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Medical Device Legislation
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New Bill Proposes Increased Monitoring of Medical Devices

hip implant device problems

A new bill being considered by Congress right now would allow the Food and Drug Administration (FDA) to force makers of artificial hips and other medical implants to track the performance of their products after they are approved for sale.

Currently the FDA does not require human testing for medical implants like it does for other medical devices and prescription drugs. To sell a new medical implant all a company has to do is show that it is similar to a product that is already available to patients. But since thousands of all-metal hip implants approved through the current system are failing prematurely in patients, patient advocate groups are urging lawmakers to grant the FDA more oversight of these products.

Along with the new bill, lawmakers are asking companies such as DePuy Orthopaedics, an artificial joint maker; Zimmer Holdings, another artificial joint manufacturer; Medtronic, a heart and spinal implant producer; and Boston Scientific, a heart device maker, to submit information about how they track product safety and recalled devices.

Various products from all of these companies have been recalled over the past couple of years, but not before they have caused considerable pain and suffering to some of the people who had implant surgeries. For more information on medical product injuries, please visit our firm’s website.

Source: "Bill Would Require More Monitoring of Implants." The New York Times. December 14, 2011.
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