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Reporting mesh complications to the MHRA

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13/08/2013

The MHRA have a similar reporting system for medical devices to the “yellow card” drug adverse event reporting system.  The Pelvic Floor Society is of the opinion that the MHRA should be informed of all Ventral Mesh Rectopexy mesh complications and where appropriate, the original surgeon.

What is an adverse incident? An adverse incident is "an event that causes, or has the potential to cause, unexpected or unwanted effects involving the safety of device users (including patients) or other persons." 

What to report? For synthetic meshes for , ODS and incontinence this may include:

Vaginal exposure

Erosion into the urinary tract

Erosion into the rectum

Infection

Pain

Fistulation

Mesh shrinkage

Organ perforation

Nerve or vascular injury

Sexual difficulty

Who should report? Clinicians and healthcare workers, patients and members of the public as well as the device manufacturers themselves can report adverse incidents

Role of medical device liaison officers in NHS trusts? All NHS trusts and CCGs have a medical device liaison officer (MDLO) whose role is to promote and coordinate adverse incident reporting and help manage the dissemination of medical device alerts. ?When a device related adverse event is reported to MHRA, the local MDLO and/or risk manager should also be informed.

How to report

website http://www.mhra.gov.uk.  This also provides facilities for copying the incident through to MDLOs, risk managers or other local relevant staff in compliance with any good practice in local reporting policies. 


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