Melinda Barrow 8

FN172. During trial this tissue was referred to variously as "the capsule" or "scar tissue" or "capsular contracture." Dr. Puszkin called it a "pseudo-capsule," a new organ of connective tissue formed in an attempt of the body to isolate the elastomer shell from the living body tissues. He described this capsule as the first wall of defense on the part of the body to the silicone gel which is bleeding from the shell of the implant. Dr. Puszkin stated that the capsule which forms around the breast implant is full of blood vessels, tissue, and nerve endings. Thus, he stated, it is a living tissue, not a scar tissue as some have described it. Dr. Shons also testified that the scar capsule was a live tissue with blood vessels. However, Dr. McCarty disagreed on this point, as he did with much of the testimony of Dr. Puszkin. Dr. McCarty testified that any implant will cause a foreign body reaction and that the capsule around a silicone gel breast implant is not a pseudo-capsule, a term which he stated has a specific meaning in pathology to designate a rapid growth tumor which is usually benign. Instead, Dr. McCarty described the capsule as a delimiting, fibrous membrane formed through the deposit of collagen consisting of a fine, delicate, connective tissue which compresses to form a capsule-like surrounding, a true capsule, when a foreign body is present. While, any substance implanted into the body causes a foreign body reaction, different types of implanted materials cause different foreign body responses. The foreign body reaction can be researched according to the material implanted. Dr. Williams stated that there is no material that can be implanted with assurance that no capsule will form.

However, according to Dr. Harris Busch, [FN173] when breast implants were first put into the human body, the type of foreign body reaction that ensued was not expected and was an astonishment to the manufacturers. [FN174] Dr. Saul Puszkin [FN175] pointed out that the foreign body reaction to other implants, such as pacemakers or solid silicone implants, is a scar tissue containing just fibers and no blood cells or foreign bodies, because no silicone gel is emerging. He found that the pseudo-capsule surrounding the silicone gel breast implant is not typical to the body's foreign body response because it is a "metaplastic" membrane with its own living blood vessels and cells and is representative of a constellation of responses to silicone gel which he has seen elsewhere in the body. [FN176] Because the silicone gel continuously bleeds outside its elastomer shell, the body is not allowed to cease its foreign body reaction, which then becomes a chronic condition. According to Dr. Puszkin, a foreign body reaction can consist of inflammation and infection. [FN177]

FN173. Dr. Busch was qualified as an expert in pharmacology as it relates to the immunology of drugs, including the testing and warnings as to drug usage. He has had a distinguished career as Chairman of the Department of Pharmacology at Baylor College of Medicine, President of the American Association for Cancer Research, and author of 939 peer-reviewed publications, including 36 textbooks, among other accomplishments. See Plaintiff's Exhibit 1.39. He has also acted as a consultant for defendant breast implant manufacturers as well as for individual plaintiffs in breast implant litigation. He has not had direct experience in the manufacture of medical devices, has not been involved in research on the effects of silicone in the human body, and does not have a specialized background in silicone chemistry.

FN174. Dr. Busch, an expert testifying for Plaintiff, stated that the first definitive work published on capsular contracture appeared in 1981, although there were earlier published reports, and stated that capsular contracture occurs in up to 90% of patients receiving breast implants. Dr. Shons, testifying for Defendant, stated that capsular contracture is known to occur in up to 80% of silicone gel breast implant patients, with wide variations which may cause deformity necessitating reoperation or removal. Dr. Zeigler, a materials expert, testified that the scar forming around the implant forces the implant into a shape more of a sphere as capsular contracture proceeds and folds in the implant occur. Dr. McCarty testified that the capsule inevitably forms around a breast implant, as well as around other types of implants, although he testified on cross-examination that the capsules formed can be different in two breasts of the same person and they can form immediately or be delayed for years in the separate breasts of the same person.

