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Advocacy groups want more answers for silicone implants

Ambulatory Surgery Reimbursement Update, May 31, 2005

The National Women's Health Network, along with 16 other consumer advocacy groups, have petitioned the Food and Drug Administration (FDA) to require makers of silicone-gel implants to answer questions about how long the devices last before the implants are allowed to be sold.

This lobbying is in response to a recent recommendation by the FDA's scientific advisers, who said silicone implants should be allowed back on the market. The advisers said implant-manufacturer Mentor Corp. could sell silicone-gel implants, which have been virtually banned for 13 years, if the company addressed questions of durability and safety with post-marketing studies, according to the Associated Press (AP).

The groups are justifying their request by saying that Federal law requires manufacturers to demonstrate this information before the device is sold, not after.

"The law does not allow for an 'approve first, test later' approach," wrote attorney William Schultz, a former FDA official who co-authored the petition for the advocacy groups, according to the AP.

A spokeswoman for the FDA said the agency would review the petition, according to the AP.

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