The US Senate examined the FDA approval process of the DePuy hip replacement system last April 13, 2011. The Food and Drug Administration’s (FDA) now infamous 510(k) premarket approval process, which DePuy Orthopaedics and other medical device manufacturers use to send their products to the market without subjecting them clinical trials was covered in a scheduled hearing made by the senate. Of course, a lot of us will agree that this hearing was quite predictive and many of us have been waiting for it because DePuy’s defectively designed hip replacement systems have affected thousands of people.

A special committee was created just for this case and this committee gathered people to testify against this particular medical device. Most of those who testify believe that for medical devices that underwent an approved through the 510(k) process were more likely to be subject to a recall than those that underwent clinical trials. After thorough investigations, the special committee concluded, “Internal reviews by FDA officials and other outside sources have found troubling lapses in the procedures by which a number of medical devices were approved,” and that, “the results of these investigations caused procedural and management changes to be implemented at the Center for Devices and Radiological Health in recent months.”

The move of the US government that takes the DePuy recall with the seriousness it deserves is taken positively by a lot of hip recall lawyers. However, these lawyers still believe that doesn’t do much for those who have already suffered injuries due to their hip replacements. So, for people who wants to be compensated for the damages created by this product, contact a hip replacement recall lawyer immediately.
 



Your comment will be posted after it is approved.


Leave a Reply.