Melinda Barrow 4

FN74. Dr. Blais and Dr. Zeigler were questioned extensively about problems in the manufacture of breast implants and, not surprisingly, had opposing opinions. Dr. Blais elaborated on the effect of the heating process on the composition of the gel during the manufacturing process, the debris from the reuse of molds, the platinum catalysts used in the shell and gel, the catalyst from the peroxide family used in the patch applied to the elastomer after it has been removed from the mold, the acetylene anti- catalyst used in the gel to hold the reaction process in check, and the zinc stearate coating on the elastomer mold which enabled the elastomer to be peeled from the mold more easily. Blais described a procedure known as "doping" or "floor reformulation" by which a technician faced with a kit for gel components close to or after the expiration date would add materials to override the expiration date. Dr. Blais testified that even within one batch of gel containing the same substance injected into different implant elastomers, the manufacturing process involving heating and different impurities in the shell can cause different reactions, leaving some implants with more or less oil and impurities than others made from the same batch of the injected material. Dr. Zeigler contested Dr. Blais' testimony as to impurities being in the shell or gel. He testified that he tested Plaintiff's explants and that they passed the cohesion and viscosity tests, the tests for heavy metals, and the tests on identity and purity of materials. He found no impurities in the materials in Plaintiff's explants. He also testified that zinc stearate has no effect on the gel and is washed off the shell without getting into the shell or leaving holes in it. Further he opined that zinc stearate has no effect on the shell strength or cohesion, does not prevent the gel from becoming a gel or prevent the gel from adhering to the shell, and has no measurable effect on the cohesiveness or quality of the gel. Dr. Blais and Dr. Zeigler also disagreed as to whether the material used in Plaintiff's implants was out of date or expired, whether there was "crazing" around the patch of the implant and whether there was a high machine force used in the application of the patch resulting in increased bleeding, whether peroxide was used as a catalyst in the manufacturing process, whether one of Plaintiff's implants was reworked or only repackaged and resterilized, whether the two implants had different patch constructions and different gel viscosities, whether 2,6 CIS was created as a degradation product within the gel, whether MEC violated manufacturing instructions in making the implants, and whether Plaintiff's implants had permanent creases or places of defective bleed due to the crease-fold theory. Contrary to Dr. Blais' testimony, Dr. Zeigler opined that not only do silicone elastomers generally not wear out in the body, but also such devices are free of flex fold failure which does occur in saline breast implants. Therefore, Dr. Zeigler stated, silicone gel breast implants with creases are safe for sale. Dr. Zeigler concluded that Plaintiff's implants were manufactured according to protocol, that this protocol of MEC was proper, that they were not defectively manufactured in accordance with MEC specifications, that there was no evidence of crazing, deviation in thickness to produce herniation, a bulge, or rupture, no excessive pressure was applied to the patch, there was no degradation or imminent rupture in the implants, and they are not defective in any way today. While Dr. Zeigler stated that he agreed with Mr. Lynch that silicone rubbers are very pure materials with no leachable additives and are very bioacceptable even over a human lifetime, he stated that the platinum catalyst used for cross-linking is not leachable. Dr. Zeigler testified that he found no evidence of defect in the shell or gel of either of Plaintiff's implants. However, Dr. Zeigler admitted that he had never himself tested the materials used in the silicone gel breast implant for suitability.

Dr. Zeigler testified from his review of the documents concerning MEC's tests of physical properties of its silicone gel breast implants such as the tests for tear strength, [FN75] tensile strength, [FN76] percent of elongation or extension tests, [FN77] thin spot testing on the elastomer shell, crease fold and rotary flex testing, [FN78] and equilibrium tests [FN79] independent of the manufacturing process as well as the tests performed by MEC during the manufacturing process such as gel cohesion tests, [FN80] gel viscosity tests, [FN81] and gel handling tests. [FN82] Dr. Williams, an expert in materials science and biomaterials, also elaborated on the tests conducted by MEC from his review of the documents, including tests for acute systemic toxicity, [FN83] intracutaneous tests, [FN84] implantation tests, [FN85] tests for hemolysis, [FN86] cytotoxicity, [FN87] and pyrogenicity, [FN88] and infrared [FN89] and heavy metals tests. [FN90] Defendant's witnesses opined that these tests were appropriate to determine biocompatibility of the silicone shell and gel, and the types and numbers of each test showed that the material was highly acceptable for use in implants. However, none of these tests was designed to determine the effect of gel bleed on the human host. [FN91]

