SMOKE - FIRE DOCUMENTS 301 - 350
 
Document #301
04/10/78
STERILIZATION/CONTAMINATION
Dow Corning Complaint Report 20602 notes a “hair inside package.”
 
CITE: CRM 296 - 300. DUPLICATE: KKH 33333. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
--------------------
 
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.” (emphasis added).
 
CITE KMM 333262 - 333264, Exhibit to MDL Rathjen Deposition. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
--------------------
 
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. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
--------------------
 
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. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
--------------------
 
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. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
--------------------
 
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 doesn’t it spend a red cent to give thousands of young women the true facts about implants and at the same time warn them about silicone breast injections. The question goes on to ask if Dow doesn’t feel some ethical and moral responsibility to do more than you are doing.
 
CITE: DCC 80021587 - 80021589, Exhibit to Tyler Deposition. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
--------------------
 
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.” (emphasis added).
 
CITE: M 660189 - 660204, Exhibit to MDL Rathjen Deposition. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
--------------------
 
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.  (emphasis added).
CITE: M 460274. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
--------------------
 
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. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
--------------------
 
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. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
--------------------
 
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.” (emphasis added).
With regard to Overton’s question on what material is bleeding, Jacubczak states that, “The material referred to as bleed represents the soluble fraction of the prosthesis gel component. Bleed is silicone (polydimethylsiloxane polymer)....” In addition, “Silicone bleed has been shown to move out and away from the gel prosthesis. Insufficient information exists to say how much and where it travels and accumulates, if it does, much less what are its affects. Dow Corning again from the industrial sales side, does have data on polydimethylsiloxane fluid and its bio path and the effects in the body.” (emphasis added).  Finally, in response to whether there is any difficulty with x-ray and mammography exams of women with breast implants, “experience will usually overcome difficulties.’ Also, Jakubvczak will review the effect of therapeutic radiation on implants.
CITE: M 250045 - 250047. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
--------------------
 
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. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
--------------------
 
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. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
--------------------
 
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.” (emphasis added).
CITE: KMM 256659 - 256660, Exhibit to MDL Rathjen Deposition. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
--------------------
 
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.” (emphasis added).
CITE: KMM 423161. NOTE: See KMM 423155 - 423156. Dow Corning Trial Exhibit List Abstracts
 
--------------------
 
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. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
--------------------
 
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 Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
--------------------
 
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. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
--------------------
 
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. (emphasis added).
CITE: CM 1133 -1134. He writes a second letter on 04/01/80 because Dow Corning did not respond to the first letter. For Dow Corning’s response, see 04/23/l80 entry. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
--------------------
 
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. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
--------------------
 
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.” (emphasis added)
 
CITE: MEA 22 - 25. DUPLICATE: MEC 7835 - 7838: MEC 9278 - 9180, Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
--------------------
 
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. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
--------------------
 
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.” (emphasis added).
 
CITE: F 629 - 630. DUPLICATE: M 250021; M 570058; F 628; KMM 232092 -232093; M 250022 - 250023; M 570059. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
--------------------
 
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. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
--------------------
 
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. Dow Corning Trial Exhibit List Abstracts.
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
--------------------
 
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. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
--------------------
 
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.” (emphasis added)
CITE: M 240072. DUPLICATE: KMM 197618. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
--------------------
 
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. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
--------------------
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. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
--------------------
 
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. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
--------------------
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 Deposition.
DUPLICATE: KKM 22739 - 227560 Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
--------------------
 
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. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
--------------------
 
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. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
--------------------
 
Document #334
04/16/81
KNOWLEDGE OF SYSTEMIC DISEASE
TESTING
Gerry Schoenig, Toxicology Consultant for Dow Corning, reviews the data from the Two-Year Implant Study of Q7-2159A and MDF-0193 Gels at Industrial Bio-Test Laboratories (IBT). He finds “fibrosarcoma around implant and malignant lymphoma in rat colony said we had a problem with cancer.”
 
CITE: KMM 390371 Dow Corning Trial Exhibit List Exhibit Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
--------------------
 
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. (emphasis added).
CITE: KMM 140223 - 140228, Exhibit to Blocksma Deposition, Exhibit to Peters Deposition, and Exhibit to MDL Rathjen Deposition. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
--------------------
 
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.” (emphasis added).
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. Dow Corning Trial Exhibit List Abstract
PENDLETON/PSC Attorney Work Product/ Privileged & Confidential
 
--------------------
 
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 Dow Corning Trial Exhibit List Abstract
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
--------------------
 
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. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
--------------------
 
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....” (emphasis added).
CITE: KMM 78006 - 78007. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
--------------------
 
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. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
--------------------
 
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 Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
--------------------
 
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.” (emphasis added).
CITE: F 685 - 686. DUPLICATE: M 780645 - 780646. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
--------------------
 
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. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
--------------------
 
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.” (emphasis added).
 
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. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
--------------------
 
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. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
--------------------
 
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). Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
--------------------
 
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. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
--------------------
 
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.” (emphasis added).
 
CITE: KMM 261745 - 261746. Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
--------------------
 
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 Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
--------------------
 
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 Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product/Privileged & Confidential
 
 

TO DOCUMENTS: 351 - 400