Implant Veterans of Toxic Exposure

Document #301
04/10/78
STERILIZATION/CONTAMINATION

Dow Corning Complaint Report 20602 notes a "hair inside package."
CITE: CRM 296 - 300. DUPLICATE: KKH 33333.

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

Rathjen, Dow Corning, memo to Gant regarding the deflation problems of the Varifil Mammary Prosthesis. Some clinicians report deflation rates as high as 8 out of 13 patients. Rathjen states "the most important factor for all of us to keep in proper perspective is that a mammary implant, with very few exceptions, is expected to function and remain in the human body for the lifetime of the patient.... Therefore, in no way can we even remotely think that a mammary prosthesis that has functioned for six months and failed is any worse than one that has functioned for a year or 18 months, and then deflated. When a product stays inflated for four months and then deflates overnight, we can't blame the doctor."
CITE KMM 333262 - 333264, Exhibit to MDL Rathjen Deposition.

Document #303
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.

Document #304
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.

Document #305
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

Document #306
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 doesnt 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.

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

A brochure entitled "Suggested Surgical Procedures for Silastic Mammary Prostheses" states that "an alternative to surgical release of a tight capsule is the closed compression technique for rupturing a contracted capsule around a breast implant."
CITE: M 660189 - 660204, Exhibit to MDL Rathjen Deposition.

Document #308
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.
CITE: M 460274.

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

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

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

Rylee questions two different sets of data from marketing and clinical and whether "Dow Corning is selling quality. The notes reflect: "1. Do we stay on the market with the existing product? (lack of clear existing data); 2. Do we introduce it without clinical trials?... A subjective decision." Dow then reviews the damages to patients: "Damages - minimal with deflation (saline) much more with gel migration." They again reaffirm there will be no recall, that the HP will be phased in, and Dow Corning will do limited clinical evaluations.
CITE: KMM 261081 - 261085, Exhibit to MDL Rathjen Deposition.

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

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

With gel-filled implants, the shell thicknesses are less. Also, he states that Dow Corning's gel "achieves its responsiveness by utilizing a large quantity of non-functional polymer in the gel formation.... This free polymer is not chemically cross-linked and is only mechanically trapped in the gel matrix. As a result, it is free to migrate through the shell and makes the entire implant much more prone to the 'bleed' phenomenon."
CITE: MCG 8487 -8489, Exhibit to Coyne Deposition, Exhibit to Grosh Deposition, Exhibit to Oppelt Deposition, Exhibit to Schreiber Deposition, and Exhibit to Petraitis Deposition.

Document #311
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."

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."

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.

Document #312
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

Document #313
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.

Document #314
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."
CITE: KMM 256659 - 256660, Exhibit to MDL Rathjen Deposition.

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

Operative report from Dr. Vinnik's patient. Patient reported being involved in a "very trivial accident, when she struck her right breast against the 'monkey bars' while playing with her child in a playground." During explantation for the ruptured prostheses, Dr. Vinnik noted that the gel ran "down the patient's chest, onto the operating table and onto the floor.... This procedure is performed because of medical necessity as a ruptured breast implant can produce serious medical problems.... Free silicone gel, particularly when it is non-cohesive as (sic - has) been known to migrate through the local area, and produces severe granulomatous response."
CITE: KMM 423161. NOTE: See KMM 423155 - 423156

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

Dr. Vinnik's cover letter to G. Jakubczak, Dow Corning, sending him the 11/07/79 operative report about a broken implant. He states, "The implant ... was definitely defective and decidedly not up to the proper standards.... I am very distressed about this apparent breakdown in quality control, as I have removed many broken Dow Corning products....(Dow Corning) should have a recall ... of some sort to the physician."
CITE: KMM 423153 - 423154.

Document #317
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

Document #318
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.

Document #319
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.
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.

Document #320
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.

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

Memo from W. Lynch and W. Stich to the Medical Engineering Corporation Field Force. They discuss Dow Corning's new shell material for their inflatable implant and claim that this new shell has twice the tear resistance of their former material. "Regrettably one of the characteristics of silicone rubber is that it has a very low tear strength. Even if Dow Corning has made a shell with twice the tear strength of what they presently have, the new value will still be low compared to other materials, such as Saran Wrap."
CITE: MEA 22 - 25. DUPLICATE: MEC 7835 - 7838: MEC 9278 - 9180

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

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

"Dow Corning has performed extensive safety testing, in animals, on the silicone materials from which SILASTIC breast implants are made. I have also reviewed our product complaint files. Your inquiry appears to be the first Dow Corning has received asking whether a silicone breast implant could be a causative agent for chronic lupus erythematosus. The data Dow Corning has suggest that it would be highly improbable that your patient's symptom of chronic lupus erythematosus could be attributed to the silicone breast implants."
CITE: CM 1135. NOTE: See 01/22/80 entry

Document #323
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."
CITE: F 629 - 630. DUPLICATE: M 250021; M 570058; F 628; KMM 232092 -232093; M 250022 - 250023; M 570059.

Document # 324
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.

Document #325
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.
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.

Document #326
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.

Document #327
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."
CITE: M 240072. DUPLICATE: KMM 197618.

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

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

"At surgery, you will note the Operative Report findings of an apparently defective gel in terms of both consistency, cohesiveness, and possibly color.... What we need to have accomplished is a thorough evaluation as to why this implant had a late failure. Was the problem inherent in the bag? Were there variabilities of thickness of shell, less than those of design tolerances? Why is this gel not cohesive as it should be? This is the second implant that we have removed which has been non-cohesive, and has shown spontaneous rupture for no apparent reason.... We need to consider whether or not a recall of all patients bearing this Lot number should be made. I think it may be wise to at least alert physicians that there may be a problem with this particular lot number.
CITE: KKH 53276 - 53277.

Document #329
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

Document #330
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.

Document #331
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

Document #332
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.

Document #333
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.

Document #334
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

Document #335
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 site. No data was received from Dr. Gerow. Seventeen of twenty doctors who were asked for their opinions said they were not in favor of the concept. The commercialization of such a gel would require long term animal studies, careful definition of the material, an IND and a campaign to overcome the bad press and emotions associated with the disastrous results reported from silicone fluid injection.
CITE: KMM 140223 - 140228, Exhibit to Blocksma Deposition, Exhibit to Peters Deposition, and Exhibit to MDL Rathjen Deposition.

Document #336
05/19/81
ACKNOWLEDGEMENT OF NEED FOR TESTING
DOCUMENT DESTRUCTION

Bill Boley memo to Sue Peters and other Dow Corning employees regarding "Biological Safety Testing of LS Q4-2840." Boley has "serious reservations" about using LS Q4-2840 to replace LS 422 as an internal coating for low bleed mammary prostheses. Boley states, "My conservative nature requires me to say that any material intended for long-term implantation in the human body should have long-term animal implant testing." At present, "Q4-2840 as a formation (has) no long-term implant data." However, Dow Corning decides to go with a 6 month study. "if in the future safety problems should arise due to the use of Q4-2840 for this application I am sure the decision to not do 2-year animal testing would be questioned. Therefore, I think it is important that this be a business decision and not a personal decision.

In my judgment the proposed testing is adequate and ethically appropriate."
CITE: DCC 8200651 - 8200616. NOTE: On the copy M 170172, there is a handwritten note dated 06/30/81 stating, "LS 422 may be discont. 2840 is potential repl. is "HP" LS is (illegible) modulus closer than LS 422."

NOTE: Attached to the version of DCC8200615 is a one page handwritten note which states, "No litigation reason to keep the records in this file. It should be brought into Rec. Retention Policy Compliance." This Same handwritten notes is located at KKA 119791. DUPLICATE: D 885; M 170172; KKA 228295.

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

Hinsch, Dow Corning, memo to Jakubczak, Kelly, Burda, Jack Smith, Marlar, and Wessel regarding a marked decline in sales of the Varifil inflatable. "For 1980, we had approximately $10,000 in prelitigation expenses for Varifil mammary deflations. Y-T-D through July, 1981, we have approximately $16,000 in prelitigation expenses. With a decline in sales and an increase in prelitigation expenses, we should review our position with this product again." CITE: KMM 78011 - 78039

Document #338
08/00/81
ACKNOWLEDGEMENT OF NEED FOR TESTING
FRAUD/MISREPRESENTATION
MISCELLANEOUS-ORGANIZATIONAL SURVEY
MISCELLANEOUS-PRODUCT LABELING
MISCELLANEOUS-SALES
TESTING

Dow Corning News for July/August 1981 containing an article on product liability. The article discusses the three theories of product liability, describes how Dow Corning fulfills its duty, and describes the anatomy of a lawsuit. The article also states that Dow Corning should follow the recommendations of Jenkins by continuing to refine its product, implement stronger training, refine and clarify warnings, make sure these warnings are explicit, review the marketability and pricing of products, continue strong research efforts and continue to study each product as it is being used to make sure any potential hazards are made known. The article also recommends that Sales, Marketing and TS&D avoid denying the importance of written disclaimers as found in the product literature, avoid making erroneous verbal representations about a product's performance and avoid promising to take care of any problems in the use of the products.
CITE: DCC 282001978 - 282001997.

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

C. Burda, Dow Corning, handwritten notes regarding the Varifil prosthesis, "Probably most vulnerable in product line w/regards to efficacy and litigation. Potential for class action suit. Product did not have clinical testing. Rathjen recommended that product not be put into market. Charged w/writing protocol but technical people did not follow....Poor field performance led to 78 decision to go to Failure to Varify causes: 1. contracture, 2. infection, 3. rupture (good or imperfect products both may fail). Varifil may have small pinhole & fluid will leak out. Also may actually split...."
CITE: KMM 78006 - 78007

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

Dr. Vinnik letter to Bob Rylee, President of Dow Corning Wright. He states, "I am considerably worried about the failure rate of gel implants, and this correlates with the research that has been done by Mr. Garth W. Hastings of England on the matter of shell fatigue." Dr. Vinnik reports a second patient experienced shell fatigue also.
CITE: KMM 427907.

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

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

Contiguous with the gel mass and separately isolated by capsule, was a roughly 4x6 cm irregular nodular mass which upon excision was an obvious siliconoma." The attached pathology report notes that, "The process ranges from a fibrous rather acellular one through concentrations of lymphocytes and plasma cells to small foreign body type giant cells tending to form granulomas. One section demonstrates an acute necrotizing inflammatory cell reaction."
CITE: F 687 - 689

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

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

"(T)here is suspicion in my mind that we are dealing once again, with a shell failure. You will see from the enclosed Pathology Report that this patient had considerable silicone reaction to the extruded material. Review of the sections by the same pathologist who has reviewed all of the silicone injection material with me over the past twelve years shows this reaction to be as marked a reaction as we ever saw with the silicone injections. I believe this proves the point that 'pure silicone' can cause severe foreign body reactions in susceptible individuals."
CITE: F 685 - 686. DUPLICATE: M 780645 - 780646.

