on the market with prior knowledge of the bleed problem." Schnabel continues, "As you know he (Dr. Grazer) had a bad experience with our varifils and with our gel salines he has yet another bad experience and we wind up with egg on our face. To put a questionable lot of mammaries on the market is inexcusable. I don't know who is responsible for this decision, but it has to rank right up there with the Pinto gas tank." (emphasis added).

CITE: F 629 - 630. DUPLICATE: M 250021; M 570058; F 628; KMM 232092 -232093; M 250022 - 250023; M 570059.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

05/07/80 KNOWLEDGE OF GEL BLEED

Yolanda Sue Peters and R. Gant, Dow Corning, author an internal Lab Report For Silastic II Mammary Implant Bleed Study. Gel bleed is "a property common to all gel-filled prostheses" which is attributable to the semi-permeable nature of silicones and the similarity in the composition of the gel and the envelope. Test results show that the fluorosilicone coating of the mammary envelope reduces the bleed by approximately 90%."

CITE: KMM 136950 - 136958. DUPLICATE: D 2926 - 2935; KMM 151111 -151120; T 8417 - 8425.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

05/29/80 ACKNOWLEDGEMENT OF NEED FOR TESTING TESTING TISSUE REACTION

Report by Dow Corning Toxicology Department, authored by Ronald Annelin, entitled, "Trace Analysis of Organosilicon In Human Urine And Milk By The ASFT Technique." The report concerns the use of the Aqueous Silanol Functionality Test to determine the organosilicon level in human urine following the incidental inhalation of Dow Corning 344 Fluid Vapors. Also included is a single analysis of human breast milk. All of these samples contained detectable amounts of monomethyl and dimethyl silicon species. Nearly twenty percent of the estimated intake of Dow Corning 344 fluid was excreted in the urine in the eight hours following exposure. The presence of monomethyl silicon in the urine suggests that cyclic dimethyl species undergo demethylation during human metabolism.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

CITE: DCC 284020681 - 284020686, Exhibit l to Frye Deposition, Exhibit 1 to Petraitis Deposition, Exhibit to Isquith Deposition, and Exhibit 3 to MDL Rathjen Deposition.

07/01/80 DOCUMENT DESTRUCTION

M. Gill memo to J.C. Smith, Dow Corning, regarding returned materials - complaints file. Gill reports that complaints had been taken to the Bio Lab for investigation. "It was noticed that all boxes had been removed from the Bio Lab and destroyed. It was discovered that the janitors had removed all these boxes and destroyed them.... These complaints ... will not be investigated."

CITE: CR 5489 - 5490. DUPLICATE: KKM 25426 - 25427.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

07/16/80 TISSUE REACTION KNOWLEDGE OF SYSTEMIC DESEASE

"R. LeVier, Dow Corning, memo to W. Boley and L. Veresh, regarding immediate adverse reactions to mammary gel implants from two patients of Dr. Charles Stone. Both patients experienced rapid evolution of wound edema with inflammation and tissue breakdown 3-6 weeks after implantation. LeVier recalls 8 patients who experienced allergic reaction to silicone fluid. "It may be that there is a small population capable of a vigorous immune rejection response to silicone fluid/elastomer; could be a complement mediated response." (emphasis added)

CITE: M 240072. DUPLICATE: KMM 197618.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

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

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

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

CITE: KKH 53276 - 53277.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

07/31/80 MISCELLANEOUS - COMPLICATIONS TISSUE REACTION

Letter to Dr. Goldwyn from Dr. Woolf, cc to Rathjen, regarding patient in the silicone study who "was doing very well until March of this year, when suddenly the face flared up again on both sides. ... The temperature in the area she was visiting in Mexico was about 110 degrees, and her face completely flared up again. ... When she returned again, she had a definite abscess in the left cheek, just beneath the anterior border of the zygomatic arch ... The abscessed area has resolved, but she still has diffuse swelling in both cheeks, with some overlying discoloration."

CITE: DCC 106006691 - 106006692, Exhibit to MDL Rathjen Deposition.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

11/19/80 KNOWLEDGE OF GEL BLEED

Handwritten note from J. Reitsma to M. Hinsch, both of Dow Corning Wright, regarding problems with the gel-saline implants. He states, "Milt, I feel we have a potential problem with the quality of our gel-saline mammary prosthesis, that is gel bleed in excessive amounts going through the outer membrane in such volume as to cause a greasy look and feel to the using surgeon." Several physicians have refused to use the product stating that they have no confidence in it - "it's to (sic) damn greasy." Reitsma informs Hinsch that the gel-saline product "has me feeling uneasy about its quality and even safety. I can not in good faith introduce this product to a competitive or new account."

