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There has been substantial media attention and reaction from affected patients regarding metal-on-metal hip implants over the last decade or so. Of course, one of the most famous examples is the articular surface replacement, or ASR, implant which was manufactured by DePuy Orthopaedics, a subsidiary of Johnson & Johnson. Tens of thousands of the devices were implanted in patients before injuries, immobility, and even metal poisoning led to their recall in 2010. More than 7,500 lawsuits have been filed against DePuy and Johnson & Johnson, seeking billions in damages, and class action suits remain ongoing. It can difficult, however, for the average consumer to understand how medical devices such as the ASR implant ever get through the testing process and receive regulatory approval before going to market.

In the case of medical devices, even ones that eventually prove dangerous, substandard manufacturing is not often the problem. Rather, getting to the product to market frequently takes priority over careful design testing processes which allow for potential issues to be remedied prior to effecting patients and consumers. Many assume that industry and government regulators, like the Food and Drug Administration (FDA), would be responsible for ensuring that poorly designed devices never make it to market. They would be partially correct in that assumption, but many device manufacturers have found a loophole in federal regulations that reduce the FDA's oversight in particular situations.

Substantially Equivalent

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Metal-on-metal hips were first marketed as providing a greater range of motion and longer lasting use for patients. However, due to poor design and performance of certain artificial hips, failure rates have rapidly increased. Medical device manufacturers Stryker and DuPuy both created and promoted products that did not undergo proper testing. As a result, many have suffered.

Reports have revealed that metal debris can slough off the artificial hip device, causing damage to surrounding tissue and entry into the bloodstream. A defective artificial hip can lead to serious conditions such as hip dislocation, disability, and permanent damage.

Two years ago, the FDA ended distribution of Stryker's Rejuvenate and ABG II artificial hip devices. Health concerns associated with these hip systems included:

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