Implant Maker Moves Closer To Open Sales
Thursday, September 22, 2005
The Food and Drug Administration told a second manufacturer yesterday 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 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. An FDA expert advisory panel earlier this year 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 have had mastectomies. Subsequent studies generally relieved those concerns, but they showed that many women have had troublesome localized reactions and ruptures that ultimately required replacement of the devices.
The silicone-gel implant issue has become highly charged, and some groups have said they may sue to keep the devices off the market. Nine of the Senate's 14 female members wrote a letter to the FDA saying they did not think silicone-gel implants should be approved because their long-term safety remained unproven.
About 250,000 American women a year receive breast implants, but since the 1992 restrictions, most have been filled with salt water.
Diana Zuckerman, president of the National Research Center for Women and Families and a critic of the FDA's handling of the issue, said the agency did not have enough information to make an informed decision.
Her group joined more than 15 others yesterday in petitioning the FDA to rescind its approvable letter and reopen the public comment period.