Melinda Barrow 5

FN99. E.g., Deposition of Lynch at 2877 & 2910. Lynch stated that not only did MEC not put $25,000 into such study, but also that this amount would not cover MEC's share of such study. Further he felt that the 100 patients proposed for this study would be too few. According to Lynch, it would take thousands of patients to conduct an appropriate study. In addition, two patient populations would be necessary, one whose members received silicone gel breast implants and one whose members did not receive silicone gel breast implants. There would have to be enough participants involved in the study to make a statistical determination whether the immune system is affected by silicone gel bleed.

In 1977, Sanders wrote a letter in response to questions from a physician at the University of Florida, stating in part: 5. We feel that the SURGITEK R mammary prostheses are superior to others on the market because: A. Our gel is noted for its consistency and that when a shell is ruptured the gel will not run or migrate through body tissue as is the case with some of the competitive products. [FN100]

FN100. Plaintiff's Exhibit 2.84. This statement was echoed in an August 18, 1981 letter from MEC's vice president of scientific affairs in response to questions from a doctor: Dr. Luhan, please be assured that we are vitally concerned that our implants are of the highest quality available on the market. To this end we want them to have a shell with sufficient strength to withstand normal forces without tearing while in situ, but with a gel so cohesive that even if the outer membrane should rupture the gel inside will not migrate. We have just performed studies in house which confirm that our shell has outstanding strength properties and the gel it contains is the most cohesive on the market. A copy of that study is included for your review. Plaintiff's Exhibit 8.69.

Lynch stated there was no data to support the statement of Sanders on behalf of MEC that there was no migration of silicone gel through the body's tissues. [FN101]

FN101. Lynch acknowledged that even a cohesive gel will bleed through a silicone elastomer shell in a breast implant. Lynch stated that MEC believed, without conducting tests or accumulating data, that its gel was so cohesive it would not migrate far.

*11 Sanders further wrote in this 1977 letter:

7. At this time we do not have any quantitive [sic] data on the bleeding process of silicone gels through silicone shells. Qualitatively we know that it occurs and this can be seen simply by lying [sic] a prosthesis on a piece of paper. As you know, we discussed the confidential project that Medical Engineering Corporation is in the midst of planning and financing to find out the answer to this exact question.

9. A supplier has indicated to us that all but 1% of the short chain molecules of "lights" have been removed from the rubbers prior to their being shipped to us. Our laboratories after applying vacuum and heat for approximately six hours has [sic] been able to remove approximately the remaining 1%. Shel, this does not mean that additional silicone cannot migrate through the shell, because they [sic] still do [sic]. We have proved this qualitatively as cited in Item 7. Again, the confidential study I cited in # 7 will attempt to answer this question, also. Of course the real interesting question is what does any migrating silicone do to tissue. The study will also attempt to answer that question. 10. We are not saying that the make-up and physical characteristics of the shells change with time. However, we do believe that there are changes and we do believe that the low molecular silicone migrating from the gel through the shell might slightly change the physical properties of the shell. This phenomena [sic] becomes static after a period of time and certainly does not change the nature of the implant to the extent that it would make it risky or hazardous for implantation. Also from a theoretical point of view, that the more the implant is handled, maybe 1,000 times, it slightly weakens the shell each time the unit is handled. Therefore, it follows at some point if a unit is handled enough it might rupture with slightly less pressure or stress than when it was originally made. Again, this is a very difficult kind of thing to measure, but theoretically, it can be shown that this is the case. [FN102]

FN102. Plaintiff's Exhibit 2.84.

Lynch stated that MEC did not have data to support these answers of Sanders to the questions about gel bleed and gel migration contained in this letter and that Sanders was taking the position of a marketing person in making these statements. Further, MEC touted its breast implants as having highly cohesive silicone gels to increase sales of its product, knowing full well that its silicone gel would bleed through the elastomer shell containing it and migrate into tissues away from the breast implant. [FN103] As of July 20, 1977, to the knowledge of Lynch, MEC did not have long-term data supporting the safety of the silicone gel it used. [FN104] Nevertheless, MEC advertised its implants as containing highly cohesive silicone gel in order to sell its product at the same time MEC knew that its silicone gel bled and migrated into tissues away from the breast implants.

FN103. Deposition of Lynch at 1150-1151. Cohesiveness of the gel has nothing to do with whether the gel will bleed. As noted by Lynch, even a cohesive silicone gel inside a silicone elastomer shell will bleed. The thicker the elastomer shell containing the gel, the longer it takes for the migrating materials to appear at the outer surface of the shell. Lynch elaborated on this in a letter dated April 23, 1980 while he was a consultant for MEC and a member of its Scientific Affairs Committee to explain why making the shell thicker would not reduce gel bleed in the MEC silicone gel breast implant. Plaintiff's Exhibit 8.42. Dr. Zeigler concurred that increase in the thickness of the elastomer of a breast implant changes the rate at which gel bleed appears on the surface of the shell but not the amount of material that is diffusing.

