Tuesday, July 29, 2008
The New York Times reports that because the US lacks a national database tracking artificial joints, the risk in the US that a patient will need a replacement procedure because of a flawed product or technique can be double the risk of countries with databases. Barry Meier writes,
Dr. Lawrence Dorr, a nationally known orthopedic surgeon in Los Angeles, realized last year that something was very wrong with some of his patients.
Months after routine hip replacements, patients who had expected to live without pain were in agony. “The pain was grabbing me around the back,” said Stephen Csengeri, who is 54, and a lawyer from Torrance, Calif.
Dr. Dorr found he had implanted the same metal hip socket in each patient. Several needed surgery again — a replacement for their replacement.
The doctor first told the device’s manufacturer, Zimmer Holdings, last year about his concerns but nothing happened. Then in April, Dr. Dorr, who was a highly paid consultant for Zimmer, sounded an alarm to colleagues in a professional association and soon heard back from doctors with similar experiences.
“I saw one of Zimmer’s engineers at a meeting, and I told her that you should pull this cup because you are crippling patients,” Dr. Dorr said.
Last week, Zimmer announced it was suspending sales of the 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.
The toll of early device replacement is magnified here because of the sheer number of procedures that take place in the United States. Nearly one million hips and knees were used last year, about half of the world’s total.
“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 Food and Drug Administration is charged with monitoring devices like artificial joints. But that system is often overwhelmed by the vast number of products it monitors and because doctors often do not report problems.
Medicare, which pays for about half the hip and knee implants in this country, rebuffed a proposal two years ago from a medical group to support a joint database. It said it was not the agency’s job to gather such data — despite the considerable savings in taxpayer dollars that might come from reducing the number of do-over surgeries.
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. A few medical organizations here, like Kaiser Permanente, operate their own registries to good effect and the Hospital for Special Surgery in New York has recently set up a registry.
But for more than a decade, efforts to set up an open national registry in this 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.
Drowned out by those complaints is what registries do for patients. “It has been very frustrating,” Dr. Malchau said.