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The Surgical Mesh Medical Disaster

“We Will Not and Should Not Be Accepted Collateral Damage”.

The Australian Surgical Mesh Investigations and final Senate Inquiry Report, gives hope to mesh injured victims of New Zealand that changes in the use of surgical mesh may be more promising.

The True Story Behind the Mesh Scandal

“Make no mistake, if it wasn’t for the courage of a few women precipitating a Senate Inquiry and a search for the truth by health consumer groups around Australia, mesh implants would be still performed under business as usual”. 
Danny Vadasz, the CEO of the Health Issues Centre in Australia

Mesh Down Under continue to work in NZ to bring about changes in the use of surgical mesh. Charlotte Korte, co leader of Mesh Down Under stated, “We have been campaigning for change since 2012, it took us five years to get the Ministry of Health, relevant health agencies and medical colleges to even sit around a table to discuss mesh complications, which is inexcusable. It shouldn’t have taken so long. Now that Australia have taken the mesh issue so seriously, we are hopeful the NZ government, relevant medical colleges and doctors will now truly acknowledge the severity of mesh injuries”.

Much of the evidence found in the 2017 retrospective study which was undertaken by the Health Issues Centre and the Australian Commission for Safety and Quality in Health Care, contributed significantly to the Senate Inquiry investigation. More importantly the findings from this inquiry mirrors the experience of New Zealanders and mesh victims globally.

Mesh Down Under has been asking for a similar study to be undertaken in NZ or to provide a platform to at least listen to mesh injured New Zealanders and for them this is still a huge priority.This is the best way to get a proper understanding of the scale of the problem and a true understanding of the severity of mesh complications. It is so important for the govt and MOH to listen to mesh injured patients to get a true account of what is happening behind the scenes.” Korte says. "But this requires funding from the Ministry of Health whom so far have been reluctant”. 

Danny Vadasz from the Health Issues Centre reflects on his experience when undertaking this research and of the horrors that they unearthed. Many questions remain unanswered!
“My disbelief was compounded by learning that nobody knew how many women’s lives had been ruined by mesh injury, in fact nobody knew how many procedures had been carried out although TVM had been the front-line procedure for dealing with pelvic organ prolapse and stress urinary incontinence for almost 20 years”.

Vadasz also talks about some of the statements made within the Australian Senate Inquiry final report.  Korte says “the points made by Vadasz are significant for the New Zealand situation, they need to be highlighted and should be considered by all”.

1. Statement in report: “Yes there may have been historical problems with older products but the newer products are much improved” Vadasz: “except they haven’t been clinically tested”.
“But surely at the least this has been a salient lesson that will ensure that this sorry story is never repeated. You would hope so but we are already witnessing a new narrative which suggests we should simply move on and that the disaster is all in the past”.

2. Statement in report: “Previous misadventures were due to poorly-trained/inexperienced surgeons”
Vadasz: “You would think after 100,000 or so of these procedures they would have got the hang of it”.

3. Statement in report: “While there may be a small number of women who have had unfortunate outcomes the majority have experienced wonderful results”
Vadasz: “Funny how the people who discredit the lack of empirical evidence of mesh failure don’t have data to support this assertion”.

Korte: “The medical community have acknowledged there is little evidence or quality research regarding the safety of these devices in the long term, which is concerning considering that it is well know that mesh complications can begin years after implantation. There are a limited number of long term studies but these have only low to moderate quality of evidence. It is clear that more robust long-term ‘gold standard’ research is needed”. 

Statement in report: “Mesh may be problematic for POP but we can’t deprive women of the option of mesh simply because of the adverse outcomes suffered by a few?”

Mesh Down Under: "This particular statement has upset many of the hundreds and thousands of mesh injured victims globally, because they are the collateral damage!  They are living in SEVERE chronic pain and in many cases have been left permanently disabled."

Vadasz: “since when was the professional commitment to “first do no harm” mediated by the proviso of acceptable collateral damage”

Although the Senate Inquiry findings have brought about more stringent monitoring and recommended comprehensive changes- Vadasz says we should also consider some of the following shortcomings highlighted by the surgical mesh inquiry:  

