As discussed, it was initially believed that metal-on-metal (“MoM”) devices—as compared to the alternatives then-available—provided a particular benefit for younger patients due to an increase in device durability and post-surgery capability. However, after its review, the panel determined that recent improvements in poly-based devices—paired with growing MoM failure rates and cobalt poisoning fears—provide an increasingly safe alternative.
Additionally, the committee made several recommendations to the FDA, as host of the event. It was suggested that the FDA should:
• Establish reference ranges as to what constitutes safe, intermediate and unsafe levels of cobalt and chromium in a patient’s blood and tissue;
• Assume a more active and leading role in disseminating information to both prospective hip replacement surgery candidates, as well as those that are currently living with a MoM device; and
• Encourage and support appropriately designed prospective studies to further explore remaining questions about the adverse health effects of MoM device implantation.
The panel consistently reiterated that this serious safety consideration requires additional research and attention by both practitioners and the FDA alike.