Thursday’s decision marked one of the rare instances when the FDA rejected the recommendation of its own scientific advisers, who had voted 9-6 to put silicone breast implants back on the market.
The FDA’s move will still allow access to the implants for women who have had mastectomies and those enrolled in research studies. The agency also left open the possibility of allowing easier access to the implants in the future.
Along with its rejection of implant producer Inamed’s request, the agency also released a draft of new guidelines for manufacturers explaining exactly what scientific issues must be settled before the devices can be widely sold.
“FDA is committed to working with sponsors and the scientific community to provide a clear, scientifically appropriate, and up-to-date pathway for demonstrating safety and effectiveness, and we welcome comments on this draft guidance,” said FDA Commissioner Dr. Mark McClellan.
The FDA document cited the need for better understanding of how long it typically takes before the implants rupture and what chemicals may leach out of the implant. The agency also said that although a manufacturer can apply to sell the device with just two years of clinical data, longer-term studies may be needed to demonstrate the product’s safety over its lifetime.
“We’re quite convinced that there are women who have these products and get a very satisfactory result,” FDA medical device chief Dr. David Feigal told the Associated Press. “The point isn’t to talk about how many have a good result and how many have a rupture. What you really need to know is, for someone who has a rupture, what are the consequences of that?”
Inamed issued a statement saying it would continue “to work cooperatively with the [Food and Drug] Agency” to gain eventual approval for the implants.
Inamed had argued that silicone breast implants should be brought back on the market because they do not cause life-threatening health problems and break no more frequently than the saline-filled alternative doctors currently use.
The company’s research does show that the implants do cause problems for some women. Inamed has found that up to 46 percent of recipients needed additional surgeries because of painful scar tissue and other complications and up to a quarter of women had the devices removed or replaced.
Women’s and consumer advocacy groups that opposed the Inamed’s effort hailed the continuation of the implant ban.
“Their decision sends a crystal clear message to women that silicone gel breast implants are not proven safe,” said Diana Zuckerman of the National Center for Policy Research for Women and Families.