Melinda Barrow 9

FN183. However, Dr. McCarty testified that there is nothing to suggest that silicone can be distributed vascularly through the blood since silicone is hydrophobic, and the vascular system is pressurized. Therefore, he opined that not seeing silicone in the blood vessel is consistent with physiologic and physical fact. However, Dr. McCarty admitted that he had not dissected a blood vessel from the capsule of a woman who had a silicone gel breast implant. Dr. McCarty discussed his review of Dow Corning documents in which a radioactive substance was tracked through the body to find the distribution of an injected fluid in 1972. The technique of radio labeled compounds with appropriate measurement and controls was in use in the 1960s. In the Dow Corning study, liquid silicone 360 was injected into rats which were killed at different times up to 90 days and their organs, urine, feces, and expired air examined to trace silicone distribution. Radioactive labeling was found in all, and the level of silicone was found to be above the background rate in many.

*19 Dr. Busch's testimony was augmented by the testimony of Dr. Puszkin who has studied the effect of silicone on human tissue since 1992 and who also opined that the molecules from the silicone gel migrate away from the elastomer and cause adverse immune responses. [FN184] Dr. Puszkin noted that the capsule which forms around the silicone gel breast implant is an inefficient and ineffective first barrier to further migration of the silicone molecules which have bled through the implant's shell. [FN185] With the use of magnification and laboratory slides he prepared from tissues taken from Plaintiff when her implants were removed, Dr. Puszkin identified silicone gel particles in the pseudo-capsule and also in the breast tissue located between the pseudo-capsule and Plaintiff's skin. [FN186] His testimony that silicone could also be seen in a blood vessel in one of the slides of Plaintiff's tissues was hotly disputed by Dr. McCarty. [FN187] Finally, Dr. Puszkin testified that Plaintiff's blood serum showed the presence of auto-antibodies, and the slides he prepared showed inflammation of a chronic nature, indicating an autoimmune reaction was occurring in Plaintiff's body. However, Dr. Puszkin did not look for migration of the silicone gel beyond the pseudo-capsule, blood vessels and capillaries, and tissue appearing on the slides he prepared, and he did not test for silicone in the lymph nodes of Plaintiff. [FN188]

FN184. Dr. Puszkin testified that he has examined over 2300 women with silicone breast implants during the last five years and performed microscopic analysis of the changes in their bodies in order to determine what happens to them with migration of silicone. He found that these women have a larger number of auto-antibodies, or antibodies which react against themselves, than women who have not been exposed to silicon, silicone gel, or silicone. He has amassed a data base using blood from women contributing to a blood bank compared to blood from women with silicone gel breast implants and has found in the latter antibodies to muscular, nerve, and connective tissue that cause inflammation, which initially is local but can be carried to the lymph nodes and in the blood and continually propagates. He has found that for many people these antibodies which the body creates do not have adverse symptoms. However, he examined samples of Plaintiff's blood and testified that she displayed an autoimmune reaction against her connective tissue.

FN185. Dr. Puszkin opined that if silicone breaches the pseudo-capsule, it will be seen in the lymph nodes and in the blood vessels of the body, breaking into smaller and smaller particles which cannot be seen but can be measured. In contrast, Dr. McCarty testified that silicone from gel bleed does not move "freely" into and out of the capsule.

FN186. Plaintiff's Exhibits 1.31(a-n) and 1.54(a-d) prepared May 26, 1994.

FN187. Dr. McCarty's testimony on this dispute particularly emphasized Plaintiff's Exhibit 1.31(e). See also Plaintiff's Exhibit 1.31(f).

FN188. But see footnote 43 supra. Dr. Puszkin testified that he saw no evidence of infection in Plaintiff.

