The Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom issued updated information and advice about the management and monitoring of patients implanted with metal-on-metal (MoM) hip replacements.
The MHRA issued this updated advice following extensive consultations with their clinical orthopaedic experts and in the light of the emerging information from the England and Wales National Joint Registry. The Agency is of the view that majority of the patients implanted with MoM hip replacements have well functioning hips and are thought to be at a low risk of serious problems. However, a small number of patients implanted with MoM hip replacements may develop progressive soft tissue reactions to the wear debris associated with the MoM articulations.
According to the MHRA, an expert advisory group has been set up to look at the management of patients with soft tissue swelling associated with MoM hip implants. With reference to the latest evidence, the MHRA is now recommending that patients with hip replacements with head diameter of 36 millimetres or more need to be monitored annually. By annual monitoring, these complications will be picked up earlier and more complex surgery on the patient can be avoided.
So far, there were no local adverse incidents related to MoM hip replacements reported.
For details, please refer to the following MHRA website:
http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/MedicalDeviceAlerts/index.htm