Metal-on-metal hip replacement toxicity: opinion of the US FDA

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Additional material for NPS article Monitoring for potential toxicity in patients with metal-on-metal hip prostheses: advice for health professionals.

The US Food and Drug Administration states that there is insufficient evidence to correlate the presence of localised lesions, clinical outcomes and/or the need for revision with specific metal ion levels for individual patients but offers detailed guidelines for the management, monitoring and review of patients with MoM implants. Patients with local symptoms such as pain or decreased joint function that appear more than 3 months after MoM implant should be referred to the treating surgeon for clinical and imaging evaluation.

View the FDA information sheet: MoM Hip Implant Surgery.