Marc Kaufman
The Washington Post
Posted on September 22,2005

Silicon-gel devices get qualified OK

WASHINGTON - The Food and Drug Administration has told a second manufacturer that it can resume unrestricted sales of its controversial silicone-gel implants for breast enlargement and reconstruction if it meets certain unspecified conditions.

The agency said yesterday it had sent an "approvable" letter to Inamed Corp. as an intermediate step in its review of an application to resume general sale of the implants. In July, the agency sent a similar letter to Mentor Corp.

Neither the FDA nor the companies have disclosed the conditions, and they gave no indication of when they might be met. Earlier this year, an FDA expert advisory panel called for more rigorous studies of the implants' safety and rupture rates and enhanced training for surgeons, as well as mandatory follow-up care and systems to track women with implants.

Because of concerns that the implants might cause a range of life-threatening autoimmune diseases, the FDA limited their use in 1992 to women who had mastectomies. Subsequent studies generally relieved those concerns but showed that many women had to have the devices replaced.

The silicone-gel implant issue has become highly charged, and some groups have said they might sue to keep the devices off the market.

About 250,000 U.S. women receive breast implants annually, but since the 1992 restrictions, most have been filled with salt water. The silicone-gel implants are generally regarded as looking more natural and are expected to become the implant of choice if the agency allows general sales.

he FDA said Inamed had agreed to take its most p rob lematic silicone-gel model off the market