Noting his disagreement on nearly every point to which Dr. Puszkin testified involving the issues in this case, Dr. McCarty stated that he had reviewed slides made from Plaintiff's explants and that there was no moderate, chronic inflammatory response to silicone in her breast capsule, [FN189] although silicone could be seen in a vacuole within a macrophage in the capsule. He emphatically stated that there was no evidence of silicone in a blood vessel shown on one of these slides as Dr. Puszkin had testified, [FN190] and the slides of Plaintiff's breast tissue showed no silicone in it. After explaining the process for preparing pathology slides and examining them by use of different lighting techniques, [FN191] Dr. McCarty was critical of Dr. Puszkin's use of magnification and lighting and Dr. Puszkin's conclusions. After categorically testifying that no silicone could be seen in a blood vessel on a slide of Plaintiff's breast tissue, Dr. McCarty opined that silicone does not travel into blood vessels "readily" because blood vessels are an aqueous media with a greater pressure gradient. He testified that he had never seen silicone in blood vessels of implanted women, citing several scholarly articles to support this statement. He then testified that women with silicone gel breast implants do not have increased silicone in their blood, but admitted that "[a]ll people have some silicone in their blood." Nevertheless, he adamantly testified that after examining the generous and significant breast biopsy tissue from Plaintiff on two slides, involving five fragments of breast tissue and showing a rich vascular, capillary, and blood vessel system and a rich lymphatic supply, no silicone whatsoever was found in that space. From this, Dr. McCarty concluded that there was no migration of silicone in Plaintiff's breasts. [FN192] While admitting that he found two, multi-nucleated giant cells in slides of Plaintiff, Dr. McCarty stated that giant cells are not limited to the presence of silicone, are not harmful, and do not cause damage. [FN193] From his observation of Plaintiff's tissue capsule, he found no local or systemic disease present, nothing to show that systemic disease would develop, and no cause for concern to her health. He concluded that Plaintiff's capsule was well matured with no active inflammation. [FN194]

FN189. Dr. McCarty admitted that whether an inflammation is moderately chronic is a function of the number and type of cells seen by the pathologist. He also opined that generally an acute inflammatory reaction occurred close to the time of the insult, and generally it takes three to five days for an acute inflammatory reaction to be deemed to be chronic, although a local inflammatory response to a foreign body may, but does not have to, progress to a chronic inflammatory response.

FN190. Using Bright Field lighting, Dr. McCarty testified that the blood vessel shown on the slide of Plaintiff's tissue was perfectly normal, came from a healthy individual, and that there was no silicone in this blood vessel. Defendant's Exhibits 1261.14-19. He further testified that while the capsule tissue showed the presence of some silicone, the amount in the vacuoles shown on the slide was about one billionth of a gram.

FN191. Three methods of lighting for microscopy which Dr. McCarty related are: (1) Bright Field by which light is transmitted directly through the slide from underneath it; (2) Nemarsky which uses wave length and polarized light resulting in incident light contrasts allowing the pathologist to see things which are not stained in three dimension; and (3) Dark Field in which an interference plate is placed so that light focuses on the edges of the material being examined, the beamed light from the sides allowing the sides of reflected objects which are not flat to be seen.

FN192. Dr. McCarty noted there was no biopsy of Plaintiff's lymph nodes. He indicated that since the lymphatic channels are vascular and separate from the blood vessels, they are in the domain of homeostasis. Less than 1/10 of 1% of macrophages enter the lymph system and consume the silicone there, and he opined that macrophages with silicone will not travel through the lymph channels to the lymph nodes because of the gradient pressure. Dr. McCarty initially admitted that a lymph node with silicone would probably be enlarged. On recall to the witness stand, he stated that he was confused by defense counsel's question and that while silicone is not always found in the lymph nodes of women with silicone gel breast implants, and macrophages with silicone may but do not always travel to local lymph nodes, silicone will stay in the lymph node, and the lymph node does not necessarily become enlarged or inflamed. Later he testified that there are case reports where no trauma to the implant has been reported and silicone has been found in the abdomen and groin. He also acknowledged that his conclusion that there is no relationship between the presence of silicone and enlargement of lymph nodes was based on his pathology review of lymph nodes. Most of the lymph nodes he has received were enlarged and without silicone. However, most of the lymph nodes he has received do not come from women with silicone gel breast implants and are associated with other medical issues. He then stated that he could not tell for certain if there was silicone in Plaintiff's lymph nodes. He also ventured that if silicone is present and a lymph node is enlarged, an MRI or fine needle aspiration or excision biopsy and ultrasound could be used to determine if silicone is there or a marker could be employed.

