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On June 20, 2012, The New England Journal of Medicine published an article concerning the difficulty of implementing effective post-marketing studies in the U.S. that would be helpful in assessing the risks and benefits of metal-on-metal hips. The authors of the article consider the current limitations and difficulties of implementing these post-market studies, and conclude by providing recommendations as to how to improve their efficacy.
According to the authors, more than 500,000 individuals were implanted with metal-on-metal hip devices in the U.S. from 2003 through 2010. Although approved by the U.S. Food and Drug Administration (FDA) through the 510(k) process, these metal hip devices are now coming under increased scrutiny due to reports of high failure rates.
The FDA issued an order on May 6, 2011 to metal-on-metal hip manufacturers directing them to conduct post-market studies on their devices. However, the authors indicate that there have been many limitations and setbacks in developing and implementing these studies in the U.S. Indeed, the FDA has only approved post-market studies for 23% of metal-on-metal hip devices.
The authors list many possible reasons for the difficulty in carrying out post-market studies on metal-on-metal hip implants. These reasons include delays in commencing studies and a lack of harmonization on what type of data will be collected among the studies. Another significant setback to the effectiveness of post-market studies is that the FDA only requires that metal-on-metal hip manufacturers conduct studies on devices for three years. According to the authors, this is simply not enough time to assess the adverse events that may occur in devices that can last for as long as fifteen years.
There are many ways that post-market surveillance studies on metal-on-metal hip devices may be improved. The authors provide three main recommendations, which include:
- Stronger collaboration between the FDA and metal-on-metal hip manufacturers to expedite the process of initiating post-market studies
- Further harmonization among the studies to allow for comparisons across data sets
- Improvement of the current U.S. orthopedic infrastructure that assesses hip devices
See the article from The New England Journal of Medicine at:
http://www.nejm.org/doi/full/10.1056/NEJMp1206794
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