Dr. Sidney Wolfe, Director of Public Citizen’s Health Research Group, criticizes the FDA's approval of silicone gel breast implants, calling them "the most defective medical device ever approved by the FDA."
Wolfe, in a statement on the Public Citizen website, writes: "The approval makes a mockery of the legal standard that requires 'reasonable assurance of safety.'
It is a terrible reminder of the double standard for women versus men that the FDA has not approved silicone gel testicular implants because of the inadequacy of clinical trials on these devices. (Saline breast implants and testicular implants have been approved by the FDA.)
This approval of such a defective medical device raises again the larger issue of the poor leadership and dangerously poor performance of the FDA’s Center for Devices and Radiological Health (CDRH). Recent examples of this include the large number of defibrillator and pacemaker recalls, primarily the fault of manufacturers such as Guidant but abetted by the lack of FDA promptness, and the approval of the vagus nerve stimulator for depression despite the opposition of dozens of FDA staffers because it lacked evidence of effectiveness."
Posted by schwitz at November 19, 2006 08:45 AM | TrackBack