FN75. Dr. Zeigler testified that the material in the shell of Plaintiff's implants could stretch over eight times its original length before it would break.

FN76. This is the measure of force per unit for cross-sectional areas of the shell.

FN77. This test is to determine the amount of force necessary to tear a sample of the shell with a nick in it made according to a standard.

FN78. Both Dr. Blais and Dr. Zeigler testified about the crease fold theory in which it is postulated that if the implant creases and there is repeated motion across the crease, weakness in the shell will occur and result in rupture across the crease line. Dr. Zeigler disputed Dr. Blais' testimony that there was a crease fold in Plaintiff's implant. Dr. Zeigler further testified that any creases in Plaintiff's implants are not visible now and did not weaken them or contribute to an increase of gel bleed.

FN79. Dr. Zeigler noted that the permeation process introduced molecules of gel into the elastomer causing it to swell and reduce its tensile strength, tear strength, and percentage of elongation but without progressively weakening the shell.

FN80. This test measures how well the gel sticks to itself. Dr. Zeigler stated that within one lot of silicone gel, some gel could pass and some gel could fail the cohesion tests due to inherent error in the experiment or within the measurement in terms of its reproducibility.

FN81. Dr. Zeigler noted that viscosity is a measure of the resistance to flow of the gel and testified that Defendant's gel was more highly viscous and therefore less likely to move away from the site in case of rupture of the implant than the gel used by other manufacturers of breast implants.

FN82. Dr. Zeigler admitted that from the different handling tests performed by MEC on its gel, MEC knew that cohesion of the gel was affected by handling. Rough handling made the gel less cohesive. However, he stated if the gel is allowed to sit, it returns to its original cohesiveness, and the handling does not result in degradation of the gel. In taking issue with Dr. Blais' testimony that in vivo mastication through movement of the muscles caused more gel bleed, Dr. Zeigler focused on the issue of whether mastication caused release of oils from the gel. While contending that mastication never causes the gel to revert to oil, Dr. Zeigler did not address the issue of whether mastication increases gel bleed. Mr. Golwitzer testified that the gel is fragile, has no tensile strength, and tests conducted for MEC showed that massage would affect the gel, making it weaker and less hard. Deposition of Golwitzer at 171-79.

FN83. This involved injecting a substance derived from the material in an animal, usually a mouse. MEC did many of these tests on its 515 gel materials and 517 elastomers material obtained from Dow Corning.

FN84. In this test, the material is extracted and injected into the skin of an animal, usually a rabbit, which is very sensitive, to observe for redness, sweating, or other alteration. Dr. Williams testified he saw many results of these tests done by MEC.

FN85. In this test, the material is implanted subcutaneously, usually in a rabbit, for a minimum of 72 hours and up to 90 days. The animal is observed, then sacrificed and examined by eye and under a microscope for evidence of a reaction compared with a negative control. Dr. Williams testified that in his opinion a 90-day test was sufficient in length to determine biocompatibility because all the irritant will subside and equilibrium will be established during this time. He testified that a 90- day test in a rabbit is a long-term test in comparison to the way the body can respond.

FN86. In this procedure red blood cells are placed in contact with the material to determine sensitivity. If damaged, they will release hemoglobin.

FN87. Cytotoxicity is tested by placing actual cells in contact either with the material or with an extract from the material.

