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New Silicone Study - Leader's Product Liability Law and Strategy - September 1, 1992

By: Noel Cohen
Leader's Product Liability Law and Strategy
September 1992

Researchers have reported finding evidence that the human body is capable of forming antibodies to silicone, the material that breast implant plaintiffs, among others, claim is responsible for injuries ranging from local irritation to debilitating autoimmune responses. While the findings are far from conclusive, some experts say the study is sure to be incorporated into silicone-implant plaintiffs' armamentarium.

In the study, published in The Lancet, Aug. 29, 1992, Vol. 340, pp. 510-513 the researchers found antibodies in blood samples taken from two children with birth defects who had silicone tubes implanted to drain fluids collecting in their brains and had developed local inflammation. Dr. Randall M. Goldblum, professor of pediatrics at the University of Texas Medical Branch in Galveston and chief author of the study, cautioned that the findings are not conclusive.

Indeed, Richard Rawls of Irvine, Calif.'s Palmieri, Tyler, Weiner, Wilhelm & Waldron, who represents breast implant maker McGahn Medical Corp., points to the study's inconclusiveness as a factor in why he believes it won't have "a significant impact on the defense" of breast implant cases. It's "only one study [with a] limited number of patients," he said, adding that a localized inflammatory response is a "normal response to any foreign object placed in the body." Cautioning that the presence of antibodies "does not mean there's a disease," Ron Actis, a spokesman for implant maker Dow Corning Corp., said researchers at the company are going through the study report "in detail." He added that the company is sponsoring research at two universities to determine whether silicone causes cancer and/or autoimmune diseases.

Plaintiffs' attorney Kenneth B. Moll of Chicago's McDowell, Moll, Fitzgibbons and Drew concedes that the study offers only anecdotal, as opposed to epidemiological, evidence, since it looked at only two cases, which courts will not deem "acceptable scientific data." However, since studies such as this are the only ones available to plaintiffs, they will use them, says Mr. Moll. When a court questions the study's validity, plaintiffs can shift the responsibility of conducting more conclusive studies to the defendant implant manufacturers, he says.

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