Thousands to face tests over faulty hip implants

THOUSANDS more patients are to be tested over fears that their metal- on- metal hip implants are toxic.

Under guidance from regulators, they will be offered X-rays and blood tests to see whether they are suffering from – or at risk of – bad reactions to metal particles entering their bloodstream.

The problems have been linked to muscle and bone damage, as well as neurological issues.

Some 56,000 patients are known to have the metal replacements, and the Medicines and Healthcare products Regulatory Agency (MHRA) said that many of these are already receiving regular check-ups.

But it now wants to make sure that thousands of patients who may not currently have symptoms are tested as well.

These patients will have their blood tested for metals and be offered X-rays, ultrasounds or MRI scans.

In February 2012, the MHRA said that 50,000 patients with metal- on-metal hip replacements would need to have annual checks – including blood tests – over concerns their implants could cause serious health problems.

Tiny molecules from the metal made up of cobalt and chromium were thought to break off from the implants and then leak into the blood.

The new MHRA guidance to health professionals says: ‘The majority of patients with metal- on-metal hip replacements currently have wellfunctioning hips.

‘However, some patients will develop progressive soft tissue reactions to the wear debris associated with metal-on-metal articulations.’

It said data from last year had continued to show that there was a risk of bad reactions to the metals, adding: ‘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.

‘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 that the MHRA has updated its current advice to ensure that patients with metal-on-metal hip implants would still receive the appropriate follow- up tests ‘ to detect emerging complications should they arise’.

Dr McGuire added: ‘ Hip implants have positively transformed the lives of many patients who in the past were subject to increasingly severe pain and progressive disability. These use a variety of metal, plastic and ceramic components.

‘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.’

Last year it emerged almost 500 patients were suing a hip implant manufacturer after being left in severe pain or immobilised.

‘Some of them had been left housebound because of damage to the muscle and tissue surrounding their implants, which were hailed as revolutionary when they came on the market in the 1990s.

The case was set to go before the High Court this October.

‘The sooner they know the better’