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Whistleblower Alleges Defects in Silicone Implants

A former employee of Mentor Corporation, manufacturer of silicone breast implants, came forward this week alleging that the company corrected leakage defects in doctors’ samples, but not in implants intended for use in women’s bodies. The whistleblower sent a letter to the Food and Drug Administration (FDA), which issued an approvable letter for the implants in July, stating “I am very concerned about the safety of women using these breast implants if they were to become widely available as an FDA-approved product,” reports the Washington Post.

In his letter, the former employee, an engineer, said that Mentor discovered that sample implants left an oily slick on the hands of doctors and prospective patients, and asked engineers to correct the issue. They did so, but the higher-quality anti-leakage patch was never put to use on implants destined for internal use. National Organization for Women president Kim Gandy said that “These findings are more proof that Mentor Corp. cares more about the bottom line than it does about women’s lives. The FDA has a responsibility to put our health first.”

Mentor denies the allegations, and FDA spokeswoman Julie Zawisza said agency officials “do not have concerns” about the issues surrounding the anti-leakage patches on sample implants, reports Reuters. However, one member of the FDA committee that evaluated the implants in April told the Washington Post that “she was disturbed to learn that women were trying out a modified Mentor device without knowing that the actual implant might be different.”

Sources:

Feminist Daily News 8/3/05; NOW press release 12/6/05; Reuters 12/6/05; Washington Post 12/4/05