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Silicone breast implants were pulled from the U.S. market in 1992 after manufacturers got hit with thousands of lawsuits. The litigation even drove Dow Corning Inc. � the nation’s largest maker of implants � into bankruptcy. But one company wants to jump back into this controversial market. Inamed Corp., a medical products firm based in Santa Barbara, California, has sold implants in 60 countries for years. The company’s plan to reintroduce silicone implants in America was approved by an expert panel of the Food and Drug Administration in October. The FDA postponed its final decision in January, however, citing a need for more information about the implants’ safety and failure rate. Yet it appears likely that Inamed will eventually get the green light. And this time it won’t have to worry about litigation, several observers predict. “There’s an awful lot of science in the last ten years that supports the safety of silicone as an implantable product,” says Jack “Skip” McCowan, Jr. A partner at Gordon & Rees in San Francisco, McCowan has represented Dow Corning in several proceedings. He adds, “There is no association between silicone and any autoimmune disease. Any company coming into the market would have the benefit of that science.” Nancy Hersh of San Francisco’s Hersh & Hersh disagrees about implant safety, pointing out that most studies have been paid for and promoted by manufacturers. Nevertheless, Hersh � who represented many women in suits against implant manufacturers � agrees that the mass litigation of the nineties isn’t likely to occur again. A Houston attorney won the first suit against an implant manufacturer in 1977. But litigation didn’t take off until 1984, when San Francisco lawyer Daniel Bolton � at the time with the Hersh firm � obtained a $1.5 million judgment for a Nevada woman. In 1991 Bolton, then a solo practitioner, followed up with a $7.3 million judgment based on the theory that leaking silicone causes connective tissue disorders, leading to problems such as joint pain, rashes, dry mouth and eyes, and chronic fatigue. A year later, the FDA requested a moratorium on new silicone implants, and manufacturers complied. An alternative � saline implants � is still available in the United States, though they are considered less natural-looking than silicone. Dow Corning, which declared bankruptcy in 1994, eventually reached a $3.2 billion global settlement with more than 300,000 plaintiffs. But because 48 plaintiffs in Nevada have refused to sign on to the deal, no money has been doled out to date. Inamed officials didn’t respond to several calls and e-mails asking why they want to produce silicone implants for American use, or whether they anticipate litigation. But defense lawyers say the company must be optimistic. “My guess is, they’ve done very careful analysis to look at the science in terms of causation and in the design of the product,” says Kevin Dunne, a partner at Sedgwick, Detert, Moran & Arnold in San Francisco. “And they feel like they’ve come up with a product that reduces the risks of side effects.” Dunne � who has defended several implant manufacturers, including Bristol-Myers Squibb Co. � says that if there are warnings on the product, “[then] there is no basis for a lawsuit.” At worst, he says, a manufacturer could be sued for an individual defect if an implant has a weak spot that ruptures.

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