Silicon implants a step closer to general sale in U.S.
Inamed Corp. looks to become the second manufacturer of silicone gel-filled breast implants to return to the market if they can meet certain criteria set by the FDA.By JOHN J. LUMPKIN
The Associated Press
WASHINGTON, Sept. 21 -- A second manufacturer of silicone gel-filled breast implants can return to the market if it meets certain conditions, the FDA said Wednesday in a move that brings the implants a step closer to general sale in the United States.
An example of the silicon gel used for breast implants that is closer to being approved by the FDA following uncited conditions be met. (AP Photo)The Food and Drug Administration did not detail what conditions were required of Inamed Corp. before its implants would be approved for marketing.
The FDA's finding goes against a recommendation by a government advisory panel last April that Inamed's implants not be approved.
The panel, which voted 5-4 against recommending Inamed's implants, cited safety concerns that were not addressed by the company's research. In particular, panelists worried that the long-term durability of the implants had not been adequately studied.
Without being specific, the FDA said Wednesday that Inamed has provided additional information to address the panel's concerns.
Inamed also said it would not sell a particular style of implant that had raised particular safety issues, according to the FDA. That style was more prone to rupture than some others.
"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 were "generally in line with our expectations" but declined to provide details, saying it would work with the FDA on a confidential basis to address them.
However, Amy Allina, program director at the National Women's Health Network, criticized the lack of information describing how Inamed may 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, another manufacturer, Mentor Corp., cleared the same regulatory hurdle as Inamed did Wednesday, with the FDA setting some confidential conditions for Mentor's implants before they could be sold 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 the 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 decision regarding the Mentor implants remains under investigation by the Senate Health, Education, Labor and Pensions Committee in response to complaints of conflicts of interest among panel members. A spokesman said Wednesday the investigation is ongoing, and the committee would consider whether the Inamed decision merited investigation as well.
Silicone gel-filled implants have been banned for general sale since 1992 because of health concerns. They have only been available to certain people participating in studies.
Proponents who have sought their return say they look and feel more natural than salt water-filled implants, which are sold without restriction.
But some women who received the silicone implants have described the substance oozing out of their bodies and years of pain and other symptoms, which they blame on faulty implants. About 14 percent of the silicone implants will break within 10 years, Inamed officials told the FDA in April, an estimate derived from a study of 940 patients tracked for three or four years.
Silicone-gel breast implants first went on the market in 1962, before the FDA required proof that all medical devices be safe and effective.
Fears about whether the implants cause cancer or other chronic illnesses have largely quieted, although some, including Zuckerman, contend the data in that area is incomplete as well, particularly on the effects of silicone moving into the body after an implant rupture.
Implants can cause other side effects, including infection and painful, rocklike scar tissue.
Plastic surgeons hailed the FDA's decision.
"We are very pleased that the FDA has taken this step in the process to let women have the choice of silicone breast implants provided the manufacturer meets its conditions," said Dr. Richard D'Amico, who heads a task force of plastic surgeons who oversee breast implant issues.
Story Produced by: Alan Festo
