Updated advice on metal-on-metal hip replacements
MHRA recommends annual checks for people with metal-on-metal hip replacements.
Posted on 28 February 2012
The Medicines and Healthcare products Regulatory Agency (MHRA), the government agency which is responsible for ensuring that medicines and medical devices work, and are acceptably safe, has issued updated advice to surgeons that patients with a particular type of metal-on-metal hip replacement should be monitored annually for the life of the hip replacement. This updates previous advice from April 2010 that patients with this type of hip replacement need only be monitored for a minimum of five years after their operation.
Metal-on-metal hip replacements
Concern about the use of metal on metal hip implants, rather than the more traditional ceramic or polyethylene implants, has been growing for some time. In its 2011 report, the National Joint Registry for England and Wales identified much higher revision rates in the non-traditional hip implants. A report published in the BMJ in December 2011 confirmed that metal-on-metal bearings seemed linked with a substantially higher occurrence of revision surgery – with its associated pain, inconvenience and distress. Revision surgery can be an arduous and painful experience for patients who have already been through surgery, and it may be possible to bring a claim for compensation if you are in this position. The medical device team at Leigh Day has unrivalled experience in handling large numbers of claims for people who have suffered serious health problem after being fitted with replacement hips.
The British Hip Society (BHS) published a paper on the subject of large diameter metal on metal bearing total hip replacements earlier this year. The BHS presented results which showed a higher than anticipated early failure rate. These range from 21% revision rate at four years (potentially rising to 35% if all currently known painful implants progress to revision) to 49% at 6 years for the ASR XL device. Other devices have a revision or impending revision rate of 12 – 15 % at 5 years.
MHRA’s updated advice
The MHRA has now issued new guidance to clinicians for the management of patients with metal-on-metal hip implants to minimise the risk of having to undergo further surgery to correct complications. This updated advice is based on updated evidence that patients with hip replacements with head diameter of 36 millimetres or more need to be monitored every year. Monitoring advice for patients with other hip implants including other metal-on-metal hip replacements with a head diameter smaller than 36 millimetres and metal-on-metal hip resurfacing devices has not changed.
Dr Susanne Ludgate, Clinical Director of the MHRA, said:
“As a precautionary measure we are updating our patient management and monitoring advice to surgeons and doctors because this particular type of hip replacement has a small risk of causing complications in patients. By monitoring patients every year, these complications will get picked up earlier and more complex surgery on the patient can be avoided.”
Bozena Michalowska said:
"We are pleased that the MHRA have taken this action, however it is too late for those affected. The investigation by the BMJ and BBC Newsnight highlights the problem of there being too little regulation around implants. Concerns about metal-on-metal hips have been growing for some time; andit is vital that there is an adequate response from the regulatorybodies.”
Jill Paterson said:
“We are very concerned that the MHRA continue to advise that further investigations, such as MRI and ultrasound scans, should be carried out on patients only if their blood Cobalt chrome levels are above 7ppb. Many of our clients have suffered significant soft tissue damage from their metal on metal prostheses even when their blood cobalt chrome levels have been found to be below this level, we therefore believe the MHRA advice could mean that many more patients will not get adequate follow up.
“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, deteriorating function. We await the long term effects of metal ions in blood which are not yet known.”
Leigh Day and medical device problems
A number of manufacturers make metal-on-metal hip replacements, and some are facing legal action because of the problems these have caused. Specialist product liability partner Boz Michalowska and solicitor Michelle Victor are currently instructed by over 350 patients who have experienced significant difficulties with their DePuy ASR hip implant.
If you would like to speak to one of our product liability solicitors about a possible claim relating to a metal-on-metal hip replacement device please contact us now for a free and friendly initial consultation. If your query relates to the DePuy ASR hip implant call on 020 7650 1311.