[News-releases] NOW Encouraged By FDA's Refusal to Approve SiliconeBreast Implants

FOR IMMEDIATE RELEASE
January 8, 2004

CONTACT:  LISA BENNETT
202-628-8669, ext. 123

NOW ENCOURAGED BY FDA'S REFUSAL TO APPROVE SILICONE BREAST IMPLANTS

"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."

On the web at: http://www.now.org/press/01-04/01-08.html