Groundbreaking Study Calls For A Ban On Metal-On-Metal Total Hip Replacements
On March 12, 2012, The Lancet medical journal published the findings of the most comprehensive study to date on metal-on-metal total hip replacements (“THR”). The study confirmed recent safety concerns over total hip replacement complications, and found that metal-on-metal THR fail at much greater rates than other types of hip replacements. These findings led researchers to call for a ban of all metal-on-metal THR. In conducting the study, British researchers analyzed data from the National Joint Registry of England and Wales, one of the largest joint implant databases in the world. The vast pool of data was provided by more than 400,000 patients who received hip replacement implants between 2003 and 2011. The study found:
- Out of the 31,000 metal-on-metal THR procedures performed, 6.2 percent of patients experienced total hip replacement complications and required revision surgery within five years.
- Only 1.7 to 2.3 percent of people with ceramic or plastic hip implants experienced problems after implant.
- Failure rates for metal-on-metal THR in women were up to four times higher when compared to women with non-metal implants.
Total Hip Replacement Complications Lead To Denouncement By Researchers
Based on the “unequivocal evidence” obtained from the study, researchers concluded that metal-on-metal THR should no longer be used. “Metal-on-metal stemmed articulations give poor implant survival compared with other options and should not be implanted,” Professor Ashley Blom from the University of Bristol in the United Kingdom and his colleagues wrote. These findings came two weeks after British health regulators issued an advisory that individuals with metal-on-metal hips should undergo annual testing for signs of total hip replacement complications, such as metallosis. Metallosis occurs when the cobalt and chromium in the metal hips wear off, releasing metal debris into the surrounding tissue, which can enter the bloodstream and cause inflammation that destroys muscle and bone.
DePuy ASR Metal-On-Metal Hips Recalled, Other Models Scrutinized; Lawsuits Filed
In 2010, DePuy Orthopaedic, a subsidiary of Johnson and Johnson, issued a worldwide hip replacement recall of its ASR hip implants. The impetus for the recall was based on data from the National Joint Registry of England and Wales, which showed that patients who received ASR hip implants experienced hip replacement failure at two to three times the industry average. 12 to 13 percent of patients required revision surgery within five years. The most recent study, analyzing current data from the same registry that led to the ASR recall, raises questions about the U.S. Food and Drug Administration’s device approval process, called the 510(k). Manufacturers used the 510(k) in order to receive market approval for metal-on-metal THR without performing clinical testing because the devices were based on a similar prior design. In an accompanying commentary to the study, Art Sedrakyan, an associate professor of public health at the Weill Cornell Medical College said, “Policy makers need to appreciate that registry data alone are not a substitute for good pre-marketing studies, which should include testing of implants.” The same concern has been expressed over certain metal-on-metal DePuy Pinnacle hip replacements, which have not been recalled but show signs of alarmingly high early failures akin to the DePuy ASR systems. There are currently thousands of hip replacement lawsuits pending against DePuy Orthopaedics.
Contact A Metal-On-Metal THR Lawyer
If you experienced total hip replacement complications arising from a metal-on-metal hip implant, you may be entitled to compensation for your pain and suffering, medical expenses and lost wages. The hip replacement lawyers at Bernstein Liebhard LLP are actively filing cases on behalf of clients who were implanted with either type of metal-on-metal hip implant manufactured by DePuy. Contact one of our lawyers today for a free case review.