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."
Complications of Silicone Breast Implants
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.