Breast implants don't last for life
Source: Agencies |
June 23, 2011, Thursday
|
Print Edition
Print Edition
WOMEN who get silicone breast implants are likely to need additional surgery within eight to 10 years to address complications such as rupture of the device, US health regulators said yesterday.
The Food and Drug Administration will work to revise safety labels for silicone breast implants after reviewing data from several long-term studies, which also showed that implants had a small link to a rare form of cancer.
"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. "The longer you have the implant, the more likely you are to have complications."
There were almost 400,000 breast enlargement or reconstruction procedures in the US in 2010, according to the American Society of Plastic Surgeons. That includes 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.
The Food and Drug Administration will work to revise safety labels for silicone breast implants after reviewing data from several long-term studies, which also showed that implants had a small link to a rare form of cancer.
"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. "The longer you have the implant, the more likely you are to have complications."
There were almost 400,000 breast enlargement or reconstruction procedures in the US in 2010, according to the American Society of Plastic Surgeons. That includes 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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