FDA Panel to Consider Safety of Breast Implants
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An FDA advisory panel will determine this week if Inamed Corp. has provided adequate assurance of safety for its silicone breast implants.
Implants filled with silicone gel were banned for most women in 1992 amid a controversy over whether they caused chronic health problems. Santa Barbara-based Inamed has applied to the FDA to sell them again.
The regulatory agency wants input from the panel on whether Inamed accurately assessed implant rupture rates, according to a preliminary analysis posted on the agency’s Web site.
A 1999 Institute of Medicine study said silicone gel-filled breast implants do break apart frequently and cause scarring and other problems, but it found no evidence that the devices caused chronic diseases, as many women alleged.
Critics charge that implant research has not followed women long enough, arguing that many problems show up several years after implantation.
The FDA will decide in the following months whether to grant the approval. The agency usually follows a panel’s advice.
Inamed shares jumped $3.12, or 4.6%, to $71.50 in Nasdaq trading Friday.
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