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FDA Approved Faulty Hip without Trials

| Nov 4, 2010

The DePuy ASR XL device has had more than 400 complaints of early failure rates, leaving 12-13% of its patients facing difficult revision surgery and nearly all of them at risk for metallosis, but how did the device even get approved in the first place?

DePuy Orthopaedics ASR XL Acetabular System hip implant was approved in 2005 by the U.S. Food and Drug Administration without clinical trials. The speedy approval process is legal under the FDA's 510(k) process, which allowed approval because the device was similar in design to other devices already on the market.

In four years after the device's approval the FDA had received nearly 400 complaints that DePuy's hip implant was failing prematurely. The device's metal-on-metal design was loosening or breaking and corroding, causing metal debris from the device to enter the bloodstream, which could lead to metallosis.

In 2006, more than 6% of total health care expenditures in the United States went to medical devices like the DePuy hip, a $123 billion industry. In 2009, joint implants (including knees) generated $6.7 billion in profits for manufacturers. None of these products carry warranties and all represent some of the highest profit margins in medical manufacturing.

The DePuy case is an example of manufacturers and agencies bypassing safety for the benefit of business. They risked the health of all their patients and now many are suffering. If you or a loved one has been injured as a result of a DePuy hip implant , have your case evaluated by a personal injury lawyer.

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