22 septembre, 2005 21:41
Breast implants near approval FDA puts conditions on return to market
Associated Press
Originally published September 22, 2005
WASHINGTON // A second manufacturer of silicone-gel breast implants can return its product to the market if it meets certain conditions, the FDA said yesterday in a move that brings the implants a step closer to general sale in the United States.
The Food and Drug Administration did not detail the conditions required of Inamed Corp. before its implants can be approved for marketing.
The FDA's finding goes against an April recommendation by a government advisory panel that Inamed's implants not be approved.
The panel, which voted 5-4 against recommending Inamed's implants, noted safety concerns that were not addressed by the company's research. In particular, panel members expressed concern that the long-term durability of the implants had not been adequately studied.
Without being specific, the FDA said yesterday that Inamed has provided additional information to address the panel's concerns.
Inamed also said it would not sell a style of implant that had raised particular safety issues, according to the FDA. That style was more prone to rupture than some others were.
"We respect the thoroughness of the FDA review process and are pleased with this decision," Inamed President Nick Teti said in a statement.
The company said the FDA's conditions are generally in line with its expectations, but it declined to provide details, saying it would work with the FDA confidentially to address them.
Amy Allina, program director at the National Women's Health Network, criticized the lack of information describing how Inamed might have addressed safety concerns about the implants.
"A decision like this puts women in a bad spot," she said. "It forces the question: Do you trust the FDA or not? At this point we have to say these products do not have appear to have answered the safety questions the agency posed."
In July, when Mentor Corp., cleared the same regulatory hurdle, the FDA set confidential conditions that Mentor had to meet before sales of its implants could resume in the United States.
Mentor's implants have not received final approval for sale, although the FDA advisory panel voted in April to recommend approval of Mentor's application to return the implants to market.
Diana Zuckerman, president of the National Research Center for Women and Families, said the companies' studies of the implants rely on too little data for them to be considered safe, particularly in breast cancer patients.
"What's amazing and disturbing is that the FDA would consider Inamed and Mentor breast implants despite the lack of crucial safety information about breast cancer patients," she said.
The FDA panel's recommendation regarding the Mentor implants is being investigated by the Senate Health, Education, Labor and Pensions Committee in response to complaints of conflicts of interest among panel members.
A committee spokesman said yesterday that the panel will consider whether the Inamed decision also should be investigated.
General sales of silicone-gel implants have been banned since 1992.
