Metal-on-metal hip implant patients to be invited for checks
It has been warned some patients may develop soft tissue reactions related to their implant.
Thousands more patients with metal-on-metal hip implants will be invited for X-rays and blood tests to check for potential complications.
Under new guidance from the regulator the Medicines and Healthcare products Regulatory Agency (MHRA), patients who may have – or who at risk of – soft tissue reactions to the implants will receive extra checks.
At present, 56,000 patients in the UK are known to have the implants.
The MHRA said many of these are already receiving regular check-ups but it wants to capture asymptomatic patients who are not adequately covered by current guidance.
These patients, of which there are thousands although the exact number is unknown, will have metals blood testing and will be offered X-rays, ultrasounds or MRI scans.
In February 2012, the MHRA said 50,000 patients with metal-on-metal hip replacements would need annual checks – including blood tests – over concerns they could cause serious health problems.
The devices have been linked to muscle and bone damage and neurological issues. Tiny metal ions made up of cobalt and chromium were thought to break off from the implants and leak into the blood.
The new MHRA guidance to health professionals says: “The majority of patients with metal-on-metal hip replacements currently have well-functioning hips.
“However, some patients will develop progressive soft tissue reactions to the wear debris associated with metal-on-metal articulations.”
It said data from 2016 “continued to show a risk of adverse soft tissue reaction to particulate debris.
“MHRA’s clinical orthopaedic experts have also observed that soft tissue necrosis may occur in both asymptomatic and symptomatic patients, and believe early detection of these events should give a better revision outcome should this become necessary.”
Dr Neil McGuire, MHRA’s clinical director of medical devices, said: “There are some patients who have had implants for a longer period of time who have soft tissue reactions.
“They’ve been asymptomatic and when they’ve become symptomatic, and considered for revision (surgery), they’ve had something more significant than the surgeon would like.”
He added: “We’ve included people who are asymptomatic. If they are going to get a soft tissue reaction, the sooner they know about it the better.”
He said the MHRA has updated the “current advice to ensure patients with metal on metal hip implants continue to receive appropriate follow up to detect emerging complications should they arise.”
He added: “If people have any questions about their hip replacement, they should speak with their GP or implanting surgeon.”