Scary Data On Medical Device Recall Rates and FDA’s Approval Process


TIME Magazine printed this statistic in its Health & Science section this week.

“71% Percentage of recalled medical devices that had been granted US FDA approval under an expedited review process for new products that are similar to existing, already tested and approved ones. ”  TIME, February 28, 2011

It was a small blurb in the lower corner of the magazine’s glossy page, but the significance of it could justify a front-page story, especially for anyone with a DePuy Hip Implant or a Zimmer Hip Replacement.  Both of these medical devices were approved for sale in the US by the FDA.  Now both are recalled and patients are suffering.  It’s all because of a loophole used by many medical device manufacturers to get their products on the market with little or no clinical testing. The FDA’s 510(k) rule allows these manufacturers to skip over extensive testing procedures if their products are substantially similar to something that’s already been approved.

With a 71% recall rate, there’s something very wrong with this process.  Johnson & Johnson and Zimmer have used these loopholes to push through defective products. But when things go bad because of a lack of clinical testing, thousands of patients are left in limbo wondering how something so wrong could have made its way into their bodies.  If you are one of the victims of the DePuy or Zimmer recalls, it’s very important that you know what to do next.  Find an experienced medical product liability attorney because this isn’t a fight you should take on by yourself.

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