By BARRY MEIER

06/11/2009 - Two House Democrats introduced a bill Wednesday to create a national database of patients who received artificial hips and knees, a system already used in some other countries to track how patients fare, reduce unnecessary surgeries and weed out inferior products.

The bill, co-sponsored by Bill Pascrell Jr. of New Jersey and Lloyd Doggett of Texas, would establish a government-backed registry to track patients’ results over time and help detect ineffective surgical practices and faulty devices.

Patient registries, in areas like orthopedics, are expected to play an important role in “comparative effectiveness” reviews that the Obama administration hopes will help identify which medical procedures and products work best.

“I think it will improve patient safety and outcomes and get rid of poorly performing devices,” said Representative Pascrell.

Makers of artificial joints and a professional association of surgeons who use them say that they support the idea of such a registry. But they said they were working to create one outside of government and argue that it could be more effective than the legislative proposal.

This country is the largest consumer of artificial hips and knees in the world, but it has long lagged behind other countries like Australia, Sweden and England in making use of joint registries. Advocates of registries say that the lack has resulted in an untold number of unnecessary surgeries and the waste of hundreds of millions of dollars.

For example, a patient here faces double the risk that a patient in a country with a registry faces of needing to have an artificial hip or knee replaced earlier than expected, according to Dr. Henrik Malchau, an orthopedist at Massachusetts General Hospital in Boston.

Zimmer Holdings, the nation’s biggest maker of artificial hips and knees, stated in response to written questions from a reporter that it was “supportive” of the creation of a national registry and had been discussing one with a specialist group, the American Academy of Orthopaedic Surgeons

In a letter sent earlier to Mr. Pascrell, the surgeons’ group sounded a similar theme and also said it preferred a privately run registry that would include both Medicare and non-Medicare patients. Dr. Daniel Berry, chairman of the orthopedics department at the Mayo Clinic in Rochester, Minn., noted that patients in their 40s and 50s, not typically covered by Medicare, now account for a large percentage of those receiving artificial hips.

The surgeons’ group, however, has tried and failed for more than a decade to set up such an independent registry, because, among other reasons, device manufacturers have balked at financing it. Dr. Berry, who is involved in the initiative, said that the group, along with another orthopedic organization, recently earmarked $450,000 to pay for start-up funding.

Long-term financing for the registry has yet to be secured, however, and device makers have yet to agree to pay for it, he added.

Still, Dr. Berry said that he believed that the device industry and others would eventually contribute. “We are at the height of optimism that things are going to take place,” he said.

Representative Pascrell said he believed that patients had waited long enough for the group to act. He also said that it was important for the government to be involved, given deferred prosecution agreements reached a few years ago between the Justice Department and makers of artificial hips and knees after investigations of illegal kickbacks to surgeons to use their products.

The types of problems associated with not having a registry were highlighted last year by an episode involving a Zimmer hip component called the Durom cup. Though some doctors warned Zimmer the device was failing at an unacceptable rate, the company kept selling it for months while it reviewed patient records in an attempt to determine how frequently the problem was occurring.

By the time Zimmer temporarily halted Durom cup sales last July, an additional 1,300 patients may have received the device. While Zimmer executives maintained they responded promptly to issue, some experts like Dr. Malchau said that having a registry would have brought the device’s problems to light far earlier.

On Wednesday, the company declined to say how many patient had undergone procedures to have the cup removed and replaced.

Under the House proposal, which is being supported by Consumers Union, an advocacy group, a joint registry would be established under the Agency for Health C are Research and Quality, a part of the Department of Health and Human Services.

The bill estimates that it would take three years to set up the mechanisms needed for the registry to operate and that it would begin producing data two years after that.

If you or a loved one have suffered or been injured from a defective Zimmer Duron Cup Hip Implant you may be entitled to compensation. Contact the Zimmer Hip Implant attorneys of Ennis & Ennis today for a free confidential case evaluation. Our on staff nurse and lawyers are standing by to answer any questions you may have regarding the Zimmer Hip Implants, a possible Zimmer class action lawsuit, or any other type of Zimmer hip implant litigation.