Medical Negligence News

MHRA Revises Faulty Metal on Metal Hip Implants Advice

Posted on: February 28th, 2012 by Medical Negligence

The Medicines and Healthcare products Regulatory Agency (MHRA) has today issued new advice to surgeons and doctors with patients who are recipients of potentially faulty metal on metal implants.

In a new MHRA Medical Device Alert, the UK Medicines Regulator advises medical professionals that patients who have received a metal on metal hip implant with a “wide head” of ≥ 36mm should be monitored annually for the life of the implant to minimise the risk of complications should the patient have to subsequently undergo revision surgery.

This MHRA Medical Device Alert supersedes the Alert of April 2010 – four months prior to the DePuy hip recall in the UK – which recommended that patients were monitored for the first five years and is based on the recommendations of an expert advisory group, established by the MHRA to review the management of patients with soft tissue swelling associated with potentially faulty metal on metal hip implants.

Dr Susanne Ludgate, Clinical Director of the MHRA, said: “Clinical evidence shows that patients have a small risk of suffering complications from having metal-on-metal hip implants. These implants have in most cases completely transformed the lives of patients who in the past were subject to increasingly severe pain and progressive lack of mobility.”

Joe Dias, President of the British Orthopaedic Association (BOA) welcomed the recommendations of the MHRA, saying “The safety of our patients is always our first concern. The British Orthopaedic Association welcomes the publication of this updated advice from the MHRA. We will continue to work closely with the MHRA to provide further advice on this matter as new information becomes available.”

Inasmuch as the new guidelines may prevent painful and complicated revision surgery in the future, many medical negligence solicitors in the UK will be watching with interest this evening as the results of a joint BBC/British Medical Journal investigation into faulty metal on metal hip implants is revealed on the BBC´s Newsnight program.