REGULAR long-term follow-up is needed in all patients implanted with metal-on-metal (MoM) hip replacements to monitor ongoing risks of soft-tissue reactions, according to updated guidance issued from The Medicines and Healthcare products Regulatory Agency (MHRA).
The new guidance – replacing previous advice issued in 2012 – highlights the risk that some patients will develop progressive soft tissue reactions to the wear debris associated with MoM articulations. It cites data from a 2016 report which continued to show a risk of adverse soft tissue reaction to particulate debris.
Clinical orthopaedic experts working with the MHRA have observed that soft tissue necrosis may occur in both asymptomatic and symptomatic patients, and believe early detection of these events should give a better treatment outcome should this become necessary.
Dr Neil McGuire MHRA’s Clinical Director of Medical Devices said: "We have updated the current advice to ensure patients with metal on metal hip implants continue to receive appropriate follow up to detect emerging complications should they arise.
"Hip implants have positively transformed the lives of many patients who in the past were subject to increasingly severe pain and progressive disability. These use a variety of metal, plastic and ceramic components.
"Although the majority of patients with these metal on metal devices have well-functioning hips, it is known some may develop soft tissue reactions related to their implant. The clinical advice we have received indicates patients will likely have the best outcomes if these problems are detected early, monitored and treated if necessary."