THE pelvic mesh scandal that has left an unknown number of Australian women with serious, permanent injuries has exposed a health system “asleep at the wheel while this tragedy has unfolded”, a leading consumer health group has told a Senate inquiry into mesh.
The health system silences and blames victims, similar to the treatment of institutional child sexual abuse victims, Victoria’s Health Issues Centre chief executive Danny Vadasz said in a submission to the inquiry which holds its first hearing in Melbourne on August 3.
“The Senate inquiry has limited itself by just looking at certain aspects of this tragedy but I have already suggested a Royal Commission is necessary,” he told the Newcastle Herald on Wednesday.
In a scathing submission after more than 2200 women – including many from the Hunter region – responded to a centre survey, Mr Vadasz said the mesh scandal exposes how the burden of proof and responsibility for raising serious health issues is left with “the people who’ve suffered in the first place”, while regulators often remain in denial.
The abuses of power, the shifting of responsibility to victims, and a system that leaves victims to fight the medical industry largely on their own when things go wrong, provide clear comparisons with the treatment of institutional child sexual abuse victims, Mr Vadasz said.
The Senate inquiry has limited itself by just looking at certain aspects of this tragedy but I have already suggested a Royal Commission is necessary.Health Issues Centre chief executive Danny Vadasz.
The mesh scandal exposes “the systemic failure of the regulatory institutions and processes established to guarantee the safety and quality of health care in Australia”, he said.
“This whole of system failure implicates Commonwealth and State health authorities, their instruments, and in particular the Australian Commission for Safety and Quality in Health Care (ACSQHC), the Therapeutic Goods Administration (TGA), the various state and federal complaints commissions, a large number of surgeons and GPs conducting or referring mesh implant surgery, and the various specialist colleges and professional associations that represent them.
“These stakeholders have all been asleep at the wheel while this tragedy has unfolded.”
Mr Vadasz said regulators had chosen “denial rather than acknowledge system failure”.
It was not unreasonable to describe the health system’s handling of mesh as a “catastrophic failure” because regulators had failed to evaluate the safety and efficacy of mesh devices, failed to establish a comprehensive register of mesh products, failed to establish an adverse reporting system that accurately represented women’s injuries, failed to enforce the need for informed consent by women patients, failed to adopt a patient-centred response when women victims sought help, and failed to apply precautionary principles in the face of mounting evidence of adverse outcomes, Mr Vadasz said.
He told the Senate inquiry that the framing of debate about mesh once problems were raised in public showed the health system was still failing patients.
”Much of the debate about the severity of this problem has been framed in terms of the good outcomes of the many outweighing the unfortunate experiences of a few,” Mr Vadasz said.
“Health spokespeople continue to refer to transvaginal mesh as the ‘gold standard’ in dealing with incontinence and prolapse, but our health system is built on values such as equity and a universal duty of care, not on a cost/benefit analysis that accepts the unavoidability of collateral damage.”
Mr Vadasz said the women’s experiences of mesh presented in the Health Issues Centre submission was to remind governments, departments, regulators and the health industry of “the human dimensions of this tragedy”.
“It’s to ensure that our sense of humanity is not subordinated to a statistical dispute over acceptable failure rates,” he said.
Mr Vadasz said many of the women victims had been characterised as outliers who were unrepresentative of the silent majority. Many were left doubting their own lived experience.
He said mesh injuries had been “dramatically under-reported” because many surgeons refused to validate complaints of adverse outcomes reported by women patients.
“To build an effective safety regime we must firstly admit that our current system has failed us. It is only by acknowledging that this crisis evaded all radar detection that we can begin the task of rebuilding a safety regime that acts decisively with foresight rather justifies its inaction in hindsight,” he said.