FDA Issues New Safety Guidance on Metal-on-Metal Implants

The FDA today issued a new safety communication about metal-on-metal hip implants for patients and for the doctors who care for them before and after surgery. The updated guidance is based on a review of the literature and on the latest guidance from an advisory committee.

Most patients should be reassessed every year or two after surgery, says the document. It takes special note of patients who are more likely than average to experience sensitivity reactions, including:

•  Patients receiving high doses of corticosteroids
•  Patients with evidence of renal insufficiency
•  Patients with suppressed immune systems

The safety communication offers details about when imaging and metal ion tests are justified in analyzing a patient's status after surgery. It also points out that patients are more likely to see other care providers than their surgeons on a regular basis, and repeats the warning signs for metal ion adverse events:

•  General hypersensitivity reaction (skin rash)
•  Cardiomyopathy
•  Neurological changes including sensory changes (auditory, or visual impairments)
•  Psychological status change (including depression)
•  Renal function impairment
•  Thyroid dysfunction (including neck discomfort, fatigue, weight gain or feeling cold.