FDA Complicit in Failure of Untested DePuy ASR Hip Implant

DePuy first sought approval of the ASR prosthesis in March 2004 when it filed for 510(k) approval with the FDA. Under this process, the company had only to show that the ASR was "substantially similar" to other implants on the market. Specifically, the company compared the ASR to its own prior hip product, the DePuy Pinnacle.

The FDA failed to draw a crucial distinction between the two devices. The Pinnacle required external fixation via screws anchored to the bone. The ASR, however, relied on the surrounding bone growing into the implant for fixation. Although markedly different from the Pinnacle, the FDA granted 510(k) approval to the ASR with no clinical trials or other tests that might have detected defects in its design.

Subsequently, some 93,000 of the hips were sold globally, with 1 in 8 failing within the first five years -- almost three times higher than the industry-standard failure rate of 5%. "It is inexcusable that the FDA did not realize that a hip that is anchored with screws and one that relies on bone growth for fixation are not the same device," said Attorney Kirk Bernard of the Seattle-based Bernard Law Group.

In addition to exhibiting chronic loosening, the ASR has also been linked to metallic poisoning. Metal debris from wear has caused inflammation and the formation of non-cancerous tumors in some patients, while others have been found to have elevated levels of cobalt and chromium in their bloodstream.

The extent of the potential long-term medical consequences for patients who have received the ASR hips is not yet clear. What is clear, however, is that the FDA is complicit in fast-tracking the approval process for a defective device in the absence of a responsible testing protocol.

For more information on the DePuy hip recall, contact a hip recall attorney immediately. An attorney experienced with the hip replacement recall will be able to assist you or your loved ones to the best extent of the law.