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DEPUY RECALL SHOWS THE NEED FOR AN ARTIFICIAL JOINT REGISTRY
What makes the United States different from a handful of other countries is that it does not have an existing artificial joint registry that tracks hip implants and other replacement devices. The public's overall wellbeing is being protected by a registry that detects badly designed or untested devices. Other countries such as the United Kingdom, Australia, Japan, and Norway all have this kind of registry in operation. In fact, it was the National Joint Registry for England and Wales which prompted the DePuy hip replacement recall. DePuy still continued selling its hip replacement devices even though it received numerous reports from foreign registries about its implants' failure. The recall of both ASR XL Acetabular Hip System and ASR Hip Resurfacing System is proof that the US is in dire need of an artificial joint registry.
Part of the problem, though, lies with the U.S. Food and Drug Administration’s (FDA) approval process. By using the FDA's regulatory loophole called the 510(k) preapproval process, corporations such as DePuy Orhtopaedics can develop new artificial joints and then rush them to the market easily. This gives companies an FDA approval by claiming that their products are similar or “substantially equivalent” to a product that was already sold in the market. However, the ASR metal-on-metal hip replacements were boasted by DePuy to have been manufactured thtough a brand new technology. It makes one wonder how the company managed to convince the FDA that the ASRs were “substantially equivalent” to existing hip replacements.
Another problem the lack of an artificial joint registry holds for the public is that manufacturers like DePuy are under no legal obligation to collect information concerning adverse effects of their drugs or medical devices. And because DePuy is not obligated to collect pertinent data, they do not need to inform the FDA about the status and adverse data concerning its hip replacements. It could continue selling the ASR implants by claiming ignorance.
Evidently, future recipients of artificial hips would benefit from having a joint replacement registry could prevent another DePuy recall. Companies won't be too careless in manufacturing products that could harm consumers. If you have been adversely affected by the defective ASR devices, you may contact an experienced hip replacement lawyer to help you through the process of acquiring compensation from DePuy. More information is available when you visit the DePuy ASR hip replacement recall center.
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