Posted on May 12, 2011 by Sean Jez
In an article posted on Tuesday, The New York Times reports that the FDA is requiring manufacturers of metal-on-metal artificial hips (e.g. the DePuy ASR) to do post market studies on the safety of their products. In particular the FDA is concerned about the damage caused by metal debris from the implants. I wrote about some of these concerns in an earlier posting on the ASR hip implant.
While I applaud the move by the FDA, I have to wonder whether all this would be necessary if medical product manufacturers were required to actually test their products before releasing them on the market. The majority of products are released through the 510(k) approval process, which allows manufacturers to avoid clinical testing if their product is “substantially equivalent” to a previous product.
In addition to requiring the studies, the FDA has also created an informational website for those concerned about metal-on-metal artificial hip implants. This website is a good source of information for those who wish to learn more on the topic.
