FDA to Finally Plan for a National Joint Orthopedic Device RegistryAug 22, 2008 | Parker Waichman LLP
FDA is in the Early Stages of Developing a Program to Create a National Surveillance Registry for Orthopedic Device Implants
The Food and Drug Administration (FDA) is in the early stages of developing a program to create a national surveillance registry for orthopedic device implants. The registry would enable the FDA to look into independent public and private registries from which claim information would be fed into a central agency-regulated network.
According to an FDA spokesman, orthopedic device manufacturers would benefit from the program because it would “offer more timely, comprehensive assessment of the ‘real world’ experience of their devices and an alternative means to conduct mandated post-approval studies.” Nevertheless, some caution that such a government-run registry might have too many limitations, given the current budget and resource restrictions plaguing the agency. “One of the challenges the FDA and other agencies face is being able to devote resources in a continuing way. And our view is that registries will bring up more questions than answers,” David Lewallen, chairman of the American Academy of Orthopaedic Surgeons’ (AAOS) American Joint Replacement Registry Oversight Board and head of the American Association of Hip and Knee Surgeons, said. “It wouldn’t be impossible to do it through a government-run agency, but it is a bigger challenge.”
Unless there are Some Safeguards in Place, People would be Wary of a Federal-Run System
Another consideration is patient confidentiality. “Unless there are some safeguards in place, people would be wary of a federal-run system. It may even discourage some people from reporting adverse events,” Lewallen said. Meanwhile, hundreds of patients who received the Zimmer Durom Cup hip implants in the U.S. experienced serious adverse reactions. Since, a prominent surgeon went public with his concerns and patient advocates have been calling for the creation of a national database—a joint registry. Advocates argue that such a system would quickly alert doctors and federal regulators to devices with high failure rates, possibly sparing tens of thousands of patients from severe, painful injuries.
Last year, Dr. Lawrence Dorr, a highly experienced orthopedist and Zimmer consultant, noticed that within months of implantation, many of his patients were suffering from crippling pain. X-rays revealed that the Durom socket was separating from the bone, not fusing with it, which required additional, excruciating replacement surgery. Zimmer ignored Dorr and attempted to blame him for the defect, but eventually, Zimmer conducted an investigation and suspended sales of the defective component. Critics argue that it never should have taken so long and, in many countries where joint registries are in place, it would not have. If the U.S. had such a database, Zimmer might have been forced to take the Durom Cup off the market much sooner.
Some critics believe a more sinister force is responsible for long blocking implementation of a joint registry; specifically the financial arrangements between implant makers and many orthopedic surgeons. Some physicians might be reluctant to report problems with a device if they are receiving compensation from its manufacturer. This would not be the first time surgeons were influenced by the payments they receive from implant makers. 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.
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