U.K. Medical Device Alerts In Brief
This article was originally published in The Gray Sheet
Executive Summary
Metal-on-metal hip replacements: The U.K.'s Medicines and Healthcare products Regulatory Agency (MHRA) in an April 22 medical device alert advises five-year postoperative follow-up of patients with all varieties of metal-on-metal hip implants and more frequent follow-up when soft tissue reaction symptoms are present because metal debris has been associated with soft tissue death and can adversely affect the results of revision surgery. While the agency notes that the majority of patients implanted with metal-on-metal hip replacements have "well functioning hips and are thought to be at low risk of developing serious problems," the alert is based on extensive consultation with orthopedic surgeons and uses information from the National Joint Registry for England and Wales. For patients with pain, MHRA also advises evaluation of cobalt and chromium ion blood levels and cross sectional imaging including MRI or ultrasound scan