The current DePuy hip replacement recall was initiated due to previous studies reporting that DePuy’s ASR XL Acetabular Hip System and ASR Hip Resurfacing System fail in about 12 to 13 percent in recipients after only five years. Unfortunately, a recent Bloomberg article has reported the failure rate for the ASR XL Acetabular System much higher than previously reported.
More and more information regarding American designed and manufactured artificial joints is coming from outside the United States.Last week, the British Orthopaedic Association and the British Hip Society issued a statement claiming, “Data on the ASR XL Acetabular System from four surgeons show the rate of second operations, or revisions, ranges from 21 percent after four years to 49 percent after six years.” This means that the ASR XL Acetabular System fails about half the time after only six years when these devices are supposed to last at least 15 years. An orthopedic surgeon presiding as chairperson of the advisory group for both the British societies added, “About 10,000 of the hips were implanted in the U.K., including 5,000 or so resurfacing devices and 5,000 of the ASR XL prostheses, also known as total-hip replacements.”
It is estimated that about 93,000 DePuy hip replacements were implanted in recipients worldwide. Should half of these defective devices fail after only six years, that would equal 46,500 corrective procedures that could have been prevented had DePuy allowed for necessary clinical testing of its products. However, a loophole in the 510(k) approval process carried out by the U.S. Food and Drug Administration (FDA) allowed DePuy to place their defective hip replacements on the market by stating that they were “substantially equivalent” to products that were already available to the public. The British advisory groups concluded that, “Based on the results presented, the use of large diameter metal-on-metal bearings in primary total hip replacement should be carefully considered and possibly avoided.”
Previous reports of DePuy’s failure rates are significantly lower than indicated. DePuy made numerous mistakes by rushing its product past regulators, ignoring studies warning of the health risks, and avoiding a public recall until it was much too late. Consequently, thousands of patients around the world are suffering the repercussions.Patients that have received defective hip replacements must seek expert legal counsel in order to protect their rights and get the compensation they deserve. For more information regarding ongoing litigation, visit the DePuy recall website.
Tags: Health and Fitness