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Silicone gel breast implants are back in the news. Should they ever be placed in your body?

Most defective medical device ever OK’d by FDA?

Dr. Sidney Wolfe, Director of Public Citizen’s Health Research Group, criticizes the FDA’s approval of silicone gel breast implants, calling them “the most defective medical device ever approved by the FDA.”

Wolfe, in a statement on the Public Citizen website, writes: “The approval makes a mockery of the legal standard that requires ‘reasonable assurance of safety.’

It is a terrible reminder of the double standard for women versus men that the FDA has not approved silicone gel testicular implants because of the inadequacy of clinical trials on these devices. (Saline breast implants and testicular implants have been approved by the FDA.)”

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