Sunday, November 26, 2006

Silicone Implants

"Federal regulators lifted their 14-year ban on breast implants made from silicone gel yesterday, dismissing concerns about harmful effects from leaks as unsupported by extensive testing."

"The officials said their review of study results made it clear that women age 22 and older can safely get the implants for cosmetic purposes. Women of all ages can have the implants for medical reasons, including reconstruction of breasts removed for cancer."

"From a scientific standpoint, the decision we are making tonight is in the best interest of American women," Dr. Daniel Schultz, director of the FDA office that regulates medical devices, said during a late-day conference call.

"Doctors emphasized that silicone gel implants can rupture or cause scarring but praised the FDA for giving women the opportunity to make an informed decision after weighing the risks."

"Patients will be happy because it means they have a choice," said Dr. Gedge Rosson, an assistant professor of plastic surgery at the Johns Hopkins University School of Medicine. He said patients have a "clear preference" for silicone gel.

"Women should have magnetic resonance imaging three years after surgery and then every two years to look for "silent" ruptures -- leaks they could not feel themselves, officials said. They estimated the life span of an implant to be 10 years. Women should know breast implants are not lifetime devices," said Schultz.
(source: Redorbit, Nov 18, 2006)

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