Most patients 'at low risk' from metal hip replacements

30th January 2012 - The Medicines and Healthcare products Regulatory Agency (MHRA) says current evidence suggests that most patients fitted with a type of metal-on-metal hip replacement are unlikely to encounter major problems with them.

Their comment comes amid reports that thousands of patients are at risk of being poisoned by the implants.

The Agency says it will continue to monitor the situation with the all-metal type of replacement.

'Too laid back'

The MHRA's latest update has drawn criticism from one health watchdog which said it was being "far too laid back" in its approach.

A health alert was sparked by a Sunday Telegraph report which said that this particular type of all-metal implant was more dangerous than previously suspected.

The problem with these devices is caused by friction between the metal ball and cup which leads to minute particles of metal breaking off and seeping into the blood where they can cause inflammation and even poisoning. The report said that problems have been found to affect people of all ages, but that young and petite women were at particularly risk.

Traditional types of hip implant used a metal ball and a plastic socket, but metal-on-metal types became more popular in the 1990s.

Withdrawn

It is thought that up to 40,000 people have been fitted with the all-metal implants, around 10,000 of them made by DePuy International Ltd. In 2010, DePuy recalled its ASR range because of an abnormally high failure rate - in some cases as high as 50% over six years.

These particular products had been in clinical use in the UK since 2003.

At the time, the MHRA said that all patients fitted with these devices should be examined each year and anyone experiencing abnormal pain, limping, swelling around the hip or deteriorating hip function should undergo blood tests or scans to check whether metal filings had entered their bloodstream.

Today a spokesperson for the MHRA said in a statement: "On the evidence currently available the majority of patients implanted with metal-on-metal hip replacements are at low risk of developing any serious problems.

"We are continuing to closely monitor all evidence. This needs more analysis before any conclusions can be drawn and further advice given.

"We have already taken prompt action to investigate safety concerns and have provided advice on patient management to relevant healthcare professionals.

"If patients have any questions they should speak to their orthopaedic surgeon."

MHRA 'needs to be proactive'

However, Peter Walsh, chief executive of Action Against Medical Accidents, was critical of the MHRA's stance. He told BootsWebMD: "It is not all that reassuring that the MHRA say that ‘most patients would not have a serious problem’ if you are a patient who has had one of these replacements.

"We think the MHRA has been far too laid back about the serious risk posed by these products.

"We need to see them being much more proactive in ensuring that patients are recalled and assessed. They should also publish the concerns of the experts which the Sunday Telegraph say exist and issue further guidance without delay."