Published: July 29, 2008, the New York Times by Barry Meier
A Call for a Warning System on Artificial Joints
By BARRY MEIER
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.
History Repeats Itself
Dr. Dorr, 67, is a veteran of more than 5,000 hip replacement surgeries, a $30,000 to $40,000 procedure lasting more than an hour in which metal tools that would look at home in a garage are clanged and bashed against bone. He has been at it for three decades, long enough to say that history is repeating itself because this country does not gather evidence of how patients fare.
Eight years ago, he alerted another implant producer, Sulzer Orthopedics, that patients with one of its hip implants were having such pain they needed replacement surgery almost immediately. Sulzer withdrew the device six months later, but about 3,000 patients got replacements for the implant, which had become contaminated by oil during manufacturing. Sulzer, deluged by lawsuits, filed for bankruptcy protection.
But because of their registry, Swedish doctors were alerted after just 30 patients got the Sulzer hip that it had an alarmingly high replacement rate, Dr. Malchau said. Also, doctors in Sweden today are much less likely than American doctors to embrace new devices until registry data show they work well. “It has made surgeons stick to well-documented implants,” said Dr. Johan Karrholm, who helps direct the Swedish program.
Last year Dr. Dorr, alarmed by a rash of problems in patients like Mr. Csengeri, first contacted Zimmer about the Durom cup. X-rays showed that the socket was separating from bone, rather than fusing with it. For patients, who had been told their new hips might last 15 to 20 years, it meant agony as the metal cup moved around in the hip socket and rubbed against bone.
Earlier this year, after Dr. Dorr urged Zimmer executives to stop selling the cup, they told him the fault was in his implantation technique, not their product – the same response he received years before from Sulzer executives. That is when he decided to alert colleagues at the American Association of Hip and Knee Surgeons.
In late May, Zimmer informed surgeons that it was investigating Dr. Dorr’s complaint but that it did not see a need for an action like suspending sales. Last week, in releasing a summary of its investigation, the company said that cup failure rates had varied widely among clinics, a disparity it attributed to varying surgical techniques. Some doctors did not have problems.
Without the benefit of a registry, Zimmer had to painstakingly review 1,300 patient records. During that time, about the same number of new patients got a Durom cup.
The company, whose officials declined to be interviewed for this article, has said it responded quickly and properly. The company did respond to detailed questions about its interactions with Dr. Dorr.
Zimmer also said in a statement that while registry data might have been helpful in the Durom case, such statistics would not have explained why the cup was failing. Registry advocates agreed, but added that Zimmer would have been alerted. “They could have seen in real time how big or small it was,” said Dr. William Maloney, a professor of orthopedics at Stanford.
While Mr. Csengeri, the lawyer, reached an undisclosed settlement with the company, Dr. Dorr said all he wanted was to stop a similar episode from happening again. “One doctor said to me that if there was ever an example of why we need a registry, this is it.”
How Registries Work
A registry for artificial joints is much like any system that can compare performance of competing cars or appliances, but in this case it involves appliances going into the human body. A patient – identified by a number – is entered into a database along with information about the device he or she received, the surgical technique used and the name of the doctor who performed the procedure. If a patient returns for a replacement, the information is recorded again, creating a rolling surveillance system.
Such databases can be examined at any time for information and groups that operate national registries issue annual reports comparing performance of devices, differing surgical techniques and hospitals.
Registries do not catch all problems and some registries have not been effective because not enough doctors participate. But the success of the Swedish program inspired Australian orthopedists to start their registry in the late 1990s through a professional association, said Dr. Stephen Graves, the program’s director. Since then Australia’s rate of early replacement procedures, or revisions, has declined.
Confronted with registry data indicating problems, a “significant percentage of companies will take the devices off the market,” Dr. Graves said. They may keep selling those devices elsewhere, including the United States. For example, Zimmer still sells a knee implant, known as the Unispacer, in the United States even though Australian doctors stopped using it three years ago after registry data showed it had quickly failed in more than half the 40 patients who got it there. Zimmer said it continued to sell the product because some surgeons think it “provides benefits to certain patients with specific conditions.”
Device makers say they support the creation of a United States registry, but point to the practical hurdles involved. Meanwhile, they have started to use registry data from abroad to promote product sales here.
In December, for instance, Smith & Nephew, an orthopedics manufacturer, released data from the Australian registry showing that its system for hip “resurfacing” – a relatively new technique that conserves bone – was outperforming competitors, in terms of a lower revision rate. But Dr. Graves added that the database also showed that the rate of early revision in Australia for all resurfacing procedures was no better than for traditional hip replacement. The Swedish registry will soon publish similar findings, Dr. Karrholm said.
In this country, Kaiser Permanente has used its registry in a variety of ways, said Dr. Donald Fithian, who helps direct that program. Seeing failures in one type of knee procedure, it discovered that most involved doctors new to it, so there is now greater supervision.
Why Not Here?
For several years, Dr. William Jiranek, an orthopedic surgeon in Richmond, has waged a lonely campaign for a registry in Virginia, one that has offered him a crash course in government, law and medical ethics.
One of Dr. Jiranek’s patients got the ball rolling in 2003 with a $50,000 donation. Then, the doctor, after learning that Virginia law needed to be changed to protect registry data, used some of that money to hire lobbyists who convinced lawmakers to do so. Soon, Dr. Malchau, the Swedish researcher now in Boston, helped provide software for doctors to enter data after a procedure.
But now Dr. Jiranek is about to hit the hard part. Thus far, only six of the estimated 200 doctors doing joint replacements in Virginia are participating. “Most of them are supportive,” Dr. Jiranek said. “Few of them are willing to do a lot of work.” Dr. Jiranek’s effort is the latest in a long series of attempts to create a registry in the United States. Even advocates acknowledge that the barriers to such a database are substantial. The American health care system is sprawling and fragmented, compared with the highly centralized systems in countries that do have the databases. Also, the number of orthopedic devices used here and the number of doctors implanting them is huge.
Along with legal and privacy concerns, there are also questions about who would pay for a registry – cost estimates range from $5 to $10 million annually – and whether doctor participation would be voluntary or mandatory. About two years ago, the American Academy of Orthopaedic Surgeons unsuccessfully tried to persuade Medicare officials to finance a pilot project that could lead to a full-blown registry.
Dr. Barry Straube, Medicare’s chief medical officer, said the proposal was complex and added that the agency, while using registries to determine the value of still unproven procedures, did not use registries to monitor proven treatments like joint implants. “If you pay for funding for one interest, you have to justify why you are not doing that for anyone else,” Dr. Straube said. Some experts think that a registry can succeed as a voluntary initiative. Dr. Jiranek said that Bon Secours Health System, where he works, recently agreed to make its Virginia hospitals part of his registry. Other experts say they believe that Medicare might have to make participation mandatory to get a registry to work on the national level.
“I believe Medicare could drive it forward,” said Dr. Peter Heeckt, the chief medical officer of Smith & Nephew’s orthopedic division. “They could tie reimbursements to registering the data.”
Some registry advocates suspect there may be another reason why a registry has not gained urgency here – the financial relationships between many orthopedists and device producers. Last year, several major manufacturers, including Zimmer and Smith & Nephew, agreed to pay $310 million to settle civil charges and resolve a Department of Justice investigation into whether the firms paid illegal inducements to get some doctors to use their products.
Today, lawyers hired by the companies to monitor their compliance are receiving tens of millions of dollars. “We could have used some of that money,” Dr. Malchau said, “for a registry.”