FN104. Lynch referred to Plaintiff's Exhibit 3.389 dated July 20, 1977 in making this statement. According to Lynch, MEC did not test its implants in animals, except rabbits and dogs, beyond ninety days, and most of MEC's implant studies were seven-day acute toxicity tests to determine if the implant materials contained any poisonous substances. As to the beagle study noted below which was commenced by MEC in 1971, Lynch testified that when DOG 450R and DOG 395R were sacrificed in 1979, MEC did not have any long-term data on its silicone gel 515/516 material.

*12 While agreeing that preclinical testing was a standard for medical devices before 1975 [FN105] and that it should be done before material was implanted in humans, Lynch stated that MEC did no clinical study lasting longer than seven weeks to determine how long its breast implants bled. [FN106] MEC's seven-week study in 1980 of different silicone shell and gel materials being utilized by different manufacturers of breast implants, including those of MEC, reflected that all samples had gel bleed within twenty-four hours and continued to bleed approximately the same amount without tapering off over the next seven weeks with no significant difference among the samples. [FN107] MEC did no study beyond seven weeks to determine how long the implants bled gel, and through the date of his deposition in February of 1994, Lynch knew of no long- term biocompatibility testing done by MEC to substantiate the safety of its silicone gel material for long-term implant use. [FN108]

FN105. Lynch referred to Plaintiff's Exhibit 30.1118, an article by Dr. Autian, and agreed with the statement: "Since many of these medical devices will be implanted in humans and other devices will have contact with drug and biological products which in turn will enter the patient, it should be mandatory for these items to be preclinically tested for safety." Deposition of Lynch at 1573.

FN106. Dr. Williams testified that from his review of MEC documents, no clinical trials were done before the silicone gel breast implant was marketed. Dr. Williams stated that such trials were not required then, and no manufacturer did them.

FN107. Plaintiff's Exhibit 4.24.

FN108. Lynch stated the purpose of the seven-week study was to determine whether a more fluid gel made a difference in gel bleed, and MEC found it did not. Lynch was not aware of any MEC data on the length of time there is gel bleed, or if the bleed is greater for a time and then tapers off. Lynch was aware of a letter written by Peter Stitch in 1981, when Lynch was a consultant for MEC, in which three types of breast implants had been placed on blotter paper. The first to bleed within twenty-four hours was the MEC silicone gel breast implant. Within four days, there was a definite pattern on the blotter paper, and the pattern continued to darken from gel bleed over the next six months.

In 1976, MEC switched from General Electric materials to Dow Corning materials for its silicone gel breast implants. However, MEC did not do clinical tests of materials it received from either General Electric or Dow Corning to evaluate them for gel bleed before they were included in the silicone gel breast implant product MEC designed, fabricated, and sold to physicians.

In a handwritten memo dated September 15, 1976, Robert Olson of MEC wrote a summary of what MEC had done to test the silicone materials used in its implants. [FN109] Lynch agreed with the statements in such memo that (1) at the time MEC switched from General Electric to Dow Corning materials in 1976, MEC's information on the biocompatibility of implant materials, a critical issue in implantable medical devices for humans, was the minimal reactivity of soft tissue in humans to these materials, [FN110] and (2) the tissue reactions of which MEC learned were primarily the result of patient histories and not from any systematic procedure to gain information in an organized manner. [FN111]

FN109. Plaintiff's Exhibit 3.450.

FN110. Deposition of Lynch at 1668 & 1670.

FN111. Lynch stated he felt these results from the field were more acceptable than studies of breast implant materials in dogs. Id at 1670.

Lynch testified that it would be irresponsible for a manufacturer to place on the market a product containing materials without first determining whether there would be biodegradation to a point that it would become dangerous or produce toxic effects. [FN112] To this end, in 1971 MEC had begun placing miniature breast implants in the mammary area in twelve beagle dogs, along with other materials, to determine if the materials were biocompatible and safe for long-term use and to study capsular contracture. [FN113] The beagle study involved ultimately twenty-two dogs over a period of time. [FN114] The first dog was implanted in January of 1971 and the last dog was sacrificed in July of 1979. [FN115] Although the beagle research did span a seven-and-one-half-year period, contrary to the public representations made by MEC in its sales literature no dog was implanted for seven years. [FN116] MEC did not insert its breast implant device in any other animal except the beagles participating in this study. [FN117]

FN112. Id. at 1695-98.

FN113. Id. at 1699-1701 & 2447; Defendant's Exhibit 715.

