Defects Of DePuy Hip Implants: Did The FDA Know?
DePuy Orthopaedics, an infamous division of Johnson & Johnson, started their own brand of hip implants, the ASR Acetabular System and the ASR Hip Resurfacing System. Since 2003, they have catered to almost 93,000 clients in the United States alone. However, after a few years of use, the recipients of these implants started to complain of excruciating pain in the hip area. Since then, more people angrily blamed the metal hip implants as the direct cause of their sufferings. Finally, last August 2010, DePuy issued a recall on all of their metal-on-metal hip implants.
How can the Food and Drug Administration allow such faulty implants to enter the global market? Was the FDA able to know what caused the DePuy hip recall? If you can trace it back to square one, DePuy should have been able to pass FDA standards regarding many health care products. That said, it is the FDA’s prime responsibility to strictly screen all products within their scope. Nevertheless, DePuy was able to outwit the agency. The company, apparently, was able to spot a loophole in the 510(k) regulatory process, with which rules they circumvented for their own selfish advantage. In fact, they were able to take advantage of the ‘substantial equivalence’ notion, so the ASR hip implants were claimed to be ‘substantially equivalent’ to older hip implants that were approved by the FDA years back. Wasting no time, they were able to gain FDA’s approval to officially sell their hip implants to the market.
There are also no known implant registries in the United States, unlike in the United Kingdom and in Australia. After hearing that the registries in the UK and Australia were effective in seeing the trends in revision surgeries performed, the US is now planning to establish their own artificial implant registries as well. This is a smart plan, because medical malpractice issues can be efficiently addressed without compromising the privacy rights of the patients.
It is quite understandable if people question the credibility of the FDA because of their passive take on DePuy’s irresponsibility in manufacturing hip implants of poor quality sold at such high prices. At this point, you ought to press charges against the company, because filing a DePuy recall lawsuit can actually help you claim your damages. A hip recall lawyer can professionally help you will all legal matters pertaining to your case.