FDAnews Device Daily Bulletin

SENATORS PRESS FDA TO INVESTIGATE BREAST IMPLANT CHARGES

Dec. 12, 2005
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Sens. Diane Feinstein (D-Calif.) and Olympia Snowe (R-Maine) are calling on the FDA to investigate allegations that Mentor misled doctors and patients on the safety of its breast implants and that those implants have a fundamental flaw.

The senators urged acting FDA Commissioner Andrew von Eschenbach in a recent letter to investigate claims that the implants leak silicone oil and that the company only fixed this flaw on demonstration models of the device. A former Mentor employee raised these allegations in a Nov. 14 letter to the Washington Post. Mentor has denied the allegations.

This controversy comes as the agency is considering whether to allow conditional availability of the product. The senators are asking the agency to conduct an investigation into the former employee's claims before making a final decision on the implants. "These allegations should be rigorously investigated and addressed by the FDA before it proceeds with the approval process," the letter states.

Mentor could not be reached for comment.

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