A "perfect storm of systemic failures" has left an unknown number of pelvic and hernia mesh surgery patients with severe complications that confirm the need for urgent health system reforms, including how medical devices are approved for use in Australia, a study has found only months after a global investigation concluded device approval processes can put patients' lives at risk.
Hernia patients were subject to the "gross minimalization of the severity of their symptoms", were not told mesh devices would be used, and resorted to alternative medicine treatments after losing trust in the health system, leading Australian consumer health group the Health Issues Centre said in a report released on Wednesday based on the experiences of 183 people.
It recommended major health system reforms less than a year after a Senate report into the pelvic mesh scandal identified long-standing serious system failures that compromise patient safety, and called for a review of doctors’ relationships with device manufacturers “to prevent the payment of inducements”.
The Senate report followed a Newcastle Herald pelvic mesh campaign and Senator Derryn Hinch's call for an inquiry into "one of the greatest medical scandals and abuses of mothers in Australia's history".
In October Federal Health Minister Greg Hunt apologised to pelvic mesh women for the "historic agony and pain" of their surgery.
A judgment in Australia's largest class action case, brought by more than 850 women against mesh manufacturer Johnson & Johnson, is expected in coming months.
Wednesday's Health Issues Centre report into hernia mesh found surgical complications are exacerbated when doctors "minimise the impact of adverse outcomes, deny responsibility, invalidate the lived experiences of their patients and seek to blame them for their circumstances".
"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," report author and Health Issues Centre chief executive Danny Vadasz found.
"There is clearly a dissonance between their best intentions to 'do no harm' and the reality of their patients’ experience. It would seem that physicians, like the rest of the community, have a problem dealing with inconvenient truth."
Mr Vadasz said he believed the extreme experiences of the 183 hernia patients could be "the tip of a very large iceberg", with the lack of data about how many Australians have received hernia and pelvic mesh an indictment of the health system.
"If you don't have the data about how many people have been implanted with devices then you can't determine risk," Mr Vadasz said.
The centre will hold a forum in April where pelvic and hernia mesh patients, device regulator the Therapeutic Goods Administration, health bureaucrats and politicians from around Australia will be brought together for the first time to discuss reforms that consumer health groups say are urgently needed, including the need for a health watchdog willing to prosecute to improve public safety.
In 2017 the TGA confirmed it had not pursued the prosecution of a single manufacturer for failing to report serious pelvic mesh injuries to women despite thousands of known serious injury cases linked to mesh, criminal sanctions if a manufacturer fails to report, and a 2013 TGA report acknowledging it “only receives 10-20 per cent” of all adverse events.
"Does Australia have a strong watchdog in the TGA? Clearly not," Mr Vadasz said.
The Health Issues Centre and the Consumers Health Forum of Australia have called for an inquiry into the responsibilities, operations and funding of the TGA, saying the current model of funding by industry rather than government was failing the public.
"It is a regulator captured by industry," Mr Vadasz said.
The Health Issues Centre report includes statements from hernia mesh patients saying they had considered suicide because of chronic pain, the failure of doctors to respond, the inadequacy of the health system to deal with complex complications after failed surgery, and the lack of clear treatment pathways.
"I almost bought a wheelchair in 2015 but I realized if I sat down in a wheelchair I was going to die with my multiple issues, so I do all I can to stay on my feet," one hernia mesh patient told the centre during the four-week survey.
Mr Vadasz said the drive for innovation prioritised in the health system meant too many in that system had lost sight of patients as human beings.
"At a time when the health system extols patient-centred care as a pillar of good health care delivery, it is ironic that the most fundamental aspects of patient-centredness are found wanting when put to the test, as is the case with pelvic and hernia mesh," he said.
Australian Medical Association NSW president Kean-Seng Lim acknowledged the existing system in NSW provided "a very fragmented approach to managing complex conditions" which left women experiencing serious pelvic mesh complications "not getting the best outcomes".
"Under the current system you could honestly spend your whole day travelling from one specific service to another for each individual consequence of the mesh surgery," said Dr Lim, who completed part of his training as a general practitioner at Lake Macquarie.
"We really need to have a much more patient-centred, coordinated approach to the management of complex cases like pelvic mesh. There does need to be a rethink about the more coordinated, appropriate approach that puts the patient at the centre, that provides a better recognition of multi-morbidities which now represent a very significant number in the community," he said.
He acknowledged that the pelvic mesh scandal where lack of transparency, accountability and informed consent were issues meant "we run the risk of losing trust in the system".
On Monday Dr Lim expressed reservations about a NSW Labor promise to provide $10 million for robotic surgery at St George Public Hospital at the request of doctors, after reputable reviews questioned whether it produced better outcomes for patients in urology and gynaecology.
Australian Medical Association spokesperson and gynaecologist Dr Steve Robson said the TGA aimed to prioritise patient safety but "like many organisations, it is dealing with multiple priorities".
"Patient safety should be the foremost priority when any medical device or therapy is considered. Systems that don't have this priority are destined to fail patients," Dr Robson said.
He said few health systems in the world, including Australia, were "equipped to adequately respond to patient safety in an era where multiple and complex morbidities (different conditions) are becoming very common".
The TGA was contacted for comment.
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