) because of safety concerns. The very next day, the panel voted 7-2 to lift the ban on almost identical implants made by Mentor (MNT
The FDA now has 90 days to decide what to do, and it's certain to get blasted by patients, doctors, and various advocacy groups who feel passionately both in favor of and against silicone. Given that emotions have trumped science for years when it comes to these devices, such lobbying could have a tremendous influence on the FDA's ultimate decision. In fact, more than 150 advocates and opponents of the implants faced off in 12 hours of emotional testimony before the advisory panel on Apr. 11, giving vent to the passions surrounding the issue of breast enlargement.
The issue, on the surface, is patient choice vs. patient safety. But plenty of women who want access to silicone implants, which give the breast a more natural appearance than the alternative saline implants, accuse opponents of making moral judgments rather than scientific ones.
HIGHER STANDARD? Silicone implants are allowed in the U.S. -- but only for women seeking them for breast reconstruction after cancer surgery. Women who want them for strictly cosmetic reasons must make do with saline. "Plenty of people see that as a contradiction," says Dr. Jeffery Ascherman, chief of plastic surgery at Columbia University in New York, and an advocate of lifting the ban. "I think [the FDA is] holding these implants to a far higher standard than most other medical devices."
Any decision the FDA makes will have a major impact on a very big business. In 2004, 264,041 breast enhancement procedures were performed in the U.S. and 75,805 breast lifts, according to the American Society of Plastic Surgeons, a group that supports bringing back silicone implants.
The FDA removed silicone breast implants from the market in 1992, over concerns that they could lead to a range of autoimmune diseases such as lupus and scleroderma, and possibly breast cancer. Some 100,000 patient lawsuits against a number of manufacturers eventually led to $4.4 billion settlement that helped bankrupt Dow Corning.
TRIAL DATA. But in 1999, the federal Institute of Medicine issued a report that cleared the implants of all connections to serious diseases, as have some 20 other studies from around the world. Silicone implants are now commonly used overseas, where they're legal, but the FDA continues to ban them for women with healthy breasts because of concerns over problems that could arise when the implants rupture.
Last year, an advisory panel -- with some of the same members as the current one -- voted 6-3 to lift the ban. The FDA, however, decided it wanted more safety data, even though it usually follows the advice of such panels.
Both Mentor and Inamed showered the panel with such data this go-round, showing relatively low rates of rupture. But FDA staffers told the advisory panel that they considered these studies of limited usefulness because they weren't large, randomized trials, and didn't track the implants over a long enough period of time.
STARK DIVIDE. The highlight of the panel's three-day hearing wasn't the dry recitation of clinical trial data but the fervent pleadings by women for and against the implants. Carolyn Wolfe of Manassas, Va., gave some of the most graphic testimony, saying after her silicone implants ruptured, the gel seeped out of her eyes, ears, and nipples. "I do not want young women to have to go through what I have gone through."
On the other side, Anna Daly of Nashville, who received silicone implants last year after breast cancer surgery, said "we all deserve to feel beautiful, and if not beautiful at least normal." Plastic surgeons mostly testified in favor of the implants, as did breast cancer patient groups, while the National Organization for Women and the consumer advocacy group Public Citizen opposed them.
The American Society for Aesthetic Plastic Surgery, which said the implants have been greatly improved over the years, called on the FDA to base its ultimate decision on science, not emotion. Good advice, perhaps, but hard to follow in a realm of medicine where safety, like beauty, is in the eye of the beholder. By Catherine Arnst in New York