New FDA report focuses on long-term safety of implants, but studies had high dropout rate
MSNBC | June 22, 2011
More than one in five women who had silicone breast implants for cosmetic purposes and half of those who got the implants after a mastectomy needed surgery to remove the implants within a decade, according to a Food and Drug Administration report out Wednesday.
“Recognize that breast implants are not lifetime devices,” says the FDA report on the longest studies on the implant to date. “The longer you have your implants, the more likely it will be for you to have them removed.”
In 2010, U.S. surgeons performed nearly 400,000 breast implant procedures. About three-quarters were for breast augmentation, while the rest were for breast reconstruction. About half the surgeries used silicone gel implants; the other half used implants filled with saline.
Silicone implants were pulled off the market in 1992, after concerns were raised about lack of safety data and worries that leaking silicone was linked to immune-system disease.
But the FDA returned the implants to the market in November 2006 after clinical trials didn’t find a link to feared diseases. Plastic surgeons and some women were clamoring for the return of the silicone versions because they say they look and feel more real than saline, which can ripple because it’s essentially a sack of salt water.
The approval required implant makers Allergan and Mentor to conduct large 10-year studies following up on patient experiences, and Wednesday’s report is the first glimpse at how the breast implants held up.
The FDA says 20 to 40 percent of patients who get silicone implants for cosmetic reasons will need another operation to modify or remove them within 10 years. For women with implants for breast reconstruction, the number is even higher, at 40 to 70 percent. The biggest issue was scar tissue hardening around the implant.
Other complications include implant rupture, wrinkling, asymmetry, pain and infection, the report said. Women with breast implants are also slightly more likely to be diagnosed with anaplastic large cell lymphoma, a rare form of cancer.
Despite the risk of complications, the FDA believes that silicone implants are reasonably safe, the report said.
But women in the studies had a high dropout rate and so other complications or long-term safety issues might be missed, the agency’s report says.
Mentor has three-year data for only one out of every five women in its study, while Allergan has two-year data for three out of every five, according to the FDA’s safety update.
“Low follow-up rates and other study limitations may limit interpretation of the data and preclude the detection of very rare complications,” the agency concluded.
Without knowing why patients have dropped out of the studies, it’s impossible to reach any conclusions about implant safety, says Diana Zuckerman, president of the nonprofit National Research Center for Women & Families in Washington, D.C.
“Did they stop going to the doctor because their implants were removed?” Zuckerman says. “Did they stop going because they died or got very sick? Or are they so happy with their implants that they skipped follow-up visits?”
The FDA has been working with the companies to improve patients’ participation in the studies and will convene a meeting of outside experts to discuss the issue later this summer, says William Maisel, deputy director for science and chief scientist at the agency’s Center for Devices and Radiological Health.
Most women who get breast implants are in their 20s and 30s, and may mistakenly consider breast implants a one-time investment.
“They need to understand they’re going to need many removals and replacements for the rest of their lives,” Zuckerman says.