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San Francisco�Silicone breast implants seemed headed for museum shelves as artifacts of cosmetic surgery after thousands of lawsuits took them off the market in 1992, driving one manufacturer into bankruptcy. But Inamed Corp., a Santa Barbara, Calif., medical products company that has sold the implants in 60 countries worldwide for years, is trying to bring them back to America. An expert panel of the Food and Drug Administration (FDA) approved Inamed’s request in October, but the agency deferred a final decision in early January, 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, which raises the question: Why plunge into the shark-infested legal waters that in 1994 forced Dow Corning Inc., the nation’s largest implant manufacturer, out of the business? Science has a say The reason, plaintiffs’ lawyers and defense attorneys say, is that science is on Inamed’s side. Recent studies favor breast implant manufacturers, they contend, and warning labels that didn’t exist a decade ago greatly reduce liability. “There’s an awful lot of science in the last 10 years that supports the safety of silicone as an implantable product,” said Jack “Skip” McCowan Jr., a partner at San Francisco’s Gordon & Rees who has represented Dow Corning in several proceedings. “There is no association between silicone and any autoimmune disease. Any company coming into the market would have the benefit of that science.” San Francisco-based Hersh & Hersh partner Nancy Hersh disagrees about implant safety, pointing out that most studies have been paid for and promoted by manufacturers. “I don’t believe those studies,” she said. “I’ve seen too many people who had the same injuries.” Nevertheless, Hersh, who represented many women in suits against implant manufacturers, agrees that the mass litigation seen in the 1990s isn’t likely to occur again. Implant history Silicone breast implants were first developed in the early 1960s for breast augmentation and reconstruction, with Texas native Timmie Jean Lindsey becoming the first recipient in 1962. A Houston attorney won the first suit against a manufacturer in 1977, but litigation didn’t spread until 1984, when San Francisco lawyer Daniel Bolton, then with the Hersh firm, obtained a $1.5 million judgment for a Nevada woman. Bolton followed up as a solo practitioner in 1991 with a historic $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 implants and manufacturers complied. An alternative-saline implants-is still available in the U.S., though they are considered less desirable than silicone. Dow Corning, which declared bankruptcy in 1994, eventually reached a $3.2 billion global settlement with more than 300,000 plaintiffs, but no money has been doled out to date. McCowan said he doesn’t believe Dow Corning has plans to get back into the business. “Claimants are anxiously awaiting payment on a plan they overwhelmingly voted approval for several years ago,” said Elizabeth Cabraser, a partner at San Francisco’s Lieff Cabraser Heimann & Bernstein, a leader in the suits against manufacturers. 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 heavy litigation. But defense lawyers say the company must have read the tea leaves and sees no problems. “My guess,” said Kevin Dunne, a partner at San Francisco’s Sedgwick, Detert, Moran & Arnold, “is they’ve done very careful analysis to look at the science in terms of causation and in the design of the product, 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., reiterates that if there are warnings on the product, “there is no basis for a lawsuit.” At worst, he said, a manufacturer could be sued for an individual defect if an implant has a weak spot that ruptures.

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