DA On Course With Comprehensive Review Of Metal-On-Metal Hip Replacements

The U.S. Food and Drug Administration has pushed for independent action due to the catastrophic events leading to the hip replacement recall . This is a highly anticipated development in conjunction with the multiple lawsuits facing the company. The FDA has created an internal website announcing its intentions to initiate a comprehensive review of all hip replacements comparable to those being recalled by DePuy.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. This loophole has proven to be deleterious to those thousands that have received DePuy’s ASR XL Acetabular System and Resurfacing System hip replacements.

A press release from the American Academy of Orthopaedic Surgeons (AAOS) fully endorsed 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.”

These “concerning exceptions” will ultimately be tantamount to thousands of hip replacement lawsuits. Those affected by the DePuy recall deserve proper compensation and should consider speaking with an experienced product liability lawyer. More information regarding the FDA’s study of DePuy’s metal-on-metal implants may be seen on the DePuy hip replacement recall website.