Silicones 16. Disease Conditions in Some Users

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<>ChemCases.com
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<>Back to Silicone 15. Breast Augmentation Implants
<>Ahead to 17. Bankruptcy of Dow-Corning

<>Chemical Concepts
<>Just as a semipermeable membrane allows passage of water, silicone membranes allow passage of minute amounts of silicone fluid. And one physical property of the silicones is they do not have high tear-resistance.

16. Silicones' low intermolecular forces

explain

poor tear resistance and porosity.

<>Three Questions

<>In the process of relating responsible decision making to the chemistry of silicones we must deal with a number of issues:

<>1. The science indicates the implants might rupture and leak fluid into the body. Are the implanted silicones harmful - do they initiate more disease in women with implants than we see in those women without implants?

<>2. Regardless of the safety of the silicones, did Dow Corning exert sufficient oversight of its products as they were being redeveloped?

<>3. Can the FDA, industry or physicians truly be certain that the chemical and physical properties of a device such as an implant are well-enough understood to be used in human subjects?

<>d. Medical Questions Arise

As result of claims that the Dow Corning implant is responsible for a series of autoimmune disease conditions in its users, Dow Corning has been involved in more than 20 years of litigation. In this ChemCases unit, we rely on the following sources we believe present an objective review of implant history.:

<>The Dow Corning Corporation - A Case Study at the Darden School of the University of Virginia.
<>Breast Implants on Trial - Public Broadcasting Frontline Series.
<>Dow Corning Corporation - Chapter 11 Information.
<>Silicone Gel Breast Implants - Report of UK's Independent Study Group from the UK Medical Device Agency.
<>FDA Breast Implant Information Source - Updated in late 1998 by the FDA.
< face="Arial" size="-1">Report: Petition for Return of Silicone Implants to approved status in 2003

<>In the lifetime of commercial products, be they television sets or breast augmentation implants, we first see a product defined. In time, the product is refined, features are added, improvements are continually researched. Dow Corning was in a highly competitive market for its silicone implants.

<>In the late 1960's, the company began careful refinement of its product. They sought a softer, more pliable implant. In this search, the company limited its research to combinations of the silicone materials, fluids and polymers, previously implanted. Dow Corning chemists modified the implant by decreasing the viscosity of the silicone fluid in the implant. And they developed a new, presterilized product that would reduce the handling of the implant in the surgery suite.

<>Dow Corning was responsible for safety studies on the implants. In researching the safety of their new developments, Dow Corning chemists considered if the lower viscosity fluid would migrate through the sac of the implant and head for the lymph nodes, from where the silicone, as a foreign body, would be eliminated. They found no increased migration of the silicones over the previous combination of materials. There always had been a trace of silicone fluid that could be found in the nodes.

<>PBS has published a chronology from here:

<>Only in 1976 did the Food and Drug Administration require that a manufacturer of a device prove to FDA that the device was "safe and efficacious," that it both do no harm and that it would work as intended. But with a decade of history of silicone implants, the FDA "grandfathered" silicone implants, believing that their safety and efficacy had been proved by the implant history itself.

<>Thousands and thousands of women elected silicone implants. In 1977, a woman who claimed her implants had ruptured, received a $170,000 settlement of a law suit from Dow Corning.

<>By 1982, the FDA was considering reclassifying the implants as a "Class III" device, requiring scientific proof of safety and efficacy. About that time, a jury in a California court awarded nearly $2,000,000 to a woman claiming a systemic autoimmune disease was caused by her silicone implant.

<>Finally, the FDA required manufacturers to provide safety and efficacy data. Dow Corning supplied the FDA with results of 329 studies, on schedule, in 1991.

<>Meanwhile, in Alabama, another jury awarded $5,400,000 to a woman who displayed only preliminary symptoms of autoimmune disease. The jury was influenced by evidence that the woman had a residue of silicone present in her lymphatic system. Experts claimed this material would present an increased risk of disease. Another California jury in 1991 awarded more than $7,000,000 to a woman whose ruptured implants are claimed to have led to autoimmune disease. Dow Corning documents appear in this trial that had not been given previously to the FDA.

<>The FDA assembled experts in 1991 and 1992 to evaluate implant safety. These experts were not convinced by the safety data presented by Dow Corning and three other manufacturers. The FDA Commissioner soon called for a voluntary cessation of silicone implant procedures except for reconstruction. The manufacturers agreed they would no longer supply implants and in 1992, Dow Corning pulled out of the implant business. At the end of that year, a jury linked autoimmune symptoms in a Texas woman to her ruptured implants. Lawyers and others admitted her symptoms were like a bad flu. But the jury awarded $25,000,000 against the manufacturer, Bristol-Meyers Squibb.

<>Dow Corning's 30-year participation in implants was over. There was pain and disease out there among implant users. Was the incidence greater than that observed among women without implants? Was the company responsible for the medical condition of the women that received its product? And would the company have a financial responsibility if it were found liable?