A CATHOLIC Church child sexual abuse survivor who prayed for death to relieve extreme pain after pelvic mesh surgery has accused key elements of Australia's health system of acting like the church over the mesh scandal.
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"I went to the Catholic Church and there was minimising, inaction and denial. I complained after mesh surgery and the response was the same from the health system. It was just denying, denying, denying there was a problem with mesh for years," said Joan Isaacs, who was one of the first Catholic survivors to give evidence to the child abuse royal commission in 2013.
"In the past we've trusted doctors, just like the church. We put doctors up on a pedestal, just like priests and bishops, and both groups have minimised and denied when vulnerable people have been hurt. There's not much difference."
She told the royal commission the church's Towards Healing process for abuse survivors was "re-abuse", and wept this week as she talked about similar feelings while dealing with the health system, including the Therapeutic Goods Administration which approved mesh devices for use in Australia.
I went to the Catholic Church and there was minimising, inaction and denial. I complained after mesh surgery and the response was the same from the health system. It was just denying, denying, denying there was a problem with mesh for years. I feel rage.
- Child sexual abuse and pelvic mesh survivor Joan Isaacs.
"I feel rage. The Catholic Church gets up there and says it is praying for victims, and too many in the health system say they're sorry for women left to deal with the consequences of pelvic mesh, but what are they actually doing for them?" Mrs Isaacs said.
"Has anything happened at all to change the way devices are approved because of what happened to too many women implanted with mesh?"
She has backed a call for a judicial inquiry into Australia's role in developing mesh devices from the late 1980s, made by the daughter of a woman who committed suicide in 2015 after failed mesh surgery, and a national forum in Melbourne in April to make health reforms a federal election issue.
Mrs Isaacs said the mesh scandal showed the need for an overhaul of Australia's medical device approval processes. In 2018 an International Consortium of Investigative Journalists report revealed how poor regulations and vested interests allowed dangerous and malfunctioning devices onto the market around the world, putting patients’ lives at risk.
Mrs Isaacs said the often callous treatment of many women experiencing severe and permanent complications after pelvic mesh surgery was little different from her treatment by the church.
Similarities between the two issues struck her regularly, including as she gave evidence to the royal commission in December, 2013.
"A child can't give consent to a sexual act. A woman patient can't give informed consent to having a medical device implanted in her body through her vagina, without information about the likely risks. Women weren't warned of the risks or how these devices were approved without the kind of evidence we're entitled to believe is there," she said.
Mrs Isaacs was implanted with a pelvic mesh device for prolapse, a complication linked to childbirth, in 2006. In a 2018 Senate inquiry submission she recounted "dreadful" immediate and ongoing pain after the surgery, difficulty sitting for any period, and difficulty emptying her bowel and bladder leading to self-catheterisation.
Over the next six years Mrs Isaacs required 10 further surgeries to address complications including mesh migration impacting the bladder, rectum and vagina, repeated severe infections and increasingly severe pain leading to an "explosion" of internal pain in 2010 where she believed she would die.
Three months after most of the mesh was removed in August, 2011 Mrs Isaacs had further surgery where another pelvic mesh "sling" was implanted. Mrs Isaacs told the Senate inquiry she agreed to the surgery after a doctor advised there was "no other good alternative for me".
One year later, and less than two weeks before then Prime Minister Julia Gillard established the child abuse royal commission in November, 2012, Mrs Isaacs had the second mesh removed by a female surgeon after further serious complications.
It was removed only months after she "begged and begged" another doctor to inject a pain blocker into her vagina because it would "keep me from killing myself".
Mrs Isaacs gave evidence to the royal commission about appalling treatment by the Catholic Church in the late 1990s after the priest who sexually abused her as a child was jailed for his offences. She gave the evidence in December, 2013, one year after the mesh removal surgery.
"The people at the royal commission were wonderful. They knew I couldn't sit for very long. They put a cushion in the witness box and a couch in the witness room so that I could watch the hearing while lying down with a blanket," she said.
She has letters to the TGA complaining about mesh and to her local MP, the then shadow health minister Peter Dutton, complaining about the TGA's lack of responses, or claim that mesh complaints were extremely low while "many thousands of these mesh devices have been implanted and proven to be effective".
Mrs Isaacs repeatedly complained that doctors were not required to report mesh injuries to the TGA, and weren't reporting them. She also complained that although mesh manufacturers were mandatory reporters under legislation, and could be prosecuted for not reporting mesh device injuries, they were not reporting them, which made a mockery of any TGA statements about low mesh surgery adverse events.
A Newcastle Herald investigation found the TGA knew only a small percentage of mesh complications were being reported by manufacturers, but has so far failed to prosecute any mesh manufacturers.
"It is a case of regulatory capture. The TGA is captured by the medical device industry," Mrs Isaacs said.
She was horrified to learn about the lack of evidence behind many mesh devices as revealed by the Herald and in court cases, including Australia's largest class action by hundreds of women against mesh manufacturer Johnson & Johnson. A decision in that case is expected soon.
"Money drives the health system but patients don't know that, and it has to stop. All these things have to be made clear to the public, and doctors have to be made mandatory reporters when things go wrong, just like the church," she said.
"And people need to know what this thing has done to women, and why it went on for so long."
In response to questions a TGA spokesperson said the agency did not prioritise innovation and ready availability of medical devices over public safety.
It operated as a "cost-recovery agency", where it recovered its costs through annual charges, application, evaluation and inspection fees imposed on sponsors and manufacturers of therapeutic goods, including medical devices.
"Regulatory decisions made by the TGA are governed by the Therapeutic Goods Act and related regulations, legislative instruments and guidance. Decisions are made by the Secretary of the Department of Health or their delegate in accordance with legislative requirements, without regard to the fees paid by the applicant," the spokesperson said.
The agency had worked with stakeholders and published an information hub to help women and health practitioners find information and support on pelvic mesh devices at https://www.tga.gov.au/hubs/transvaginal-mesh.
