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The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
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Posted 28 February 2012 | By Alexander Gaffney, RAC
The Medicines and Healthcare products Regulatory Agency (MHRA) issued advice to patients and surgeons urging them to monitor so-called metal-on-metal hip replacements on an annual basis for the lifetime of the device.
Previous advice by MHRA has only advised patients and surgeons to monitor the device for 5 years after the device was implanted.
"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," said MHRA in a press release posted to their website.
While "most patients with metal-on-metal hip replacements have well-functioning hips and are at a low risk of developing any serious problems," the monitoring constitutes a "precautionary measure," said MHRA.
The news comes in the midst of a scandal over regulatory oversight of breast implant product manufactured by French company Poly Implant Prothese (PIP).
While MHRA head Kent Woods has sought to deflect criticism and has called for modest regulatory improvements, some prominent voices have leveled harsh criticisms at the agency for "hiding under the CE marking."
MHRA - Press release: MHRA updates advice for metal-on-metal hip replacements
Tags: Surgeons, Hip Implants, Woods, PIP, hip, metal-on-metal, Latest News, patients
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This article provides a variety of websites with important information on recent changes to FDA guidances and tables ...