Silicone Breast Implants Prone to Rupture, Report Tells FDA
Up to 93 percent of silicone breast implants rupture within 10 years, health regulators estimated in a report to the U.S. Food and Drug Administration, which is considering allowing the implants' return to the market.
An FDA advisory panel is set to convene Monday to pore over recent studies of the implants' safety, and to hear testimony of women who have had the devices, The New York Times reported Thursday.
In estimating the 10-year rupture rate, the reviewers assumed that the devices were more likely to break as they aged. Without that assumption, the estimated rate would be about 21 percent over 10 years, the newspaper said.
The FDA panel is expected to decide by April 13 whether to recommend re-approving the implants for wider use. In 1992, silicone use was restricted to a very small number of women who participated in studies that investigated a slew of claims that the implants caused a number of connective-tissue and autoimmune diseases.
While the FDA usually supports the suggestions of its expert panels, the agency balked at giving the implants the green light the last time it considered the issue. In October 2003, the expert panel voted 9-6 to bring the implants back. But the panel's chairman wrote a letter to the agency advising that more study was needed, and the FDA ultimately sided with the chairman, the Times said.
The advisory panel will reconsider three primary issues relating to the implants: how often they break, what happens to the silicone once they do rupture, and what health effects result, the newspaper said.
A separate expert committee of scientists met in 1999 and found that there was no evidence to support claims that the implants caused disease. Rather, the panel found, side effects were generally limited to local complications like infections, pain and scarring, the Times reported.
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