TRISH Sara was implanted with a Johnson & Johnson pelvic mesh device in 2008 by a gynaecologist who did the surgery "against my better judgment" after he was "talked out of" a non-mesh option by a Johnson & Johnson representative and a senior surgeon enlisted by the company.
She is the Hunter woman who asks the question that leaves some mesh-injured women suicidal, and all scathing of governments that refuse to confront known problems in the health system, including lack of transparency and the influence of pharmaceutical companies.
"The question the health system can't answer is how do they help us live the rest of our lives like this?" said Mrs Sara, 60, as Johnson & Johnson returns to the Federal Court today to discuss compensation for possibly 10,000 women after a landmark pelvic mesh decision against the company in November.
Money won't take away pain so severe you can struggle to breathe or address injuries doctors can't repair, said Mrs Sara and four other Hunter women left with permanent and life-altering injuries after Johnson & Johnson pelvic mesh surgery at Hunter public and private hospitals.
The women warned that more patients will die and be left injured unless there are changes in a health system skewed by money.
"No one is taking responsibility for what happened to so many women, but they all failed. Governments allowed these devices to be used. Doctors put them in women. Hospitals allowed it to happen. And when things went wrong no-one wanted to know," Mrs Sara said.
"You don't have to have a degree to know what's going wrong. We've just been abandoned. We don't know where to go for help. They can't fix the damage that's been done to some of us which is why we're just referred from one place to another."
In a message to Federal Health Minister Greg Hunt and state health ministers around the country, on behalf of women left with sometimes "catastrophic" injuries after pelvic mesh surgery, Mrs Sara, Robyn Ramster, Kathryn Best, Francene Henderson and a fifth woman named Kim were scathing.
"Get off your ass and do your frigging jobs," Mrs Sara said as the women met in February to support each other and weep, one with injuries so severe she is unable to sit after she was implanted with Johnson & Johnson's Prolift and TVT pelvic mesh devices at Belmont Hospital in 2007.
Get off your ass and do your frigging jobs.Hunter woman Trish Sara
Hunter gynaecologist Dr Oliver Brown described Mrs Sara as "my only badly harmed patient from the mesh era", in a letter to Mrs Sara's GP in April, 2019 in which he acknowledged, "Obviously she has been through a lot over the last few years".
"I think the surgery that caused Patricia's issues was the repeat posterior Prolift which was done against my better judgment. I'd originally planned an abdominal sacrocolpoplexy but was talked out of it by the Gynecare (a Johnson & Johnson product) rep and their surgical preceptor, who participated in Patricia's surgery on that day," Dr Brown wrote.
Mrs Sara, 60, said she did not know the Johnson & Johnson "rep" and the senior surgeon were in the theatre with Dr Brown at Newcastle Private Hospital when her Prolift pelvic mesh device was implanted.
She did not know Dr Brown implanted the Prolift against his "better judgment", or that he advised her GP in the weeks before the March, 2008 surgery that Mrs Sara was a "good candidate for the new Prolift mesh procedure, which I use very sparingly".
She found out in 2019 after obtaining the letters and other documents as part of the Federal Court case.
She did not know Johnson & Johnson in 2005 released the Prolift device, one of the largest and most injurious of its nine pelvic mesh devices marketed in Australia, despite the company knowing serious complications could result in a "handicapped patient".
The discoveries left Mrs Sara shocked, devastated and horrified by a health system where patients cannot access necessary information, but bear the consequences when things go wrong, and where very little has changed to protect patients despite repeated scandals, particularly involving surgical devices.
In March 2018 a Senate inquiry recommended the Federal Government undertake an audit of all pelvic mesh procedures in Australia and their outcomes since they were first developed in the late 1980s and an estimated 150,000 were implanted. The Government established a register for all future mesh surgeries instead.
The Senate inquiry called for specialist multidisciplinary units across the country for mesh-injured women, to assess and manage complications, provide highly specialised support for partial or full mesh removals, and specialist pain management.
Mrs Sara had three appointments to attend one of the multidisciplinary clinics in Sydney, but all three were cancelled by the clinic until one last week.
Dr Brown said he performed 10 to 15 Prolift surgeries at Newcastle Private Hospital and John Hunter Hospital but stopped after Mrs Sara's complications.
"Prolift I found was a very difficult operation to do. It was a very challenging operation for difficult cases of recurrent prolapse," Dr Brown said.
The preceptor - generally a senior specialist enlisted by companies - would "come along when most Prolifts were put in because he was a specialist in pelvic floor surgery and very experienced, and back then I was fairly newly qualified".
Dr Brown said he imagined there was "some sort of arrangement" where the preceptor was paid by the company but "I had no idea what it was and it was certainly played down from his angle".
Pelvic mesh devices such as the Prolift were adopted by doctors after "making an appearance at conferences", he said.
"There was a continence society conference in 2006 and the whole conference was basically taken up about meshes and the early data on it," Dr Brown said.
"It was very confusing to interpret. Looking back, there were people who were not as expert as what they were making out, perhaps on the payroll of Gynecare."
The Senate inquiry recommended the Department of Health review systems in place "within the device manufacturing industry and the medical professions to support consistent, high ethical standards, with specific emphasis on systems in place to prevent the payment of inducements to medical professionals and teaching hospitals".
Dr Brown supported Mrs Sara's involvement in the Johnson & Johnson case and said it was "heartbreaking to see what she's going through".
The Royal Australian and New Zealand College of Obstetricians and Gynaecologists "really did not get hands-on in any big way through the mesh era" and certified urogynaecologists who were "doing a lot of mesh surgeries didn't provide a lot of guidance", Dr Brown said.
He supports a "properly-run clinic" in the Newcastle area for many women dealing with mesh device complications, some extremely severe.
Although women were injured in the United Kingdom, where Dr Brown did urogynaecology training, Australia has a bigger pelvic mesh problem, he said.
"I think this is an Australian issue. The system here is very reliant on the good character of a doctor. That's the thing that strikes me. When you've got someone of poor character you're relying on them doing the right thing," Dr Brown said.
"I think the Australian system has higher highs and lower lows."
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