America’s FDA Slams Metal-on-Metal Hip Implants

More weight was given to the increasing number of class action suits being filed against DePuy Orthopaedics, with the release of a Public Health Statement by America’s Food and Drug Administration (FDA). The FDA is responsible for protecting and promoting public health throughout America, and regulates the provision and use of all medical devices in the United States.

In a statement posted on the FDA website, concerns are raised about the use of metal-on-metal hip systems, which are “known to have adverse events including infection and joint dislocation”. The statement lists many of these “adverse events” which include pain around the hip or groin, localised swelling or numbness, and a change in the patient’s ability to walk.

In addition, and reminiscent of the Erin Brokovich case, the FDA also highlights concerns about metal ions from the implant entering the blood stream. They cite cases where patients have developed a reaction to these ions and experienced medical problems relating to their nervous system, heart and thyroid gland.

The FDA statement comes months after the DePuy ASR Hip Replacement recall in Ireland, and class action lawsuits being filed in both the United States and Australia.