CITE: KMM 232094 - 232095.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

12/10/80 KNOWLEDGE OF SYSTEMIC DISEASE MISCELLANEOUS - COMPLICATIONS TESTING TISSUE REACTION

"Metabolism of Octamethylcyclotetrasioxane in the Monkey, Report No. 5265," by Spielvogel and Robinson. A copy was sent to Boley, Hobbs, C. Lentz, LeVier, Stark, Frye, Ryan, Speier, Bey and others. D4 was administered orally to two monkeys and the excretions (urine and feces) were collected and examined. Gas chromatography-mass spectrometry revealed the presence of three metabolites: dimethylsilanediol, tetramethy1-1,3-disiloxane diol and hexamethyl-1c5-trisiloxane diol. The authors reasoned that D4 might undergo metabolic transformation to either an alkyl hydroxylated and/or conjugated species or silanol functional species that would likely be soluble in moderately polar solvents." (KP 30523).

D4 appears to be well absorbed from the gastro-intestinal tract and broadly distributed throughout the body. The primary route of excretion is urine. "The bio-transformation of D4 is similar to that 2,6-cis and 2,6-trans-diphenylhexamethyltetrasiloxane and diphenysilanediol. All of the compounds appear to be readily hydroxylated and as a result are converted from highly lipophilic compounds to highly polar, easily excretable metabolites." (KP 30626). Also, "The metabolic fate of D4 closely parallels the metabolic fate of 2, 6-cis and 2, 6 - transdiphenylhexamethylcyclotetrasiloxane. All of the cyclic siloxane compounds examined to date are metabolized to a series of low molecular weight polar compounds that are predominantly excreted via the kidneys."

CITE: T 8796 - 8813, Exhibit to Harris County Ruhr Deposition, Exhibit to Bennett Deposition, Exhibit to Isquith Deposition, Exhibit to LeVier Deposition, Exhibit 4 to Stark Deposition, Exhibit to Compton Deposition, Exhibit to Ryan Deposition, Exhibit to Isquith Deposition, and Exhibit 31 to Zimmer Deposition. DUPLICATE: KKM 22739 - 227560

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

02/09/81 KNOWLEDGE OF SYSTEMIC DISEASE GEL MIGRATION

Boley, Dow Corning, memo to Frisch, LeVier, Spielvogel, Cooper, Rylee, and Wessel regarding "Baboon Study To Evaluate the Fate of Silicone Wear Particles." Boley notes that:

"Silicone particles have been found in the axillary lymph nodes of patients with Silastic finger joints. These particles have been detected as a consequence of biopsy of nodes that have become painful and enlarged.... Of concern to the surgeon is whether these particles will continue to migrate beyond the regional nodes into the thoracic or abdominal cavities. Since concerns about malignancies requires that any chronic swelling of lymph nodes be biopsied or excised, wear particles could create the need for a surgeon to breach the body cavities.

CITE: KMM 328166 - 328167. DUPLICATE: KMM319434 - 319435.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

03/05/81 KNOWLEDGE OF LIQUID SILICONE DANGERS TESTING

Yolanda Sue Peters, Dow Corning, letter to Dr. Frank Gerow requesting his information and data that supports the use of gel for implantation. All the data Peters has contraindicates its use in this manner. She understands that Dr. Gerow has both animal studies and clinical information on the implantation of gel for augmentation of soft tissues areas such as the face and breast.

CITE: M 320037.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

04/16/81 KNOWLEDGE OF SYSTEMIC DESEASE TESTING

Gerry Schoenig, Toxicology Consultant for Dow Corning, reviews the data from the Two-Year Implant Study of Q7-2159A and MDF-0193 Gels at Industrial Bio-Test Laboratories (IBT). He finds "fibrosarcoma around implant and malignant lymphoma in rat colony said we had a problem with cancer."

CITE: KMM 390371

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work Product/Privileged & Confidential

04/29/81 ACKNOWLEDGEMENT OF NEED FOR TESTING GEL MIGRATION KNOWLEDGE OF GEL BLEED

Peters, Dow Corning, memo to Jacubczak, Marlar, Rylee and Wessel reporting that Dr. Gerow has requested an injectable gel for soft tissue augmentation (face and breast). There is very little published data on the fate of implanted gel. Some authors feel that the gel which bleeds from the envelope contributes to capsular contracture. Dow Corning data indicates that the gel is subdivided by vascularized connective tissue, which could result in the site of the implantation becoming very firm (breast) and/or transport of gel away from the sit