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Publications

Published: March 2013
Revised 31 May 2017

Urogynaecological Surgical Mesh Implants

Prescriber Update 34(1):10
March 2013

Medsafe recommends that healthcare professionals who are implanting or following patients with urogynaecological surgical mesh implants should familiarise themselves with the Royal Australia and New Zealand College of Obstetricians and Gynaecologists (RANZCOG) advice.

Information regarding urogynaecological surgical mesh, including RANZCOG advice, is available on Medsafe's website www.medsafe.govt.nz/hot/alerts/UrogynaecologicalSurgicalMeshImplants.asp

Links to information from various regulators and professional bodies are also published on Medsafe's website. These regulators include the Australian Therapeutic Goods Administration (TGA), Health Canada, US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA). In 2008, Medsafe investigated a number of adverse event reports relating to urogynaecological surgical mesh. Medsafe concluded that surgical mesh is safe when used in accordance with the manufacturers' instructions by an appropriately trained surgeon. This finding was supported by an independent panel of healthcare professionals and is consistent with that of other medical device regulators and professional bodies. Medsafe continues to monitor adverse event reports relating to surgical mesh.

Healthcare professionals and patients who wish to lodge an adverse event report with Medsafe relating to any medical device, including surgical mesh implants, should use the reporting form available for download from the Medsafe website(www.medsafe.govt.nz/regulatory/DevicesNew/9AdverseEvent.asp)

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