Where were the regulators for more than a decade, and particularly device watchdog, the Therapeutic Goods Administration?

Johnson & Johnson's related companies, Ethicon Inc and Ethicon Sarl, had nine mesh devices cleared for use in Australia from 1999 to treat prolapse and incontinence in women after childbirth. Before doing so they conducted inadequate, or no, clinical trials to establish devices were safe to use without risk of significant injuries, or would achieve the repairs claimed.

Ethicon put devices on the market to be used in women's pelvises, an area Justice Katzmann found was "subject to a great deal of stress and strain". They were made of polypropylene that had only ever been used as suture material, or for abdominal hernia repair, without any evidence to support the crucial shift.

Ethicon wasn't ignorant of the fact it might need to treat women's pelvises with care. It just didn't do so. Some time after it released one of its largest and injurious devices, the Prolift, on the Australian market in 2005, it acknowledged a problem internally and confidentially.

"Today's vaginal implants do not consider the patients' biomechanical needs" which could, and did, lead to "misfunction, pain and shrinkage" and ultimately a "handicapped patient", an Ethicon research and development team acknowledged.

But rather than pull Prolift from the market Ethicon continued to spruik it at doctors' conferences around the world, and released a revised device in an attempt to address the problems, with "little clinical evidence".

It considered designing a mesh device specifically adapted to a woman's pelvic floor but, as Katzmann found, "nothing eventually came of it and the project was abandoned in 2011".

In her summary, read to a silent and packed courtroom over 45 devastating minutes, Katzmann asked the question thousands of women in Australia, and around the world, have asked since the pelvic mesh device tragedy was exposed by women via legal cases and through the media.

"So how was this possible?" she asked, and then answered. It was a damning assessment of one multinational's actions, and an indictment of a health system that has profoundly betrayed women.

Johnson & Johnson and its Ethicon companies "saw the commercial opportunities presented by the new devices and were keen to exploit them before their competitors beat them to it". There was money in it, in other words.

And in what Katzmann found was a "largely self-regulating" Australian medical device approval system - part of a global system through which billions of influential device manufacturer dollars flow - women didn't stand a chance.

The Therapeutic Goods Administration continues to defend a model that relies on responding to consumer complaints but failed to prosecute even one mesh device manufacturer. The Department of Health acknowledged early this year that only 0.5 per cent of all medical device "adverse events" are likely to be reported. This is unsurprising when the companies that make the devices are the only mandatory reporters.

In March, Australian Competition and Consumer Commission chairman Rod Sims called for a general safety provision in law to protect consumers from goods that kill and injure thousands each year, but that did not include medical devices. The ACCC called the TGA our medical device "specialist safety regulator", a description that is almost grotesque when you listen to women describe the agony of life after mesh surgery.

Our health system relies on historical fundamentals - that patients can trust their doctors and give informed consent to treatment, assured that practitioners are obliged to "first do no harm". Those are fundamentals established long before the corporatisation of health, the deregulation era, technological innovation, the rise of an extraordinarily politically influential medical device industry and the digital age.

The mesh device "tragedy" - the word used by former Australian Medical Association president Michael Gannon - has exposed how profoundly Australia's health system needs to respond to these dramatic changes of the past few decades, because women's trust in the system was truly blind, through no fault of their own.

There are glaring transparency gaps that need addressing to allow patients to give informed consent to many treatments. Device manufacturers are required to have evidence of safety and efficacy, but in most cases the TGA is not required to assess it. It may only be when it receives complaints - and that means a lot of complaints - that the TGA might dig deeper. In any case, why isn't the research that supports a medical product available online?

The mesh device tragedy pulls two significant campaigns together: the media's Your Right to Know project and the Me Too movement. Women suffered in silence for years because our health system grievously failed them. Then they broke the silence by speaking to the media and others came forward to say, "Me too".