FDA To Embark On Comprehensive Review Of Metal-On-Metal Hip Replacements
Thursday, March 24th, 2011The disastrous DePuy hip replacement recall has led the U.S. Food and Drug Administration to take independent action. 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. 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. 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.
In a press release given by the American Academy of Orthopaedic Surgeons (AAOS), they claim that the FDA has their utmost support. 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”. If you have been a victim of the DePuy recall and are seeking punitive damages, speaking with a hip replacement lawyer should be top priority. For more information on the FDA’s scrutiny of the DePuy implants , visit the DePuy lawsuit center.