MD on implants: Continue to be cautious

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http://www.msnbc.com/news/999397.asp

Breast Implants: Continue to Be Cautious

There is still no end to the controversy over implant safety

By H. Shmerling, M.D.NEWSWEEK

Dec. 8 issue — For a while this fall, it looked as if silicone breast implants were poised to make a comeback.

THE FOOD AND DRUG Administration pushed the devices off the market in 1992 because of safety concerns. Unhappy recipients, who believed the implants caused a host of symptoms and illnesses, filed some 20,000 lawsuits during the 1990s, and the manufacturers agreed to a $4 billion class-action settlement. But the wind shifted as researchers studied the devices and published reassuring results. In 1999 the Institute of Medicine (a branch of the National Academy of Sciences) concluded there was no convincing evidence that silicone implants were connected with serious systemic diseases such as rheumatoid arthritis, lupus or scleroderma. Other respected medical groups have taken a similar stand. And this October an FDA advisory committee voted 9-6 in favor of lifting the ban. Soon after, however, the committee’s leader announced that he opposed such a move and urged the FDA to ignore his committee’s recommendation. It’s not clear how the controversy will end, but some worries can now be laid to rest. Despite claims to the contrary, there is no evidence that silicone implants cause breast cancer, make breast-feeding unsafe or harm a fetus during pregnancy. And studies suggest that most women are highly satisfied with them. The most compelling reason for caution is the risk of local complications. Silicone implants can cause infection, scarring or bleeding in the breast and nearby tissues. They can also rupture, causing pain and disfigurement. The Institute of Medicine estimates that in the first year after a silicone implant, complications occur in 18 percent of women having breast augmentation and 36 percent of those having breast reconstruction. Roughly a third of breast implants are removed within 10 years because of complications. Saline implants—the only kind on the market for the past 11 years—are associated with fewer local complications than silicone, and they haven’t been blamed for systemic disease. Unfortunately, they don’t look or feel as natural.

If the FDA lifts the decade-old ban, women will again have to decide whether silicone’s cosmetic advantages justify a slightly higher risk of complications. And they’ll have to reach their own conclusions about the risk of systemic illness. High-quality studies have failed to link silicone implants to any autoimmune disease. It can be hard, however, for even the largest studies to detect small but real risks. And while these disorders may be rare, they’re also serious, causing everything from fever and fatigue to joint inflammation and hardening of the skin. How safe is safe? We may never reach a consensus on that question. But all sides agree on one point. If silicone implants return, anyone receiving them should be carefully monitored over time.

From Harvard Medical School and Beth Israel Deaconess Medical Center. For more health information from Harvard Medical School, visit health.harvard.edu and its Harvard Women’s Health Watch newsletter.