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FDA dispels implant safety charge

Article-FDA dispels implant safety charge

Washington — The Food and Drug Administration has cleared breast implant manufacturer Mentor Corp. of accusations that it withheld safety data on its silicone gel implants.

In a Reuters report, an FDA spokeswoman stated that the agency had taken the allegations — raised by a former Mentor employee in June — very seriously, but that, following a thorough investigation, the FDA had found "nothing that would raise questions about the safety of the product under review or the integrity of the data submitted."

In October, the group Public Citizen had called for a "criminal investigation" into what it termed the "apparent failure" of the firm to provide FDA with all available safety data. A Mentor statement said that, to the company's knowledge, all questions had been answered to the FDA's satisfaction.

FDA approval is pending for the general use of silicone gel implants manufactured by Mentor and by rival Allergan's Inamed unit.

Cosmetic Surgery Times reports on a new Web-based, patient-driven implant registry for women who have undergone breast augmentation and reconstruction.

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