Britain Steps Up Metal Hip Implant Monitoring
According to a report at the New York Times, the latest research from Britain has prompted health regulators there to change the guidelines for patients who have received metal-on-metal hip implants. Previously, patients were advised to go in for monitoring of their hip replacements for the first five years after surgery. Now officials are urging patients to commit to annual monitoring for the life of the replacement, which is typically 15 to 20 years, unless the device fails early.
“By monitoring patients every year, any complications will get picked up earlier and more complex surgery of the patient may be avoided,” Dr. Susanne Ludgate, clinical director of the Medicines and Healthcare Products Regulatory Agency, told the Times.
Despite complaints, no Zimmer hip replacement recall is issued
Some Zimmer hip lawsuit plaintiffs have claimed early failure of the “Durom Cup” metal-on-metal hip implant. Plaintiffs allege to have suffered Zimmer hip replacement problems such as metallosis, loosening and dislocation of the cup, and the need for revision surgery.
Metallosis is a condition that occurs when small particles of metal rub off of the hip implant and enter the bloodstream and surrounding tissue. This condition can lead to serious Zimmer hip replacement problems in some patients, including inflammation of soft tissue and pain around the joint.
Although sales of the Zimmer Durom Cup were temporarily suspended in 2008, allowing Zimmer to examine the problems associated with the device, no Zimmer hip replacement recall has ever been issued.
FDA addresses reports of Zimmer hip replacement problems
The FDA has given no indication of implementing a Zimmer hip replacement recall. In May 2011, the FDA ordered manufacturers of metal-on-metal hip implants to conduct research on the effects of metallosis in hip recipients. However, a spokesperson for the FDA, Erica Jefferson, told CBS that the British findings would not change the guidelines currently in place for hip patients in the United States – at least not until results of the research ordered by the FDA are reported.
“We continue to recommend that hip replacement patients undergo regular follow-up with their physicians,” Jefferson said.
Brits stop short of demanding Zimmer hip replacement recall
Though the British researchers believe problems with metal-on-metal hip implants (such as Zimmer hip replacement problems with the Durom Cup) are extensive, they stopped short of recommending a recall.
Until recently, around one-third of the 250,000 hip replacement surgeries performed in the U.S. annually were done using metal-on-metal devices. Many of these involved the Zimmer Durom Cup. Zimmer hip lawsuit plaintiffs have cases pending in courts nationwide.
“This isn’t the unlucky failure to spot the misdemeanors of one rogue company or the occasional unforeseen breakdown of a small number of devices,” Deborah Cohen, British Medical Journal investigations editor, was reported saying at CBS. “It is the inability to prevent a whole class of failing hip implant from being used in hundreds of thousands of people globally.”