FN114. MEC sold its breast implants before the beagle study was commenced. The beagle study was primarily to examine capsular contracture which Lynch felt might be related to gel bleed. The main purpose of implanting the beagles with several different materials was to prove the materials were similar to those materials on which physical and toxicological tests had already been done. MEC implanted silicone gel breast implants containing Dow Corning materials into some of these dogs. Deposition of Lynch at 1863 65 & 2452. Lynch testified that he held an ownership interest in Cape Laboratories, which was one of the laboratories that participated in the testing during MEC's beagle study. Id. At 2460-61.

FN115. Id. at 2454; see also Defendant's Exhibit 748.

FN116. The sales literature published by MEC stated:

Long Term Implant Studies in Dogs:

Materials used in the SURGITEK Mammary Implant are subjected to implant evaluations in dogs for periods up to seven years. Test animals are given frequent physical examinations for determination of untoward results such as carcinogenic reaction. Specific animals are sacrificed annually with complete histopathic examinations of the implant sites, the implanted prothesis and 15 to 18 body organs. Those materials implanted into dogs to date have elicited no adverse reactions or carcinogenic activity, (up to 45 months in-situ time). Plaintiff's Exhibit 7.59. Mr. William Stith, the person in charge of MEC's Scientific Affairs Committee which looked into new materials and procedures to increase the biocompatibility of materials MEC used for medical implants, testified that he had reviewed thoroughly the dog studies. Deposition of Stith at 219 & 901-02. He admitted that no dog in the beagle study had material implanted for eighty-four months, and he had no other evidence that anyone did a seven-year dog study on the materials in the Surgitek mammary implants, whether they contained General Electric or Dow Corning components. Id. at 901-04.

FN117. Deposition of Lynch at 1865.

*13 Adverse findings or abnormalities were found in the liver, kidney, thyroid, and lymph nodes of some beagles in this study, particularly in Dog 450R and Dog CC74. [FN118] MEC was advised by a scientist participating in the study that as to some beagles:

FN118. Id. at 2457; see also Defendant's Exhibits 744, 745, & 710.

All specimens exhibited an energy pulse in the region of silica. The kidney and liver appeared to have greater peaks than the other tissues though thyroid from CC74 also exhibited a significant peak. The data at this point suggest that there is a high suspicion of the presence of a silica containing compound in very low concentrations. It is recommended that more tissues be examined. [FN119]

FN119. Plaintiff's Exhibit 3.158(a). Lynch agreed these adverse findings were inconsistent with MEC's published statement that all biocompatibility testing of MEC's breast implant materials was universally negative and other statements contained in printed information which MEC provided its sales representatives to convince doctors to buy its implants. See Plaintiff's Exhibit 7.59; Deposition of Lynch at 1885 & 1891-95. For instance, the sales literature of MEC in 1974 stated that the implants had been tested in dogs for periods up to seven years with no adverse reaction when at that time no dog had been implanted for seven years and there had been adverse findings. Deposition of Lynch at 1896-98. Lynch agreed these statements were false at the time they were made. Further, there was no follow-up system of user response to provide data necessary to ongoing product safety programs and to assure users that Surgitek breast implants were safe for long-term use as stated in MEC's sales literature except for sporadic physician complaints and returns of implants by physicians to MEC. Id. at 1899-1900. No formalized follow-up system was put in place by MEC to determine adverse reactions in women implanted with MEC breast implants. Id. at 1901 & 2910-13; see also Plaintiff's Exhibits 7.92 & 7.43; Deposition of Lynch at 1908-16. Lynch testified he felt these written statements disseminated to physicians and others were exaggerations but that MEC still had a good, biocompatible product. Deposition of Lynch at 2528-31.

Lynch interpreted this to mean silicon had been found in these organs which he felt could be in the organs of the beagles naturally . [FN120]

FN120. Deposition of Lynch at 2454-81.

In October of 1978, Lynch confirmed to MEC the finding of silicon in the tissue samples from selected organs of dogs CC74 and 450R in the study: Silicon in various inorganic forms occurs in animal tissues. Silicon may be functionally involved in certain biological functions such as calcification and mitosis. The microscopist's report, based on the tissues he examined, indicates the presence of low concentrations of silicon. It is difficult to draw any conclusions from his observations because of the lack of reliable data concerning organ and tissue distribution of silicon. [FN121]

FN121. Defendant's Exhibit 743.

On July 17, 1979 Lynch sent MEC's president Sanders an interoffice memo stating that two dogs receiving long-term silicone implants showed low but definite concentrations of silicon in selected organs with highest concentrations of silicon being found in their kidney and liver tissues. [FN122] Lynch recommended that the dogs' tissues be examined by a Molecular Optics Laser Examiner ("MOLE"), which could differentiate between silicon compounds at a cost of not more than $850 to MEC. [FN123] Instead, the dogs' tissues were destroyed, and the beagle study was abandoned by MEC in favor of conducting less expensive and shorter ninety-day rabbit studies. [FN124]