Document #343
11/16/81
SILICA

Gene Jakubczak, Dow Corning, informs Sue Peters of a telephone conversation with Dr. Charles Vinnik on 10/10/81. Dr. Vinnik believes that the work performed by Garth Hastings and Paul Wulfusander (sic: Wilflingseder) (his European partners), concerning phagocytoses or silicone shedding from the breast prosthesis, is a factor in the failure of an implant. Also, Dr. Vinnik thought the LS bleed resistant mammary implant was "worse than what was brought out previously." Jakubczak informs Dr. Vinnik, "that we would review the data ... plus Dow Corning's own internal data to determine... the fate of silica shedding from the breast prosthesis." Jakubczak says Dow Corning is also looking at data on the permeation of drugs out of silicone.
CITE: F 728. DUPLICATE; KMM 447167; DCC 242031444.

Document #344
11/30/81
SHELL STRENGTH - THICKNESS

Sue Peters, Dow Corning, memo to Milt Hinsch discussing the shelf life of the Silastic and Silastic II implants after (1) year. "After one year shelf life, the Silastic standard mammary has a 78.6% decrease in tear resistance, a 31.6% decrease in tensile strength, and a 23.3% decrease in elongation." "The Silastic I and Silastic II No Barrier also have significant decreases in tear resistance, tensile strength and elongation after a one year shelf life."
CITE: M 160031 - 160036. DUPLICATE: M 180106 - 180107; M 570068 - 570073; D 247 - 248; F690 - 691; KKA 227400 - 227401; M 180136 - 180137). NOTE: Breast implants lose 50% of their strength when left on the shelf for 1 year but plastic surgeons were never informed.

Document #345
12/10/81
MISCELLANEOUS - COMPLICATIONS
TESTING
TISSUE REACTIONS

Monthly activity summary for a 14-day subchronic oral gavage study with octamethylcyclotetrasiloxane (D4) in rats absolute and relative liver weight data. Lists organ weight data for females foe each animal number and to dosage levels. CITE: P 15115.

Document #346
12/22/81
TESTING
TISSUE REACTION

Hughes Research and Development sends a letter to W. Boley, Dow Corning, regarding the proportion of rats with malignant lymphoma in groups treated with TX-1210 and TX-1211 fluid. It states "We feel that there is a treatment related increase in the incidence of malignant lymphoma in male and female rats treated with TX-1210 and TX-1211...."
CITE: KMM 33826 - 33827. DUPLICATE: KMM 330368 - 339374. NOTE: KMM 339368 includes KMM 339369 - 339374 which is a revision of the histopathology report to evaluate the carcinogenic potential of TX-1208, TX-1209, TX-1210 and TX-1211 (Dow Corning B-7811 implant study in albino rats).

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

Sue Peters, Dow Corning, memo to Milt Hinsch regarding closed capsulotomies and the Silastic II mammary prosthesis. "Please make it very plain to your sales people that it is incorrect to promote or to imply any benefit of this mammary because of increased strength allowing a closed capsulotomy to be performed. We have no data to support that type of claim or implication."
CITE: D 4897. NOTE: Dow Corning did not warn of the risks of closed capsulotomy with the Silastic II until 1986.

Document #348
02/04/82
CONCEALING FROM FDA
FRAUD/MISREPRESENTATION

Handwritten notes concerning the history of the Dow Corning Varifil implant. (Handwriting appears to be Chick Burda's). He notes that in 1977, Petraitis warned Bey and Jakubczak that the "boob tester was indicating failure and Petraitis wanted to spill the story but was not listened too (sic). Petraitis quit." The author also noted that Rathjen was told that it was a business decision and to "fall back."
CITE: KMM 261745 - 261746.

Document #349
03/30/82
SHELL STRENGTH - THICKNESS
SHELL DEGRADATION

Dr. Bernard Morgan writes to Dow Corning Wright regarding implants which "showed heavy leaching and were almost disintegrated.... I would like to know if there is a change in the envelope which produces spontaneous disintegration and/or whether this leaching is a phenomenon which has been reported to you previously."
CITE: KMM 23084

Document #350
04/08/82
CONCEALING FROM FDA

515(B): Betty Lock Wiles, Manager of Regulatory Affairs, Medical Engineering, sends their outline on proposed reclassification to HIMA. (MCG 004946 - 004951). Harvey Steinberg, Senior FDA Legal Counsel to Dow Corning, also sends their outline and comments to HIMA.
CITE: MCG 4953 - 4956

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

Dr. Vinnik sends a letter regarding his meeting with G. Jakubczak, Bob Rylee and Tom Brown, Dow Corning, in which he details many breast implant problems and his proposed solutions. He recommends changing the patient and physician pamphlets to include warnings on shell fatigue, rupture, and gel migration. He provided Jakubczak with the pathology reports of a patient who showed such "...extensive and violent silicone reactions comparable to the worst of those seen with the old silicone injections."
CITE: KMM 140193 - 140197. duplicate: KMM 243027 - 243031; KMM354986- 354990.

Document #352
05/10/82
ACKNOWLEDGEMENT OF NEED FOR TESTING
KNOWLEDGE OF SYSTEMIC DISEASE

J. Cooper, Dow Corning, memo stating that the Two-Year Implant Study of Q7-2167 and Q7-2168 was flawed and useless. Cooper states that, "Prior to completion of the study and interpretation of the results IBT (Industrial Bio-Test Laboratories) was cited by the FDA for poor clinical/laboratory practices including loss of records and falsification of data. The corporation was subsequently dissolved." In addition, "the data were considered highly suspect because of abnormally high disease rates among all of the test animal groups -- including the saline injected and untouched groups.... We have since had opinions from several external pathologists and veterinarians that the colony was disease ridden and the entire exercise was badly flawed and useless. We have concluded this study has resulted in no usable information and that no conclusions can be drawn from it. We are now back at the same point we were at in 1975 except that we have expended $200M in the study and its subsequent evaluation/condemnation."
CITE: F 814 - 815. DUPLICATE: m 170070 - 170071: M 430209 - 430210; KMM 361951 - 361952; KMM 339375 - 339378. NOTE: Dow Corning has no long-term studies and, even though they admit that "we still need the two year study...," Dow Corning does not begin another such study until 1988.

Document #353
05/14/82
TISSUE REACTION
KNOWLEDGE OF SYSTEMIC DISEASE

Dr. Robert Parsons, Professor of Surgery at the University of Chicago, writes a letter to Gene Jakubczak at Dow Corning informing them of their research on implanted silicone prostheses. "our data suggest strongly that the fibrosis and capsular contracture seen clinically maybe (sic) an immunologically mediated phenomenon." (emphasis added). Dr. Parsons states that macrophages aggregate and adhere to the surface and actively erode the silicone envelope after implantation: macrophages ingest and process silicone; macrophag-lymphocyte communication occurs by intracellular bridging in the lymph nodes and have identified silicone containing microvacuoles in both the macrophages and lymphocyte ends of the bridges; and significant inhibition of macrophage migration by silicone sensitized lymphocytes in vitro has been shown. Dr. Parsons, Dr. Heggers and their research assistant, Nir Kossovsky, suggest that their work may enable them to develop a method of screening patients for "hypersensitivity to silicone" before they are implanted.

The research team found that the body's reaction to silicone created giant cells called macrophages that erode the silicone envelope and can migrate to the lymph nodes. Dr. Parsons believes that the body's immune reaction could be causing such problems as capsular contracture. Requests for finding from Dow Corning for further research to better understand this immune response were denied by the company.
CITE: F 748 - 749. DUPLICATE: FDA 19612 - 19613: KMM 447084 - 447085; Staff Report prepared by the Human Resources and Intergovernmental Subcommittee of the Committee on Government Operations, December, 1992, p. 15.

Document #354
05/17/82
FRAUD/MISREPRESENTATION
CONCEALING FROM FDA

Dow Corning submits its portion of the industry-coordinated response to the proposed reclassification to HIMA. Dow Corning's portion consists of a discussion of the long-term effect of silicone breast implants.
CITE: MCG 5454 -5462.

Document #355
10/19/82
TISSUE REACTION
KNOWLEDGE OF SYSTEMIC DISEASE

Eldon Frisch, Dow Corning, responds to Richard Swett, M.D., concerning an allergy-type reaction to Silastic brand implants made from medical grade silicone. Frisch states:

"Clinically, the implants have been used in several million patients with very few reports of suspected inflammatory or allergic reactions. In the past, with one recent exception, when the reactions were evaluated by patch testing, by subdermal implantation of a small specimen, or by cell culture studies of the implant the reactions have universally been negative."

Frisch notes another report of a potential allergic reaction to silicone reported by George Francis, M.D. (emphasis added).
CITE: M 480031 - 480032.

Document #356
05/20/82
CONCEALING FROM FDA

515(B): Two meetings take place in Washington D.C.: one in the morning for manufacturers and HIMA, and afternoon meeting for manufacturers, ASPRS and HIMA, and afternoon meeting for manufacturers, ASPRSS and HIMA. 3M, Dow Corning, Medical Engineering Corporation, ASPRS, HIMA, and the AMA attend the meetings. Harvey Steinberg, Dow Corning's FDA Counsel, Tells group that reclassification is important to Dow because from the industry standpoint "$$ have to be diverted, generated for PMA. (This) effects how co.'s practice - sites, plant improvements ..., effects how management allocates resources. Very significant cost factors enter in." (MCG 5427 - 5431). He also states that "Risks 40 yrs. down the road cannot be determined." Betty Lock Wiles, Surgitek, writes a memo to Surgitek personnel about the May 20 meeting and states that the manufacturers "reviewed the cost, time, and liability affect of Class III."
CITE: MCG 5427 - 5431. DUPLICATE: MED 11222.

Document #357
06/03/82
MISCELLANEOUS - LOBBYING
TESTING

Letter to Goldwyn from Rathjen regarding the unacceptable situation with the clinical investigators, "I am missing annual follow-up reports (see protocol), photographs, injection reports, etc. With a very few investigators, the lack of attention to the protocol is absolutely unacceptable. ... The FDA doesn't want to hear excuses why investigators' records are incomplete or why there is an apparent lack of control or attention to detail. ... This impression concerning the conduct and results could conceivably carry over into other device areas, i.e., the breast prosthesis reclassification." Strongly worded letter.
CITE: DCC 106006096 - 106006099, Exhibit to MDL Rathjen Deposition.

