Five years after allowing silicone breast implants back on the market, the FDA says that further studies showed that the decision was sound.
The FDA was criticized by consumer groups in 2006 for approving the implants after a 14-year hiatus because of widespread fear that they caused a wide range of illnesses.
But research by the two manufacturers of the implants, released in a report Wednesday, indicates that they have a "reasonable assurance of safety and effectiveness" when used properly, the FDA said.
"I don’t know what the critics will ultimately say," said Jeffrey Shuren, MD, director of the FDA’s Center for Devices and Radiological Health, in an interview, "but what we can say is the current data doesn’t indicate that silicone-gel-filled breast implants are linked to breast cancer or connective tissue disease or infertility."
[Source: Los Angeles Times]