Home' Greymouth Star : August 9th 2017 Contents Greymouth Star
6 - Wednesday, August 9, 2017
ix years before Jonathan
Coleman took up the health
portfolio in 2014, 14 cases
involving patients implanted
with surgical mesh were
flagged by ACC.
In each of these cases,
patients had undergone repair surgery
for either incontinence or pelvic organ
prolapse. The implanted mesh, made out of
polypropylene, was supposed to strengthen
weakened tissue and muscle areas, and
alleviate their symptoms. However, between
2005 and 2008, those patients all suffered
unexpected and severe complications from
Classed as ‘adverse events associated with
the use of surgical mesh’, the patient cases
were referred by ACC to Medsafe — the
Ministry of Health unit responsible for
therapeutic product regulation.
Those 14 people — whose surgeries took
place at both public and private hospitals
around New Zealand — triggered the
first Medsafe review into surgical mesh.
Importantly, they also laid the groundwork
for what has become one of the country’s
worst-handled mass medical botch-ups.
To date, ACC has approved 800 injury
claims related to surgical mesh, costing the
taxpayer at least $12 million.
A two-year Health Select Committee
review into the use of the products —
also used in hernia repairs — has proven
ineffective, with hundreds of patient horror
stories, and a hefty, nine-year paper trail
involving numerous government bodies,
members of the medical fraternity and
politicians, showing a lack of management
and accountability for the “surgical mesh
Patient advocate group Mesh Down Under
(MDU), headed by Charlotte Korte, Carmel
Berry and Patricia Sullivan, has grown to
nearly 500 members since it was founded
in 2012. In that time, numerous petitions,
communications and meetings with officials
from ACC, Medsafe, the Ministry of
Health, as well as the Royal Australian and
New Zealand College of Obstetricians and
Gynaecologists (RANZCOG), the Medical
Council, the College of GPs, MPs and even
Coleman himself, have taken place.
Most recently on July 28, Korte and
Sullivan met with the Health Minister in
“ We thought that we were finally making
headway in getting that meeting, but it
appeared he was relying on advisors who
were obviously not giving him the full
picture because he had no real idea of what
the major concerns were,” Korte said.
First, the pair was told Coleman would
only have 15 minutes to meet.
During that time, only two concerns about
surgical mesh were discussed — and even
that was rushed.
“He wanted to leave after the first concern
was raised,” Sullivan said.
“His responses to our questions about
the lack of progress in implementing
Select Committee recommendations was
completely unsatisfactory. He just told us
that his advisors assured him they had been
implemented, even when we pointed out
they had not,” Korte said.
“Looking back, it seemed like a PR exercise
to show he was meeting with an advocacy
group. His attitude towards us and ongoing
problems with surgical mesh has been
extremely tough to understand and endure
— e specially since he is a GP,” Sullivan said.
“ We see more New Zealanders being
injured and have watched overseas
authorities respond to the problem, yet the
Health Minister seems apathetic in attitude
When questioned by Newsroom, Coleman
was adamant his handling of the use of
surgical mesh in New Zealand had been
“ What I’ve said to the people (Korte and
Suillivan) I met with . . . because they
raised a couple of issues (was to) . . .
put them in writing. All the advice I’ve
had is the (Health) Select Committee
recommendations have been implemented,
and that officials have followed up this issue
in an appropriate way,” Coleman said.
Seven recommendations were released
by the committee in June last year at the
conclusion of its review into the use of
surgical mesh. Prompted by Berry and
Korte’s 2014 petition, a range of actions were
recommended, including. —
The development of a national surgical
Expansion of Medsafe’s role so it can
assess the quality and safety of a medical
device prior to its approval for use in New
A review of best practice around the
informed consent process for surgical mesh
Formalising the requirement for the
ongoing education of surgeons in the use of
mesh, and its removal
The use of a consistent coding system
for surgical mesh by health practitioners,
enabling the identification and monitoring
Documents from Medsafe the Ministry
of Health, ACC and RANZCOG, dating
as far back as July 2007, show these
organisations were well-aware of serious
gaps in New Zealand’s approach to the use
of surgical mesh.
Notifications from overseas bodies,
including the United States Food and
Drug Administration (FDA), Australia’s
Therapeutic Goods Authority, and
equivalent authorities in the United
Kingdom, Canada and Europe, warning of
severe complications associated with surgical
mesh over that 10-year-period, were all
received by the Ministry of Health, Medsafe
Even more concerning, are the similarities
between the cautionary advice outlined in
those documents — reviewed by Newsroom
as part of this investigation — and the
recommendations released last year by the
In one e-mail dated May 22, 2014 from
Medsafe group manager Stewart Jessamine,
two orders proposed by the FDA to address
health risks associated with surgical mesh
used in pelvic prolapse repair are discussed.
