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16,800 Adverse Effects from Metal-on-Metal (MoM) Joint Replacements and Rising

That's the number of “adverse events” related to metal-on-metal (MoM) joint replacements recorded during the first eleven years of the 21st Century. And over 72% of those occurred in 2011 alone.

According to the FDA, there was a 400% increase in such reports from 2007 to 2008 – and a similarly dramatic increase beginning in 2010 when Johnson & Johnson's DuPuy Orthopaedics division started recalling their devices. In 2011, there were over 12,000 adverse events reported on MoM devices as opposed to around 6,300 for other types.

Today, DePuy's parent company faces over 6000 lawsuits stemming from the failure of these hip implants.

Unfortunately – but perhaps not surprising – the post-marketing studies of the devices ordered by the FDA will probably not be of much help in tracking device failures going forward. Most of this is due to two serious problems. First, the FDA failed to establish standards for these studies. Essentially, this means that each manufacturer of these MoM joint implants can conduct their studies any way they like, and there will be little consistency when it comes to results.

The other problem is that the FDA does not have the authority to order these studies longer than thirty-six months – and some of these devices may go much longer than that before they begin to fail.

In a recent article in the New England Journal of Medicine, Dr. Joshua Rising and colleagues suggested that, due to the slow pace at which this process is starting, the FDA still has time to rectify the situation.

In the meantime, the FDA will be holding public hearings at the end of June in order to discuss the dangers of MoM hip implants and the importance of testing patients for levels of metal ions in the blood – and most importantly, whether or not these devices should be subject to more rigorous testing standards.

Sources

Bolek, Michelle. “FDA to Discuss Risks And Benefits of Metal-on-Metal Hip Replacements” (News Release). U.S. Food & Drug Administration, 29 March 2012. Available at http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm297745.htm.

Edney, Anna. “Hip Implants Concerns Reacher 16,800 in 2011, FDA Says.” Bloomberg, 21 June 2012.

Rising, Joshua MD, et. al. “Delays and Difficulties in Assessing Metal-on-Metal Hip Implants.” New England Journal of Medicine, 20 June 2012.

Learn more about DePuy Hip Replacement & Stryker Hip Replacement

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