Document #358
06/11/82
GEL MIGRATION

Burda, Dow Corning, reports on Complaint Report WM2570 in which the left implant ruptured and "silicone gel migrated down the patient's arm."
CITE: CO 1417 - 1429.

Document #359
06/30/82
CONCEALING FROM FDA

FDA: Dow corning submits its response to the FDA concerning the proposed reclassification of silicone breast implants.
CITE: KMM 275488 - 275512.

Document #360
07/13/82
KNOWLEDGE OF GEL BLEED

Duel, Dow Corning, memo to Jakubczak regarding comments, questions and recommendations on the letter from Dr. Schmidt. Among Duel's comments are shells are very oily, we lubricate the valves with silicone, H.P. shells have visually more bleed, all gel-saline units bleed, and our distributors are well educated but poorly informed.
CITE: M 250033 - 250034.

Document #361
08/11/82
ACKNOWLEDGEMENT OF NEED FOR TESTING

Gene Jakubczak, Dow Corning, memo to Jim Wessel and Jerry Marlar on the two year rat implant studies using mammary prosthesis silicone gels. He supports the acquisition of implant data on Q7-2167 and Q7-2168 gels. Further, he "recommend(s) that systemic fate of the material or extract should be stud(ied) as well as the metabolic fate.... The study should be expanded to make sure that we know what happens to gel bleed or gel and what is its metabolic fate."
CITE: M 250033 - 250034.

Document #362
09/01/82
SHELL STRENGTH - THICKNESS

Tom Brown, Dow Corning, memo to Milt Hinsch about the staggering reject rate with the larger size Silastic II mammaries. Dow Corning changes from a 3.2 cm patch to a 4.5 cm patch to "compensate for the inherently less responsive and elastic character of the Flourosilicone-coated envelope.CITE: d 2226

Document #363
09/13/82
COHESIVENESS - LIQUID COMPONENT OF GEL

McMahon and Sweet, Dow Corning, memo to Cooper and Metevia regarding "Progress Report On The Mammary Gel Cohesion Project." Sample implants were taken from the plant and a gel cohesion test was performed. "The data generated showed that 23% failed the gel cohesion test." They observe that "inconsistency within a lot could mean mechanical breakdown of gel or a shift of the cross-link network." Also, they state, "First of all, we found that the catalyzed gel was approximately 75% non-reactive fluid...." Using gel with the additional factors enter in "although the extent of importance is not understood. The mammary envelope is an addition cured elastomer and ... any unsaturated vinyl groups at the envelope/gel interface can react with active hydrogen from the gel cross-linker. If this occurs then part of the cross-linking network is disturbed."
CITE: KKA 245424 - 245426

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

Dr. Charles Vinnik letter to Robert Rylee, Dow Corning, regarding a patient who experienced severe reaction to the gel in a ruptured Silastic implant. Dr. Vinnik states, "Review of the sections by the same pathologist who has reviewed all of the silicone injection material with me over the past twelve years shows this reaction to be as marked a reaction as we ever saw with the silicone injections. I believe this proves the point that 'pure silicone' can cause severe foreign body reactions in susceptible individuals."
CITE: M 780645 - 780649. NOTE: See 12/06/83 entry. M 780641 - 780644, for the second letter written to Rylee regarding this same patient.

Document #365
11/05/82
FRAUD/MISREPRESENTATION

L. Smith, Dow Corning, memo regarding implementation of a complaint system "Direct Response" program. She states that the reviewer should "not say anything on the form that you do not want the complainant to know." There will be a separate form to write on which will not be provided to the complainant.
CITE: KKA 236497.

Document #366
12/17/82
TESTING

Letter to Dr. Goldwyn from Rathjen regarding receipt of clinical data, "the quality of documentation is self explanatory. Absolutely unacceptable! I suspect the validity! ... There is no room for friendships here. He has embarrassed you and me, he has disregarded the Protocol, ignored the reputation of his colleagues and the A.S.P.R.S."
CITY: DCC 106003897, Exhibit to MDL Rathjen Deposition.

Document #367
00/00/83
SILICA

Researcher N. Kossovsky studies the surface morphology of explanted mammary prostheses and reports that the surface was covered with embedded spheres and surrounded by pits. Kossovsky suggests these surface anomalies may be the result of the "grazing" of silica filler particles from the envelope of the prosthesis by phagocytic cells. CITE: M 790186 - 790193.

Document #368
01/26/83
TISSUE REACTION
KNOWLEDGE OF SYSTEMIC DISEASE
GEL MIGRATION
RUPTURE
TESTING
CONCEALING FROM FDA

Dr. Nirmal Mishra, staff toxicologist at the FDA, presents the FDA's reasons for this recommendation which include: gel migration, granulomatous foreign body reaction, loading of the reticuloendothelium system, unknown subsequent disposition in the body with little epidemiologic or experimental data on effects.
CITEP KMM 120705 - 120729, Exhibit 3 to Harris County Rathjen Deposition. DUPLICATE; M 100083 - 100143.

Document #369
02/02/83
KNOWLEDGE OF LIQUID SILICONE DANGERS
KNOWLEDGE OF SYSTEMIC DISEASE
Stark, Dow Corning, memo to Marlar, Rathjen, Steinberg, Jakubczak, Weyenberg, Lentz and Hobbs reporting that "the number and type of abnormalities noted with the 360 fluid studies in rabbits, i.e., classic cyclops condition of the eyes, clubbing of extremities, ankles bent in the wrong direction, were all indications of potential birth defects related to silicones: and the "this issue is of paramount importance. It has relevancy to the safety of all silicone applications and must be resolved ASAP.
CITE: DCC 17042386 - 17042387, Exhibit to California Lentz Deposition, Exhibit 93 to Bennett Deposition, and Exhibit to MDL Rathjen Deposition. DUPLICATE: KKA 22785 - 22786.

Document #370
02/03/83
KNOWLEDGE OF GEL BLEED
MISCELLANEOUS - PRODUCT LABELLING

G. Jakubczak, Dow Corning, memo to Milt Hinsch regarding revisions to the package insert for the Silastic implant. Jakubczak suggests routing all comments on inserts to Jim Matherly, Chick Burda, Harvey Steinberg and Marcia Marsh since this is a "very high potential liability product." Jakubczak suggest adding language on silicone bleed - "Silicone bleed from a gel filled mammary has been identified in surrounding tissue."
CITE: KMM 301297 - 301301. NOTE: Need to cross check the final package insert to see if Jakubczak's suggestions were incorporated.

Document #371
02/17/83
TESTING

Hobbs, Dow Corning, memo to Lentz stating that data produced 15 years ago would likely produce adverse publicity because the data does produce doubt, the laboratories producing the data can easily be criticized relative to their performance standards and the studies involved would likely not withstand validation.
CITE: DCC 204005659 - 204005660.

Document #372
04/01/83
KNOWLEDGE OF SYSTEMIC DISEASE
MISCELLANEOUS - COMPLICATIONS

Gregory patient no. 29 follow-up. The patient developed rheumatoid arthritis in the back and shoulders and has an over active thyroid.
CITE: B 1453 - 1454, Exhibit 14 to Harris County Rathjen Deposition, Exhibit to MKL Rathjen Deposition.

Document #373
04/05/83
DOCUMENT DESTRUCTION

C. Burda, Dow Corning, memo to J. Matherly regarding the "severe status of record keeping by TSS&D" on Slapstic II Lot History Records. Burda states, "Tim Pinto and I encountered a serious problem of HX master records being incomplete and/or missing." When "Attempting to determine the number of Silastic II implants distributed by Dow Corning the following conditions have been encountered. Master HX records have not been properly prepared and recorded. Many ... are not available for lots processed by the plant. Supportive records and/or references are often not provided." There is also a four page listing of irregularities found in at least 56 lot history and device master records including the reject cause tally does not reconcile with the quantity rejected, incomplete and missing information in the records, sizes combined in a single lot, and implants unaccounted for. "The HX master record is (a) suitable document for device manufacturing work. But it has not been used properly. As the records indicate people using it do not use it as a serious GMP type document. The management of the HX system is totally missing as written by failure to check and approve each lot. Furthermore it appears no audit was ever performed to check if HX lots were ever completed and records returned.... There are no exceptions for failure to comply to good manufacturing processes."
CITE; D 4924 - 4929. NOTE: Dow Corning has cited to lot history records in responding to inquiries from the FDA and Physicians about problems with implant shells. Specifically, Dow Corning Claims that the lot history records show that there was no problem with the particular lot in question. See, e.g., 06/21/82 entry.

Document #374
04/20/83
COHESIVENESS - LIQUID COMPONENT OF GEL

Gene Jakubczak and Tom Brown of Dow Corning recommend rejection of loose gel HH0223099 (Drums 1,2) (Used in Silastic II Mammaries) as "unsuitable for sale." The lot of gel passed all lot acceptance requirements but it was atypical gel. The recommendation is based upon their observations that the gel "appeared sloppy," that some Slapsti II units "failed catastrophically," and others failed ASTM cohesivity tests. "Gel fell en masse from envelopes.... Gel appeared to 'flow' and when manual attempt to squeeze from envelope was made, no tendency to spring back into the envelope was noted upon release.' (emphasis added). Further, "On the basis of the risk which would be posed to a patient having one of these units implanted, prudence requires their rejection. The ease with which gel may be displaced from the shell (as evidenced in the hang test) is sufficient cause for concern."
CITE: F 726 - 727. DUPLICATE: DCC 800441416 - 80041417.

Document #375
05/03/83
COHESIVENESS - LIQUID COMPONENT OF GEL

Dr. Vinnik writes to Robert Rylee, Dow Corning Wright, regarding a Dow Corning silicone gel implant "which does not appear to conform to your own minimal specifications with respect to gel cohesion." The attached Operative Report notes "THE GEL ON BOTH SIDES APPEARED TO BE DEFECTIVE, BEING EXCESSIVELY THIN AND RUNNY."
CITE: KMM 3885 - 3891

Document #376
07/20/83
ACKNOWLEDGEMENT OF NEED FOR TESTING
KNOWLEDGE OF SYSTEMIC DISEASE

C. Lentz, Dow Corning, memo to D. Weyenberg discussing staffing needs to conduct toxicological studies. He writes, "The work we do has a wide range of urgency connected with it. On one end of the range is the work that must be done now and on the other end is work which needs to be done some time but can be put off for now ...until it reaches the 'must be done now' stage." Lentze states that Dow Corning's current mode is that the toxicology department is understaffed or "inadequately' staffed, that they are "borrowing" pathology and veterinary skills from Dow Chemical and that Dow Corning has "no resources available to do long term studies or fundamental information type studies." Lentz urges Dow Corning to immediately hire two people to meet Dow Corning's "here and now obligations." A long term (2 year) state of the art study on the health effects, including carcinogenic potential of implanted silicone gel "must be done. Dow Corning no longer has the option of not doing or delaying the study.'

