Thousands of patients with “metal-on-metal” hip implants are due to be recalled for tests, including MRI scans and blood tests, due to concerns over toxicity.
The alert, issued by the Medicines and Healthcare products Regulatory Agency (MHRA), has increased the number of patients believed to be at risk of bone or muscle damage from the devices, which have been implanted in around 56,000 patients in the UK.
A large number of these patients already attend annual check-ups, due to existing concerns over the devices where they are given questionnaires, blood metal tests and scans to establish whether metal particles have sheared off the implants and been deposited in surrounding tissue. If this happens, revision surgery may be required.
Previously, patients with certain sizes of the device were considered low risk, but the latest guidance suggests that all patients with “metal-on-metal” hips – including those who have had the devices for many years with no problems – should now be followed up. This will mean thousands of extra patients will need to undergo testing, although the MHRA said it does not anticipate an increase in the number of revision surgeries.
The MHRA’s clinical director of medical devices, Dr Neil McGuire, said: “We’ve now included a group of people who were at low risk, but were not at no risk. It’s more about catching people who could be developing these complications early.”
The new guidance, aimed at doctors, was issued after MHRA’s experts found that soft tissue necrosis may occur even in patients who are not suffering symptoms such as hip pain or swelling.
Inez Brown, Partner from Medical Accident Group said “This news will be of concern for many patients who have undergone such surgery and who were unaware of the risks that they were facing at the time of the operation. As advised by the NHS website, patients should see their doctor if they start to suffer from pain in the groin, hip or leg, swelling at or near the hip joint, a limp or problems walking or grinding or clunking from the joint”.
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