FN88. This test looks at the possibility of bacteria in conjunction with the material. A sterilized material is implanted, and the animal is observed for fever.

FN89. In this test, infrared light is passed through the material dissolved in chloroform, and a peak is seen on a graph to which a standard reference is applied.

FN90. According to Dr. Williams, MEC did many of these tests on the shell and gel using atomic absorption spectroscopy in which the amount of light passing through a flame derived from burning the materials produces wave lengths of different elements which gives rise to a spectrum of absorption concerned with the frequency of atomic vibration.

FN91. Dr. Williams testified that he had not seen any test documents from MEC's Scientific Affairs Committee on gel bleed.

Lynch testified that he knew from his first involvement with the manufacture and distribution of MEC's silicone gel/silicone elastomer breast implants that they bled. [FN92] MEC knew of gel bleed from the inception of its sale of the silicone gel breast implants to physicians and prior to the manufacture and sale of the implants inserted into Plaintiff. [FN93] Lynch described gel bleed as the phenomenon in which the "lites," or low weight molecules in the silicone gel, "go into solution," passing through the silicone elastomer shell and coming through such membrane's outer side, in part due to the permeability of the molecules which make up the silicone elastomer shell. [FN94] The higher the weight of the molecule, the slower the gel bleed. Lynch stated that it might take ten years for some higher weight molecules in the silicone gel to bleed through the silicone elastomer, but both high and low weight molecules in the silicone gel will bleed through the silicone shell. A bleed plateau will be reached eventually and maintained if the implant is not further disturbed.

FN92. See, e.g., Deposition of Lynch at 1942-44 & 2502. Lynch testified that gel bleed can be seen from the residue left when a silicone gel breast implant is placed on a piece of paper on a flat surface.

FN93. See, e.g., Plaintiff's Exhibits 2.84, 5.73, 5.75, 2.237, 3 .220, 3.248, 3.273, 3.496, 8.42, & 8.248; see also Plaintiff's Exhibit 3.140. Gary Golwitzer also described the tests that he and Rita Taylor developed and conducted for MEC on silicone gel breast implants. Deposition of Golwitzer at 70-73, 146, 178, 182, 192, & 199. These tests dealt with the physical properties of the implant materials.

FN94. Lynch explained that the weight of the molecule is related to the number of atoms in it. During the chemistry in forming the silicone polymers for breast implant shells and gels, catalysts are used to cause cross-linking of molecules. Both short and long chains of molecules are formed. The molecular weight is related to the length of the chain. Some molecules will have short chains that are highly cross-linked and thus have a higher molecular weight than those with longer chains but less cross- linking. Some molecules are highly cross-linked with resulting higher molecular weight and some are not. The more volatile moieties are called "lites," which in silicone polymers are short chained molecules with no cross-linking and low molecular weight. Silicone polymers contain mixtures of molecules with different weights. Lynch testified that no matter who the manufacturer is, "lites" are always present in the production of silicone gel even though the gel may be treated during the manufacturing process to reduce the number of "lites". Two batches of silicone gel can be similar or radically different depending on the amount of "lites" each contains despite being made from the same compounds and according to the same recipes. Thus, if two silicone gel batches have different molecular weight distributions, their properties can differ. The lower weight molecules in the silicone gel migrate more quickly through the membrane of the silicone elastomer shell. According to Lynch, it is not possible to determine how many lower weight molecules or "lites" will bleed through the shell from batch to batch of silicone gel.

*9 Lynch knew this in 1969 when he formed MEC. From his own tests, Lynch determined that gel bleed occurs in all silicone gel breast implants in which silicone gel is contained in a silicone elastomer shell, regardless of the manufacturer. Lynch tested different kinds of commercially available silicone gel breast implants and found they all bled, even after being implanted in women. Further, his tests confirmed that both low and high weight molecules in the silicone gels bled through the silicone elastomer shell in all silicone gel breast implants with silicone shells, regardless of the manufacturer. Further, from testing different viscosities of silicone gel, Lynch determined that the only difference between the gel bleed of lower weight molecules and that of higher weight molecules was the rate of the gel bleed. Higher molecular weight molecules of the silicone gel bleed through the silicone elastomer but do so more slowly. However, none of the tests done by Lynch or by MEC were conducted for a sufficiently long period of time to determine at what molecular weight, if any, the gel bleed would stop.

