Uncomfortable stiffness. Excruciating pain. Those who have experienced the unmanageable symptoms of a deteriorated hip know how difficult daily activities, such as walking or sitting, can be. Often, the course of action many patients pursue to correct their hip problems is total hip replacement. Unfortunately, it has been the wrong choice for many.
In the United States, the U.S. Food and Drug Administration (FDA) has approved four device options for hip replacement: metal-on-polyethylene, ceramic-on-polyethylene, ceramic-on-ceramic and metal-on-metal. Until recently, surgeons regularly used all four options. However, in 2011, many surgeons have chosen to abandon the use of all-metal devices due to complaints of defective hip replacements and the potential danger to patients.
The Problems With Metal-on-Metal Hip Replacement Devices
What dangers could an FDA-approved metal-on-metal hip replacement device cause? Ann Morrison, a physical therapist from Newark, Delaware, knows all too well. In 2008, she underwent a double hip replacement using an all-metal product. Shortly after, she developed such severe pain, rashes and inflammation that her hip-replacement devices were replaced just a year later.
The culprit causing Morrison's problems and affecting thousands of others seems to be the metal debris created by standard wear of the devices. Though the problems due to the particles of cobalt and chromium have not proven life-threatening, they have been life changing: Morrison now requires a brace to walk and she is unable to work.
Defect Reports Filed With the FDA
Since January 2011, more than 5,000 reports have been filed with the FDA citing failed metal-on-metal hip implants. That is more than the combined total of similar complaints received over the previous four years. Due to the complaints, the FDA has been prompted to take action. Whereas many metal-on-metal devices were legally placed on the market without patient testing or performance tracking, the FDA is now requiring producers of the all-metal devices to study the failure rate and the threat to patients.
Though the FDA requirement is not optional, it is proving difficult. Due to the lack of patient registries, producers are challenged to identify and recruit enough patients to participate in the mandated studies. With the hope of generating qualified leads, some companies are turning to health systems and to hospitals that operate and maintain their own registries. In addition, researchers have been tasked with discovering and understanding the effects of metallic debris on human tissue.
Researchers expect it will take at least a year to develop standard protocols for measuring metallic particles and detecting tissue damage. And for studying the failure rate of the metal-on-metal devices, the FDA has until November 2011 to approve the proposals submitted by producers; however, the findings and subsequent evaluation of patient safety could be years away.
"We will be the little crash test dummies here," said Morrison in a statement to the New York Times, "until they figure out the health ramifications for us down the road."
