In March of 2010, Depuy finally halted sales of its ASR metal on metal hip implant. While Depuy did not announce a formal recall of the device, and maintains that it is not defective, it is curious that they pulled the device from the market in December of 2009 in Australia, where the National Device Registry there showed alarmingly high failure rates of this device, yet continued to sell it in the United States, which also happens to be Depuy’s largest market. Depuy continued to sell this device to unsuspecting patients throughout the country despite the fact that the FDA has received approximately 300 complaints regarding the Depuy ASR cup since 2008.
The alleged problems with this implant are numerous and very serious. Some experts feel that the design of the ASR XL cup is too shallow, resulting in hip implant dislocations. Further, studies have shown that the metallic debris caused by the friction of these implants is causing metallosis, an allergic reaction that causes the tissues surrounding the joint to darken or turn black and often causing tumors in the area surrounding the implant. While not conclusive at this point, other studies suggest that this metal wear debris can affect organs away from the implant itself, as both Cobalt and Chromium (the elements which make up the implants) can be hazardous to humans, and in some cases are considered carcinogenic. You can read more about the problems with metal-on-metal implants HERE.
The Depuy ASR Cup was cleared by the FDA in 2005 via a process known as the 510(k) approval process. This process allows a manufacturer to obtain market approval with very little clinical testing of the device. All the manufacturer has to argue is that the device is “substantially equivalent” to a device that is already on the market, and they can get approval. For more information about the 510(k) approval process versus the more rigorous PMA process, click HERE.
If you or a loved one believes that they may have a Depuy ASR hip implant and would like more information, please contact us immediately for a fee consultation.
