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."