January 11, 2004
FDA rejects silicone breast implant request

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.

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.

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.

Read entire article here.

Posted by Ellen at January 11, 2004 06:38 PM

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