FDA Issues Safety Communication on Metal-on-Metal Hip Implants

Possible recalls of more hip implants may follow DePuy’s ASR model off the market.

On Thursday, January 17, 2013, the United States Food & Drug Administration advised that patients should be better informed of the benefits and risks of metal-on-metal hip implants.  These risks include information concerning the likelihood that the implant may need to be replaced.  With significant recalls both in the U.S. and worldwide over the past few years, there is a growing concern that the once-perceived and heavily promoted benefits of the “longer lasting” metal-on-metal models may just not be worth the risks involved.  The FDA noted that these models, including Johnson & Johnson / DePuy’s ASR (which has been recalled and taken off the market completely as of 2010), Stryker Trident and Zimmer Durom, can cause soft-tissue damage that may lead to pain and the need for more surgeries.

The FDA said that the metal ball and metal cup design of the implants may rub against each during walking or running, and sometimes results in metal being  released from those parts and damaging to the bone and soft tissue surrounding the implant and joint.  On it’s website, the FDA stated that “Metal-on-metal hip implants have unique risks in addition to the general risks of all hip implants”.

Various regulators in Europe, North American and Australia have warned that full MoM implants may likelier to fail and cause tissue damage around the joint as compared with the other types of implants.   They have also warned that MoM implants may be more likely to deteriorate and could expose patients to higher levels of metals including cobalt and chromium.ASR

There have been thousands of DePuy ASR lawsuits to date, alleging that DePuy and Johnson & Johnson hid the risks associated with the ASR model, which resulted in thousands of DePuy ASR plaintiffs being marketed and sold faulty hip implants.    Stryker Trident lawsuits and Zimmer Durom lawsuits also exist in similar numbers.   The first DePuy ASR lawsuit is set to begin in Los Angeles on Tuesday, January 22.

In July 2012, the FDA advised that there are few reasons left to use MoM implants. Experts decided they had fewer benefits than risks. The main concern was how they exposed patients to released metal particles.  As such, it is possible that more metal-on-metal hip implant prosthetics may follow DePuy ASR off the market in the months and years to come, and anyone needing a new hip should keep these concerns in mind when discussing options with their doctor.

If you have questions about a potential faulty Stryker, Zimmer or DePuy hip replacement and would like to know more about your legal rights, please contact the product liability lawyers at Slater Slater Schulman LLP at (800) 251-6990 or by filling out the form on this page.


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