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Silicone breast implants seemed headed for museum shelves as failed relics of the American culture’s obsession with cosmetic surgery after thousands of lawsuits took them off the market in 1992, driving one manufacturer into bankruptcy. But the 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 approved Inamed’s request in October, but the agency deferred a final decision on Jan. 8, citing a need for more information about the implants’ safety and failure rate. Yet it appears likely that Inamed will eventually get the go-ahead, which raises the question: Why proceed with a product that in 1994 forced Dow Corning Inc., the nation’s largest implant manufacturer, out of the business? 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,” says Gordon & Rees San Francisco partner Jack “Skip” McCowan Jr., who has represented Dow Corning in several proceedings. “There is no association between silicone and any auto-immune disease. Any company coming into the market would have the benefit of that science.” 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,” says Hersh, who is based in the firm’s San Francisco office. “I’ve seen too many people who had the same injuries.” Nevertheless, Hersh, who handled many suits against manufacturers, agrees that the litigation of the ’90s isn’t likely to reoccur. Silicone breast implants were first developed in the early 1960s for breast augmentation and reconstruction. 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 United States, 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 says he doesn’t believe Dow Corning plans to get back into the business. “Claimants are anxiously awaiting payment on a plan they overwhelmingly voted approval for several years ago,” says Elizabeth Cabraser, a partner at Lieff, Cabraser, Heimann & Bernstein, which was a leader in the suits. Inamed officials didn’t respond to several calls and e-mails asking why they want to produce silicone implants for U.S. use, or whether they anticipate litigation. But defense lawyers say the company must have seen no problems. “My guess,” Sedgwick, Detert, Moran & Arnold’s Kevin Dunne says, “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 the Bristol-Myers Squibb Co., reiterates that if there are warnings on the product, “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. Cabraser predicts that’s likely to happen, noting that silicone implants have a rupture rate of up to 90 percent over 10 years. Cabraser also points out, however, that despite the possibility of ruptures causing permanent scarring and disfigurement, demand by women remains high. “Companies, attuned to this demand and the profit potential, may be willing to bear the risks of future litigation if new-generation implants prove as defective as their predecessors,” she says. Cabraser insists that manufacturers “lucked out,” arguing that women’s problems weren’t properly studied. “This should have made implant manufacturers more cautious, not less, in research and development of the product,” she says. “As it was, nearly a million women became guinea pigs in the breast implant experiment, and well over one-third of them have made disease, rupture, or injury claims.” McCowan says it’s sour grapes. “That’s sort of a very typical response you get from plaintiffs lawyers when the science developed by honest and ethical scientists doesn’t support their position in a lawsuit,” he says. McCowan also warns any plaintiffs lawyers against initiating a new legal war on silicone implants, noting the “latter history of the breast implant litigation — which was defense victory after defense victory. “The science,” he says, “caught up with the plaintiffs lawyers.” Mike McKee is a reporter for The Recorder, the American Lawyer Media newspaper in San Francisco, where this article first appeared.

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