The Surgical Mesh Medical Disaster
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, a support group for mesh injured women and men, continue to work in New Zealand to bring about changes in the use of surgical mesh.
Charlotte Korte, co-founder, 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 disgraceful. Because 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 undertaken by the Australian Commission for Safety and Quality in Health Care and the Health Issues Centre, contributed significantly to the Senate Inquiry investigations. “This 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 and this is still a HUGE priority. This is the best way to get a proper understanding of the scale of the problem and understanding of the severity of mesh complications”. Korte says. “But this requires funding from the Ministry of Health who so far have been reluctant”.
Danny Vadasz 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, need highlighting and should be considered by all”.
- 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”.
- 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”.
- 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 says “the medical community have acknowledged there is very little evidence regarding the safety of these devices in the long term- which is concerning considering that it is well know that mesh complications can happen years after implantation”
- 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?”
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 mesh.
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 20year period other than to rely on inventory estimates that between 100,00 – 150,000 products that have been distributed by manufacturers? (As in Australia, there is still no way for patients implanted with mesh to be identified in NZ).
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 have received only 183 reports to August 2017).
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? (we have 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 NZ).
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?
There is no way for New Zealanders’ to be notified after a medical device recall because there are no systems in place which enable patients implanted with a surgical mesh device to be identified. There is also no way to determine what medical device they have been implanted with.
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”.Let’s hope that the recent progress made in Australia to address the Surgical Mesh Issue will encourage our government to act now.
Let’s hope that whatever changes are adopted in New Zealand will happen urgently!
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