The U.S. Food and Drug Administration has pushed for independent action due to the catastrophic events leading to the DePuy hip replacement recall . This is a highly anticipated development in conjunction with the multiple lawsuits facing the company. An internal website has been created by the FDA stating that it is embarking on a comprehensive review of all hip replacements similar to those that were recalled by DePuy. 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.”
Not only could this review not have come at a better time, but it also exposes the inefficiency of the 510(k) approval process used by DePuy and other manufacturers to allow their defective hip replacements to be cleared for the public market. Manufacturers utilize the loophole provided by the 510(k) approval process to claim that their new products are similar to ones already approved and on the market in order to obtain FDA approval for these new products without subjecting them to clinical trials. 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. However, in an effort to maintain some diplomacy, AAOS President John Callaghan stated, “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. If you or a loved has been affected by the DePuy recall, you should seek the compensation you deserve by speaking with an experienced hip replacement 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.
Tags: Health and Fitness