Regulatory approval – How did over 100 variants of a poorly tested device make their way into the market without adequate clinical testing for safety and efficacy? (Medsafe relies on the TGA as under current legislation they have no power to regulate medical devices).
Medical device register – How could we not know how many of these devices have been implanted over a 20 year period other than to rely on inventory estimates that between 100,00 – 150,000 products that have been distributed by manufacturers? (Just as in Australia, there is still no way for patients implanted with mesh to be identified in New Zealand.)
Adverse event reporting – How could the mandatory process of adverse event reporting so dismally understate the extent of the problem-96 cases recorded by the TGA over 5 years? (Medsafe received only 183 reports to July 2017, then staggeringly over 1000 reports once they intergrated data with ACC Tretment Injury claims.)
Complaints reporting – How could the various state and federal complaints mechanisms fail to detect an alarming pattern of recurrence in mesh related complaints and fail to signal alarm? (Mesh Down Under has been highlighting this problem in NZ since 2012).
Informed consent – How is it that only 34% of women surveyed believe they were given sufficient information by their clinician to provide informed consent to the procedure? And is even that number meaningful when none of them were forewarned that mesh is intended to be a permanent implant and removal is problematic? (The NZ Health Select Committee have acknowledged that informed consent is still a huge problem in New Zealand).
Practice standards – How can the relevant professional associations claim that the mesh catastrophe is a consequence of inadequate training and certification of their own members yet refuse to accept any historical responsibility?
Conflict of interest – How could we allow practitioners to personally receive manufacturer kick-backs for performing mesh implants without disclosure of their pecuniary interest?
Product recall procedures – Why can we respond to a single case of food contamination with a total national recall within 48 hours, yet we leave discredited medical devices indefinitely in the market place?

Korte states that “currently there is no way for New Zealanders to be notified after a medical device recall even if there are serious concerns with the device. There is also no way to determine what specific device patients have been implanted with, because NZ does not have the system capacity for patients to be identified or even notified when something goes wrong".

The damage caused by these surgical mesh procedures globally, has resulted in thousands upon thousands of people living is severe chronic pain and, in many cases, permanently disabled. Surgical mesh is designed to be permanent (remain in the body for life) and in many cases it is not possible to fully remove it. Partially removing the mesh can lead to potential migration of the device and further erosion into the surrounding tissue and organs.

Surgeons acknowledge that mesh removal surgery is complex with few surgeons having the ability to competently undertake mesh removal surgery. Attempts at removal surgery by surgeons’ who do not have the appropriate level of skills to undertake these procedures, has resulted in more damage to the patient. The upskilling of surgeons in mesh removal surgery is urgent and this needs to be both acknowledged by the medical community and fast tracked.
It is extremely concerning that even with all the current evidence which clearly highlights the severe nature of mesh complications (both within the available medical literature and also governmental inquires) and also knowing how difficult it is to remove these devices, surgeons continue to implant them. Let’s hope that the recent progress in Australia to address the Surgical Mesh issue will encourage our government to act now!
The SEVERITY of mesh complications should be the main focus for surgeons.
Let’s hope that whatever changes are adopted in New Zealand will happen urgently!
Because of surgical mesh, people are being left to live in severe chronic pain and in many cases permanently disabled, THIS is actually what needs to be focused on. Numbers and stats are important, but it is actually people’s lives we are talking about here”.





PRESS RELEASE

Monday 3 September 2018              FOR IMMEDIATE RELEASE

The growing number of patients suffering from surgical mesh injuries is totally unacceptable.  Government still to take action.
Medsafe and ACC records now show a whopping jump to over a thousand everyday New Zealanders who have reported that they are suffering with dreadful complications caused by a plastic medical implant known as surgical mesh.

Carmel Berry and Charlotte Korte petitioned the New Zealand Health Select Committee back in 2014 and begged for a full inquiry into its use.  They were told that an inquiry would take too long to make effective changes. 

“We were lead to believe that the committee would make strong recommendations restricting the use of surgical mesh within a very short timeframe” said Carmel Berry today “but apart from the withdrawal of some pelvic mesh products late last year, very little has changed at all – except the ongoing and continually increasing numbers of patients suffering.”

“When we established patient support group Mesh Down Under in 2012 we had just six members, now we have over 650 members, and I’m seeing at least ten new enquiries to join every single week” Berry explained.  “Too often the new members have had their mesh implanted for less than a year and are struggling with chronic pain, battling with ACC to get their injuries covered and searching for medical help.  Increasingly our members are a family member who just doesn’t know where else to turn after being told their loved one will have to learn to live with the pain”.

Posts by members of Mesh Down Under showed great appreciation for Christine Rankin’s open letter that was sent to the government this morning. Christine has herself spoken out publically about how she suffered significantly from a mesh implant and how difficult it was for her to get an acknowledgement of the complications and effective revision surgery.

Ms Rankin joined their call for the government to follow the lead of the UK in halting the use of surgical mesh for the treatment of stress urinary incontinence. Christine has echoed many of the points that Mesh Down Under has also alerted the government to, including the words of Baroness Cumberlege who is leading a review in Britain:
"We must stop exposing women to the risk of life-changing and life-threatening injuries”.
"We must have measures in place to mitigate the risk, and those are sadly lacking at the moment."
"We strongly believe that mesh must not be used to treat women with stress urinary incontinence until we can manage the risk of complications much more effectively,"

“All of the countries in the UK have now imposed a suspension of these procedures” said Berry “its high time New Zealand health officials put patient safety first and put a halt to these procedures until proper credentialing and patient care pathways are established”.
“JUST DO IT!”
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