Medical Implant Devices and the FDA: User Beware? (part 2)

We previously discussed an ongoing public health concern where the FDA’s approval process for medical devices appears to be dangerously lacking—to the point that many devices get released to market without a clinical trial. What does this truth mean for you or your loved ones who might need an implanted medical device? What steps can you take to stay safe? Do Your Own Research If your doctor recommends a certain medical device, you don’t have to assume it’s safe because your doctor says so. Find out about the device—not just what it is and what it does, but who makes…

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Medical Implant Devices and the FDA: User Beware? (part 1)

When the U.S. Food & Drug Administration (FDA) approves a medical device designed to improve your health, can you assume the device is safe? Not so fast, according to some critics. Modern medicine relies more and more on implantable medical devices to help certain patients—from artificial hips and knees to coronary stents and pacemakers, from cataract lenses to breast implants. Yet remarkably, as author/reporter Jeanne Lenzer points out in a recent interview, less than 1 percent of FDA-approved medical devices even undergo clinical trials. (By comparison, drugs must go through at least two trials prior to approval.) Even devices considered…

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