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More Information Emerges From FDA Documents About DePuy Hip Implants

For over a year and a half our Illinois DePuy hip recall lawyers have been sharing information about the safety concerns of certain metal-on-metal hip implants given to thousands of patients. The devices were used in traditional hip replacement operations and were recalled in August of 2010. However, before the recall it has been estimated that as many at 93,000 patients worldwide received the defective device-including some in our area. The recall was initiated amid various concerns about the device’s safety. There were worries that the metal on metal designs led to small metallic particles rubbing off and entering a patient’s bloodstream. In addition, failure rates of the devices seemed to be far higher than previously thought. The implants were supposed to last for fifteen years, but many were failing much sooner-leading to pain, suffering, and long-term complications for the unsuspecting patients.

Of course, in all situations like this, it is important to understand what the companies involved knew about the safety of their devices and when. A recent New York Times article on the situation last week sheds more light on some of those questions. In 2009 the U.S. Food and Drug Administration sent a “nonapprovable” letter to DePuy company officials letting them know that a hip device used in an alternative hip replacement procedure called “resurfacing” would not be approved for use in the U.S. This device was used in places outside of the U.S., but officials were growing concerned about the failure rates of the device. In particular, in not approving the product, the FDA apparently noted that data submitted by the company in its application differed somewhat from data collected in locations where the product was already being used. For example, data from Australia indicated that the devices were failing at higher rates than acceptable, in many cases requires revision just a few years later, instead of lasted the expected 15 years.

The exact device at issue in the recently released FDA documents was never approved for use in the U.S. However, a companion device was used here. The companion device (known as articular surface replacement, ASR) was used globally for an 8-year period, with tens of thousands of U.S. patients receiving the product. It wasn’t until August of 2010 that these devices were recalled. However, a year earlier, shortly after the FDA letter’s about safety concerns for the companion device, the company which owned DePuy decided to phase out the ASR hips. That phase-out allegedly involved trying to deplete its inventory first-having more patients receive the potentially dangerous product that was still left in stock.

The Illinois medical malpractice lawyers at our firm understand the difficulties that face patients who have a procedure performed at a hospital only to have complications make the situation far worse. At times those complications are caused by the misconduct of the medical professionals involved (which is medical malpractice). However, at other times the harm is not the result of any negligent doctor or nurse actions but by dangerous products used in the procedure. The legal issues involved are different in each of these situations. However, patients should remember that in both cases the law may allow those hurt to recover for their harm. Be sure to share your story with a legal professional in our area to learn more.

See Our Related Blog Posts:

Number of Injuries From DePuy Hip Replacements Continues to Grow

Illinois Hip Implant Recall Shows Problems with Improper Product Testing