MHRA urges more checks on hip replacements after investigation exposes dangers of all-metal implants
The UK medicines regulator has recommended more frequent checks following hip replacement surgery, after an investigation found millions of patients may have been exposed to ‘dangerously' high levels of toxic metals.
The Medicines and Healthcare products Regulatory Agency (MHRA) said annual checks should be carried out in patients after hip replacement surgery, so that any complications from failing implants would be picked up earlier.
The guidance comes after a joint investigation by the BMJ and the BBC found ‘metal on metal' hip implants could leak metal ions, causing damage to muscle and bone, and leaving some patients with long term disability.
Under current guidelines orthopaedic surgeons are required to do five-yearly checks, including an x-ray to ensure the implant is not beginning to loosen.
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.'
‘As a precautionary measure, we have today issued updated patient management and monitoring advice to surgeons and doctors that they should annually monitor patients for the lifetime of their metal on metal total hip replacements that are sized 36 millimetres or more because this particular type of hip replacement has a small risk of causing complications in patients.'
‘By monitoring patients every year, any complications will get picked up earlier and more complex surgery on the patient can be avoided.'
BMJ editor Dr Fiona Godlee said: ‘Hip replacements are one of the great successes of modern medicine. But a combination of inadequate regulation and untrammelled commercialism has caused actual and potential harm for large numbers of patients around the world.'
‘They should have known about the risks, as the manufacturers and regulators did, but they were not told.'
Joe Dias, president of the British Orthopaedic Association welcomed the new advice: ‘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.'