FDA Metal-on-Metal Hip Implant Panel Recommends Patient Monitor, Warnings for Psuedotumors and Other Side Effects

FDA Metal-on-Metal Hip Implant Panel Recommends Patient Monitor, Warnings for Psuedotumors and Other Side EffectsA panel of medical experts said yesterday that patients with metal-on-metal hip implants need to be monitored due to the risk that the devices break down and shed dangerous amounts of metallic debris in patient’s blood streams. According to a report from the Associated Press, most of the panelist felt there were few, if any, cases where they would recommend using metal-on-metal hip replacement devices.

The U.S. Food & Drug Administration (FDA) had convened its Orthopaedic and Rehabilitation Devices Panel to examine the safety of metal-on-metal hip implant devices.  Among other things, the 18-member panel was asked to make recommendations regarding the best practices for monitoring patients with metal-on-metal hip replacements.

As we’ve reported previously, it was thought that metal-on-metal hip implants would be superior to devices made from plastic or ceramic when they were first brought to market about a decade ago.  But since the August 2012 worldwide recall of DePuy Orthopaedics ASR hip implant devices, it’s become increasingly clear that all-metal hip implant’s haven’t been living up to their promise.  Patients have increasingly complained of pain and early implant failures, while a number of studies have pointed to significant problems with metal-on-metal hip implants.  Last week, the FDA revealed that it had received 16,800 negative event reports involving metal hips between 2000 and 2011. Of those, more than 14,000 involved revision surgeries, in which a defective implant was removed.

During their two day meeting, some experts on the FDA panel questioned why all-metal implants would ever be used, considering their poor track record.

“I do not use metal-on-metal hips, and I can see no reason to do so,” said meeting chair Dr. William Rohr of Mendocino Coast District Hospital, according to the Associated Press.

The panel ended up recommending that metal-on-metal hip implant patients who were suffering symptoms of a failing device undergo regular x-rays and blood tests.  Revision surgery was recommended for patients whose implants showed signs of failure.  An MRI or CT scan should be performed in some cases, and follow-up visits should take place at least every three to six months for patients who’s x-rays did not show failure, the panel said.  They also recommended that all patients with metal-on-metal hip replacement devices undergo annual X-rays to monitor their implants, regardless of symptoms, according to the Associated Press.

According to a report from Law360.com the advisors recommended including label warnings about pseudotumors and high levels metal ions in patients’ blood.  They also made a recommendation for a warning stating that metal-on-metal hip implant recipients are more sensitive to the devices’ positioning than patients with other types.

As we reported previously, the panel was not asked to make recommend whether or not the devices should undergo more extensive testing, or be subjected to additional regulation.  For the most part, all-metal hips used in total hip replacement are eligible for the FDA’s 510(k) clearance process, which does not require human testing if it can be shown a device is substantially similar to a predicate product.  Some patient advocates argue that tougher testing of the devices would have kept dangerous implants off of the market.

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