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.
Saline-filled implants, on the other hand, stay more rigid and remind some users of overfilled water balloons. Typically hidden under a layer of muscle and breast tissue, saline devices can often be seen and felt under the skin if there's not enough tissue to camouflage them. "For extremely thin women and mastectomy patients with virtually no breast tissue, silicone is a better bet," says Roxanne Guy, president of the American Society of Plastic Surgeons and Pardue's surgeon. That's why the FDA had allowed breast--reconstruction patients, such as those who have undergone a mastectomy, to get silicone implants during the ban if they agreed to be monitored in clinical trials.
Today's silicone implants bear little resemblance to more leak-prone implants of the '80s. The shell is thicker and more durable, and the gel inside is solid enough to cut through. "The implant retains its shape to give better results, and the higherviscosity silicone is less likely to migrate into breast tissue if the product ruptures," says Joshua Levine, ceo and president of Mentor, an implant maker.
While salt water poses little risk, silicone can travel through tissues and trigger an immune response, potentially causing hard lumps in the breast tissue, pain, and inflammation. "There's no compelling evidence linking rupture to these consequences, but we can't be 100 percent certain that it doesn't happen," says Tillman.
There's also the possibility an implant could burst from, say, the force of a high-impact car accident or a fall. In very rare cases, extreme pressure could cause the silicone to flow through the breast tissue into the armpit and surrounding lymph nodes. Silicone that gets stuck in these areas, Moelleken says, has been known to cause extensive pain and irreversible nerve damage.
Most often, silicone implant leaks cause no symptoms and the wearer is none the wiser. While saline leaks cause fluid to whoosh out quickly, deflating the breast noticeably, the thick silicone gel usually remains firmly within the implant. Still, the FDA recommends that any ruptured implant be removed for safety reasons. The silicone implant makers report a 1 to 2 percent rupture rate--similar to that of saline implants--in the first three years. After 12 years, the rate rises to 15 percent.
To ensure that silicone leaks are discovered promptly, the FDA recommended that women who opt for silicone implants get an MRI-- mammograms and physical exams can't detect leaking silicone-- within the first three years of implantation and then every two years after that. "MRI is quite effective at detecting silent leakage and whether silicone has moved outside the shell of the implant," says Ellen Mendelson, chief of breast imaging at Northwestern Memorial Hospital in Chicago.
Screening puts an even heftier price tag on breast implants. While insurance covers implants for breast reconstruction, it typically does not cover cosmetic procedures. At $1,600 to $1,800 a pair, silicone implants cost more than double the saline ones. And surgery to implant them can run anywhere from $4,500 to $12,000. The MRI scans for monitoring can cost upwards of $1,000.
Some plastic surgeons are not convinced that the MRIs are necessary. "I think the FDA is being very cautious," says Guy. She plans to do yearly physical exams on her patients to decide if an MRI is warranted. "If a woman has no symptoms or signs of rupture," she says, "there's probably no reason to do one."
Still studying. But the FDA isn't so ready to close the book on the safety aspect of silicone implants. In addition to recommending regular breast scans, the agency is requiring implant manufacturers to recruit 43,000 women for a 10- year study to learn more about the rate of silicone ruptures and complications. "We wanted a large enough study to also detect if there's any increased risk in rare autoimmune diseases like scleroderma," says Tillman. "Though we have no evidence of this, we'd like to finally get a definitive answer."
While many women are already reserving their place in line to get the new implants, some may opt to wait until the long-term studies settle the health risks once and for all. Others, though, may never be convinced. "After the silicone scare of the '90s, I think some women will always be too frightened of the implants to ever consider using them," says Moelleken.
291,000 Number of women in the United States who had breast augmentation last year.
46,000 Number of breast cancer patients who had breast reconstruction with implants during the same period.
3 Ranking of breast augmentation among popular cosmetic surgery procedures in women. No. 1? Liposuction, followed by rhinoplasty.
This story appears in the December 4, 2006 print edition of U.S. News & World Report.