Lentz adds, "Commencement of a gel implant study is overdue and at this time we would not be able to convincingly demonstrate due diligence in pursuing knowledge."

One of the recipients of the memo, Forrest Stark, writes a handwritten note back to Lentz at the top of M 420069: "Bringing appropriate professionals in house has my wholehearted support. I still think that a reorganized TOX within HES could give us efficiencies."
CITE: M 420068 - 420072, Exhibit to Harris County Boley Deposition, Exhibit 7 to Zimmer Deposition, Exhibit to Rylan Deposition, and Exhibit 19 to Harris County Zahalsky Deposition.

Document #377
08/09/83
ACKNOWLEGEMENT OF NEED FOR TESTING
KNOWLEDGE OF SYSTEMIC DISEASE
TESTING
TISSUE REACTION

Memo to Rathjen from Isquith regarding Immunological Research Proposal, "It has long concerned me that our knowledge in this area is virtually nil and should not be. ... Knowledge from such a study ... could be a tremendous asset in better understanding tissue reaction to silicone implants."
CITE: KMM 205513 , Exhibit to Isquith Deposition and Exhibit 65 to MDL Rathjen Deposition.

Document #378
08/25/83
ACKNOWLEDGEMENT OF NEED FOR TESTING

Weyenberg, Dow Corning, memo to C. Lentz. J. Cooper, Rylee, Stark, Steinberg, and Ziarno regarding a toxicity evaluation of silicone gel.

"Will you please take the leadership in the preparation of a definitive proposal for a chronic tox study on gel implants? Please consider the options of a study conducted within our TOX Department versus and externally funded study. The proposal should include the options and your recommendations on scope, expense (including APS) and timing for the study--A proposal which can be used by the Health Care Group and the RDES function for decisions on funding this project.
CITE: M 420067.

Document #379
09/15/83
ACKNOWLEDGEMENT OF NEED FOR TESTING

Boley, Dow Corning, memo to J. Matherly regarding "Biological Safety Testing Of Gel For Implants." He states the "only gel to my knowledge that has had long-term implant testing performed on it" is X-3-0885 (Sylgard 51). "Gel Q7-2218 only has tissue cell culture data available for it. Therefore, if we are to continue to sell this material as "medical Grade," immediate action should be taken to bring it into compliance with the business definition of Medical Grade."

"It is my opinion the Q7-2167/2168, Q7-2150/2146, and X-3-0885 are similar enough in formulation such that testing performed on one gel is applicable to the other two... we have no valid long-term implant data to substantiate the safety of gels for long-term implant use.... Only inferential data exists to substantiate the long-term safety of these gels for human implant applications.
CITE: F 838 - 839. duplicate: M 170034 - 170036; M 580061; KMM 380518 - 380520; KMM 140198: KMM 386581: KMM 483550 - 483552; KFD 1655 - 1658: KKA 1. NOTE: In 1983, Dow Corning is till complaining of no long term testing and no real safety data.

Document #380
09/23/83
FRAUD/MISREPRESENTATION
ACKNOWLEDGEMENT OF NEED FOR TESTING
TESTING

Jim Matherly, Dow Corning Wright, memo to Jim Cooper and Jerry Zoarmp. Regarding Biological Testing of Gel For Implants Matherly states that:

"Within the past two months, we have received inquiries relating to a broken gel testicle and a broken mammary, as well as from Cox-Uphoff and Ruthton Corporation. To our embarrassment, we were unable to provide more than tissue culture and heavy metals analysis. Furthermore, our product literature on these gels imply that safety testing to qualify them as implant materials does exist and can be obtained readily from Dow Corning."

Matherly notes an added rationale for the safety of the implants is the assumption the gel is contained in an envelope. "This supposes that ruptures do not occur or are removed quickly... (but) experience has shown this later statement to not be accurate...." Matherly concludes "Only inferential data exists to substantiate the long-term safety of these gels for human implant applications." He also points out the "data produced by IBT is ... generally suspect in the industry due to their poor laboratory practices."
CITE: m 170037 - 170038. DUPLICATE: F 854 - 855: m 430215 - 430216: F 838 - 855: KMM 483548 - 483549: KKA 4 - 5; KMM 27693 - 27694; KMM 361961 - 361962: KMM 329306 - 329309: KMM 380521 - 380522.

Document #381
09/26/83
ACKNOWLEDGEMENT OF NEED FOR TESTING
MISCELLANEOUS - PRODUCT LABELING
TESTING
TISSUE REACTION

Boley, Dow Corning, memo to Marlar, Rylee, Wessel, Cooper, Rathjen and Hobbs with copies to Lentz, Stark and Steinberg regarding "Repeat of Dr. Heggers Published Procedures Claiming Antigenicity Of Silicone Gel." Boley wanted to repeat the study with an outside laboratory but the estimated cost of $20,000 was too much. He states: So Economically, I find it difficult to justify expending much time and money on this matter. For the present, I believe it may be adequate to begin updating our product data sheets to read "low-sensitization" or "minimal sensitization" rather than "non-sensitizing." The issue of sensitization of silicone polymers will eventually be resolved by the medical community with or without our help. Therefore, perhaps the appropriate course is to wait. In any event, the sensitization potential of silicones will be extremely low or non-existent and therefore, should have little economic impact on Dow Corning."
CITE: KMM 337395.

Document #382
09/30/83
COHESIVENESS - LIQUID COMPONENT OF GEL
TESTING
KNOWLEDGE OF GEL BLEED

Dow Corning "Investigation of Q7-2167/2168 Formulation Parameters Which Might Influence Gel Cohesivity And Bleed" by Joan McMahon, Randall Sweet, and Virgil Metevia. They discuss that in mid-1982, Dow Corning Wright's TS&D requested the Medical materials Department of Dow Corning to address issues of gel cohesivity and bleed with Q7-2159A (the gel used in Silastic and Silastic II), which is the catalyzed version of Q7-2167/2168 gel.

Thirty (30) mammaries were taken from inventory and tested. 23.3% (7 of 30) failed the cohesivity test. Mammaries within the same lot passed while others in the same lot failed this test. Some has excessive bleed and some did not. There was little area where the gel would be cohesive and still fall in the specification range of 75-300. Data showed the specification could be brought to 50-150 and still likely pass the ASTM F703-81 gel cohesivity test. The responsiveness of 50 penetrations was not considered to be objectionable. Gel bleed is already known to be a problem.
CITE: KKA 121630 - 121669. DUPLICATE: KKA 88488 - 88495; KMM 270149 -270162; KMM 173990.

Document #383
10/05/83
FRAUD/MISREPRESENTATION

Bruce Reuter, Dow Corning, memo to the Territory Managers and Sales Representatives regarding Natural Y breast implants. Reuter lists Natural Y's claims about polyurethane implants and cites to medical publications which disprove their claims. Reuter criticizes Natural Y for not having supporting references for its claims. He states that, "The contracture free claim is a joke! We have had reports of infection, pre-operative rupturing and contracture from around the country." Additionally, Reuter states, "Have you felt a Natural Y prosthesis. There is no envelope around the gel, just an easy peel off foam coating. The FDA is going to move mammaries from Class II to Class III because of the concerns with gel bleed and here is a mammary that is a gel bleed time bomb."
CITE: KKH 56082 - 56087. DUPLICATE: D4503

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

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

"The silicone gel, as demonstrated to Mr. Reuter and Mr. McGuire, and as seen and commented on by Mr. Matherly, Ms. Duel, Mr. Jakubczak and others at Dow Corning was in fact lacking in cohesion. Various theories were postulated as to why this gel was not cohesive and thus reacted as migratory gel within this patient's body producing considerable inflammation, foreign body reaction and discomfort. Nonetheless, all of these theories are moot as there has never been any representation to the medical public or the lay public that in any way, shape or fashion does the silicone gel change its physical characteristics once implanted in the human body with or without the intact shell.... There would be no requests to you for compensation for this patient's problem were the gel cohesive. If the gel was cohesive, she would have no problem.... I think (this) points up the fact that there should be some type of a liability insurance scheme with impartial analysis which would appropriately compensate people for products which are defective. I keep using the word 'defective' with respect to the silicone gel as there is yet to be any hard scientific evidence to show that what happened in this patient's case is anything other a defect in manufacture
CITE: KKA 246750 - 246753. DUPLICATE: KKA 152422 - 152425; M 780641 -780644.

Document #385
12/13/83
CONCEALING FROM FDA
TISSUE REACTION
KNOWLEDGE OF GEL BLEED

FDA: "The FDA inspects Dow Corning's Hemlock plan and lists numerous violations in the complaint reporting system. The investigator notes that Complaint MD 1081 dated 04/21/81 showed a "giant cell reaction with imbedded silicone particles." Dow Corning failed to follow-up this complaint and get more information. Also, there were numerous complaints about implants being "greasy" and Dow Corning had failed to respond to them. Other violations included production records, oven records, "dirt & debris on top of packaged sterile mammaries," and other problems with sterility in the dipping room and manufacturing process.
CITE: FDA 17098 - 17137.

