Breast implants still plagued by safety concerns

The latest development: On Wednesday, the Food and Drug Administration announced it was investigating a possible link between breast implants and an increased risk of a rare cancer called anaplastic large-cell lymphoma, or ALCL.

As many as 60 women have developed ALCL among the 5 million to 10 million worldwide with implants. That compares to the rate of breast tissue ALCL in the normal U.S. population — about 3 in 100 million. The disease arises in scar tissue that forms around the implant, either silicone or saline, and is treatable.

The development comes at a time when breast implants have had a number of years without bad press. Indeed, breast augmentation remains the most popular elective cosmetic surgery in the U.S.: Even with a drop during the recession, the surgeries have risen 36% since 2000.

Much of the popularity involves resolution of a decadelong battle over the safety of silicone implants.

In 1992, the FDA placed a ban on silicone implants, except as part of clinical trials, because of fears that silicone leaking from the implant could trigger autoimmune disease and other health problems. The agency lifted the ban in 2006, but asked the two U.S. manufacturers, Mentor and Allergan, to continue to collect data on 40,000 women for 10 years to further monitor safety.

Today, although both silicone and saline implants are available, "virtually nobody picks the saline anymore" because the safety concerns over silicone have been alleviated and because silicone looks and feels more natural, said Santa Monica plastic surgeon Dr. Michael McGuire, former president of the American Society of Plastic Surgeons. "Breast implants are the most studied device in the history of medicine. When you look at the magnitude of the studies around the world, there is just about no evidence to support many of the fears that arose in the '90s," he said.

But though the FDA no longer considers autoimmune disease a risk, the agency lists other complications. The main ones are the need for additional operations, pain, changes in nipple and breast sensation, capsular contracture (shrinkage of a lining of scar tissue that forms around the implant, causing pain and breast hardness), rupture, and, for silicone-gel implants, migration of silicone should a rupture occur. Implants can also make it more difficult to read mammograms."