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Sunday, August 6, 2017

New Zealand Health Minister "Mansplains" Pelvic Surgical Mesh Scandal to Harmed Women



Teuila Fuatai
August 6, 2017  FiDA highlight
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 investigates
Six 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 the surgery.
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 at least $12 million to the taxpayer.
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 problem”.
Mesh Down Under
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.
"It appeared [Coleman] was relying on advisors who were obviously not giving him the full picture."
Charlotte Korte

Most recently on July 28, Korte and Sullivan met with the Health Minister in Dunedin.
“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 – especially 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 and action.” 
Coleman’s response:
When questioned by Newsroom, Coleman was adamant his handling of the use of surgical mesh in New Zealand had been satisfactory.
“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 mesh register
-       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 Zealand
-       A review of best practice around the informed consent process for surgical mesh procedures
-       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 of patients]
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 US Food and Drug Administration (FDA), Australia’s Therapeutic Goods Authority, and equivalent authorities in the UK, 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 and RANZCOG.
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 committee.
“He [Coleman] needs to either step up, or step aside.”
Charlotte Korte
In one email 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 email, sent to two senior MedSafe advisors and a senior media staffer, 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 US 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 otherwise 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 email.
“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 continued.
“This requirement for disclosure and communications has always been in place and the FDA redesignation does not change or increase it.”
Another email 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 surgical mesh.
Dated November 6 2014, the email 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 been correct.
When asked why he had not done this earlier, Coleman said he had been unaware of any dissatisfaction regarding the implementation process.
"There’s clearly a gap in the view of the people who I met ... compared to the advice I’m getting.”
Jonathan Coleman
“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 interview, 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 formalised
-       Whether a consistent coding system for surgical mesh was being used by health practitioners so patients could be identified and monitored
When asked how long was needed to implement recommendations - particularly given the mounting number of injury claims - Coleman refused to identify a specific timeframe.
“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.”
Lines in the sand
Coleman’s engagement with the issue, particularly in the past month, has pushed Korte and MDU to near breaking-point.
"I have not made a mistake. I have the deepest sympathy for all ... who have been affected by this."
Jonathan Coleman
Ït’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 idea.
“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 said.

https://www.newsroom.co.nz/2017/08/06/41379/surgical-mesh-a-decade-of-debilitation

FiDA addition:  Rebecca Solnit,  coined the term "mansplaining:"
It's the presumption that makes it hard, at times, for any woman in any field; that keeps women from speaking up and from being heard when they dare; that crushes young women into silence by indicating, the way harrassment on the street does, that this is not their world.

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