Document #386
12/27/83
MISCELLANEOUS - COMPLICATIONS
MISCELLANEOUS - PRODUCT LABELING
TISSUE REACTION

Lentz memo to Marlar with copies to Boley, Cooper, Hobbs, Rathjen, Rylee, Steinberg and Wessel regarding Marlar's 11/21 memo about "plans to change the silicone gel product literature to indicate some degree of sensitization.... I would like you to delay a final action on this plan until a group representing a broader product responsibility in the corporation has had a chance to discuss the subject and reach a conclusion. I believe this is essential because the major component of gel is polydimethylsiloxane. This material is used in a very broad spectrum of products and consequently a variety of human exposure does occur. For example, PDMS is used in a variety of personal care products, such as skin lotions. If your literature suggests silicone gel causes some degree of sensitization, there is significant potential for implicating other PDMS products."
CITE: KMM 336678

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

Dr. Charles A. Vinnik writes to Gene Jakubczak of Dow Corning regarding a pathology report from a patient whose implant lost its shell integrity. The pathologist found some silicone material engulfed by macrophages. "The type of reaction seen here is very similar to that in which liquid silicone is ingested by phagocytes converting them to foreign body giant cells and 'foamy macrophages'." (emphasis added). One of the rationales given by Dr. Vinnik for this reaction is, "The factor X within the shell of the implant. the reaction ... sustained is very similar to those which I have seen rarely over the years associated with faulty polymerization of the shell and/or filler. It is possible that the birefringent particles described by the pathologist (was) silica used as the filler material in the implant shell.... These findings have been reported by Wilflingseder and Brown with the silica particles confirmed by scanning electron microscopy." Dr. Vinnik hopes that Dow Corning will do more than its "usual casual, perfunctory and useless analysis...."
CITE: M 490041 - 490045. DUPLICATE: KKA 246784 - 246785

Document #388
02/16/84
ACKNOWLEDGEMENT OF NEED FOR TESTING
KNOWLEDGE OF SYSTEMIC DISEASE
TESTING

Holmes, Dow Corning, memo to Rathjen regarding "S.H. Miller Study Protocol." Holmes states: "It seems almost inconceivable that we do not know more about the human immunological response to silicone at this point...." He states that the study is "certainly needed" and that Dow Corning should support it.
CITE: KMM 205503, Exhibit to MDL Rathjen Deposition.

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

E. Frisch, Dow Corning, memo to R. Dumas, G. Jakubczak, and S. McGuire referring to a visit with Dr. Vinnik. Dr. Vinnik stated that many of Dow Corning's implants were "defective with thin spots causing them to be easily ruptured.... The gel in removed implants has lost its cohesiveness, and suggested that biodegradation may be occurring." Frisch claims it is not Dow Corning's envelopes and gel which are the problem, but that implant manipulation "would probably result in localized stressing of some areas of the implant, particularly if there were a thin spot, or if the stretching were uneven such that it created an aneurysm. The subsequent manipulations would probably stretch these areas resulting in progressive weakening and ultimately rupture...." There is no machine that duplicates this kind of manipulation that is commonly recommended by doctors to prevent capsular contracture.
CITE: KMM 259750 - 259751. DUPLICATE: DCC 80030963 - 80030966.

Document #390
03/14/84
COHESIVENESS - LIQUID COMPONENT OF GEL
TISSUE REACTION

Dr. Charles Vinnik, Dow Corning, letter to Gene Jakubczak, Dow Corning, regarding an implant which had lost its shell integrity. "(T)he patient did have a silicone reaction exterior to the intact capsule...." He states that Dow Corning's gel was "greatly inferior" to other manufacturer's gel because of its "looser consistency." Bruce Reuter, Dow Corning's National Sales Manager, writes at the top of the letter, "I think we should cut Dr. V. loose!"
CITE: DCC 242051086 - 242051087

Smoke/Fire Document #391
03/30/84
TESTING

Abstract of Dow Corning study of "Tissue Cell Biocompatability of Dow Corning 200 Fluid, 65 cs" states that, "The test material was evaluated for cytopathic effect by placing the material in direct contact with a confluent monolayer of human embryonic cells.... A distinct cytopathic effect was observed by the test material in both initial and retesting of the samples."
CITE: 38813 - 38821. DUPLICATE: KKH 59302 - 59320.

Document #392
04/16/84
ACKNOWLEDGEMENT OF NEED FOR TESTING
TESTING

Letter to Miller from Rathjen re the March 28th letter covering prospective breast study,. In July, patients will receive an examination for their 12 year follow-up.
CITE: KMM 205496 - 205497, Exhibit to MDL Rathjen Deposition.

Document #393
04/18/84
TESTING
GEL MIGRATION

Linda Veresh, Dow Corning, "Final Report on Dow Corning 382 Elastomer, skin sensitization test; the original report is dated 1982. Two of the guinea pigs died with no cause determined but the implants had migrated and whitish lesions and granular particles were found on the lung, ventricles of the heart, spleen and liver. In addition, hemorrhagic spots were found on the cerebrum.
CITE: T 11768 - 11817

Document #394
04/23/84
DOCUMENT DESTRUCTION
COHESIVENESS - LIQUID COMPONENT OF GEL

Reuter, "Dow Corning, memo to Wessel regarding C. Vinnik's runny gel complaints. "These escapades are costly! The price tag on this one is greater than $3,000.00 and we settled another claim for $5,000.00 late in 1983. ... P.S. Please read memo then destroy. Do not keep for files."
CITE: KKH 76226. DUPLICATE: M 490088.

Document #395
04/26/84
DOCUMENT DESTRUCTION
FRAUD/MISREPRESENTATION
TISSUE REACTION

Handwritten note to Jakubczak, Dow Corning, that Wessel called regarding Dr. Barker. "Please call Dr. Barker re two sentences Jim thinks should be deleted to reduce product liability. 1. Chronic inflammatory cells caused by gel. 2. Gel causes contracture. Jim feels above does not reflect the truth."
CITE: M 500016. NOTE: "Dr. Barker was writing an article about capsular contracture with silicone breast implants.

Document #396
05/09/84
KNOWEDGE OF SYSTEMIC DISEASE

Eldon Frisch, Dow Corning, memo to Bill Boley, Marcia Marsh, and Jim Wessel concerning Baxter Travenol's presentation at the biomaterials Meeting. The poster presentation demonstrated a cell culture method Baxter developed for assessment of immunotoxicity. Frisch states that Baxter "tested a number of materials, including silicones, and have found that many, if not most, plastics and elastomers elicit an immunotoxicity reaction. ... This may be of interest in the alleged case of human adjuvant disease."
CITE: KMM 37828.

Document #397
05/21/84
KNOWLEDGE OF SYSTEMIC DISEASE

Frisch, Dow Corning, letter to Dr. John Madden (cc to Boley) regarding a female hydrocephalic patient described in an attached abstract entitled "Evidence For Immune Response to Silastic Implants" by Michael R. Wasserman. The described patient experienced an alleged immune response to silicone elastomer.
CITE: DCC 10005769 - 10005770.

Document #398
06/84
KNOWLEDGE OF SYSTEMIC DISEASE
MISCELLANEOUS - COMPLICATIONS

Gregory follow-up for patient no. 8. She developed arthritis in 1978, 6 years post-implantation.
CITE: B 1084 - 1085, Exhibit 11 to Harris County Rathjen Deposition, Exhibit to MDL Rathjen Deposition.

Document #399
07/09/84
KNOWLEDGE OF SYSTEMIC DISEASE
MISCELLANEOUS - COMPLICATIONS

Gregory follow-up of patient no. 48. Five years post-implantation she was diagnosed with idiopathic thrombocytopenia purpura.
CITE: B 727 - 750, Texas Exhibit No. 8, Exhibit to Harris County Rathjen Deposition, and Exhibit to MDL Rathjen Deposition.

Document #400
07/09/84
KNOWLEDGE OF SYSTEMIC DISEASE
MISCELLANEOUS - COMPLICATIONS

Gregory follow-up of patient no. 26. The patient developed arthritis in her fingers.
CITE: B 1401 - 1403, Exhibit 12B to Harris County Rathjen Deposition, and Exhibit to MDL Rathjen Deposition.

Document #401
07/09/84
KNOWLEDGE OF SYSTEMIC DISEASE
MISCELLANEOUS - COMPLICATIONS

Gregory follow-up of patient no. 47. The patient developed urinary bladder papiloma and a palpable node in the left axilla.
CITE: BL 676 - 709, Exhibit 17B to Harris County Rathjen Deposition, and Exhibit to MDL Rathjen Deposition.

Document #402
07/09/84
KNOWLEDGE OF SYSTEMIC DISEASE
MISCELLANEOUS - COMPLICATIONS

Gregory follow-up of patient no. 36. The patient developed rheumatoid arthritis in the upper extremities.
CITE: B 1584 - 1586, Exhibit 16 to Harris County Rathjen Deposition, and Exhibit To MDL Rathjen Deposition. DUPLICATE: DCD 173003868 - 173003869

Document #403
07/09/84
KNOWLEDGE OF SYSTEMIC DISEASE
MISCELLANEOUS - COMPLICATIONS

Gregory follow-up of patient no. 31. The patient developed discoid lupus in 1982.
CITE: B 1516 - 1517, Exhibit 15 to Harris County Rathjen Deposition, and Exhibit to MDL Rathjen Deposition.

Document #404
07/10/84
KNOWLEDGE OF SYSTEMIC DISEASE
MISCELLANEOUS - COMPLICATIONS

Gregory follow-up of patient no. 50. The patient had minor arthritic changes in her hands.
CITE: B 804 - 805, Exhibit 18 to Harris County Rathjen Deposition, and Exhibit to MDL Rathjen Deposition.

Document #405
08/01/84
IDENTIFICATION OF CHEMICALS

Joint Research Agreement For Identification Of Agricultural Chemicals between Dow Corning (signed by Weyenberg) and Dow Chemical (signed by P. Gehring). Dow Chemical produces and sells pesticides, herbicides,
insecticides, acaricides, nematocides and fungicides and has developed expertise in perceiving structural-activity relationships in non-organosilicon compounds. Dow Corning has expertise in the synthesis and manufacture of organosilicon compounds referred to as silicones. The parties will work together to "identify commercially salable organosilicon compounds and formulations therof with biological activity as pesticides in the agricultural chemical field...: Dow Corning appoints Dr. John Ryan as its representative: Dow Chemical appoints Dr. Yulan Tong. The Joint Research Program will begin with 1 or more meetings between the designated representatives. Dow Chemical will disclose the type of pesticides it seeks to develop and the kinds of chemical structural groups that DOW believes impart desired agricultural chemical properties. The parties may select compounds for screen tests by Dow Chemical. The designated representatives shall generate a plan for conduct of the Joint Research Program. The information developed under this program shall be kept confidential for 10 years.
CITE: DCC 2001173 - 2001192.

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

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

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

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

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

Dumas also documents the practice of sending returned implants to TS&D from the Medical Plant in mail envelopes via the plant mail. "Many of the units arrived in a smashed condition making analysis extremely difficult. Imagine trying to analyze a mammary flattened like a pancake inside a gel soaked mail envelope."
CITE: KKA 119771 - 119774.

