Replacement Parts
How the FDA allows faulty, and sometimes dangerous, medical devices onto the market
By Kit R. Roane
Posted 7/21/02
Page 8 of 8
BETTER THAN SURGERY? The AneuRx aortic stent, shown shrinking the balloon aneurysm at left, is billed as less risky than open surgery. But the FDA approved the device despite serious questions about its clinical data and the ability of doctors to properly use it. The manufacturer, device giant Medtronic, is fighting numerous lawsuits related to the stent, including one filed by William Anderson (right). Anderson had the stent implanted in 1998. The device broke, damaging his artery. He says that he has not been able to work steadily for four years.
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