MESH products for women suffering birth complications, that were approved for sale without scientific evidence of their safety, have led to “one of the greatest medical scandals and abuses of mothers in Australia's history,” says Senator Derryn Hinch.
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He has backed mesh victims’ call for a Senate inquiry after comparing the release of mesh products from 2005 to the sale of Thalidomide in the 1960s that left children born with severe physical disabilities.
“Once again the drug companies and the so-called watchdogs like the Therapeutic Goods Administration (TGA) are letting victims down,” Senator Hinch said in a speech to Federal Parliament in November after meeting with women who suffered catastrophic injuries after they were implanted with transvaginal mesh products.
The women – some from the Hunter – were treated for prolapse after birth or pregnancy, and then “treated like mushrooms: kept in the dark and fed bullshit by doctors, hospital administrators, the drug companies and even the TGA”, he said.
The TGA approved the first of more than 40 different mesh devices for transvaginal (through the vagina) surgery to treat prolapse in 2005. It approved the devices despite no evidence of their safe use in prolapse cases and clear warnings in 2003 of the need for controlled trials on related mesh devices.
Eleven years later, in a letter to a patient advocate in 2014, the TGA conceded its assessment process for mesh devices had not been “mature” and lacked “rigour”. The letter coincided with belated TGA action requiring clinical evidence from manufacturers of the safety and efficacy of transvaginal mesh devices.
Senator Hinch’s office is collecting details of women who have suffered mesh injuries after the Federal Government queried the extent of the mesh problem, after telling Parliament he would “not let it rest” until a Senate inquiry was called.
The Australian Commission on Safety and Quality in Healthcare – established by the federal and state governments – held the first of four meetings with mesh victims in Brisbane in January, with further meetings planned for Perth, Sydney and Melbourne.
Gai Thompson, who received a mesh implant in 2008 and suffered serious complications, said she was grateful for Senator Hinch’s support.
In a report to the TGA in 2011 she said she could no longer have sex and her life after February, 2008 had become “a living nightmare”.
The report noted multiple urinary tract infections leaving her resistant to some antibiotics, chronic and severe pelvic pain, chronic bowel problems, incontinence, multiple areas where the mesh had eroded into her vagina, and that she was unable to stand for any length of time, suffered constant fatigue and stress, and had needed successive surgeries and treatments.
“For all this time we’ve been told we’re just the unfortunate ones we were warned about – the 0.01 per cent of cases that don’t go well. But there’s a lot of women who aren’t getting help,” Mrs Thompson said.
“It’s not just that this has happened. You’re shamed by it as well because of what it is. Talking about surgery in that part of a woman’s body, and what can happen when things go wrong, is not something people want to talk about,” she said.
“If it’s a hip issue where the TGA approved something without evidence, that seems to be settled far more quickly. But this has gone on for years and years.”
Women are asked to contact Senator Hinch’s office by emailing carly.gibbs@aph.gov.au
For details on the Australian Commission on Safety and Quality in Healthcare phone (02) 9126 3600 or email mail@safetyandquality.gov.au