June 22, 2011— -- Silicone gel-filled implants are not lifetime devices, and the longer they're in the body, the more likely there'll be complications, U.S. health regulators said Wednesday.
Despite the likelihood of complications, the Food and Drug Administration announced that silicone breast implants, which the agency approved in 2006 after they'd been off the market for 14 years, are for the most part safe.
The report included preliminary data from post-approval studies, an analysis of adverse effects reported to the FDA and a review of clinical studies about the safety and effectiveness of the silicone gel-filled breast implants.
But after getting silicone implants, women still need to be vigilant.
Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, was quick to warn that follow-up visits, along with routine MRI scans, are crucial for all women who receive the implants to screen for infection and ruptures.
And most women who get the implants will need to replace them or have additional surgery within eight to 10 years.
"The longer the woman has the silicone implant, the more likely she is to have experienced complications," said Shuren in today's press conference.
Experts said 5 million to 10 million women worldwide have breast implants. While the most common complications include hardening around the implants, which can lead to pain, wrinkling, asymmetrical pain, infection and implant rupture, most women report satisfaction.
While the health regulators said that there is no evidence that silicone breast implants cause breast cancer, they did touch upon anaplastic large cell lymphoma, a rare type of cancer that made headlines this winter when the FDA explored its occurrence among a small group of women who had breast implants.
Shuren said there are 34 cases in published literature and, at most, 60 cases worldwide, of the rare lymphoma among the millions of women with implants.
Health officials said they're confident in their data so far, but the FDA noted that more studies are needed. To help women understand the risks and benefits of the saline gel-filled implants, the FDA updated its website, which now offers literature and videos covering a host of different breast implant topics.
"We think the data is good at this point," said Shuren. "We also think there are certain limitations in the data, and we'd like to see higher follow-up rates. Right now, we think the tide is turning, and we're starting to see improvements in follow-up rates."
Shuren did not confirm the percentage of follow-up rates that the agency is seeing right now, but he said if study researchers began seeing 85 percent follow-up rates, "that's very good."