Zimmer Hip Replacement Problems Spur Regulatory Response
As the number of Zimmer hip implant lawsuit filings grows, the U.S. Food and Drug Administration has announced an intensive two-day review of metal-on-metal implants to determine if further safety measures are required. The agency plans to convene an expert panel on June 27-28, 2012, to hear input from medical professionals, scientists, patients, and researchers on the controversial prosthetic joints.
FDA announces review of all-metal hip implants
The goal of the panel is to “discuss recent information on these devices so that the agency can continue to make reliable safety recommendations,” according to a statement released by Dr. William Maisel, deputy director of science at the FDA’s Center for Devices and Radiological Health.
The panel is expected to address a range of issues previously reported by plaintiffs who have filed suit through a Zimmer hip lawyer, including metallosis, failure rates, risk factors, and revision surgeries. The FDA review comes a year after the agency directed manufacturers of all-metal implants to collect safety information on their products.
Advocates call for national joint registry
One proposal to be discussed at the FDA conference is the creation of a nationwide artificial joint registry. The United States, unlike most European countries, lacks any meaningful way to track the long-term success or failure of a new artificial hip system. The U.S. is the largest consumer of artificial joints in the world, spending $6.7 billion annually on hip and knee procedures, but it lags behind Sweden, England, and Australia in identifying and rejecting devices that perform poorly. Government-backed registries in those countries were instrumental in recognizing the higher-than-expected early failure rate of all-metal hips.
Evidence from European registries has also been used in many Zimmer hip implant lawsuit trials. Joint registries have proven effective as early warning systems for problematic orthopedic products. According to Dr. Henrik Malchau, an orthopedist at Massachusetts General Hospital, a patient in the U.S. faces twice the risk of early artificial joint failure than does a patient in a country with a registry.
In 2009, legislation was introduced in the Congress to create a government-run registry, but no proposal has yet passed.
Would registry may have prevented Zimmer hip replacement problems?
Many believe that an artificial joint registry might have protected at least 1,300 patients who received Zimmer’s Durom cup implant after initial concerns arose over its failure rate. Zimmer continued to sell the product while it gathered patient data that would have been readily available from an effective registry.
By the time Zimmer finally halted sales of the Durom cup in 2008, hundreds of additional patients had received the implant. Registry advocates maintain that problems with the Durom cup would have been detected sooner, and patient harm would have been avoided, if a registry had been in place. Patients who have suffered injury have consulted with a Zimmer hip lawyer to see if they are eligible to file litigation.