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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.
© Scoop Media
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