Hip joints may need lifetime monitoring
Wednesday, 29 February 2012
People with certain types of metal-on-metal (MoM) replacement hips must be monitored annually for life because of the risk of soft tissue reaction to the wear debris the implants produce, warns official guidance. The Medicines and Healthcare products Regulatory Agency previously recommended annual monitoring of MoM joints for a 5-year minimum period, but has now issued more stringent updated advice for certain types of implants.
The MHRA has examined emerging evidence from the England and Wales Joint Registry and found that, although most recipients of MoM replacement joints suffer no associated health problems, a small number develop progressive soft tissue reactions to the wear debris. This can lead to soft tissue necrosis, and adversely affect the results of revision surgery.
The guidance states: “The MHRA’s clinical orthopaedic experts are of the opinion that early revision of poorly performing MoM hip replacements should give a better revision outcome.”
The MHRA has produced detailed management recommendations for patients with MoM replacement implants. The Agency now advises that people who have had either stemmed total hip replacement with a femoral head diameter of at least 36mm diameter, or any type of DePuy ASR hip replacement, should have annual monitoring for life. This should include monitoring of blood metal ion levels and MARS MRI or ultrasound scanning in most cases.
The MHRA’s clinical director Dr Susanne Ludgate said: “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 ...
“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.”
Click here to watch the MHRA's chief executive, Professor Sir Kent Woods, on the BBC's Newsnight programme.