FDA: Silicone Breast Implants Not 'Lifetime Devices'
Federal health officials say the latest data on silicone breast implants show they are relatively safe, despite persistent problems that lead one in five women to have the implants removed within ten years to address complications such as rupture of the device.
Issued Wednesday by the Food and Drug Administration, the report is the agency's first assessment of the implants since the devices were returned to the market in 2006. That followed a 14-year ban when only saline-filled implants were widely available.
"The key point is that breast implants are not lifetime devices," said Jeff Shuren, director of the FDA's Center for Devices and Radiological Health, to Reuters. "The longer you have the implant, the more likely you are to have complications."
The Associated Press reports:
Patients and plastic surgeons say the silicone-filled implants look and feel more real than saline versions.
The approval came [to return silicone implants to the market] with conditions, including a requirement that the companies complete studies on women who have received the implants.
The FDA's safety endorsement is primarily based on those studies, conducted by the two U.S. manufacturers of the products, Allergan Inc. and Johnson & Johnson's Mentor unit.
But industry critics point out that most of the studies are incomplete, and many women have already dropped out.
Side effects for silicone breast implants include: implant rupture, wrinkling, and lopsided appearance. The most common problem, however, is scar tissue, which hardens around the implant, warping the shape of the breast.