THE Senate will hold an inquiry into how gynaecological mesh devices that have left some women with catastrophic injuries were approved for sale in Australia.
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The Senate voted for the inquiry on Wednesday after Senator Derryn Hinch compared the registration, in 2005, of transvaginal mesh devices for women experiencing prolapse after pregnancy and childbirth with the approval of morning sickness drug Thalidomide in the 1960s which caused birth defects in children.
The registration of mesh products was “one of the greatest medical scandals and abuses of mothers in Australia's history”, he said in a speech to Parliament in November during which he vowed that a Senate inquiry would be held.
“Once again the drug companies and the so-called watchdogs like the Therapeutic Goods Administration (TGA) are letting victims down,” Senator Hinch said 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.
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”.
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.
The inquiry will consider the Therapeutic Goods Administration’s role in investigating the suitability of the devices for use in Australia, on-going monitoring of the devices and knowledge of the number of women suffering negative impacts because of the mesh implants.
It will also consider the information provided to women before receiving the devices and what assistance there is to women experiencing severe injuries as a result of mesh.
The inquiry will report to the Senate in November.