Document # 407
08/27/84
KNOWLEDGE OF SYSTEMIC DISEASE
MISCELLANEOUS - COMPLICATIONS

Operative report of a Gregory patient indicates a "tingling numbness which radiates up and down both legs. The point of onset varies each time; it may start in the groin, thigh or calf region but always involves both legs" She was diagnosed with aortofemoral stenosis.
CITE: B 1017 - 1019, Exhibit 10 to Harris County Rathjen Deposition, and Exhibit to MDL Rathjen Deposition.

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

Dr. Muller sends a letter to Dow Corning Valbonne regarding a rupture in situ. When he performed the explantation, he found only gel and no envelope. "In our opinion, this result is very critical." He requests information from Dow Corning.
CITE: M 460195. NOTE: Dow Corning does not respond to the substance of Dr. Muller's inquiry for three years when, after considerable letter writing, Jakubczak answers him in a letter dated 08/13/87.

Document #409
10/22/84
KNOWLEDGE OF SYSTEMIC DISEASE
TESTING

Devries and Siddiqui, Dow Corning, report the results of the "Acute Oral Toxicity Study of Diphenylmethylsilanol In "Rats, "TX-84-0110-03. Signs of toxicity exhibited by rats include lethargy, tremors, slight ataxia and coma which terminated in death. The authors conclude that diphenylmethylsilanol is "slightly toxic" when ingested on an acute basis targeting the central nervous system.
CITE: T 29120 - 29165. DUPLICATE: CGS 1321 - 1322. NOTE: Refers to complaint CGS 1306 -1319.

Document 410
12/07/84
KNOWLEDGE OF SYSTEMIC DISEASE TISSUE REACTION

Veresh, Dow Corning, report on the "Ninety-Day Implant Study of Dow Corning Q7-2218 Silicone Gel System." The pathologist noticed the presence of "a mild to moderate eosinophil infiltrate in the intramuscular and subcutaneous Q7-2218 implant sites in Rabbit #1564 at 30 days, and a trace eosinophil infiltrate at an intramuscular Q7-22l8 site in Rabbit #1570 at 90 days. Dr. Geil noted that the presence of eosinophil in a tissue response is considered indicative of an allergic response."
CITE: T 39610 - 39704.

Document #411
01/02/85
ACKNOWLEDGEMENT OF NEED FOR TESTING
FRAUD/MISREPRESENTATION
KNOWLEDGE OF SYSTEMIC DISEASE
TESTING

Frye memo to C. Lentz regarding "1984 accomplishments." There is inconclusive daphnia data/D4 data. Frye also notes the "concerted year-end efforts to respond to the ITC recommendations for further testing of D4 for environmental fate and ecological impact. We might also include our efforts to head off publication of VanDerPost's silanol nonsense in a highly respected journal. It should at least qualify as 'fire prevention' effort where I would also classify our correspondence relating to Shin Etsu Hondotai's allegations of cyclosiloxane insecticidal (sic) properties and the Hutzinger et al manuscript alleging absorption and bio-transformation of a series of cyclic and linear oligomeric methylsiloxanes. Our Kyoto presentation was also an attempt to prevent silicones in aquatic sediments from being improperly categorized as ecologically threatening materials."
CITE: FRY 364 - 366, Exhibit 2 to Ryan Deposition.

Document #412
01/08/85
TESTING

J. Cooper, Dow Corning, memo to C. Lentz, R. Rylee, H. Steinberg and K. Yerrick concerning "Biosafety Testing Concerns." There is an apparent shift by the FDA to require animal lifetime, device carcinogenic potential testing for all new implant applications.

If we operate from the premise that lifetime carcinogen testing is required, our only approved materials are HP Elastomers, the mammary shell material (MDF0077) and MDX44515 (a peroxide catalyzed elastomer) all of which were tested in rats for two years.

Most of our claims to date have been based on a two-year dog study (five materials). However, a dog study must continue for seven years to qualify as lifetime testing. The materials used in the two-year dog test would not be approved under the lifetime test criteria. These include Adhesive A, MDF 0372 Tubing, MDF 0355 Foam Elastomer and MDF 0382 Elastomers....

Heaven forbid, is it possible the FDA will require such testing for each combination of materials for each application? This must be vigorously opposed. (emphasis added). Cooper also urges Dow Corning to conduct a study of the effects of the human immune system of silicone gels, fluids, and elastomer particles.
CITE: M 170062 - 170065. DUPLICATE: F 751 - 754; KKA 160337 - 160341. NOTE: In l985, Dow Corning is complaining about the FDA requirements which they can not meet.

Document #413
01/29/85
ACKNOWLEDGEMENT OF NEED FOR TESTING

A.J. Isquith, Dow Corning, memo to W.F. Boley with recommendations for Dow Corning Q7-2159A gel basic genetic toxicology screening. "It is important to recognize that the tests outlined are capable of measuring genetic potential of chemical toxicity. The tests would not detect cancer potential due to hormonal imbalance (example, effect of estrogen or 2,6-cis diphenylhexamethylcyclotetrasiloxane) or cancer caused by chronic tissue destruction related to the geometry or physical state of an implanted material (solid state carcinogenicity)."
CITE: F 853, Exhibit 12 to Isquith Deposition, Exhibit to Harris County Boley Deposition, and Exhibit 19 to Harris County Zahalsky Deposition. DUPLICATE: M 170040 - 170041; M 580052. NOTE: See 03/07/85 entry.

Document #414
02/19/85
ACKNOWLEDGEMENT OF NEED FOR TESTING
KNOWLEDGE OF SYSTEMIC DISEASE

Boley, Malczewski and Cooper of Dow Corning Health Care Group Research submit a Project Proposal titled "Investigation of the Effects of Silicone Fluids, Gels and Particles on the Immune System." Proposed is an immunotoxicology program involving "a series of animal tests and in vitro tests designed to assess the risk of adverse immunological sequela associated with the presence of silicone materials in the human." The authors note that silicone materials are causally linked to three different immunology-related disease states. First, a direct immunological sensitizations to implanted silicone material involving an immediate systemic response which is not correctable by explantation. Finally, the presence of silicone material in the lymphatic system may suppress the immune response to pathogenic organisms and tumor cells. Animal studies suggest that silicone materials modify the immune system both by eliciting a specific immune response and by nonspecifically enhancing or suppressing the immune system. Further, many recent clinical reports in the medical literature suggest that silicone materials elicit or modify the immune system. More sensitive testing methods by some researchers finding an immune response to silicone materials may explain conflicting reports by others who do not. Accordingly, proposed is a comprehensive screen of the immunotoxicity potential of silicone fluids, gels and particles. More than five series of sensitive in vitro tests will access nonspecific suppressing or enhancement of individual immune cell populations, as well as evaluate cell-mediated and antibody-mediated immune response to specific antigenic stimulation. Test will also evaluate the ability of animals to resist proliferation of pathogenic bacteria and tumor cells. Different species of animals will be used in the implantation studies to account for interspecies variations. Expected benefits from this testing include:

1. An assessment of the real risk potential for an immunological response to silicones.
2. An awareness of immunological problems that may erupt so that they can be engineered around if possible.
3. Five or six publications in literature to defuse the current wave of negativism toward silicones.
4. Possible ability to evaluate suspected human silicone sensitivity cases.
5. Data available for defense in lawsuits. NOTE: handwritten entry states "or prove guilty."

The authors estimate a recourse requirement of "6 effort years...expended over a 3 year period," and that "Health Care Group Research currently has adequate people skills and resources to conduct this work.
CITE: KMM 386643 - 386659, Exhibit to LeVier Deposition, Exhibit 21 to Harris County Hayes Deposition, Exhibit to Boley Deposition, Exhibit 12 to Popoff Deposition, and Exhibit to Isquith Deposition.

Document #415
03/07/85
ACKNOWLEDGEMENT OF NEED FOR TESTING
KNOWLEDGE OF SYSTEMIC DISEASE

B. Boley, Dow Corning, responds to A. Isquith's memo of 01/29/85 on "Genetic Toxicology Screen of Dow Corning Q7-2159A Gel." Boley states, "There is currently no valid carcinogenic test data on the silicone mammary gel Q7-2159A. I recognize that short term in vivo and in vitro mutagenicity tests are no substitute for a 2-year animal carcinogen study.... I feel the Health Care Business has an obligation to do what it can to assess the carcinogenic potential of this material.... Without this testing, I think we have excessive personal and corporate liability exposure." (emphasis added".

Boley authorizes tests such as the Ames Test, InVitro Forward Mutation Test, In Vitro Chromosome Aberration Test, and In Vitro Transformation Assay Test. According to Isquith's memo of 01/29/85, this is the "minimal testing" that would meet the FDA guidelines.
CITE" M 170039, Exhibit to Harris Country LeVier Deposition, Exhibit to Peters Deposition, Exhibit to Boley Deposition, Exhibit to Isquith Deposition, and Exhibit 20 to Harris County Zahalsky Deposition. DUPLICATE: F 851; M 580051; DCC 17016611 - 17016613. NOTE: see 01/29/85 entry.

Document #416
03/12/85
TESTING
GEL MIGRATION

Dow Corning Health Care Group Research Report 150 by Boley and Bejarano entitled "Fate of Q7-2159A Gel Injected Sub-dermally In Rats: Macro Observations." Fibrous tissue can infiltrate Q7-2159A gel and partition it into many smaller masses. The disappearance of 50% of the gel from the injection site is of concern. Whether the gel migrated or was trapped in capsular tissue is unknown.
CITE: DCC 800311717 - 800311729, Exhibit 9 to Bejarano Deposition, Exhibit to Frisch /Deposition, and Exhibit 32 to Zimmer Deposition. DUPLICATE: F 160 - 175; KMM 297691 - 297705.

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

Dow Corning receives a complaint report MD2402 for an implant that ruptured necessitating removal. Dow Corning states, "Gel mammary rupture not covered by labeling."
CITE: CO 3106 - 3112

Document #418
04/10/85
ACKNOWLEDGEMENT OF NEED FOR TESTING
KNOWLEDGE OF SYSTEMIC DISEASE

R. Steele, Dow Corning, memo to G. Hignite regarding subjects discussed at a Health Care Business Board Meeting, Steele notes that the mission of the Health Care Business Board is on "internal profitability issues." One subject dealt with a presentation made by Bill Boley to the Executive Committee about a research study of the effects of silicone on the immune system. "The benefits of such a program would be to test for the real potential of immunological response to silicones.... Hopefully, we can diffuse any negativism that might exist toward silicone through publication of this data. This study would also give us the basis for an ability to potentially evaluate the sensitivity of individuals to silicone materials. Finally, the data would be available for defense in litigation
proceedings."
CITE: F 842 - 846.

