FDA Advisory Makes Breast Implant Ruling - KCBD NewsChannel 11 Lubbock

4/13/05

FDA Advisory Makes Breast Implant Ruling

After three days of emotional testimony, an FDA advisory panel voted late Wednesday to recommend silicon breast implants be allowed back on the market.

But this applies only to California manufacturer 'Mentor'. Tuesday another manufacturer, 'Inamed' was denied its return to the market. Mentor convinced the panel its product is more durable, less prone to leakage and safe.

"And after thoughtful consideration of various points of view presented by the public, the panel voted 7 to 2 for recommendation for approval with conditions as outlined this afternoon," says Dr. Michael Choti, Chairman of the FDA advisory panel.

Conditions for Mentor include limited distribution to specially trained and board certified plastic surgeons, tracking the devices through a long term registry, with those patients advised to get an MRI after five years to check for leaks.

The panel's recommendation now goes to the FDA for final approval and that decision could take several weeks.

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