FN193. Dr. McCarty noted that lymphocyte cells are part of the inflammatory reaction of the immune system. Dr. Williams explained that foreign body giant cells are caused by the merging of macrophages, frequently for the purpose to ingest particles.

FN194. Dr. McCarty qualified this testimony on cross-examination by stating that he did not say that Plaintiff did not have systemic disease, but instead that he had testified that there are no changes or diseases in Plaintiff's breast that would indicate a risk for, or be associated with, any systemic disease.

*20 Concurring with Dr. McCarty, Dr. Alan Shons testified that after reviewing the records of Dr. Worthing and the report of the pathologist after Plaintiff's explant, he found no evidence of silicone migration outside the breast capsule. However, Dr. Shons testified that from the hospital pathology report on Plaintiff's explant, a foreign body reaction could be discerned in the tissue surrounding the implant, which he described as dense, fibrous tissue containing foamy histiocytes which are part of the foreign body reaction. He further opined that since the silicone gel which has bled from the elastomer is hydrophobic and stays on the surface of the shell, in the fibrous capsule, and in the territory of the regional lymph nodes, such gel is not permeable to the scar capsule and does not migrate through the body. [FN195] However, this testimony was of a conclusory nature as Dr. Shons apparently has done no testing himself of the tissue to explain how he arrived at this opinion. [FN196] Further, without elaboration, Dr. Shons testified that he had not seen silicone migration except in the axillary lymph nodes in patients other than Plaintiff. [FN197]

FN195. Dr. Shons testified that just as gel droplets are not permeable to the scar capsule and are encased in macrophasia, silicone gel that reaches the lymph nodes has the same reaction as in the scar capsule, that is a scar tissue barrier is formed which localizes the gel, encases and immobilizes it, and seals it off. However, Dr. Shons did not describe how the gel particles escaped from the scar tissue which he earlier testified acted as a barrier to gel migration. Further, he described the means by which the particles moved to the lymph nodes as being through lymphatic fluid in the lymphatic channels, a one-cell layer in the subcutaneous tissue just below the skin surface. Dr. McCarty also testified that silicone has been located in the axillary lymph nodes of implanted women, although he denied that there was any evidence in Plaintiff's medical records that she had silicone in her lymph nodes.

FN196. Dr. Shons testified that he had agreed to be an expert witness for the Defendant because silicone gel breast implants are important to his specialty as a reconstructive plastic surgeon, particularly in the case of mastectomies, and that he felt women had been unnecessarily scared by publicity concerning breast implants. Other than his surgical work, Dr. Shons served as one of three plastic surgeons on an eight-member Scleroderma Task Force which met once in June of 1990. For this group, Dr. Shons conducted a survey in 1990 of plastic surgery literature on the relationship between connective tissue disease and silicone gel breast implants that consisted of approximately 94 articles. Of these, approximately 28 articles dealt with immune disease and breast implants. He then published an article about his review of this literature in the Annals of Plastic Surgery. Defendant's Exhibit 1251. Dr. Shons related five other cases involving silicone gel breast implants in which he has testified for the defendant breast manufacturer. Other than his professional work as a plastic surgeon involved primarily in breast reconstruction, a small percentage of breast augmentations, his survey of literature in the speciality of plastic surgery in 1990, and his examination of Plaintiff on October 13, 1997, Dr. Shons did not appear to have any direct experience in the testing or manufacturing of implants or the study of the effects of such implants on the human host. In fact, he testified that he was not a materials expert, that he had implanted no silicone gel breast implants since 1993, and that he had implanted only eight to ten saline implants in that time. He testified that his report filed in this case was written and typed by someone at the office of counsel for Defendant after he discussed it with counsel. Defendant's Exhibits 1154 & 1158.

FN197. Although he denied that there was gel migration from silicone gel breast implants, Dr. Shons admitted that if silicone gel were injected directly into the breast, it would diffuse throughout the breast, multiple scar tissue capsules would form around the injected droplets, and lymphocytes and macrophages would attack the gel. While contending that the elastomer was a safety factor to hold the silicone gel in place, Dr. Shons agreed there would be a reaction in the body to silicone gel which had not been contained in the elastomer and scar tissue.

