Improved Implants (Sort Of)
Yes, they're back, but they still require a heck of a lot of scrutiny
Silicone or saline? Women considering implants for breast reconstruction or augmentation once again have a choice. The Food and Drug Administration, after a 14-year ban, has decided that silicone implants don't pose any serious health risks. Plastic surgeons are applauding the move and fielded phone calls all last week from those seeking to get the new implants. Denise Pardue, 36, of Melbourne, Fla., plans to have her saline implants replaced with silicone ones, which her surgeon tells her will conform better to her thin frame. At 5 feet, 4 inches tall and 110 pounds, she thinks her saline implants, which she got eight years ago to fill out her 32 AAs, look too artificial. "When I bend over, I can see ripples around the edges of the implant, and my breasts feel hard, not soft," says Pardue. "I want my breasts to feel as natural as possible."
But many women may be reluctant to put silicone in their bodies after the initial scare that led the FDA to outlaw the implants in 1992. At the time, anecdotal reports in medical literature suggested that leaking silicone could trigger an exaggerated immune reaction, causing diseases like lupus and rheumatoid arthritis. Dow Corning, a onetime implant maker, spent nine years in bankruptcy after paying out $3.2 billion to settle tens of thousands of injury claims. Since then, though, a spate of studies, including a 1999 landmark report from the Institute of Medicine and the manufacturers' clinical trial data, have found no link between silicone and autoimmune disorders. "The toxicity tests we reviewed show that silicone has no adverse effects," says Donna-Bea Tillman, who heads the FDA's office of device evaluation.
Not permanent. Still, the FDA added a cautionary note: Breast implants won't last a lifetime. "Within four years, about 20 to 25 percent of women who have received the implants for augmentation can expect to have additional surgeries due to hardening of the breasts, shifting of the implants, sagging, and less commonly, ruptures," says Tillman. The companies in fact offer lifetime warranties to replace defective saline and silicone implants and cover $1,200 of the surgical cost to replace them within the first five years.
Women over the age of 22 who have no active infections, existing breast cancers, or abnormal breast biopsies, and who aren't pregnant or nursing can get the silicone implants--the same stipulations that come with their saline counterparts. Up to 15 percent of women with either type of implant experience side effects such as breast pain, swelling, or capsular contracture, a hardening of the breast around the implant.
The big difference between the two implants is no mystery: Women prefer the look and feel of silicone. The Jell-O-like substance behaves similarly to breast tissue. "It conforms to the body more closely and moves when you push on it," says plastic surgeon Brent Moelleken, an assistant clinical professor of medicine at the University of California--Los Angeles Medical Center who helped test the implants in one of the manufacturer's clinical trials.