Silicon implants are back. Banned by the FDA for the past fourteen years, the implants are now once again been approved for use by plastic surgeons doing breast enhancement surgery. The medical evidence showed no link between the silicone implants and any diseases. Breast cancer patients argued especially strongly for the return of the implants because silicone gives a much more natural looking and feeling breast than the saline implants do.
Because the implants made of silicone gel are softer than the saline implants currently available, plastic surgeons said they would quickly become preferred among the more than 300,000 women in this country who have breast implants each year.
Critics of the decision lambasted it and said that longstanding safety concerns had not been resolved. But supporters of the implants, including leading surgeons, applauded it.
"For us, it's a triumph of science," said Dr. Richard A. D'Amico of Engelwood, N.J., president-elect of the American Society of Plastic Surgeons. "We’ve always felt that the science would bear out the use of the implants."
Dr. Daniel G. Schultz, director of the F.D.A.'s Center for Devices and Radiological Health, said that the agency's review, based on company-sponsored studies as well as long-term use of the implants abroad, had determined that their sale is in the best interest of women.
But Dr. Schultz warned that no device is foolproof and that there was a possibility that women would have to have the implants replaced at some point, sometimes because they rupture. Studies have found that the majority of women with silicone implants would have a rupture at some point. According to the federal agency, one study found that 69 percent of women had a rupture.
"Women should know that breast implants are not lifetime devices," he said in a telephone briefing for reporters last night.
"Women having these procedures done need to be prepared for the fact that there is a likelihood they will require additional surgery," he said.
He also recommended regular M.R.I.'s to monitor the devices for "silent rupture," which can occur without a woman’s knowledge. He said the first M.R.I. should be performed when the implants are 3 years old. Because many of the procedures are cosmetic, it was not clear whether those M.R.I.'s would be covered by insurance.
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Defending the decision to lift the ban, Dr. Schultz said, "we have been looking at this data continuously for the last 10 years. We have been watching as data had been collected, we have been watching as data has accumulated. We believe that from a scientific standpoint, the decision that we'e making tonight is, in fact, in the best interest of American women."
But he said the agency would require the companies to conduct post-approval studies involving a total of 80,000 women to continue monitoring the safety of the implants. He said that information would be collected about rates of rupture, cancer and autoimmune diseases and effects of the implants on reproduction. That would enable the agency to evaluate concerns about the implants in a large number of women.
Good for the FDA. Women should have the choice of silicone implants if they want them, and if they have all the risks explained to them before any surgery.
