Updated guidance on hip replacement implants

5-Mar-2012

MHRA orders annual reviews for patients with implants of 36mm or more

The Medicines and Healthcare products Regulatory Agency (MHRA) 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 implant.

This updates previous advice from April 2010 that patients with hip replacements using implants of 36mm or more need only be monitored for a minimum of five years after surgery.

The new advice is included in a MHRA Medical Device Alert that has been issued to clinicians today for the management of patients with these hip implants to minimise the risk of having to undergo further surgery to correct complications.

As a precautionary measure, we have today issued updated patient management and monitoring advice to surgeons and doctors that they should annually monitor patients for the lifetime of their metal-on-metal total hip replacements that are sized 36mm or more because this particular type of hip replacement has a small risk of causing complications in patients

An expert advisory group was set up by the MHRA to look at the management of patients with soft tissue swelling associated with metal-on-metal hip implants. This group meets regularly to evaluate new scientific advice and observations from clinicians and the updated advice is based on fresh evidence that patients with hip replacements with head diameter of 36mm or more need to be monitored every year.

Dr Susanne Ludgate, clinical director at the MHRA, said: “Clinical evidence shows that patients have a small risk of suffering complications from having metal-on-metal hip implants. These implants have in most cases completely transformed the lives of patients who in the past were subject to increasingly severe pain and progressive lack of mobility.

“As a precautionary measure, we have today issued updated patient management and monitoring advice to surgeons and doctors that they should annually monitor patients for the lifetime of their metal-on-metal total hip replacements that are sized 36mm or more because this particular type of hip replacement has a small risk of causing complications in patients. This updates previous advice that patients with this type of hip replacement need only be monitored for a minimum of five years after their operation. By monitoring patients every year, any complications will get picked up earlier and more complex surgery on the patient can be avoided.

The MHRA was the first regulatory agency in the world to issue advice to clinicians about metal-on-metal hip implants in April 2010 and we, in combination with our expert advisory group, are continuing to closely monitor all the latest evidence about these devices

She added: “The MHRA was the first regulatory agency in the world to issue advice to clinicians about metal-on-metal hip implants in April 2010 and we, in combination with our expert advisory group, are continuing to closely monitor all the latest evidence about these devices. If patients have any questions, they should speak to their orthopaedic surgeon or doctor.”

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Joe Dias, president of the British Orthopaedic Association welcomed the guidance. He said: “The safety of our patients is always our first concern. The British Orthopaedic Association welcomes the publication of this updated advice from the MHRA. We will continue to work closely with the MHRA to provide further advice on this matter as new information becomes available."

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