In addition, when Lynch began the manufacture and sale of breast implants, he knew that Dow Corning and others had experience with direct injection of a liquid silicone, the same material produced as a "lite" in the silicone gel in MEC's breast implants, with resulting complications and death. [FN95] Lynch testified that when he began the manufacture and sale of silicone gel breast implants through MEC, he had read about the experience of another manufacturer, Dow Corning, with direct injections of liquid silicone, or polydimethylsiloxane, and the resulting complications when the substance entered into the blood and lymphatics of the human host. Further, he knew from his research that women had died from injections of liquid silicone. While admitting that the injected silicone was the same as the "lites" produced in the silicone gel manufactured for silicone gel breast implants by MEC, Lynch explained the difference was, in his view, that injecting 300 cubic centimeters of silicone liquid is not the same as the minuscule amount of silicone gel that seeps through the silicone elastomer of MEC's breast implants. However, he testified that it would be irresponsible for a plastic surgeon to inject silicone directly into a woman's breast because the result of such injection is known.

FN95. Lynch stated that even after the FDA banned direct injection of silicone fluids except into the face, direct injections of liquid silicone into the breast were still done with harmful results. Further, when the FDA began regulating breast implants more stringently, Lynch testified that the demand for them was so great, women "went underground" to obtain them.

While acknowledging that prior to its manufacture and sale of silicone gel breast implants MEC did not test to determine the effects of silicone on the body's immune system, the effects of migrating gel on the body, the amount of gel bleed, or the life expectancy of a silicone gel breast implant, Lynch testified that this testing was not done because MEC felt there was so little gel escaping from the elastomer and further because MEC believed that its gel was so cohesive that it would not migrate far. Although at this time saline filled breast implants were being sold on the market, silicone gel implants were preferred by MEC because Lynch felt that silicone was biocompatible and that the silicone elastomer was the most compatible elastic material, being odorless and tasteless, containing no toxic heavy metals, and showing a complete lack of toxicity and minimum tissue reaction when implanted in animals. [FN96]

FN96. At first, Lynch had selected the Perras-Papillon breast implant for sale by MEC. It did not bleed because it did not have a pure silicone envelope. Dr. Perras asked Lynch to develop a silicone gel-filled implant, and she and Dr. Papillon assigned their patent to MEC. The Perras-Papillon implant manufactured by MEC used XD-1 for the shell, a copolymer material, manufactured by General Electric which MEC called "114". Deposition of Lynch at 2413-15. Prior to marketing this implant in late 1971, MEC tested the shell material in rabbits for five to ten months without tissue reaction. Id. at 2416-19. The shell material was also subjected to toxicological testing with no significant acute toxicity of heavy metals reported. Id. at 2419-23. The Perras-Papillon implant was filled with a silicone polydimethyisiloxane gel, also obtained by MEC from General Electric, which was labeled by MEC as "122". The silicone gel was also subject to acute toxicity, pyrogenic, and heavy metal testing with no toxic results reported. Id. at 2425. Ninety-day tissue reaction tests of the silicone gel were also performed on rabbits. Id. at 2427. When MEC began using a different General Electric material for its breast implant shells in 1973, called "MEC-127," it was also tested for tissue reaction by being implanted in rabbits for ninety days. Id. at 2430-34. Lynch also authorized Dr. Perras and Dr. Papillon to implant these MEC devices in women in Canada in a clinical trial with the following report: Perras, Papillon, Bosse of Montreal, Canada, and Korkos of Milwaukee have implanted a large number of devices manufactured from MEC-114 and reported noticeably less inflammatory tissue reaction than that experienced when similar devices manufactured from medical grade dimethyl silicone were implanted. Id. at 2437. These clinical trials authorized by Lynch were not to determine biocompatibility but instead were to determine the practical nature of the implant's design. Id. at 2442. These rabbit studies did not last as long as the beagle studies referenced later in this opinion. Id. at 1705-08; see also id. at 2903; Defendant's Exhibits 942 & 904.