Document #419
04/11/85
ACKNOWLEDGEMENT OF NEED FOR TESTING
KNOWLEDGE OF SYSTEMIC DISEASE
TESTING

Boley, Dow Corning, Memo to Hobbs, Lentz and Cooper regarding "HCB" Research Immunotoxicology Program." Boley states that the Health Care Business has approved research on immunotoxicology. Handwritten notes indicate that Al Munson, University of Virginia, is involved.
CITE: KMM 386642, Exhibit to LeVier Deposition, Exhibit to Boley Deposition, Exhibit 5 to Harris County Burchiel Deposition, and Exhibit to Isquith Deposition.

Document #420
04/30/85
GEL MIGRATION
TISSUE REACTION

Krystyna Pasyk, M.D., University of Michigan, writes a report to Dow Corning concerning pathological analysis of three slides of lymph nodes from women's tissues who were implanted with silicone breast implants. "All three slides show similar microscopic changes - hyperplasia of the lymph node sinuses with infiltration of foamy histiocytes and foreign-body reaction most probably to silicone."
CITE: T 31093 - 31108.

Document 421
06/04/85
MISCELLANEOUS - PRODUCT LABELLING

Art Rathjen, Dow Corning, Memo to Duel, Jakubczak, Rigas and Wessel regarding the "Revised SILASTIC II Product Insert." Attached is Rathjen's handwritten changes and comments to the product insert. Rathjen states in the cover memo:

It isn't a matter of semantics. It's a matter of being articulate, precise. In the Health Care Businesses, there probably isn't a more important or meaningful document than this one currently under revision. I think it is important enough that each sentence should be studied and analyzed as it relates to the sentence proceeding it and the one following it. Some sentences are way too long. They ramble. There is an overdose of repetition. Some subjects are out of order or sequence. I wouldn't have spent the time nor the effort on this revision if I didn't feel it was important.

CITE: KMM 232474 - 232480, Exhibit to MDL Rathjen Deposition.

Document #422
06/30/85

Boley memo to Cooper, Lentz.
CITE: KMM 386490 - 386491. (TO BE SUPPLEMENTED).

Document #423
07/17/85
ACKNOWLEDGEMENT OF NEED FOR TESTING

"A complaint from Dr. Muller is handled through Dow Corning Valbonne. Wilfried, a sales representative, inquires why no one has responded to Dr. Muller's prior complaints and inquires. "Prof. Muller is seriously considering publishing those bad results which probably is one of the least desirable things which should happen to us here in Germany. It once more underlines the necessity to give a scientific watertight answer to problems if and when they occur. I do regard this case as serious as it could potentially damage our image here in the market and moreover could potentially do us further harm."
CITE: M 460190.

Document #424
07/30/85
ACKNOWLEDGEMENT OF NEED FOR TESTING
KNOWLEDGE OF SYSTEMIC DISEASE

Boley, Dow Corning, memo to Cooper, Lentz, Rylee, Weyenberg, Yerrick, DeVries, Hobbs, and Siddiqui regarding "Summary of Meeting with IIT Research Institute to Discuss Immunotoxicology Testing of Silicone Materials." He identifies seven issues which Dow Corning must decide including "The major business issue of whether Dow Corning should commit to immunotoxicology testing of silicone materials." (underlined portion -emphasis in original). IIT Research Institute proposes to research adjuvant disease, immune sensitization, and immune suppression. Boley is "convinced that immunological testing of at least some silicone materials used for medical applications is appropriate."
CITE: KMM 386490 - 386491.

Document #425
08/08/85
ACKNOWLEDGEMENT OF NEED FOR TESTING
KNOWLEDGE OF SYSTEMIC DISEASE
MISCELLANEOUS - COMPLICATIONS
TESTING
TISSUE REACTION

Dow Corning Study titled "Thirty-Day Implant Study of Dow Corning Q7-2218 Silicone Gel System" by Bejarano. He states:

Mild encapsulation of the gel by fibrous tissue was evident in nine of the ten test animals by unaided visual observation. Fibrous tissue encapsulation of the U.S.P. polyethylene control sites was not evident. Microscopic evaluation of tissue sections of the intramuscular implant sites revealed a greater cellular response to the Q7-2218 gel than to the U.S.P. polyethylene control. In addition, increased numbers of eosinophiles were evident at the Q7-2218 gel implant site.

The presence of eosinophiles at the Q7 2218 gel implant site suggests the possibility of immunological sensitization to a component of the gel formulation. Additional studies are required to either substantiate or disprove the possible sensitization potential of this silicone gel.
CITE: T 31514 - 31571, Exhibit to Boley Deposition and Exhibit to Isquith Deposition. DUPLICATE: KKH 40082 - 40139.

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

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

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

"Reports of serious or life threatening problems directly related to the implant itself are rare. There is no evidence that there is any relationship between breast implants and cancer.

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

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

Occasionally, closed capsulotomy can cause bruising, bleeding or even rupture of the implant."
CITE: KMM 41248 - 41261

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

Dr. Charles Vinnik letter to Bruce Reuter, Dow Corning Wright, concerning another implant which had lost shell integrity and the gel was "terribly runny." He states, "I am forced to believe Gene and Lois' hypothesis of the physical disruption of the gel by prolonged contact with tissue fluids and fat. Inasmuch as this is not generally known by my colleagues, I feel that your company has both a moral and legal obligation to make this information available through your representatives and in your literature. I am loathe to publish my series of cases as I feel that it may open a Pandoras Box. I do feel, however that rapid dissemination of this information is very necessary to protect your company and my colleagues."
CITE: M 240116 - 240117. DUPLICATE: KMM 4625 -4626; KKH 1086 - 1087; DCC 242051124.

Document #428
09/23/85
ACKNOWLEDGEMENT OF NEED FOR TESTING
GEL MIGRATION

D. Weyenberg memo to J. Cooper, Dow Corning, regarding an "immunomodulation Study." Weyenberg outlines the objective of the study:

What is the potential for silicone gels and fluids intended for disposition in the body, and which migrate and persist indefinitely in the body, to cause or contribute to clinically significant disorders? Where does the material accumulate: Where would theory predict it to accumulate? What might be the impact of certain accumulations? Are there elimination mechanisms? Does it migrate from any initially deposited site? The phenomenon of silicone migration within the body is very central to any of these questions, and I am bothered by our apparent lack of knowledge of this phenomenon and the low emphasis on phenomenon in our potential program.
CITE: KMM 369357, Exhibit to Weyenberg Deposition.

Document #429
10/01/85
EMBOLISM
KNOWLEDGE OF GEL BLEED
KNOWLEDGE OF LIQUID SILICONE DANGERS
MISCELLANEOUS - COMPLICATIONS
SHELL DEGRADATION
TISSUE REACTION

In an Infor-Med, Natural Y discusses the recurring problems of painful fibrosis and implant distortion associated with the standard smooth silicone implant. "The dangerous implications of ongoing fibrosis, accompanied by cell anoxia, vascular impairment and pain, have been consistently documented by microbiologists and histologists as being precursive to cancer. Additionally, the hazards of free silicone, well documented in silicone injections, are leading to more granulomas and silicone gorged lymph nodes." The memo also describes more specific and

basic areas of concern: "Smooth surfaced polymers, because of their disruptive effect on cell products, are generally regarding as unsuitable for long term implantation.... Early design smooth silicone breast prostheses -- commercially available until the mid 1970's were vulnerable to extreme gel bleed and volume loss.... Possibility of embolism." CITE: MEI 4230 - 4233.

Document #430
10/10/85
GEL MIGRATION
KNOWLEDGE OF GEL BLEED
KNOWLEDGE OF SYSTEMIC DISEASE
TESTING
TISSUE REACTION

Study titled "Characterization of C-U Silicone Elastomer Shells." The use of plastic embedding significantly enhances our ability to resolve the presence of silicone gel as well as those cells involved in the response. Plastic embedding provides retention of the interface between the fibrous capsule and the foreign body. The silicone gel is removed from the immediate locality and taken to the periphery of the capsule where one can only assume it is then transferred to the reticuloendothelial system as observed with similar materials used in other clinical situations A significant difference in degree of cellularity, number of lymphocytes and cells at the interface is noted when gel implants are compared to the extracted implants. It is my impression that the use of silicone gel prostheses represents a significant risk to the patient. The literature suggests that individuals can develop an allergic and immunologic reaction to silicone gel and oil. It would behoove us to develop in an expeditious fashion a non-permeable silicone shell with subsequent replacement of the gel with another polymer system.
CITE: CUI 300317 - 300414, Exhibit 11 to D. McGhan Deposition, Exhibit to Oppelt MDL and Harris County Depositions, Exhibit 7 to Harris County Pool Deposition, and Exhibit to MDL Pool Deposition.

Document #431
10/10/85
SHELL STRENGTH - THICKNESS
SHELL DEGRADATION

John Conrad, Territorial Manager for Dow Corning Wright, reports that a very loyal customer has switched to using Surgitek products. The reason for the switch is that the doctor, Dr. Mobley, experienced 6-7 post-op loss of shell integrity with Dow Corning implants including one where the "shell has been eaten away by something." There was no evidence of a shell whatsoever. Conrad requests follow-up by Dow Corning Wright.
CITE: KMM 425114.

Document #432
10/17/85
SHELL STRENGTH - THICKNESS
SHELL DEGRADATION

Clauss, Dow Corning Valbonne, memo to Frisch regarding Dr. Muller. Dr. Muller complained that the envelope has disappeared and suggests that there was a chemical dissolution of the envelope by the gel, that the body Metabolized the envelope, or that the envelope migrated. Clauss states that the first and second hypothesis "seems for me, according to our silicone behavior knowledge, the most credible."
CITE: M 460185.

Document #433
12/04/85
COHESIVENESS - LIQUID COMPONENT OF GEL
KNOWLEDGE OF GEL BLEED

Matherly sends a confidential memo to Jakubczak, Dow Corning, regarding "Dow Complaint MD2579." In it, he states that, "The claim is really extraordinary in that it alleges that gel volume has been lost while envelope integrity is maintained." Matherly then suggests "We probably should include a carefully constructed professional statement (from you or Lois) that would discount weight loss from an intact envelope." He also discusses the investigator's inability to find any other problem with the prosthesis, "He, I don't believe, meant to convey the message that I think is obvious here, and which seems to be very dangerous in that it implies something he didn't observe." Matherly says he is seeing enough problems in the Complaint Analyses that he is scheduling a meeting in January to review concerns and provide training.
CITE: KKH 38544.

