The Evidence Gap: A Call for a Warning System on Artificial Joints
August 4, 2008 – 6:55 pm
Three weeks ago, Zimmer announced it was suspending sales of a device, known as the Durom cup, until it trained doctors how best to implant it. The company said a “low” percentage of the 13,000 patients who got the socket would need replacements, but some doctors fear the number could reach into the hundreds.
If those patients lived in other countries where artificial joints were tracked by national databases - including Australia, Britain, Norway and Sweden - many might have been spared that risk. And Zimmer might have suspended sales of the cup months ago.
But the United States lacks such a national database, called a joint registry, that tracks how patients with artificial hips and knees fare. The risk in the United States that a patient will need a replacement procedure because of a flawed product or technique can be double the risk of countries with databases, according to Dr. Henrik Malchau of Massachusetts General Hospital.
Experts say that the United States wastes billions of dollars annually on medical treatments which may not work. But the financial and human consequences are also large when evidence exists but is not collected.
“We are No. 1 both as a provider and user of implants,” said Dr. John J. Callaghan, a professor of orthopedics at the University of Iowa. “We should be the leader in the follow-up of them.”
The use of joint registries has proven beneficial abroad. In Australia, regulators use such data to force manufacturers to justify why poorly performing hips or knees should remain available, and products have been withdrawn as a result. In Sweden several years ago, surgeons alerted by their national registry stopped using a badly flawed hip long before their American counterparts did. But for more than a decade, efforts to set up an open national registry in our country have failed. One witness to those events has been Dr. Malchau, who worked for a decade at the Swedish registry. He and other registry advocates have heard all the reasons a registry cannot work here – busy doctors hate paperwork, plaintiffs’ lawyers would mine a database to find cases, general hospitals would be unfairly compared with specialty ones, to name a few.
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