FDA rejects silicone breast implant request
From Saundra Young
CNN
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Silicone-gel implants, right, were banned in the United States in 1992, leaving saline implants the only option.
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HEALTH LIBRARY
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WASHINGTON (CNN) -- The Food and Drug Administration has rejected a manufacturer's application asking to restore silicone breast implants to the market, the firm said in a statement Thursday.
Silicone-gel breast implants were taken off the market in the United States more than a decade ago, following reports that linked ruptures in them to autoimmune problems in some patients.
Instead of approving a return to the market, the FDA on Thursday issued new guidelines for Inamed Corp. and other breast implant manufacturers about assessing the safety and effectiveness of the products before they are available to the public.
"The FDA, sponsors, and the clinical community have learned a great deal about breast implants, especially silicone gel-filled breast implants, over the last 10 years," FDA chief Mark McClellan said in a statement. "Based on this knowledge, this revised guidance is our view on the information needed to provide a reasonable assurance of safety, and to allow women and physicians to make informed decisions about silicone implants."
Inamed, a Santa Barbara, California-based company, said it received what's called a "not-approvable" letter from the FDA Wednesday night. According to company officials, the letter outlines additional information the company must provide prior to the FDA's further review of a pre-market approval application.
"Although we are disappointed with the current outcome, we appreciate the serious and thorough review of our [application] by the Food and Drug Administration," said Nick Teti, chairman, chief executive officer and president of Inamed. "The FDA letter that we received provides directions for us to follow, and we intend to work cooperatively with the agency to place the [application] in approvable form."
Last year, an FDA advisory panel voted 9-6 to resume allowing silicone-type implants, but only if biopsies were conducted when an implant is removed to check for any complications. The panel also recommended that an MRI should be considered if it's suspected that an implant has ruptured.
In cases of confirmed rupture, the panel recommended mandatory removal of the implant. The committee said the manufacturer must track and report rupture rates, and must make changes in implant labeling to prohibit their use in anyone under the age of 18 unless there is a medical condition for which they are indicated.
