A newly published study from Australia (and reported in the New York Times) advises that recent artificial hip and knee technology didn’t perform any better than prior versions. The new technology – referred to as metal-on-metal in hip designs because both the ball and cup are comprised of metal – are expected to fail prematurely rather than lasting the 15 years that artificial joints are supposed to last. The problem could affect tens of thousands of patients in the U.S., where the newer design is widely used.
Some additional findings:
- No artificial hip or knee introduced between 2003 and 2007 was any more durable than older ones; in fact, 30% performed worse
- Surgeons used the new designs with little test data
- The expense of replacing the new all-metal hips in Australian patients could cost that country’s companies, insurers and taxpayers billions of dollars
It’s important to note that the study was generated from data collected by Australia’s orthopedic registry. As the NYT article describes,
“In a registry, information about a patient is entered into a database when he or she receives an implant. Then, when that patient undergoes surgery again to replace that device, more data is added. By looking at large numbers of patients followed in a registry, researchers can tell whether certain device models are failing prematurely at significantly higher rates.”
The U.S. doesn’t have a registry, but the FDA is funding efforts to determine whether overseas databases as well as those maintained by U.S. hospitals can be employed to monitor device performance. This is a significant move given that 700,00 Americans received knee and hip replacements each year, a figure that will most certainly rise as our population grows older.
The U.S. Senate is now reviewing proposed legislation that would compel implant manufacturers to track the performance of their products once the FDA greenlights them. The bipartisan bill, however, faces strong opposition as the industry and its supporters in Congress argue that additional regulations slow research and development of new products.
Says Dr. Stephen E. Graves, the director of the Australian National Joint Replacement Registry and a co-author of the study, “The purpose of regulation is not to impede innovation but to ensure safety and effectiveness of medical devices. This protects patients, but it also protects companies.”
If you have had hip or knee replacement surgery and your implant has failed to relieve your pain or has caused more pain and disability, you should investigate the problem by contacting the defective medical device experts at Sommers, Schwartz. Call either Rob Sickels, Jason Thompson or Matt Turner.