It seems inconceivable that the tragedy of failed vaginal mesh implants could have continued undetected for 16 years. And yet it did.

In fact mesh implants remained the preferred clinical procedure to deal with pelvic prolapse and urinary stress incontinence, with estimates suggesting that over 100,000 women have undergone the procedure in Australia.

Obstetricians and gynaecologists have been so confident of the outcome of these implants, they haven’t felt the need to warn their patients of the risks or that the implants are irreversible.

Even when warning signs emerged – and there were plenty of them – women suffering post-operative injury were characterised as outliers, unfortunate but rare failures in the shadows of the glowing success of the devices.

The Therapeutic Goods Administration (TGA) whose role it is to establish the efficacy and safety of medical devices recorded only 99 adverse outcomes over five years from 2012. From its perspective, this doubtlessly vindicated the claims of manufacturers and surgeons that mesh implants had enhanced the lives of thousands of women.

However we, the Health Issues Centre (HIC), repeatedly heard from women who claimed their lives had been destroyed as a consequence of these implants.

In fact it took a senate inquiry, the HIC and a network of small consumer health organisations to expose what is without a doubt the worst self-inflicted public health crisis since the thalidomide tragedy.

Over six weeks in April and May 2017, HIC conducted research to determine how many women in Australia have been adversely impacted by mesh implants. In those six weeks, we received over 2,000 survey responses and the data was horrifying: 58% of respondents claimed that the procedure failed to resolve their health concerns, with 65% describing their consequent suffering as severe (23%), debilitating (31%) or unendurable (12%). Just 35% believed they had been adequately informed of the risks and potential adverse outcomes of mesh implants.

So why were we able to identify what had evaded the guardians of our health system for so long?

Because we went looking and gave women anonymity and the opportunity to be tell us of their experiences without the added stress and humiliation of public disclosure.

Sadly much of the current debate about the extent of the problem has been framed in terms of the good outcomes of the many outweighing the unfortunate experiences of a few, with clinicians continuing to refer to mesh implants as the gold standard for dealing with incontinence and prolapse.

What they forget is that our health system is based on values such as equity and a universal duty of care, not on a cost/benefit analysis that accepts the unavoidability of collateral damage.

When a few hundred babies were born with birth defects in the 1950s as a result of thalidomide, nobody suggested this was a defensible offset against the thousands of women who had been cured of morning sickness. The product was swiftly and decisively withdrawn from use.

Perhaps we need that event to remind us of the human dimensions of the mesh implants tragedy and to ensure our sense of humanity is not subordinated to a statistical dispute over acceptable failure rates.

But beyond the personal tragedy of women whose lives have been ruined by failed mesh implants is the catastrophic system failure of the very regulatory institutions established to protect public health.

Interestingly, it was in direct response to the thalidomide crisis that the government created what would be the precursor to the TGA. The intent of the organisation was to ensure the public would never again be victims of unproven clinical treatment.

Ironically it is the TGA that has now been singled out for its failure to adequately assess mesh devices before allowing them to proliferate.

While the TGA has many questions to answer, it is not alone in failing its duty of care. Vaginal mesh implants represent a whole-of-system failure and implicates Commonwealth and state health authorities, the various state and federal complaints commissions, the large number of surgeons conducting mesh implant surgery without informed consent, and the professional associations representing these practitioners.

All these guardians of public health have been asleep at the wheel while the mesh implants tragedy has unfolded. They have collectively failed to:

• adequately evaluate the safety and efficacy of medical devices and procedures;
  
• establish a comprehensive register of mesh products and procedures;
  
• provide adverse reporting systems to accurately represent health consumer outcomes;
  
• act on international evidence and warnings including those of the FDA;
  
• initiate the recall of products held in stock even after they have been withdrawn from market;
  
• enforce adherence to the principles and practice of informed consent;
  
• adopt a patient-centred approach in the treatment of affected women;
  
• apply precautionary principles in the face of mounting evidence of adverse outcomes.

However the mesh implants tragedy is also indicative of a broader social and political failure. Despite the lessons we should have learned from the under-reporting of rape, domestic violence and child sexual abuse, we have yet again failed in our duty of care to protect the vulnerable.

In all of these circumstances we elect denial rather than acknowledge system failure. We diminish the tragedy by characterising the cases as exceptional, unrepresentative of typical outcomes. We put the burden of proof on the shoulders of victims who have already been shattered by their experiences. We challenge and discredit them until they doubt their own lived experience. We plead ignorance of the facts and search for convenient scapegoats. We look for closure through expressions of regret rather than genuine remorse and reform.

To rebuild trust in our safety regime, we must firstly admit that our current system has failed us, then begin the task of rebuilding a safety regime that acts decisively with foresight rather than justifying inaction in hindsight.