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

Eldon Frisch, Dow Corning, memo to Thiess and Wessel regarding "Rupture of Gel-Containing Mammary Implants." Frisch states, "In about 1974, Dow Corning modified the implant in response to competitive pressure by making the envelope thinner and the gel softer and more responsive." He concludes that "the potential for rupturing implants was quite well known, based upon the information provided by Weiner, Talcott, Bloomenstein, and Vistnes. I have always taken the position that any reasonable person would realize that a gel-containing breast implant is a rather fragile, delicate implant, somewhat analogous to a water-filled balloon
CITE: DCC 240000969 - 240000970.

Document #435
12/09/85
COHESIVENESS - LIQUID COMPONENT OF GEL
GEL MIGRATION
TESTING
TISSUE REACTION

Study by Siddiqui, Stanton and Kolesar titled "Pharmocokinetic Profile Of Dodecamethylpentasiloxane In Rats Following Oral Administration," TX-85-0131-08. On the basis of the total recovery in the urine, expired air, and tissues and assuming no biliary excretion of L5, it is safe to conclude that approximately 25% of the administered dose was able to absorb from the gastrointestinal tract of the Sprague-Dawley rat.
CITE: T 32215 - 32226.

Document #436
02/11/86
ACKNOWLEDGEMENT OF NEED FOR TESTING
KNOWLEDGE OF SYSTEMIC DISEASE

Ken Yerrick, Dow Corning, memo to Boley, Cooper, Hayes, Rylee, C. Lentz and Weyenberg regarding immunotox Studies." Yerrick states:

It is my understanding that as a result of the recent visit by Jack Dean we are proceeding with the development of protocols to investigate the effects of silicones on the immune system. From my discussions with Lentz and Boley it is also my understanding that Dean agreed to act, in the future, as an expert witness should the need arise. Of course, he will agree to do this if he is given the opportunity to approve the protocol. I believe we should follow this approach as we proceed with the study. I recognize there are some 1986 budget issues, i.e., no funds budgeted for this project.
CITE: KMM 329406.

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

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

The extent and duration of this response to silicone gel has not been well characterized.... The assumption can be make that the gel will behave similarly to the fluid. Animal tests on PDMS (polydimethylsiloxane) fluid suggest that the granuloma response should be self-limiting and resolve with time. However, it was recently stated to me by one experienced clinician that he did not believe this response would resolve itself in humans. I think the answer to the question is, that at this time we do not know what the clinical sequel (sic) will be.
CITE: KMM 202743. DUPLICATE: DCC 204000522.

Document #438
04/22/86
ACKNOWLEDGEMENT OF NEED FOR TESTING
KNOWLEDGE OF SYSTEMIC DISEASE

H. Ratajczak, R. Thomas and J. Fenters, IIT Research Institute, letter to W. Boley, Dow Corning, Proposing research protocol for "Tests of Potential Immunomodulation by Polydimethylsiloxane Gel." Study is estimated to take two years with the final four months used to prepare the final report.
CITE: KMM 369361 - 369377.

Document #439
04/29/86
KNOWLEDGE OF GEL BLEED
KNOWLEDGE OF SYSTEMIC DISEASE
TISSUE REACTION

In an Infor-Med, Jackie Markham, Natural Y Surgical Specialties, claims that there is overwhelming agreement among ASAPSs members that the less exposure of silicone to the lymphatic system the better because it means less of a load on the immune system. Surgitek and Dow Corning are accused of dumping and "fire-saleing" high-bleed mammary implants which they had advocated for years on the market.
CITE: MEI 4237 - 4239.

Document #440
07/08/86
SHELL STRENGTH - THICKNESS
RUPTURE
FRAUD/MISREPRESENTATION

Clauss in Valbonne, memo to Matherly and others at Dow Corning concerning Dr. Muller's five ruptured implants. Dr. Muller would like answers to the cause of the ruptures, the potential consequences of a rupture, the statistics for ruptures, and whether Dow Corning recommends that patients be followed up to check implant integrity. Clauss states that he understands the response "must be carefully prepared on the legal point of view."
CITE: M 460180. DUPLICATE: M 460196.

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

Outline of issues and answers regarding breast implant contracture in which the occurrence of capsular contracture is termed "logical, rational, predictable, and entirely explainable." It is noted that, since fibrous tissue is merely scar tissue, "fibrous tissue encapsulation cannot be prevented, even with the 'best' biomaterial." Treatment can include daily manipulation, open or closed capsulotomy, initial placement of implant beneath pectoralis muscle, use of certain bioreactive materials, placement of implant in an oversized surgical pocket, and partial deflation of implant when capsule has matured. Three theories for prevention are identified: use of biodegradable covering (such as porous polyurethane), use of a porous coating, and use of shape retaining implants.
CITE: KKA 16168 - 16174.

Document #442
03/20/86
MISCELLANEOUS - COMPLICATIONS
TISSUE REACTION

Complaint Report MD 2692 stating that a lymph node was removed and biopsied finding a foreign substance that was later identified as silicone. The diagnosis was lymphadenitis.
CITE: COM 1348 - 1357. NOTE: This was originally listed as "08/20/86" on Plaintiff's Trial Exhibit List.

Document #443
10/14/86
MISCELLANEOUS - SALES

Reuter, Dow Corning Wright, writes a "Dear Plastic Surgery Resident" solicitation offer.

As you approach that point in your career when you are planning to set up your practice, DCW wants to help you offset some of the expense of getting started. When you open your practice, we will provide you with 5 free pairs of Silastic II mammary implants and a 50% (up to maximum of &10,000) discount on all DCW plastic surgery products during your first year in practice.

CITE: M 370227 - 370234.

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

Dr. Charles Vinnik writes to Gene Jacubczak, Dow Corning, regarding the gel implant failures Dr. Vinnik has seen and "whether or not the gel changes within a patient or we are just dealing with a variation in the spectrum of gel cohesiveness used during the manufacturing process." He also notes that during routine mammography screening, he is discovering a loss of implant shell integrity "far more frequently in the general population than has been anticipated...."
CITE: DCC 242051156.

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

M. Bejarano and W. Boley, Dow Corning, perform an internal study on "Dow Corning Q7-2159A Gel Injected Subcutaneously Into Rats" which concluded that the gel caused an increasing inflammatory response and tissue in-growth into the gel, "partitioning it into numerous smaller masses.... It is reasonable to assume that a similar response may occur in humans." This test resulted from the concern over the fate of gel if the prosthesis ruptured.
CITE: KMM 270273 - 270283. DUPLICATE: KMM 278641 - 278650.

Document #446
00/00/87
MISCELLANEOUS - RECKLESS/CONSCIOUS DISREGARD
MISCELLANEOUS - SALES

Dow Corning document titled "DRIVING FORCE: PROFITABILITY AND CONSOLIDATION. MAJOR OBJECTIVE: PROFITABILITY - EVERYTHING CURRENTLY BEING DONE OR BEING PROPOSED IS DESIGNED TO IMPACT THIS OBJECTIVE." (emphasis added). The key objectives are to increase sales in 1987 for the Silastic II by 25%. To accomplish this, Dow Corning Wright plans to use the Battelle study and P.R.E.P. program and focus its sales efforts to "targeted key accounts for conversion to SILASTIC II." Also, "Continue close working relationship with PSEF, ASPRS, and ASAPS for obvious political benefits."
CITE: KKA 71925 - 71948.

Document #447
00/00/87
FRAUD/MISREPRESENTATION

Dow Corning advertisement: "Silastic Mammary Prostheses." The advertisement states: "When you use the Silastic Mammary Prosthesis, you know all possible precautions have been taken:"

"At least 207 tests-from raw materials to finished product-all for your professional protection."

"19 years of clinical experience."

"A half of a million mammary implants since 1962."

"FDA registered and inspected manufacturing facilities."

"And, if our prosthesis costs a few dollars more, think of it as your malproduct insurance."

CITE: M 700030. DUPLICATE: M 370055.

Document 448
01/00/87
GEL MIGRATION
KNOWLEDGE OF GEL BLEED
KNOWLEDGE OF SYSTEMIC DISEASE
SHELL DEGRADATION
SILICA
TISSUE REACTION

Z. Glaser writes a brief article or report entitled "Chemistry of Silicones used for breast implants and other soft tissue applications." Glaser discusses the composition of silicone breast implants, gel migration and bleed, and degradation of silicone by the body. He cites two cases where gel migration into the lymph nodes was noted and an "acute serum-sickness-like reaction" occurred 24 hours past implantation, both instances were from intact implants.
CITE: M 780070 - 780073. NOTE: See 01/00/85 entry. See 07/25/88 entry; possible attachment to M 780066 - 780069.

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

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

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

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

(emphasis added). Vinnik also complained about the lack of meaningful analysis given to complaints and returned implants. "What really has burned me is the fact that on many of these reports when I received them, there are gratuitous self serving statements wherein the evaluator obviously speculates that somehow or other the patient has, at my direction, abused the implant." Dr. Vinnik questions the cohesivity of the gel in recent implants stating, "Imagine my disappointment and shock when I found the gels were not what they were represented to be." He recommends a "thicker more cohesive silicone gel ... a much softer gel" be used than what is used in the SILASTIC II.

Loss of shell integrity is also an increasing problem on older prosthesis. "Loss of shell integrity is discovered on mammography when in fact it is clinically not evident.... I am hesitant, particularly with the poor quality of cohesion of some of the silicone gels that we have encountered to allow patients that I discovered to have lost implant shell integrity to keep those implants in place.... I do not want to have the responsibility of problems with respect to migratory gel on my hands as was the case with the many, many cases that McGhan accumulated.... It is amazing to me that apparently nobody has done this very simple test.
CITE: F 674 - 678. DUPLICATE: DCC 80031352 - 80031354.

Document #450
01/16/87
KNOWLEDGE OF SYSTEMIC DISEASE
MISCELLANEOUS - COMPLICATIONS
TESTING
TISSUE REACTION

Study by LeVier to Frye, Lane, LeVier, Skinner, Hobbs, Rylee and Stark titled "Organosilicon Insect Toxicants," report number 6053, series number 10030. A selection of linear siloxanes, siloxane copolymers and cyclic siloxanes were found to posses toxicant activity against crickets, alfalfa weevils, feline fleas and bovine lice. The mode/mechanism of toxicity was not determined. Cost and lack of chemical reactivity preclude use of these structures as agricultural insecticides.
CITE: DCC 2010235 - 2010283