FDA Panel Recommends Against Readmitting Silicone Gel-Filled Breast Implants

April 12, 2005

"Today's decision is a tremendous victory for women's health," said NOW President Kim Gandy. "Rather than succumbing to political pressure, this time the FDA panel ruled on the side of science and medicine."

In a 5-to-4 vote an FDA panel voted to reject Inamed Corp.'s application to bring back silicone gel-filled breast implants to the open market. NOW is participating in a three-day hearing this week on the safety and effectiveness of silicone breast implants. Gandy and other NOW leaders testified before the panel, advocating on behalf of the millions of women who suffered from having these implanted.

"This is an acknowledgement to the women who shared their heartwrenching stories with the panel that their voices were heard," said Gandy. "Today's decision validates their concerns and will prevent other women from enduring unnecessary agony."

While the FDA's final decision may not come for months, NOW finds today's vote encouraging. NOW anticipates that Wednesday's vote on a similar application from Mentor Corp. will be in-step with today's recommendation.

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