19 novembre, 2006 13:24
Ban on Silicone Breast Implants Lifted (CBNNews)
By Cheryl Thomas
November 17, 2006
CBNNews.com - WASHINGTON The government has ended a 14-year virtual ban on silicone-gel breast implants Friday, despite the fact that many lingering safety concerns remain about them.
They will now be available to tens of thousands of women who have clamored for the implants.
The problems not yet addressed about the devices is whether or not they may break in the body, and what effects the silicone inside them would have, if released.
Broken implants don't always cause immediate symptoms, so the FDA asked manufacturers to use MRI scans to track durability.
Mentor Corp. cited one study suggesting three-year breakage rates ranging from fewer than 1 percent to 5 percent of patients.
Inamed data showed that over four years, implants ruptured in 3.4 percent of women who had received them for breast enlargement -- and in 20.5 percent of breast cancer patients who received implants after a mastectomy.
The company attributed that higher rate to a particular implant model that is being redesigned.
The Food and Drug Administration approved the implants made by Inamed Corp. - now part of Allergan Inc. - and Mentor Corp., the two California companies said.
The FDA planned a teleconference late Friday to announce the new product approval.
