Jan. 8, 2004 -- Silicone breast implants still aren't quite ready for reuse in women, according to the FDA.
Hours after the agency sent a "not approvable" letter to silicone implant manufacturer Inamed Corp., FDA officials today announced that they've revised their advice to manufacturers on what they should show in order to gain approval, citing a need to know more about the long-term safety of the devices.
"What is most important is to be able to understand what are the things that predict rupture and subsequent failure," says David W. Feigal, MD, director of the FDA's Center for Devices and Radiological Health. "Because rupture of these products is the most important problem relating to failure and frequently to surgical removal of the product."
Aside from needing more information about silicone breast implant rupture rates, Feigal says the FDA also needs to know more about what to do with so-called "silent ruptures," in which leaking silicone implants are only detectable by MRI (magnetic resonance imaging) scans.
The move is the latest in an ongoing saga between silicone breast implants and the FDA, which has generated considerable interest from public interest groups, politicians, and researchers.
By demanding better proof of the devices' safety, women's health advocates say the FDA's action will send a clear message to the medical device industry.
"This decision has the potential to convince implant makers to try to develop a safer breast implant, and that is good for consumers and good for the companies," says Diana Zuckerman, PhD, president of the National Center for Policy Research for Women & Families, in a statement released today.
Inamed says they plan to work with the FDA to meet their revised expectations.
"Although we are disappointed with the current outcome, we appreciate the serious and thorough review of our PMA [premarket approval application] by the Food and Drug Administration," says Inamed Chairman Nick Teti in a news release.
Silicone Breast Implants and the FDA
Silicone gel-filled breast implants were introduced in the U.S. in the early 1960s, before medical devices became subject to FDA regulation in 1976.
By the early 1990s, concerns about potential health risks associated with silicone breast implants began to emerge, including leakage and rupture problems, reports of connective tissue disorders, and a possible cancer risk among women with the implants.
These concerns caused the FDA to ban the sale of silicone breast implants in 1992 except for use in clinical trials. The ban also prompted a string of lawsuits against implant manufacturers from women who said they suffered health problems or disfiguration as a result of their silicone breast implants.
In December 2002, Inamed filed a product marketing application with the FDA for a silicone implant based on the results of their own study of 1,000 women with the implants who were followed for at least three years, as well as other research published since the ban was enacted.
On Oct. 15, 2003, an FDA advisory panel voted 9-6 in favor of recommending reapproval of the sale of silicone implants under certain conditions, such as warning patients of the risks associated with silicone breast implants, yearly testing for leaks, and continued monitoring of implant recipients.
But in a highly unusual move, panel chairman Thomas Whalen, MD, sent a letter to the FDA and members of Congress a month after the meeting in which he implored the agency not to approve the silicone gel-filled implants, citing serious concerns about the long-term safety of the devices.
"As the dust has settled on the panel, and I've reflected more and more on the information that was revealed during the panel session, I've become increasingly uncomfortable with what I clearly feel has been the lack of demonstration of long-term safety of the devices," said Whalen in a November 2003 interview with WebMD. "I most clearly and unequivocally would have voted against it."
As chairman of the FDA advisory committee on general and plastic surgery devices, Whalen is not allowed to vote in panel decisions unless there is a tie.
Booming Market for Breast Implants
Meanwhile, saline-filled breast implants are already approved for use in breast augmentation and reconstruction surgery. These implants contain a saltwater solution similar to that used in IV fluids.
Although saline implants are also likely to leak or rupture over time, research shows that the risks posed by leakage are less serious because the body readily absorbs the saline solution.
Despite some uncertainty about breast implants, the demand for them is clearly increasing.
According to the American Society of Plastic Surgeons, more than 225,000 women received breast implants for cosmetic reasons in 2002, a 593% increase since 1992. Breast augmentation was also among the top five cosmetic plastic surgery procedures in 2002.