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MHRA publishes updated guidance on metal-on-metal hip implants

Posted: 03/07/2017


The Medicines and Healthcare products Regulatory Agency (MHRA), the UK’s regulator for the safety of medical devices, has issued updated guidance to healthcare professionals on patients fitted with metal-on-metal (MOM) hip components.

In 2012 the MHRA published generic guidance to healthcare professionals on what action should be taken in respect of patients who had been fitted with MOM hip articulations. The advice was provided following increased understanding of the risks posed to patients and the realisation that a small number of people implanted with those hips might develop progressive soft tissue reactions to the metal debris, causing soft tissue necrosis. This could adversely affect the results of revision surgery.

At the time, the advice was that all symptomatic, but only some asymptomatic patients, should be reviewed with MRI imaging and blood tests to check the level of metal in their blood, and whether they were at risk of problems.

The MHRA, along with the Metal-on-Metal Expert Advisory Group, has continued to monitor the performance of MOM hips for the occurrence of soft tissue reaction. MOM hips are still associated with soft-tissue and bone necrosis, and higher than average failure rates, and it is thought that early detection and treatment can lead to a far better revision outcome than if the metal reaction is found later.

The MHRA has, therefore, updated its advice to recommend that all patients who have been fitted with MOM hip articulations be reviewed with blood tests and MRI scans to establish whether they are suffering bone and/or soft-tissue damage, and/or metal toxicity, and whether they require revision surgery.

Arran Macleod, a solicitor in the product liability team at Penningtons Manches LLP, said: “We welcome the news that the MHRA has updated its guidance to ensure that all patients fitted with these potentially dangerous devices are checked to make certain that they are not suffering early, but undetectable, problems.

“Anyone who has been fitted with an MOM hip should get in contact with their GP so that they can be referred for appropriate investigations as soon as possible. We would be happy to speak with patients who have concerns about their MOM hips, and to provide some preliminary advice on their options.”

 

 


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