FDA Undertaking Comprehensive Review of Metal-on-Metal Hip Replacements

The disaster that has been the DePuy hip replacement recall has spurred independent action at the U.S. Food and Drug Administration. This is a welcome development amidst the numerous DePuy hip replacement lawsuits the company faces. The agency has created an internal web site claiming that it is undertaking a comprehensive review of all hip replacements similar to DePuy’s recalled ones. The web site states, “FDA is actively working in several areas to further assess the safety and effectiveness of metal-on-metal hip implants.”

This review could not be better timed, but it also speaks to the worthlessness of the 510(k) approval process DePuy and other manufacturers use to clear their defective hip replacements onto the market. The 510(k) approval process is really a loophole. Companies can claim that their new products are merely substantially similar to ones already approved and on the market, and consequently the FDA approves them without subjecting them to clinical trials. For DePuy’s ASR XL Acetbular System and ASR Hip Resurfacing System, this proved catastrophic for thousands of hip replacement recipients.

The American Academy of Othopaedic Surgeons (AAOS) approved of the FDA’s efforts, as it stated in a press release. However, AAOS President John Callaghan adopted a conciliatory opinion by saying, “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.”

In reality, those exceptions will amount to thousands of hip replacement lawsuits. If you’ve been affected by the DePuy recall and would like compensation for the harm the company has caused you, complete our contact form to the right or click here for a free initial consultation with one of the Rottenstein Law Group’s hip replacement lawyers.