FDA Seeks Comprehensive Review Of Metal-on-Metal Hip Replacements

The U.S. Food and Drug Administration is seeking independent action as a result of the hip replacement recall fiasco 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. According to 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 has not only proven to be advantageous, it also sheds light as to the duplicitous 510(k) approval process that allows DePuy and other manufacturers the ability to clear their defective hip replacements for public use. The loophole in the 510(k) approval process enables companies to claim that their new products are fundamentally similar to those that are already approved and on the market which ensures FDA approval of these new products without being subject to clinical trials.Thousands of patients receiving DePuy’s ASR XL Acetabular System and Resurfacing System hip replacements experienced first hand just how disastrous this loophole could be.

A press release from the American Academy of Orthopaedic Surgeons (AAOS) fully endorsed the efforts of the FDA. With respect to the sensitive nature of the lawsuits, AAOS President John Callaghan tactfully 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.”

Thousands of hip replacement lawsuits will realistically be a direct result from these “concerning exceptions”. 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 scrutiny of the DePuy implants may be seen on the DePuy hip replacement recall website.