After a decade of worries over silicone, they have had a number of years without bad press. But now comes news of an increased risk of a rare cancer.
For years, Michell Anne Kimball of San Diego considered breast augmentation but worried about the health risks. Three years ago, the 47-year-old decided the time was right, consulted with a plastic surgeon and, after four more months of pondering, received silicone implants.
She loves them, she said. And she continues to agonize over them. "Are these things safe or not? Are we ever really going to know?"
Though modern breast implants have been around for decades, questions of safety continue to plague augmentation even as the artificially enhanced bosom has become common.
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 cancer risk, if it exists, is miniscule, and women with implants need not undergo tests or have implants removed if they are not having problems, the FDA said. But they should be aware of the symptoms of ALCL, which include swelling, pain or lumps around the implants.
The news shouldn't be cause for panic, said Los Angeles plastic surgeon Dr. Geoffrey R. Keyes, president of the California Society of Plastic Surgeons. "But it will require substantial research to determine exactly what the risk is," he said.
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.
The rate for the most common and bothersome problem, capsular contracture, is roughly 10% in the first five years for saline implants and about 30% in the first three to five years for silicone implants, according to FDA data. More data are available at http://www.fda.gov/MedicalDevices.
Researchers are continuing to explore the pros and cons of a growing variety of implant designs, including textured silicone-gel implants — versus the traditional smooth silicone gel — and so-called extra-high-projection implants, which are larger implants that project out further from the chest. Recent studies suggest highly textured implants may increase the rate of capsular contracture.
Manufacturers are testing a different type of implant, the cohesive gel implant, available for now only in clinical trials.
The FDA cautions that most women will need operations to correct ruptures, complications or poor cosmetic outcomes. Complication rates increase for each revision surgery. But many don't heed the warnings, Keyes said. Even when doctors explain the risks, "patients … often de-emphasize the negatives and accentuate the positives."
The market for breast implants, which have with a price tag of about $4,000, is expected to grow about 7% per year over the next four years, said Sana Siddiqui, manager of the aesthetic division at Millennium Research Group, a Toronto-based market research company. Women ages 19 to 34 are a fast-growing segment of the market.
Kimball hasn't had problems with her implants, but her mother and sister have cancer and she has skin cancer on her breast. The illnesses have renewed her worries.
"There is pressure on women in California to look a certain way. It's unfortunate," she said. "But the implants are in there. I'm not going to have mine removed."
Shari Roan, Los Angeles Times
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