April 14, 2005 F.D.A. Panel Backs Breast Implants From One Maker By GARDINER HARRIS http://www.nytimes.com/
GAITHERSBURG, Md., April 13 - Silicone breast implants made by a California company should be available to women who undergo cosmetic breast surgery, a federal advisory panel voted on Wednesday, rejecting arguments about serious health problems. The panel chairman called the 7-to-2 vote to approve an application by the company, the Mentor Corporation, unexpected. On Tuesday, the panel voted, 5 to 4, to reject a similar application from the Inamed Corporation. Before the vote on Wednesday, Mentor was widely seen as having the weaker of the two applications because it had followed patients in its principal breast-implant study for a year less than Inamed. Most panel members said they were comfortable with the long- term safety of Mentor devices, and most dismissed concerns that ruptured implants caused the kind of serious diseases that some women's groups have listed. The diverging votes sent a mixed message to the drug agency, making predictions about what it would decide all but impossible. In 2003, the panel, with some different members, voted, 6 to 3, to approve an Inamed application. The drug agency rejected it in January 2004, saying more information was needed. Many experts say they believed that the agency had toughened oversight of device and drug manufacturers in recent months. Yet, the agency generally follows the advice of its advisory panels. The three-day hearing on implants began on Monday and included more than 160 witnesses who gave impassioned pleas to approve or reject silicone implants. Dozens of women said implants had sickened them severely, and some gave gruesome testimony about silicone from ruptured implants squeezing out of their eyes and ears. Dozens of other women pronounced silicone implants a safe boost to their self-esteem. Nearly all studies have found no link between silicone implants and serious disease. The potential market for silicone implants could approach several hundred million dollars a year in the United States. About 250,000 breast augmentation operations are performed annually, and if the stigma and uncertainty attacked to silicone implants are removed, more women may choose the procedure. At the moment, just saline implants are allowed for purely cosmetic operations, even though many patients and doctors say silicone implants feel more natural and look better. Several panel members said they had voted to approved the implants because Mentor made a more convincing presentation than Inamed. "I want to explain to myself and everyone else why I could vote yes on one application and no on another," Dr. Stephen Li, a panel member who is president of Medical Device Testing and Innovations in Sarasota, Fla., said after the vote. Mentor silicone implants "had an extremely low rupture rate," Dr. Li said. "And we didn't have nearly the questions on this application that we did on the last application," he added. The president of Mentor, Joshua H. Levine, said it was " very grateful that the panel looked at the science" and decided that "these products are not all created equal." Mr. Levine said he hoped that the F.D.A. would follow the guidance from the panel. Inamed and women's groups complained about the votes. "I'm stunned and amazed by a bizarre and strange decision by a few panel members who yesterday demanded longer-term safety data and today accepted shorter-term data," a vice president of Inamed, Dan Cohen, said. Dr. Diana Zuckerman, president of the National Research Center for Women and Families, called the conflicting votes illogical and predicted that the drug agency would reject both applications. Bitter rivals and crosstown neighbors in Santa Barbara, Calif., Mentor and Inamed each has 50 percent of the silicone implant market in the United States and together control 75 percent worldwide. Silicone implants are mostly available just for patients undergoing breast reconstruction after cancer. With the companies evenly matched, the differing votes represent a public relations coup for Mentor. Mentor shares, which rose 77 cents, to $35.33, in trading during the day, before the vote was announced, shot as high as $39.66 in after-hours trading. Inamed shares, by contrast, plunged $2.90, or 4.37 percent, to close regular trading at $63.51. The stock fell even more rapidly after hours, after the vote was announced, dropping as low as $60. Saline implants sell for about $400 and silicone implants for $800. Insurance almost never covers cosmetic procedures but does cover reconstructions. As with the Inamed presentation on Tuesday, much of the panel's discussion on Wednesday revolved around how often Mentor implants ruptured and what happened to women with ruptured implants. The two questions have plagued silicone implants for more than 20 years. Mentor described a study in which it is closely following 420 patients. The study has 3 of an expected 10 years of figures, and the women in the study have had just two screenings with magnetic resonance imaging. Screening is important because physical examinations by patients and their doctors rarely spot ruptured silicone implants. After two years, six patients, or 1.4 percent, had ruptures. All were "silent," meaning patients and doctors were unaware of the problem until the screening showed it. With two years of data from its own study, Mentor relied on studies by others to predict the long-term viability of its implants. Those studies showed that Mentor implants had a lifetime of 25 to 47 years, the company said. After 12 years, it estimated, 9 to 15 percent of the recipients could experience ruptures. Given such limited data, the drug agency did not even try to estimate the long-term rupture risks for the Mentor implants as it had for Inamed. Staff members of the agency pointed out that Mentor had dropped women from its study when they had their implants removed and not replaced. The outside study that Mentor relied on for many of its long-term estimates had myriad problems with the selection of women used, the agency said. Dr. Sahar Dawisha of the office of device evaluation in the drug agency told the panel that even if the Mentor rupture estimates were correct, the widespread use of its implants would lead 22,500 Americans to suffer ruptures every year. The panel placed nine conditions on a Mentor approval, including requiring that surgeons receive hands-on training with silicone implants before using them and that Mentor continue to study ruptures. The F.D.A. has little power to enforce such conditions after it renders an approval. Mentor promised to abide by the conditions. Most panel members said the company gave them confidence. "We don't have exhaustive knowledge about these devices," said Dr. Michael Miller, a panel member and a professor of plastic surgery at the University of Texas. "We have sufficient knowledge to justify their use." Dr. Barbara R. Manno, a panel member and professor of psychiatry at Louisiana State University, said the panel wanted to give women a choice of implants. "And it isn't to have a choice," Dr. Manno said. "It is to make a choice. And tough luck if it doesn't work out." The American Society of Plastic Surgeons offered extraordinary support throughout the hearing to the manufacturers. Dr. Scott Speer, president of the society, is an Inamed consultant and delivered much of its presentation. --- Barnaby J. Feder contributed reporting for this article. 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