Posted: Jun 22, 2011 10:14 PM
June 22, 2011 -- A new report from the FDA shows that 20% of women who get silicone gel implants to increase the size of their breasts, and half of all women who get them for breast reconstruction, will have those implants removed within a decade, often because of complications like breast hardening or rupture.
"Breast implants are not lifetime devices," said Jeffrey Shuren, MD, director of the FDA's Center for Devices and Radiological Health, at a news conference. "The longer a woman has silicone gel-filled breast implants, the more likely she is to experience complications."
The most common complications reported in studies that are tracking the long-term health of women who get silicone breast implants are contracture, or hardening of the breast, reoperation, and implant removal. Other common complications include rupture, wrinkling, asymmetry, scarring, pain, and infection.
"These risks and complications, though frequent, are well understood," Shuren says, "And most women who receive silicone gel-filled breast implants are satisfied with their choice."
The FDA report shows that complications, when they do happen, tend to be confined to the area around the breast.
The report did not update information on the safety of saline implants.
Concerns that silicone leaking from breast implants could contribute to systemic diseases led the FDA to yank the devices off the market in 1992.
Subsequent large-scale studies found no evidence of a link between systemic diseases and silicone breast implants.
And in 2006, the FDA approved two new silicone breast implants, made by Allergan and Mentor, after the companies provided safety data that satisfied regulators.
As a condition of approval, the FDA required each manufacturer to conduct six long-term studies to monitor the health of women who received these implants.
The information in the new FDA report comes from those studies as well as the agency's review of recent scientific literature.
"Our review of this information continues to support the safety and effectiveness of silicone breast implants when used as intended," Shuren says.
The FDA's safety update on silicone breast implants comes on the heels of a new report from the American Society of Plastic Surgeons showing breast augmentation and reconstructive surgeries are on the rise.
Nearly 300,000 women opted to boost their breast size with implants in 2010, making it the most popular cosmetic procedure in the U.S. Over the last decade, the number of breast implants performed in this country has increased 40%.
Breast reconstruction, which is typically done with implants, was the fifth most common reconstructive procedure in 2010, with an increase of 18% over the last decade.
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.
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.