A European Parliament committee unanimously passed a resolution at the end of April that would create registries to track patients who receive implants and methods to trace the devices themselves, Fierce Medical Devices reports.
“It is essential to … strengthen surveillance and safety controls and placing on the market requirements,” the committee stated.
In January, The Telegraphreported that the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) was investigating the safety of the implants because a British Hip Society study found that 49 percent of such devices require revision surgery within six years.
By the end of February, the MHRA was recommending that patients with all-metal hip implants — especially those with a head diameter of 36 millimeters or larger — have their devices monitored on an annual basis for the life of the device.
The larger components of the hip replacement system were found to suffer more wear as they rubbed against each other, producing metal shavings.
The findings suggest that the metal shavings cause changes to cells that could be precursors to cancer in 20 percent of patients with all-metal hip-replacement systems.
In addition, the metal particles have been blamed for tissue damage, tumors, high metal ion blood counts and metal blood poisoning.
Then came the MHRA warning that yet another hip implant combination—Mitch TRH cups made by Finsbury Orthopaedics used with Accolade femoral stems made by Stryker Orthopaedics — caused high failure rates and the need for early corrective surgeries.
This news was yet another blow to consumers worldwide, who are already grappling with DePuy Orthopaedics’ recall of 93,000 ASR metal hip implants, which included its ASR XL Acetabular System total hip replacement and ASR Hip Resurfacing System, in August 2010. Previously, in 2008, Zimmer Holdings recalled its Durom Cup for similar problems.
Almost 50,000 patients in the U.K. are affected by the metal-on-metal hip implant warnings and recalls, the Daily Mail reports. It’s clear their government intends to act in its citizens’ best interest by pursuing the truth about the dangerous hip implants and taking steps to track medical devices in the future.
Certainly, the sluggish U.S. Food and Drug Administration (FDA) could learn a lesson from its British counterpart.
- US Drug Watchdog Now Offers To Help All Recalled DePuy ASR Hip Implant Recipients (earlsview.com)
- Failure Rates High in All-Metal Hip Implants, Not Just DePuy (earlsview.com)
- Press release: MHRA updates advice for metal-on-metal hip replacements : MHRA (earlsview.com)
- BBC News – Surgeons call for end to metal hip replacements (earlsview.com)
- Metal-on-Metal Hip Implants > Concerns about Metal-on-Metal Hip Implant Systems (earlsview.com)
- Metals from hip replacements present toxic risk for millions, investigation warns (earlsview.com)
- Metal-on-Metal Hip Implants Should Be Banned, Lancet Study Finds – Bloomberg (earlsview.com)
- Parker Waichman LLP Calls for Ban on Metal-on-Metal Hip Implants, Backs Lancet Researchers’ Ban Recommendation (prweb.com)
- US Drug Watchdog Warns There Could 100,000s of Failed Metal on Metal Hip Implants Involving US Hip Implant Recipients and the DePuy ASR was Just the Starting Point – Yahoo! News (earlsview.com)
- 200 Irish Patients Plan DePuy ASR Hip Implant Lawsuit | NewsInferno (earlsview.com)