FN175. Dr. Puszkin testified as an expert in biochemistry, pathology with emphasis on immune-pathology, and neurobiology. His curriculum vitae is Plaintiff's Exhibit 1.34. He holds a doctorate in biochemistry and has done research for many years in the areas of pathology, toxicology, and immunology. He was extensively cross-examined about the circumstances surrounding his departure to Columbia University from a tenured teaching position he held at Mt. Sinai for over twenty years and allegations of misrepresentation of research and his advanced degrees.

FN176. Additionally on this issue, Dr. Gary Solomon, a practicing rheumatologist who is board certified in internal medicine and rheumatology, testified that the capsule which forms in response to a silicone gel breast implant is not a nonspecific response to any implant or intrusion, similar to the body's reaction to a splinter; instead, the tissue around a silicone gel breast implant has many layers, caused by the interaction between the immune system and the foreign invader, leading to an ongoing, specific immune response. Dr. Williams noted that the human body is designed to react to an implant, and the inflammatory reaction is a natural response to all implant situations of all materials, which then proceeds to a period of tissue repair with a fibrous material formed around the implant. In contrast to Dr. Puszkin and Dr. Solomon, Dr. Williams stated that the capsule, a layer or zone of fibrous material consisting primarily of collagen forming around the implant, is structurally the same for a breast implant and for a pacemaker.

FN177. As noted later in this opinion, Dr. Puszkin testified that silicone gel had migrated away from Plaintiff's breast implants and into tissue in her breast area. From his examination of slides from Plaintiff's explant, Dr. Puszkin testified further that Plaintiff's tissues reacted to the silicone gel as a foreign material and became inflamed, a condition which is chronic when the silicone continues to leak into the area.

Dr. Busch testified to the problems encountered when liquid silicone was actually injected into the human body. He stated that such direct injection produced significant harmful local effects; it produced scar formation, ulcerations, invasion by various kinds of white cells, distortions of the structure, bleeding, and the development of inflammatory masses called siliconomas or masses of inflammatory tissue, blood vessels, and white cells in the breast. [FN178] According to Dr. Busch, when MEC did ninety-day studies of the Dow Corning breast implant product components, it found that inflammatory reactions developed around the implants of the type similar to those that had been found when various kinds of silicone had been directly injected into the breast.

FN178. Dr. Busch testified that inflammation is a redness or increased area of warmth or heat due to increased blood of the cell invasion. He also testified that a granuloma is a mass composed of capillaries, white cells, inflammatory cells, and giant cells that can be painful and interfere with a person's normal functioning. According to Dr. Busch, siliconomas are granulomas which contain significant amounts of silicone. While first agreeing that the formation of granuloma is a form of biologic reaction, Dr. McCarty contended that granulomas do not form in response to silicone, although silicone may be associated with granulomas without always producing a granuloma, and he drew a distinction between giant cell reaction, a granuloma, and a macrophage reaction. Later he testified that "granuloma" is a term reserved for a granulomatous response and the formation of a nodular mass, and there are immunogenic granulomatous responses and non-immunogenic granulomatous responses, or foreign body responses, as well as specific and nonspecific inflammatory body responses. While immune granulomas are harbingers of systemic disease and a chronic inflammatory response can be part of a systemic disease, Dr. McCarty stated that he would not describe it as a harbinger of systemic disease if the inflammation is local. Further he stated that a local inflammatory response to a foreign body may, but does not have to, progress to a chronic inflammatory response. He also related several definitions of a granuloma from different authors, only one of which he felt was reasonable. Dr. McCarty testified that there were no granulomas in the records or tissue of Plaintiff and that the presence of a granuloma does not indicate illness. However, he testified that he did see two "clear" foreign body giant cells in slides from Plaintiff's explant.