The e-mail, sent to two senior Medsafe
advisors and a senior media staff member,
explained the FDA announcement but
proposed no action regarding surgical mesh
products in New Zealand.
At the time, the announcement prompted
several manufacturers to pull mesh products
from the United States market because
they could not show the FDA’s safety and
effectiveness standards had been met.
“The redesignation of surgical mesh by
the FDA to a higher risk category does not
other wise effect (sic) products approved
in the past or those that are currently on
the market, nor does it impose any further
requirements on manufacturers clinicians to
use these devices in any different way to that
previously required,” Jessamine said in the
“The key issue is communication
with the patient to explain the surgical
procedure, what is proposed to be used in
that procedure and what are the risks and
benefits of use of one particalr (sic) surgical
approach or material against another,” he
“This requirement for disclosure and
communications has always been in place
and the FDA redesignation does not change
or increase it.”
Another e-mail from Jessamine referring to
research commissioned by the executive arm
of the European Union also demonstrated
the selective approach Medsafe had when
considering and endorsing information on
Dated November 6, 2014, the e-mail
was written 18 months before the Health
Committee published its recommendations.
“If no health select committee
reconsideration by the time the SCENHIR
(Scientific Committee on Emerging and
Newly Identified Health Risks of the
European Commission) is published, I
would be pushing for us to propose that
the minister (Coleman) consider not
supporting select committee reconsideration
at all, (obviously this depends on result of
European report),” Jessamine said.
Where are we now
Since meeting with Korte and Sullivan,
Coleman has decided to “check” whether
advice he has received from “the officials” has
When asked why he had not done this
earlier, Coleman said he had been unaware
of any dissatisfaction regarding the
“The first was that this was raised as a new
and unresolved issue has been in the past
two weeks,” he said last Monday ( July 31).
“ We had that (public) meeting on Friday
the 14th of July, I was away for the next
week, and then I met with them (Korte and
Sullivan) last Friday ( June 28th).”
However, Coleman — either directly or
through his staff — received and answered
numerous queries on surgical mesh from
constituents like Korte and Sullivan, as well
as fellow MPs, in the past six months.
Following his inter view, Coleman also
sent Newsroom a document outlining the
“timeline” for committee recommendations,
dated May 31, 2017.
The document referred to various
discussions between health authorities and
medical bodies, new ACC and Medsafe
forms, updated information on surgical
mesh on the Medsafe site, as well as the
development of new therapeutics legislation
for New Zealand.
It did not specify:
If and when a national surgical mesh
registry would be created
What, if any, expansion of Medsafe’s
role would occur to enable it to assess the
quality and safety of a medical device before
it is used in New Zealand
Any outcome regarding a review into
best practice and the informed consent
process for surgical mesh procedures
Whether ongoing education of surgeons
working with surgical mesh would be
Whether a consistent coding system
for surgical mesh was being used by health
practitioners so patients could be identified
When asked how long was needed to
implement recommendations — particularly
given the mounting number of injury claims
— Coleman refused to identify a specific
“ I think the recommendations have or are
in the process of being implemented, but
I fully accept that . . . many things that are
done by the Government may not happen
as quickly as those who are affected by them
would want them to happen,” he said.
“ It also reflects there’s clearly a gap in the
view of the people who I met . . . compared
to the advice I’m getting from the Ministry.
We just need to check whether that ’s
resolvable — that or there may just be some
differences in perception.”
Coleman’s engagement with the issue,
particularly in the past month, has pushed
Korte and MDU to near breaking-point.
It’s just not acceptable,” Korte said.
“These people’s lives have been destroyed.
How many more people’s lives have to be
ruined before the government and Jonathan
Coleman start listening?
“ He needs to either step up, or step aside.
We need an independent commissioner
to take charge, someone who is capable
of fixing the problems associated with the
surgical mesh issue and who can put patients
first,” she said.
Meanwhile, Coleman has dismissed the
“ We’re not appointing an independent
commissioner. I have not made a mistake.
I have the deepest sympathy for all those
people who have been affected by this,” he
A decade of damage
It has been almost 10 years since NZ’s government
was alerted to an issue with surgical mesh. Since
then, hundreds have suffered injuries from high-risk
surgeries. Authorities, including Health Minister
Jonathan Coleman, have passed the buck continuously.
TEUILA FUATAI of Newsroom investigates.
Health Minister Jonathan Coleman
Charlotte Korte and Carmel Berry
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