*10 In 1971 and 1972, there was no standard or regulation requiring the completion of tests on animals before a medical product was surgically placed in humans. [FN97] Before the silicone gel breast implant was marketed and released for sale to physicians, MEC did no limited clinical study on a small group of women nor did MEC do a study of the effect of such implanted device in animals. [FN98] According to Lynch, the only testing MEC did before releasing its silicone gel breast implants for sale was to test the biocompatibility of the silicone elastomer shell on the body by testing the localized reaction of tissue samples to various shell materials and to conduct tests on beagle dogs. Thus, prior to the sale of its silicone gel breast implants, there was (1) no testing by MEC to determine the effects of silicone gel on the body's immune system, whether from gel bleed, rupture, or degradation of the implant, (2) no testing by MEC to determine the effects of migrating silicone gel on the body, (3) no testing by MEC to determine the amount of silicone gel bleed that occurs in the body, and (4) no testing by MEC to determine the life expectancy of a silicone gel breast implant.

FN97. The initial FDA standards for breast implants fell under FDA rules for the types of containers in which foods or drugs can be placed (Food Contact Series 6 Standards). As explained by Dr. Williams, in the late 1960s to early 1970s there was an absence of formal standards for testing biomaterials for implanting, so manufacturers followed their own initiatives. The U.S. Pharmacopeia had test methods for determining suitability of plastic containers for drugs, and manufacturers used these standards for testing biomaterials for implants. In 1980, the 20th edition of the U.S. Pharmacopeia included a sentence that these tests were appropriate for determining the suitability of plastics for implants in humans and gave three types of tests to determine suitability of polymers for implanting from the biologic point of view. Defendant's Exhibit 1270. From his review of the MEC documents, Dr. Williams opined that MEC did all of the tests stated in the U.S. Pharmacopeia, lasting from 72 hours to 90 days, without finding significant evidence of toxicity or reaction attributed to implant material.

FN98. Lynch testified one reason for this was that MEC was unable to find an exact animal to substitute for a human. In addition, MEC felt that there was very little silicone gel bleeding through the implant shell, although Lynch did admit there was some opinion at that time that gel bleed might play a role in the degree of capsular contracture around the implant in the human breast. Lynch stated it would take too long to determine the life of the device, perhaps 50 years, and long-term testing would have to be on an animal, not a woman. He opined that long-term implants in a dog would not yield much information. Lynch testified that MEC felt if it could prove the materials were not toxic and did not contain heavy toxic metals, that probably meant more than any animal test that MEC might conduct.

In 1976 Sanders of MEC established a Scientific Affairs Committee within the company and made Lynch a member of it. MEC disseminated information to the public and to physicians, stating that this committee would study: (1) capsule formation and the part played by silicone gel in such phenomenon, (2) silicone gel migration and its interaction with various tissues of the body, and (3) the resultant pathology and toxicology of tissues that interfaced with silicone gel breast implants. MEC publicized this committee and its ostensible work to physicians using its products, to its own sales representatives who were making sales calls on physicians, and at various seminars and physicians' meetings. However, these publicized studies were never undertaken by MEC.

Lynch testified that in 1977 he also attended an Ann Arbor, Michigan scientific meeting at which was discussed a study to be conducted on capsular contracture and human immune response as well as other matters and which was to be jointly funded by manufacturers of silicone gel breast implants. However, MEC never funded a study of this nature to examine the immune response of women receiving silicone gel breast implants, nor did it participate with other manufacturers to fund such study. [FN99]