More than 50,000 patients in the UK with “metal-on-metal” hips are being told to undergo X-rays and blood tests after watchdogs found they are far more toxic than was thought.
The Daily Telegraph reports that every person fitted with the devices is being advised to have checks, in a safety alert issued by the Medicines and Healthcare Products’ Regulatory Agency (MHRA).
The report says concerns have been repeatedly raised about the devices, with watchdogs previously recommending patients with particular types of implant, or troublesome symptoms, to undergo tests. But the new advice means 56,000 patients – every single person with such implants – is being asked to undergo a series of medical tests, to establish whether they are suffering muscle or bone damage, and metal toxicity.
The unprecedented decision could result in thousands of people undergoing revision surgery, to replace the implants.
According to the report, watchdogs said the alert had been issued because of growing evidence that muscle damage caused by the implants can become progressively worse, and even irreversible, without patients suffering symptoms. Surgeons are particularly concerned about consequences for female patients, who will be told to undergo annual checks even if no concerns are detected.
The report says it follows a series of investigations, which uncovered widespread problems with the devices, which have now been largely phased out.
Metal-on-metal implants were introduced in the UK in the 1990s when they were promoted as offering better mobility than those which use a metal ball and plastic socket. They were seen as a better option for younger patients, who were likely to be more active and put more pressure on the joint.
Dr Neil McGuire MHRA’s clinical director of medical devices said: “Although the majority of patients with these metal on metal devices have well-functioning hips, it is known some may develop soft tissue reactions related to their implant.
“The clinical advice we have received indicates patients will likely have the best outcomes if these problems are detected early, monitored and treated if necessary.”
“If people have any questions about their hip replacement they should speak with their GP or implanting surgeon,” he said.
The report says the previous recalls meant that patients with particular types of devices, and those suffering particular reactions had been subject to extra checks. The MRHA was unable to say how many patients this amounted to, but said that as many as half of patients with the devices may already be having some level of monitoring.
The recent decision was taken after tracking of thousands of case surgeons found the devices are still causing soft tissue reactions, many years after they were implanted.
It means that patients will be asked to undergo a series of checks – even if they are currently suffering from no symptoms at all.
The decision does not mean that every patient with such hip implants would need to have them removed, the report says the MHRA stressed. Revision surgery will only be recommended if scans, blood tests or scored used to measure pain suggest the devices are causing unseen harm.
All women who have the implants will need to have annual checks for the rest of their lives, under the guidance – even if they are currently are suffering no problems. Studies have found that women were particularly likely to need revision surgery, with suggestions the smaller components used in surgery leaves less margin for error. Men suffering symptoms which could denote muscle damage will undergo annual checks, and while those without will have tests at least every three years.
The alert warns: “MHRA’s clinical orthopaedic experts have … 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 becomes necessary.”
Registers of patients have found that patients who received the implants in the last decade are “continued to show a risk of adverse soft tissue reaction to particulate debris” it states.
The report says in 2013, the UK’s National Health Service (NHS) hospitals were told to stop fitting most metal-on-metal hip replacements after a study found unacceptably high failure rates among 17,000 patients.
The guidelines said the NHS should stop using any hip implant with a failure rate higher than five per cent at five years, ruling out most types of metal on metal implants.
In 2010, two hip implants made by company DePuy were withdrawn from the market after concerns about their safety. These accounted for around 10,000 of the metal on metal hips fitted in the UK since 2003.MHRA Alert The Daily Telegraph report