*18 Dr. Blais, Dr. Puszkin, Dr. Batich, and Dr. Busch testified that the silicone gel breast implant is not an inert device, [FN179] that the implant will reshape its environment, the tissue of the host, and cause other processes to occur which are not part of normal biology or physiology and which will also alter the implant itself. [FN180] Thus, the continued gel bleed from the silicone gel breast implant causes changes in the implant's elastomer shell and a continuous foreign body reaction both in the capsule forming around the breast implant, which can become hard, calcified, and distorted, and in the tissues where the silicone gel molecules migrate.

FN179. An inert substance does not react with the environment. Dr. Shons testified that plastic surgeons regarded silicone as being inert or having minimal tissue response. However, Dr. McCarty testified that he did not believe that silicone is completely inert, although he contended that silicone did not cause a biologic reaction when it was treated as a foreign body, ingested, and stored by macrophage cells.

FN180. While Dr. Zeigler testified that fumed amorphous silica in the intermediates supplied by Dow Corning for the implant shell increased the tear strength of the shell and also were coated to make the surface of the shell hydrophobic, he elaborated that the fumed amorphous silica reduces permeation, concluding that silicone is stable in the body because of its exceptionally high bond strength and because silicone polymers have an unusually long service life in comparison with other polymers. However, this testimony appeared to be crafted to confuse the physical properties of the silicone implant components with the issue of gel bleed and its effect on the human body. Dr. Zeigler, who is a gifted expert in the physical properties of silicone polymers, is not a medical doctor and does not appear to have qualifications to knowledgeably opine as to the effect of gel bleed on the human host. Dr. Kotzin testified that he had seen no evidence that fumed amorphous silica in any appreciable amount gets into the system of women from the elastomer of a breast implant, and even if it did, there would be no lasting effects from a large amount of fumed amorphous silica.

3. Migration of Silicone Gel Molecules From Gel Bleed

There was contradictory testimony among the experts as to what happens after the molecules of the silicone gel have traveled through the elastomer shell to the outside of such shell implanted in tissue of the breast. The issue between these experts was not whether migration of the molecules occurs; instead the issue was how far such molecules migrate from the surface of the implant. [FN181] The main points of contention between the experts for the Plaintiff and those for the Defendant were whether migration of the silicone molecules from gel bleed from the outside of the breast implant elastomer to other parts of the body occurred, and if so, what effect this migration has on the human host.

FN181. As Dr. Solomon testified, "Everyone accepts that silicone is in the shell and is in the capsular tissue around the breast implant ."

Several witnesses for Plaintiff explained the process of migration of the silicone molecules. Some based their testimony on theory stemming from their knowledge of chemistry and the properties of the polymer; some based their testimony on study of tissues and examination of slides; and others based their opinions on study of scientific literature or their experience with patients in their respective medical practices.

Dr. Blais and Dr. Busch testified that the silicone gel, which began as a biologic material, ends as a chemical material in that the aqueous portion of the human body does not keep the gel bleed at the implant's outer shell. Instead, Dr. Blais explained, the oil and impurities bleeding through the shell over time meet proteins, metals, and salts carried in watery portions of the body. The proteins coat the particles of silicone oil like a soap, and the aqueous environment provides movement of the oil coated with protein along the shell. The globules detach and disperse in the fluid. As the implant ages, the fluid becomes so rich with these substances that it becomes thick, like a toothpaste, and the vehicle of release allowing the silicone oil to disburse in the breast tissue. This is a process which Dr. Blais called "emulsification".

Dr. Batich concurred that silicone gel is not an appropriate "fit" as a biomaterial for insertion into the human body in view of his research demonstrating migration of silicone gel droplets increasing over the surface area of the implant and degradation of the gel bleed through oxidation and hydrolysis. [FN182] Dr. Busch described three probable pathways for silicone migration within the human host: through the fascial planes, through the lymph system, and through the blood stream. Dr. McCarty also testified that there were three possible mechanisms for silicone migration away from the breast implant's surface: (1) gravity across tissue planes, (2) lymphatic transportation, and (3) vascular transportation. [FN183]

