New advice from MHRA and a BBC Newsnight/British Medical Journal investigation are causing more concern about the risk of metal-on-metal hip implants. Several major recalls of these types of implants have demonstrated the risk of metal debris that can cause complications such as inflammation. Now MHRA has issued guidance to surgeons saying that patients with metal-on-metal hip implants that have head diameters of 36 mm or more need to be monitored for the life of the devices. The guidance was issued today, the same day BBC aired the report on metal-on-metal hip implants.
MHRA based the advice on recent clinical evidence showing that about 49,000 patients in the United Kingdom that have large-head hip implants are in a high-risk category. Previous recommendations stated that patients with these implants should only be monitored for five years. The BBC report found that several orthopaedic companies altered their hip implants to make the heads larger without conducting trials or post-market studies or informing MHRA. The findings are sparking a new debate on the European regulatory system for medical devices.
Researchers continue to look for solutions that could improve the safety of metal-on-metal hip implants by reducing the release of metal debris. Coating the implants with nanodiamonds or adding a lubricating layer of graphitic carbon could be two solutions in the future.Camilla Andersson