According to a recent article in the New England Journal of Medicine, more than 500,000 patients in the United States have received metal-on-metal hip implants, most of which were implanted between 2003 and 2010. Unfortunately, there is now compelling evidence that these implants fail at a higher rate than hip implants made from other materials.
On June 27-28, 2012 the FDA convened the Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee seeking expert scientific and clinical opinion on the risks and benefits of metal-on-metal hip systems including:
• Failure rates and modes;
• Metal ion testing;
• Imaging methods;
• Local and systemic complications;
• Patient risk factors; and • Considerations for follow-up after surgery.
Results from this Committee have yet to be made public.
However, new legislation called the User Fee Reauthorization Bill passed. This bill is funded by medical device makers and will give them a step up in the regulatory process. The FDA will provide the medical device makers with feedback sooner vs. later in the marketing approval process.
While this may sound like great news for the medical device makers, you have to wonder how the consumer fares.
Let’s take for instance hip implants. The metal-on-metal (MoM) hip has a failure rate of nearly 50% in six years. What would be the benefit to the consumer to have hip implants, knee implants, or any implants or medical devices perhaps pass through a shorter regulatory period?
When the regulatory process is paid for by the very organizations that are supposed to be regulated – isn’t that a conflict of interest?
This type of hand-holding regulation already exists for the drug makers and has led to the release of dangerous products which have been approved and then later recalled and/or banned. Meanwhile public health and patient safety are at risk for personal injury, wrongful death, and metal on metal hip implant lawsuits.