FN182. On this issue, Dr. Zeigler testified that silicone is not very soluble in water, being hydrophobic, or water-hating. He noted that body tissue is hydrophilic, or water-loving. However, he admitted on cross- examination that silicone is lipophilic or likes fat, and breast tissue is composed of fat. Further, the cell membranes of the body, which have lipids in them, are on balance hydrophilic because the body is mostly water. Zeigler opined that to the extent contact between the scar capsule and the elastomer destroys the equilibrium of gel bleed, silicone will not necessarily be drawn to the lipophilic breast tissue due to its polymer structure because breast tissue is by its nature aqueous. Thus, he theorized, the silicone will not disperse readily in an aqueous environment, and there would not be a tissue reaction with silicone since human tissue is aqueous to a large extent. However he acknowledged that silicone had been found in the lymph nodes of persons who had silicone gel breast implants and also reflected that from an article authored by Lynch in 1978 there is reason to believe that silicone could migrate from a rubber joint protheses via the marrow and lymphatics into the blood stream. Plaintiff's Exhibit 3.218. He also stated that while silicones do not "react" strongly with water, which is what is meant by hydrophobic, they do "interact" with water, and if there are chemicals such as lye or sulfuric acid present, silicones will react with water. He noted that the stability of silicones in water is why they are used in marine products. However, Dr. Batich testified that he supervised a test on silicone elastomers which were immersed in water for a long time. The elastomers became hydrophilic, not hydrophobic, and no longer "beaded up". Dr. Batich concluded that there is degradation of silicone gel in the biologic condition due to oxidation and hydrolysis or reaction with water, both of which occur at the surface of the breast implant. Through the process of oxidation and hydrolysis, he opined, the oils from the gel bleed are converted back into silicone gel, and the particles from the gel bleed are broken down into smaller molecules, forming over a large surface an area of tiny droplets, some of which break off. Dr. Batich quantified this by stating a droplet with a radius of one centimeter can break into micron sizes, covering a surface area from a few centimeters to ten square meters in a process called emulsification. Since the interaction between the body and gel bleed occurs at the surface of the implant, he opined, one could expect more interaction than just that which occurs at the surface of the implant. However, he admitted that he did not know what happened beyond this in the human body. Dr. Batich testified that what happens to the small molecules that come out of the gel and how they react with other things in the human body has been little studied, and his own findings have not been published or peer reviewed although they are his conclusions reached through his direct observation of slides. He has engaged in research to try to answer where silicone migrates inside the body by conducting tests on rabbits. Dr. Batich found from his study that in the control rabbits which had no implants there was little silicon. In rabbits with silicone gel breast implants, there was significant silicone around the implant, and in rabbits with silicone gel breast implants with a cut in the elastomer, there were significant silicone levels in the brain of the rabbits. He measured the level of silicon, the element, by grounding up the brain, dissolving it in hydrofluoric acid, and testing it with a spectrometer. While silicon is necessary to life, and he assumed the control rabbits and the rabbits implanted with saline breast implants had some silicon in their bodies already, he testified that silicon in the rabbits naturally was at such a low level that it could not be measured, unlike the level of silicon which he found in the rabbits with ruptured silicone gel implants in his research study. In contrast to this testimony of Dr. Batich based on his research, Dr. Shons testified, without elaborating on any underlying supporting evidence of testing, that silicone is hydrophobic, it will stick to itself and not to other things, and therefore it stays on the breast implant shell and scar tissue surrounding it. Dr. McCarty testified that since the capsule is a fibrous membrane formed through the deposit of collagen, an extremely aqueous protein which gives form to the soft tissues and is a critical part of the connective tissues, the capsule contains or holds the particles of silicone fluid. However, Dr. McCarty noted that in examining slides of Plaintiff's tissues he did not see silicone in her tissue "appreciably" outside the capsule. He also acknowledged that silicone loves fat, or is lipophilic.