Revised: 11 October 2019

Medical Devices

Surgical Mesh Implants - Adverse Event Reporting and Monitoring

Medsafe continues to monitor adverse event reports relating to the use of surgical mesh implants for the treatment of pelvic organ prolapse, stress incontinence and hernia repair and to review published information on the use of surgical mesh.

Medsafe surgical mesh implant events report

All adverse event reports relating to the use of surgical mesh implants received by Medsafe are recorded in a Medsafe database and reviewed and included in the on-going monitoring.

The first “Adverse Events Reports Relating to Surgical Mesh, Summary of reports received by Medsafe” document was published in December 2013. This original document has been regularly updated since that time. The key difference between this latest report and earlier versions is the way the adverse event report information is presented. Previously the report has included summary information on each adverse event report received by Medsafe. Due to the large number of adverse event reports supplied to Medsafe, this information is now being provided graphically.

Link to latest October 2019 report (PDF 16 pages, 294KB)

Reporting Adverse Events to Medsafe

Adverse Event reports are sent to Medsafe by the suppliers of the medical devices, by healthcare professionals, by consumers, and information on treatment injury claims relating to surgical mesh is supplied by the Accident Compensation Corporation. Further information, including reporting forms, is available at http://www.medsafe.govt.nz/regulatory/DevicesNew/9AdverseEvent.asp