BOA/BHS joint statement: MoM hip implants – update from the Medicines and Healthcare products Regulatory Agency (MHRA)

Friday 30th June 2017

The British Orthopaedic Association (BOA) and British Hip Society (BHS) welcome the update issued by the Medicine and Healthcare Devices Regulatory Authority (MHRA). We have been monitoring the issues surrounding metal on metal bearing hips for some time.

This is a planned update as the MHRA has said all along that it would issue new updated guidance as more information and research became available. It provides a framework within which patients can be assessed. The BOA and the BHS have been asked to support and comment on this further advice and are enthusiastic about it’s contents.

The majority of patients at highest risk of problems are already under follow up and in surveillance programmes.

The use of metal on metal bearings has dramatically reduced and is now less that 1% of all hips; these are largely confined to truly active males with larger hip sizes, having hip resurfacing. This surgery is now performed in a few specialist centres and the results in this difficult, high demand patient group continue to be good.

The MHRA has suggested that all patients with metal on metal hips should have follow up. This is a slight increase in the number of patients recommended for surveillance in comparison to their 2012 advice. This brings patients with metal on metal hips in to line with existing BOA/BHS guidelines, which recommend follow up of all hip replacements, every three years, beyond the seventh year.

As the MHRA has stated, patients with metal on metal hips who are at low risk of adverse reactions and problems will be offered the security of periodic assessment with a blood test and / or a scan. These additional check-ups are a precautionary measure to reduce the small risk of complications and the need for further surgery.

There is now evidence that patients who have had metal on metal hips and required revision for adverse reactions are doing well. This suggests that surveillance and the opportunity for follow up and early intervention (if needed) is beneficial.

Metal on metal hip implants have caused concern world-wide – the UK was the first country to issue patient safety guidance in this area and the BOA/BHS supported by data from the National Joint Registry have also continued to monitor the situation. Most patients who have had hip replacement do not have metal on metal hips. The use of metal on metal bearing was about one in six (15%) at its peak, and has been less than 1% for the last 5 years.

The majority of patients with these devices have well-functioning hips. While a few may develop soft tissue reactions related to their implant, the evidence shows that the best outcomes are achieved if these problems are detected early, monitored and treated if necessary.

Individuals affected can now expect to receive advice directly from the hospital that undertook their initial operation in order to put in place the follow up steps required. Anyone with concerns or questions should contact the hospital where their operation took place, or their GP.

 

MHRA updates guidance for healthcare professionals

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