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FDA: Silicone Breast Implants Don't Last a Lifetime

Report Shows Many Silicone-Gel Breast Implants Are Removed Within 10 Years

Perspective of Plastic Surgeons

Experts say they believe women know what they're getting into when they select a silicone implant.

"I believe that patients generally understand that these are not lifetime devices any more than total joints or heart valves are," says Scott L. Spear, MD, chief of plastic surgery at Georgetown University Hospital in Washington D.C.

He says the survival rates for silicone implants are largely age dependent. Younger women who get them are more likely to also need to have them replaced, simply because they may live longer than a woman who gets them in her 70s.

Spear says the removal rates cited by the FDA reflect cases where women choose to get their implants taken out as well as cases where the removals are medically necessary, and for that reason, he thinks the numbers may seem unnecessarily frightening.

"The removal rate that FDA sites seems high to me and does not, to the best of my knowledge, reflect my personal experience or the experience of many surgeons," Spear says. "FDA tends to clump all reasons for removal together, including changing size, removing the implants electively for reasons of personal taste, and removal after radiation therapy or mastectomy, etc."

Other experts agree.

"The way those numbers are put together, it includes women who have decided, without a complication, to have their implants removed," says Phil Haeck, MD, president of the American Society of Plastic Surgeons  and a practicing plastic surgeon in Seattle. "We would have felt a little better, if they had put down a different category for elective decisions that women make to change their implants."

"I'm very satisfied with the report and it verifies what plastic surgeons are experiencing in their offices every day," Haeck says.

But consumer watchdog groups say the FDA's report did not go far enough.

"Public Citizen continues to oppose the FDA's 2006 decision to return silicone breast implants to the market for cosmetic use in women for augmentation," says Sidney M. Wolfe, MD, director of Public Citizen's Health Research Group, in a news release.

He points to the FDA's January warning that women with breast implants, either saline or silicone, may be at higher risk of an extremely rare kind of cancer called anaplastic large cell lymphoma.

"The agency's newer information about the risk of implant-associated lymphoma and the previously known risks are serious enough to warrant advising women against having these implanted," says Wolfe.

Advice to Women With Silicone Implants

For now, the FDA advises women who have silicone breast implants to schedule regular follow-up appointments with their doctors and plastic surgeons to check on the health of their implants.

Additionally, Shuren says women should be getting an initial MRI scan three years after implantation and every two years thereafter to check for silent ruptures.

But many women don't get these scans because they aren't covered by insurance.

"It's a significant out-of-pocket expense for a woman," Haeck says.

Additionally, women with silicone breast implants should pay attention to changes in their breasts, including pain, swelling, hardness, or asymmetry.

These changes should be reported to both the FDA and a woman's doctors, Shuren says.

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