Hip Replacements Manufactured by DePuy to Undergo FDA Review
About four hundred complaints were received by the United States Food and Drugs Administration regarding the apparent adverse effects DePuy's ASR XL Acetabular System and ASR Hip Resurfacing System inflicts upon recipients resulting in the hip replacement recall. A series of studies conducted by foreign joint registries then prompted DePuy Orthopaedics to recall their products. Now, it would seem that the FDA is taking independent action to address adverse event reports that they have received about the ASRs. The FDA's new site has this to say, “FDA is actively working in several areas to further assess the safety and effectiveness of metal-on-metal hip implants.”
The whole recall could have been avoided had DePuy not taken advantage of the FDA's premarket notification or the 510(k) regulatory loophole. This would allow corporations such as DePuy to gain approval for their products by claiming that the devices are substantially equivalent to ones which are already on the market. The company does not need to subject the hip replacements to cinical trials and testings if the FDA gives the ASRs a 510(k) ruling. In essence, DePuy was able to sell products it says bear new technology but at the same time claims they are similar to preexisting products on the market.
The President of the American Academy of Othopaedic Surgeons (AAOS), John Callaghan, commented on a press release, “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 'exceptions' have led to hundreds of recipients filing DePuy lawsuits against the company.
If you have been affected by the flaws and complications the DePuy devices inherently have, you should contact a hip lawyer immediately. Compensation is within reach if you consider your next steps carefully. More information regarding the FDA's review on DePuy's implants can be found in the hip replacement recall center.