Early Warning Systems Such As Joint Registries Needed Following The DePuy Recall
The United States is unique for not having an artificial joint registry that tracks hip implants and other replacement devices. This would serve as a detector for badly designed or untested devices that protects the public’s health and wellbeing. Currently, countries such as the United Kingdom, Australia, Japan, and Norway all have established a joint registry. 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 company’s ASR XL Acetabular Hip System and ASR Hip Resurfacing System are evidences that the country should have a joint registry in place.
The DePuy ASRs were made to undergo the United States Food and Drugs Administration approval process which is part of the problem. 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. An FDA approval can be obtained when these companies assert that their products are “substantially equivalent” to ones that have been previously approved and has been sold in the market. However, the ASR series of implants are metal-on-metal hip replacements, a novel 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 arises in this situation wherein the lack of artificial joint registry does not make companies like DePuy obligated 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 hip replacement recall center.