Silicone Implant Ban to Stay
The Food and Drug Administration, rejecting the recommendation of its advisory panel, refused Thursday to lift its restrictions on the use of silicone gel breast implants, saying more research was necessary to prove their safety.
The surprise decision in the highly charged scientific debate casts uncertainty on the future of the implants. Specifically, the FDA said it would not approve widespread availability of the devices until more research was done into why they tear or break.
“What’s significant here is that there is material that will be leaking out when these devices rupture. We need to know how often that happens, why that happens and what the consequences are,” said Dr. Daniel Schultz, director of the FDA’s office of device evaluation.
The FDA’s decision to maintain restrictions on the implants is the latest twist in a medical drama that has played out before government regulators for more than a dozen years. And while almost everyone was surprised to see the agency reject the October recommendation of its advisory panel to make silicone implants widely available, no one believed that Thursday’s action was the government’s final word.
In 1992, the FDA limited the sale of silicone implants to women seeking breast reconstruction after cancer surgery and others willing to participate in long-term clinical studies. The only widely available choice is a saline-filled implant.
Since the FDA restriction took effect, women’s demand for larger breasts has grown more than sevenfold. In 2002, more than 225,000 women had breast augmentation surgery, according to the American Society of Plastic Surgeons. The majority received saline implants, which many women and doctors believe are less natural in look and feel than silicone implants.
Nicholas L. Teti, chief executive of Santa Barbara-based Inamed Corp., which had sought FDA approval for the marketing of its silicone gel implant, said Thursday that his company saw the decision “as a setback, but by no means do we see this as the end of the road.”
Late Wednesday, after the nation’s stock markets had closed for the day, company officials received a “non-approval letter” from the FDA.
Such a letter is less a rejection of the company’s application than a “not now” response to a marketing request, FDA officials said Thursday.
“A non-approval letter is not a final action,” Dr. David W. Feigal , the FDA’s chief regulator of medical devices, told reporters in a conference call. Inamed’s “application is still under review,” he said, but implant manufacturers will need to conduct new studies and address additional concerns to “establish that those products are safe and effective.”
Investors, however, reacted swiftly and Inamed’s stock price dropped almost 12% on Thursday. Inamed and its cross-town rival, Mentor Corp., split the $200-million breast implant market.
Less clear was the short-term impact of the FDA’s decision on women who want silicone gel implants for breast enlargement or for breast reconstruction after cancer surgery.
Dr. Robert W. Bernard, president of the American Society for Aesthetic Plastic Surgery, said his organization would e-mail its 2,100 members to tell them of the FDA’s decision. He stopped short of suggesting that doctors tell their patients that the FDA had not determined the safety of silicone implants.
But Diana M. Zuckerman, president of the National Center for Policy Research for Women & Families, a Washington-based research and advocacy group, said the FDA’s action Thursday should give pause to a woman considering silicone implants.
“This doesn’t tell her not to get them. But it does tell her, ‘We don’t know what the risks are,’ “Zuckerman said.
Bernard and Zuckerman were among 107 people, all but 17 of them women, who testified in October at a two-day hearing of the FDA’s 17-member general and plastic surgery devices panel.
Scores of women said they had suffered years or decades of health problems caused by silicone implants. They cited breast and joint pain, headaches, sinus infections, breathing difficulties, fibromyalgia, arthritis and other conditions.
Supported by several national women’s organizations and their own “implant survivor” groups, the women urged the FDA to maintain its restrictions on silicone implants.
But Inamed officials, several plastic surgeons and many women who had undergone breast enlargement surgery urged the FDA to make silicone implants more widely available. They cited studies that found no cause and effect between the implants and illness.
Other studies, however, including one conducted by the FDA, had concluded that there could be an association between fibromyalgia and silicone gel that had leaked out of ruptured implants.
In the end, the advisory panel voted 9 to 6 to recommend an end to restrictions on the implants if Inamed improved patient education and provided additional training for surgeons.
While the FDA often follows the recommendation of its advisory panels, that has not always been the case. In 2002, for example, the FDA approved Allergan Inc.’s Restasis eyedrops for the treatment of dry eyes; three years earlier, an advisory panel had recommended that the prescription-only product not be marketed because it was only marginally more effective than over-the-counter medications.
In the case of Natrecor, a drug used to treat congestive heart failure, an advisory panel recommended approval in 1999, only to be reversed by the agency a month later. Two years later, however, after manufacturer Scios Inc. had conducted additional studies, the FDA approved the drug.
In explaining the FDA’s decision to ignore its panel’s recommendation and shelve Inamed’s application, Feigal said that while the agency bases its decisions on science, “the science is not perfect and the science evolves.”
Specifically, the FDA’s new guidelines ask implant manufacturers to submit the devices to rigorous mechanical tests under conditions more similar to those in a woman’s body. While Inamed executives sought to assure the company’s investors that it could easily address the agency’s concerns, Dan Cohen, Inamed’s vice president for global government affairs, said in an interview that the company has not previously conducted such tests.
Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group and a longtime opponent of silicone implants, commended the FDA for its action but said he remained concerned about a final outcome.
“It is extremely unlikely” that manufacturers can prove that silicone devices are safe, he said.
Sybil Niden Goldrich of Beverly Hills, a longtime activist on implant issues, said Thursday that the FDA’s action left her feeling “guardedly optimistic.”
“I think we have a real opportunity to get an implant that works and is safe,” she said.
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Times researcher Robin Cochran contributed to this report.
