Total Recall: system failures surrounding medical devices and mesh

Danny Vadasz
CEO Health Issues Centre

The measure of any system is how well it performs on a bad day.

The automotive industry understands that, as does the food industry.Remember when you would hear about some unfortunate car buyer discovering they’ve purchased a “lemon”? Those of you who have grown up under the post ‘60s Toyota Total Quality Control (TQC) System may not be familiar with the concept of a congenitally flawed vehicle but you will be familiar with what happens when something does go wrong. Who hasn’t been subject to virtual harassment alerting you to replace your Takata airbag?

And as for the food industry, in the event that some poor victim suffers food poisoning from a maverick can of tuna there are systems in place to recall every product by unique batch number from every shelf in every distribution point in the country within days.

In the consumer goods world, the idea that faulty products could be left in the marketplace for decades is inconceivable. So surely the same should hold for out health system? Right?

Australia’s health quality and safety regime, which was shown wanting in the case of trans-vaginal mesh implants, is not just having a bad hair day. When the Health Issues Centre challenged the glaring underreporting of adverse outcomes associated with mesh by collecting more than 2,000 cases in six weeks we signalled that beyond the tragedy of widespread injury was the tragedy of system failure. Since then there has been a Senate Inquiry, a Ministerial apology and a formal government adoption of the recommendations of the inquiry. But has anything been solved?

Last November the Health Issues Centre, in response to consumer alerts, conducted wide ranging research to determine which other medical devices demonstrated a pattern of failure. Perhaps unsurprisingly, the most frequently cited product was mesh used for hernia treatment.

This time the research was not intended to quantify the scale of the problem, just to identify products that warranted further investigation. But what stood out glaringly across all circumstances was a consistent consumer experience reflective of multiple points of system failure.

In this context the regulator, the TGA, has generally been the whipping boy for allowing inadequately tested devices to market. And certainly there is an element of Catch 22 in a framework that allows manufacturer self-audits to validate devices deemed to be level one low-risk but relies on post-market monitoring to identify level 3 high-risk thereby triggering a clinical trial (until 2018 pelvic mesh was considered level 1 low-risk).

But our research tells us that this is only one aspect of a perfect storm of system failure.

The survey results for hernia mesh indicate that 87 per cent of respondents believed they were given insufficient pre-operative information to enable them to make an informed choice. Many claimed if they had known the risk and potential impacts they would not have gone ahead.

This is a clear failure to obtain mandatory informed consent, however, even if surgeons and doctors want to enable an informed decision about a medical device procedure, they can’t. That would require disclosing the risk profile for the product. But Australia does not register medical devices nor do we currently require unique identifiers to enable us to track a product from manufacture to implant (you know, the sort of advance technology that allows you to staple a microchip in your dog’s ear).

Unlike cans of tuna, we have no way of knowing how many pelvic and hernia mesh devices have been implanted and how many have failed. When you add to that the woeful under-reporting of adverse outcomes it becomes impossible to quantify risk. (Risk equals number of failed procedures divided by the total number of procedures equals “don’t know” over “don’t know”.)

To further confound the problem many consumers found themselves challenged as to whether in fact they had experienced an adverse outcome.
Both pelvic and hernia mesh patients reported they were frequently subjected to gross minimalization of their symptoms (“get back on your bike”). Many were made to feel responsible for their injury because they were overweight, difficult, lying or suffering hypochondria.

There appears to be an unwillingness or inability by a section of the medical profession to countenance that their own best efforts may sometimes result in life-ruining outcomes.

The testimonials of patients confirm their high regard for and trust in their physicians. This leads to a sense of betrayal when subsequent unintended outcomes are dismissed or trivialised. Patients could be expected to demonstrate forgiveness when something unexpectedly goes wrong but their dismay turns to anger and bitterness when they encounter clinicians in denial of an inconvenient truth.

The flaws in our system extend way beyond the specific circumstance of mesh – whether we look at the lack of informed patient consent, the absence
of device registration, the gross minimalization of injury by clinicians’ leading to under-reporting of adverse outcomes or the inadequacy of post-event treatment pathways – the problems exist even without product failure.

Systems aren’t perfect and even if they were, humans aren’t. The car industry understood this by going beyond TQCs and introducing a Customer Follow-up System so that when things do go wrong, there is a back-up plan to deal with unintended consequences.

We need the same duty of care applied to our bodies as we get for our cars. Perhaps we should allow the car industry to run the health system.