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NYTimes: In F.D.A. Files, Claims of Rush to Approve Devices

By January 13, 2009 No Comments

Regarding breast implants and FDA testings:

Diana Zuckerman, president of the National Research Center for Women and Families, said the Bush administration had “finally made the device approval process so meaningless that it’s intolerable to the scientists who work there.” Ms. Zucker, a longtime critic of the agency’s device approval process, particularly as it relates to breast implants, added, “Virtually everything gets approved, no matter what.

The F.D.A. has a three-tiered approval process for medical devices that, depending on their newness or complexity, requires varying amounts of proof.

A growing chorus of critics contends that the agency requires few devices to complete the most rigorous of these reviews and instead allows most devices to be cleared with minimal oversight. In 2007, 41 devices went through the most rigorous process, compared with 3,052 that had abbreviated reviews.

(Emphasis mine)

Full article here.

To learn more about the downsides of breast implants – and their potentially disastrous consequences for women’s health – check out Kacey’s site: Implants Out. Essential read.