Washington — A petition is urging U.S. regulators to deny applications by Inamed Corp. and Mentor Corp. to sell silicone gel-filled breast implants — contending that neither company has met legal requirements to prove safety.
At least 16 consumer groups and individuals are represented in the plea, including Public Citizen, the National Organization for Women, National Women's Health Network and others, according to news reports.
"Even if interpreted in the manner most favorable to Inamed and Mentor, the data regarding safety are inconclusive, and FDA therefore must deny both applications," the petition states.William Schultz, a former U.S. Food and Drug Administration (FDA) official who co-authored the petition, adds, "The law does not allow for an 'approve first, test later' approach."
The petition opposes the recommendation of FDA scientific advisers, who in April said Mentor should be permitted to sell the implants with conditions, including post-marketing studies designed to prove durability and safety of the implants. The advisory committee voted 5-4 against Inamed's implants, while urging approval for Mentor's by a 7-2 vote. The FDA is considering those recommendations and is expected to make a final decision this month.