FDA: Breast Implant Safety Studies Will Continue, Web MD, August 31, 2011

Sep 3rd, 2011 | By | Category: Media Reports

Web MD reports the current post-approval studies on silicone-gel implants will continue according to the FDA’s Center for Devices and Radiological Health (CDRH) even though among the original 100,000 women enrolled in the studies, researchers have lost track of up to 79% of the women. That was just three years into a 10-year study.

William Maisel, MD and chief scientist at the CDRH said the studies will continue despite the fact that the studies have lost the ability to find complications such as connective tissue disease they were intended to find.

Read the rest of the story here.

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We hope you find this a helpful resource. National News Editor, Jane Akre, began MDND with the hope of providing the latest news, information and perspective from the regulatory, industry and patient point of view, something that goes under-reported in much of the coverage of medical devices. The public is just now becoming aware that many devices do not undergo the same scrutiny as prescription drugs and are instead grandfathered in under an FDA loophole that has gone largely unchanged since the 1970s. As a result, patients become the post-market clinical trial subjects, and many suffer devastating and permanent injuries.