Reporting mesh complications to the MHRA
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.
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."
synthetic meshes for , ODS and incontinence this may include:
Erosion into the urinary tract
Erosion into the rectum
Nerve or vascular injury
should report? Clinicians
and healthcare workers, patients and members of the public as well as the
device manufacturers themselves can report adverse incidents
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.
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.