NEARLY 50,000 patients with metal hip replacements will need annual check-ups amid mounting concerns the implants could trigger serious health problems.
The warning comes as a new investigation claimed hundreds of thousands of people worldwide have been exposed to dangerously high levels of toxic metals from failing implants – despite the risks being known for decades.
Numbers affected by problems linked to muscle and bone damage and neurological complaints could surpass those affected by the faulty breast implant scandal.
In an alert, the Medicines and Healthcare Products regulatory Agency (MHRA) said 49,000 patients will need annual blood tests, while those with symptoms of damage will also need MRI scans.
Some 10,000 patients with DePuy ASR implants, which were recalled in 2010 after performing worse than other implants, will need both checks.
Surgeons are being told to consider replacing implants if scans are abnormal or they are concerned about rising metal ion levels in blood.
Last night Peter Walsh, chief executive of Action against Medical Accidents, called for an urgent review of drug and medical device regulation.
“It is shocking enough that patients have been harmed by these hip replacements, but it is even more scandalous that tens of thousands of patients have been put needlessly at risk by the failure by manufacturers and regulators to act quickly,” he said.
Bozena Michalowska, of law firm Leigh Day & Co which represents more than 400 claimants, said wider checks were still needed.
“Our clients have reported a large number of issues with their implants. These include hip pain, swelling, impaired movement, numbness/lack of feeling in the leg and deteriorating function,” she said. “We await the long-term effects of metal ions in blood which are not yet known.”
An investigation by the British Medical Journal (BMJ) and BBC’s Newsnight yesterday claimed it had been known for decades that metal implants posed a risk caused by metal ions seeping into the tissues of patients, destroying muscle and bone and leaving some patients with long-term disability.
It claimed manufacturers kept silent as evidence mounted and regulatory bodies failed to act. Some makers had changed designs without full trials, risking the release of toxic metals.
BMJ Editor in Chief Fiona Godlee blamed “inadequate regulation and untrammelled commercialism” for causing serious problems to patients around the world.
“They should have known about the risks, as the manufacturers and regulators did, but they were not told,” she said.
Around 65,000 people have received metal hip implants since 2003 in the UK, of which 49,000 are affected because the joint head is 36mm or greater.
Susanne Ludgate, of the MHRA, said it had been first aware of problems in 2008. Evidence showed surgical revision rates were up to three times higher.
She said: “Most patients with metal-on-metal hip replacements have well functioning hips and are at a low risk of developing any serious problems.”
The guidance meant “any complications will get picked up earlier and more complex surgery on the patient can be avoided”.
Prof Joe Dias, president of the British Orthopaedic Association, said: “The safety of our patients is always our first concern. We will continue to work closely with the MHRA to provide further advice on this matter as new information becomes available.”