Ongoing Harm Without Regulation

The Federation of Women’s Health Councils Aotearoa endorses calls for the immediate halt to uro-gynaecological surgical mesh sling procedures in New Zealand. “It is deeply concerning that serious harm is continuing to occur to patients undergoing these surgical mesh procedures. It appears the steps taken in 2019 by the Ministry of Health, Medsafe, ACC and the professional colleges to address the concerns raised now for over a decade, have fallen well short”, says Barbara Robson, Co-convenor of the Federation.

“For more than 20 years the Federation and other groups have lobbied for regulation of medical devices in New Zealand. There has been a litany of disasters with the use of medical devices in this country in the absence of regulatory control”.

“The last we saw of the proposed new regulatory framework was the draft Therapeutic Products Bill early in 2019, then silence”.

We ask, “Where is the Therapeutic Products Bill and the associated regulatory controls? While we are waiting acknowledged harm from use of surgical mesh goes on relentlessly.”

Ms Robson says, “It is absolutely unacceptable that medical devices can be inserted into human patients without robust evidential support for their production controls, reliability/quality, efficacy, and safety. We have had endless claims of adverse reactions from the insertion of mesh but still no regulation to protect consumer interests and wellbeing. Why is there still no formal post-market monitoring system in place”?

We believe the relevant professional colleges should be taking more responsibility to protect patients from harm within both the public sector and private sector.

Te Whatu Ora - Health New Zealand must also take some leadership and ensure this issue is not buried amongst the complexities of the ambitious health reforms. Ministry of Health, Medsafe and ACC must step up and fulfil their respective responsibilities.

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