ASR Hip Replacement Recall
On August 26, 2010, DePuy Orthopaedics, a division of Johnson & Johnson, a multinational corporation engaged in the manufacture and sale of a broad range of products in the health care field, issued a voluntary hip replacement recall.
Products Affected by the Hip Replacement Recall
The hip replacement recall was issued for DePuy Orthopaedics’ ASR XL Acetabular System, which is used for total hip replacements, and the ASR Hip Resurfacing System, a newer bone-conserving device. The ASR XL Acetabular System is approved by the Food and Drug Administration (“FDA”), however, the ASR Hip Resurfacing System is not. Nonetheless, the ASR Hip Resurfacing System has been used in some patients in the United States as a result of a clinical trial.
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Events Preceding the Hip Replacement Recall
The hip replacement recall was issued after new data from a British joint replacement registry showed that approximately 1 in 8, or about 12 %-13%, of those patients who received the implants needed corrective procedures, called revisions surgeries, within five years. According to experts, this failure rate is two to three times the industry average.
Lawyers involved in DePuy hip replacement lawsuits and industry experts believe the company was aware of these problems at least two years before they issued the recall. Hundred of complaints had been filed with the FDA, noting the increased failure rates of the ASR hip replacement products.
Need for Revision Surgeries Caused Hip Replacement Recall
Most people with a hip replacement can expect their new implants to last for the rest of their lives. In some instances, due to loosening (when the components detach from the bone), infection, or disease, implants have to be removed and replaced in a revision surgery. A revision surgery is more complicated and costly than a primary replacement because surgeons have less bone and more scar tissue to work with. Thus, because the DePuy products increase the likelihood for revision surgeries, a hip replacement recall was instituted.
Implants Subject to the Hip Replacement Recall
There are a combined total of about 93,000 implants that are subject to the hip replacement recall. Signs that an implant may be failing include pain and difficulty walking. Following the hip replacement recall, DePuy Orthopaedics advised people who know they have ASR implants to schedule follow-up appointments with their surgeons, whether or not they are experiencing problems. Doctors will evaluate how the implants are functioning and may give patients blood tests to check for signs of microscopic metal particles around the implant, a sign of abnormal wear.
Contact a DePuy Hip Replacement Recall Lawyer
Contact us today for a free and confidential evaluation of your legal rights from one of our hip replacement recall lawyers.
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