Although admitting that he had not tested silicone gel and was relying only on his own reading of the literature, Dr. Williams testified that in gel bleed, the molecules diffuse through the elastomer, and the majority of molecules adhere to the outside of the silicone shell because it is of similar molecular composition. [FN198] Some very small microscopic droplets get into the capsule, and he would expect macrophages, which would ingest the silicone droplet, to be present because this occurs with other materials. The macrophages with the silicone droplets may move toward, and deposit the silicone in, a lymph node, but to his knowledge macrophages do not go into the bloodstream, and there is no deleterious effect on the lymph nodes or the patient. Although admitting that he had only read about and had not studied implants himself, he testified that molecular diffusion of silicone gel through the elastomer would result in the droplets staying on the hydrophobic, outside surface of the shell and eventually equilibrium, or cessation of gel bleed. While he could not recall one article discussing equilibrium being reached in a silicone gel breast implant device, Dr. Williams supported his opinion by stating, "It's a basic law of physics." Thus, Dr. Williams opined that from his reading on the subject, his study of body reaction, and his work with silicone elastomers, there is no harm to humans, whether local or systemic, from gel bleed or the long-term presence of silicone in the body. [FN199]

FN198. Dr. Williams also testified that the first draft of his Rule 25 expert witness disclosure was prepared by attorneys for Defendants, although the substance of the report was his.

FN199. Dr. Williams further supported this conclusion by saying that the silicone molecule is stable and does not interact chemically with its environment because the silicon-oxygen bond which forms its backbone is one of the strongest in terms of stability. Other polymers are not as strong because their backbones contain carbon which body chemicals or enzymes can cause to break down. In contrast, silicone polymers have the greatest resistance to attack by the body, and this stability applies to gel, fluid, and elastomer because all have the same silicon-oxygen backbone. Thus, while no material has no reactivity in the body, silicone and Teflon or gortex used in artificial arteries are materials of low reactivity. However, on cross-examination Dr. Williams admitted that macrophages, as part of the body's non-specific immune system, could ingest silicone droplets on the surface of the elastomer, and then a small number of them could travel away or stay there. While Dr. Williams testified that silicone gel and silicone elastomer are appropriate for use for breast implants and do not affect the immune system in humans, Dr. Williams has never tested a silicone gel breast implant in his laboratory, has never written an article on the biocompatibility of such implant, has never tested any longterm silicone gel-filled device intended for long-term implant, has never seen a breast capsule or tested it, and has received no award for work with silicone gel, oil, or liquid. While familiar with gel bleed, Dr. Williams has never attempted to determine the rate of bleed. He stated that his work is primarily with silicone elastomer which is generally safe for human implant as shown in rabbit tests for toxicity. Dr. Williams did agree that in some polymers, lower weight molecules are more toxic and have greater solubility than higher weight molecules. He further admitted that he had not seen subchronic toxicity testing of components of the implant device by MEC, and that components may have different properties when tested separately than those properties manifested on tests when they were combined in the device. In relying on literature to opine on MEC's breast implant product, Dr. Williams admitted that there were peer-reviewed articles concluding that silicone is not biocompatible and that silicone chronically causes problems when used in an implant. However he testified that such articles were omitted from the list of articles on which he relied.

As to the issue of whether silicone migrates beyond the breast tissue, the experts also drew conflicting conclusions from the scholarly publication of Dr. Lencio Garrido. Dr. Garrido published a report in which he related finding silicone from silicone gel breast implants in the tissues and blood and degradation of silicone products in the implanted human through the use of nuclear magnetic resonance ("NMR"). Dr. Zeigler, who since age sixteen has worked with NMR, referenced the work of Dr. Peter Macdonald who, he testified, tried without success to replicate the scientific work of Dr. Garrido. [FN200] Dr. Zeigler testified that Dr. Macdonald found it would take centuries to obtain an observable signal showing silicone to be unequivocally present and duplicable by scientists using the same technique used by Dr. Garrido. Reciting other authors who could not find silicone in the blood or degradation products using NMR, or who have tried but were unable to find the signals which Dr. Garrido reported he found, Dr. Zeigler testified that Dr. Garrido's findings were at the outside limits of present technology and were based on unreliable data. [FN201]