NOW Encouraged By FDA's Refusal to Approve Silicone Breast Implants

January 8, 2004

"The National Organization for Women is encouraged by the FDA's decision not to approve the immediate return of silicone breast implants to the market," said NOW President Kim Gandy. "We have been saying all along that there is simply not enough long-term data to warrant telling hundreds of thousands of women that they are safe to use."

In October 2003, a Food and Drug Administration (FDA) advisory committee conducted hearings to consider allowing silicone gel-filled breast implants back on the market after an 11 year ban. The FDA withdrew silicone implants from general use in 1992 following numerous reports of illness following rupture and leakage.

The advisory committee voted 9-6 to allow the implants back on the market; however, the non-voting chair of the panel sent a letter to the FDA Commissioner expressing strong reservations about the safety of the devices.

Yesterday, the FDA sent a "not-approvable" letter to Inamed Corp, the manufacturer that applied for authorization to sell its silicone implants to a wider market. (The implants are currently available to mastectomy patients and in clinical trials) The FDA has requested additional information from Inamed in order to further review the company's application.

"I found it astounding that, with less than three years of data presented by Inamed, the panel went ahead and recommended approving silicone implants," said Gandy, who testified at the advisory committee hearings. "I am relieved to hear that the full FDA is taking the health of women more seriously."

"Most of the serious health problems with silicone implants develop seven to ten years after implantation. In a symposium NOW held last year, top health experts agreed that further research must be done before putting even more women at risk," Gandy said. "NOW applauds the FDA's caution, and we will be watching to see what happens next."

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