MHRA updates guidance for healthcare professionals.
The Medicines and Healthcare products Regulatory Agency (MHRA) as a precautionary measure has today issued updated guidance for healthcare professionals who manage patients implanted with metal-on-metal hip replacements.
Previous guidance was issued to ensure appropriate followup to monitor the potential for the already well-known risks of soft-tissue reactions. This updated guidance replaces the previous advice provided in 2012.
The key changes include additional recommendations regarding monitoring patients and are designed to ensure longer term followup is undertaken for all patients with these implants. Details of the changes are in the Medical Device Alert issued today.
Dr Neil McGuire MHRA’s Clinical Director of Medical Devices said:
We have updated the current advice to ensure patients with metal on metal hip implants continue to receive appropriate follow up to detect emerging complications should they arise.
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.
Although the majority of patients with these metal on metal devices have well-functioning hips, it is known some may develop soft tissue reactions related to their implant. 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 you have any questions about your hip replacement, speak with your GP or implanting surgeon.
Notes to editor
Please find the link to the latest Medical Device Alert
MHRA is responsible for regulating all medicines and medical devices in the UK. All our work is underpinned by robust and fact-based judgments to ensure that the benefits justify any risks. MHRA is a centre of the Medicines and Healthcare products Regulatory Agency which also includes the National Institute for Biological Standards and Control (NIBSC) and the Clinical Practice Research Datalink (CPRD). The Agency is an executive agency of the Department of Health. www.mhra.gov.uk
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Published: 29 June 2017