February 02, 2012
/24-7PressRelease/ -- A new report from the British Medical Journal raises serious questions about the safety of newer metal-on-metal hip implants. The study, coupled with a request by the Food and Drug Administration (FDA) that manufacturers study the frequency of failure in the devices, has patients and doctors worried about their continued use.
The British Medical Journal Report
When the newer devices were introduced, it was thought that the metal-on-metal design would wear less and reduce the risk of dislocation when compared with other types of implants. However, after an unexpectedly high rate of premature replacement, it became clear that the initial promise of the new devices needed re-evaluation.
The FDA-sponsored report published in the British Medical Journal combined and analyzed 18 studies. One conclusion was that metal-on-metal hip implants were no more effective than their counterparts in allowing the patient to complete normal daily activities.
More importantly, however, the study concluded that patients who received the all-metal implants were more likely to experience a failure of the joint, which could present itself as pain, joint dislocation or swelling. In severe cases, the joint could cause toxic levels of metal ions in the body, leading to systemic damage.
As a result, the FDA requested that the makers of the metal-on-metal implants, including DePuy, Smith & Nephew, Zimmer Holdings, Biomet and Wright Medical, track usage of their products and record suspected failures for future analysis. While experts emphasize the need for further testing to determine the full extent of the issue, the preliminary results seem to suggest the devices fail at a higher rate than the older, nonmetal implants.
Other Developments
The release of the report followed a 2010 recall of the metal Articular Surface Replacement device made by DePuy. In that case, the FDA issued the recall due to a much higher than expected failure rate. According to the New York Times, between January and August of this year, the FDA received in excess of 5,000 complaints regarding the all-metal devices. In most cases, the filings show patients who have either already had their implants removed or are scheduled to complete the procedure soon.
In Great Britain, the National Joint Registry for England and Wales reports that the all-metal hip replacements seem to be failing at a significantly higher rate than the older devices. The registry previously indicated that the metal joints recalled last year in the U.S. failed in about one-third of patients, lending support to the recent findings.
Despite these developments, the all-metal hip implants are still used in the U.S., although at a much lower rate than in years past. At the height of their use, the metal-on-metal implants accounted for roughly one-third of the 250,000 replacements performed in the U.S. every year.
With repeated stories of failure, it remains to be seen whether the all-metal implants will continue to be used. Manufacturers are already facing a multitude of lawsuits over the safety of the products, a situation that is unlikely to change in the near future given the recent BMJ report and expected future research.
If you or someone you know has experienced pain or required surgery due to an all-metal hip implant, contact an experienced personal injury attorney to assess your situation.
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