The US Food and Drug Administration (FDA; Silver Spring, MD, USA) is looking for guidance on how to monitor patients who have received metal-on-metal implants.

The FDA has recently 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. Following these reports and a growing concern over all-metal hip implants, the FDA convened the 18-member Orthopedic and Rehabilitation Devices Panel of experts over a two-day hearing to examine data from around the world on the metal implants, following reports that the devices break down at higher rates than plastic- or ceramic-coated models, and that the resultant metal flakes in the bloodstream can lead to medical complications.

The panel recommended 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. A magnetic resonance imaging (MRI) or computerized tomography (CT) scan should be performed in some cases, and follow-up visits should take place at least every three to six months for patients whose 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.

“I do not use metal-on-metal hips, and I can see no reason to do so,” said panel chair William Rohr, MD, of Mendocino Coast District Hospital (Fort Bragg, CA, USA), according to a report in the Associated Press.

The panel also recommended including label warnings about pseudo-tumors and high levels of metal ions in patients’ blood, as well as 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. The panel was not asked to make recommendations whether or not the devices should undergo more extensive testing, or be subjected to additional regulation.

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