WOODCARVING & ACCESSORIES

DEPUY RECALL SHOWS THE NEED FOR AN ARTIFICIAL JOINT REGISTRY

Tracking hip implants and other replacement devices is the sole job of an artificial joint registry which, sadly, the United States does not have at present. This would serve as a detector for badly designed or untested devices that protects the public’s health and wellbeing. Many other advanced countries have them, e.g. the United Kingdom, Australia, Japan, and Norway. In fact, it was the National Joint Registry for England and Wales which prompted the DePuy hip replacement recall. Although the company had received negative reports from foreign joint registries regarding the ASRs’ higher-than-normal failure rate, the company still sold the implants. DePuy’s ASR XL Acetabular Hip System and ASR Hip Resurfacing System provide good examples for why the United States needs an artificial joint registry.

It would seem that the U.S. Food and Drugs Administration is partly to blame because the devices were made to go through its 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 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.

It is obvious that having a joint replacement registry could prevent another DePuy recall and would be an advantage to future hip recipients. 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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