DA On Course With Comprehensive Review Of Metal-On-Metal Hip Replacements
The disastrous hip replacement recall has led the U.S. Food and Drug Administration to take independent action. This comes at a most advantageous time in light of the multiple lawsuits that the company faces According to the internal website created by the FDA, a comprehensive review will be made of all hip replacements similar to those involved in the DePuy recall. As stated on the website, “The FDA is actively working in several areas to further assess the safety and effectiveness of metal-on-metal hip implants.”
The timing of this review is not only warmly welcomed, but is also speaks volumes as to the futility and inefficiency of the 510(k) approval process that DePuy and other manufacturers utilize in order to clear their defective hip replacements for marketing and distribution.Companies use the 510(k) approval process as a loophole in order to avoid subjecting their new products to clinical trials and getting FDA approval for distribution by claiming that they are fundamentally similar to ones already approved and on the market. Subsequently, this has been a nightmare for those thousands that have received DePuy’s ASR XL Acetabular System and Resurfacing System hip replacements.
The American Academy of Orthopaedic Surgeons (AAOS) has given a press release supporting the efforts of the FDA. In order to placate both parties, AAOS President John Callaghan states, “We believe that a significant majority of metal-on-metal hip replacement implants have successfully relieved pain and improved function without any problems for the patients who have received them but there have been some concerning exceptions.”
Stating that there are “concerning exceptions” is an understatement considering that these exceptions will results in thousands of hip replacement lawsuits. Those affected by the DePuy recall deserve proper compensation and should consider speaking with an experienced product liability lawyer. For more information on the FDA’s scrutiny of the DePuy implants , visit the DePuy lawsuit center.