The FDA will revise safety labels for silicone breast implants. Jeff Shuren, director of the FDA's Center for Devices and Radiological Health. said "The key point is that breast implants are not lifetime devices. The longer you have the implant, the more likely you are to have complications."
Breasts are big business in America.
The American Society of Plastic Surgeons said there were almost 400,000 breast enlargement or reconstruction procedures in the United States in 2010 involving silicone and saline implants.
Post-approval studies showed up to 70 percent of all women who received reconstruction surgery, and up to 40 percent of those getting an enlargement procedure using silicone, needed another surgery within eight to 10 years.
The FDA first approved silicone gel-filled breast implants in 2006 for Allergan's Natrelle and Mentor Worldwide's MemoryGel. Since then, the manufacturers and the agency have been conducting studies to review post-operation safety.
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