Wednesday 20 December 2017

Surgical MESH

District Heath Boards have been advised by MEDSAFE NZ that it is actively reviewing the evidence for safety of MESH products for surgeries treating pelvic organ prolapse (POP) and stress urinary incontinence (SUI).

This follows the recent decision of the Therapeutic Goods Administration (TGA) in Australia to discontinue use of transvaginal MESH products for POP and some SUI tapes.

MEDSAFE has given the relevant product companies until the end of January 2017 to provide safety data for consideration.

DHBs do not know how long after that there will be specific directives regarding which MESH products for POP and which TAPEs will be discontinued in New Zealand.

Given the findings of the TGA and other regulatory bodies overseas there is some expectation amongst clinical experts in the field that abdominal MESH procedures and some SUI TAPES will meet MEDSAFE's stringent safety criteria and remain available.

While the review takes place, Lakes DHB Surgical & Elective Services (Gynaecology, Urology and General Surgery) are deferring scheduled MESH surgeries for POP and TAPE procedures for SUI.

Affected patients will be contacted and offered clinic appointments to review their individual circumstances.

Optimal surgical plans can then be revised from the options available, with due diligence to informed consenting procedure.

Issued on behalf of Dr Martin Thomas, Chief Medical Officer for Lakes DHB