DERRYN Hinch says there have been “Watergate-style cover-ups” leading to thousands of Australian women living desperate, silenced lives because of pelvic mesh surgery.
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The claim was made months after he compared pelvic mesh with the drug Thalidomide and successfully called for a Senate inquiry, after describing mesh as “one of the greatest medical scandals and abuses of mothers in Australia's history”.
At the first public hearing day in Melbourne the former journalist turned Victorian Senator said he is expecting “horror stories” from women left with permanent and life-altering injuries, and challenges to regulators about how so many pelvic mesh devices were cleared for use without evidence of safety and efficacy.
“The Therapeutic Goods Administration’s going to come under great scrutiny. I’m going into this with my journalistic background,” he said.
“I don’t know where this is going to go, but I’m just bloody determined to find out how this happened.”
- Derryn Hinch
The Senate community affairs references committee will hold a full-day hearing in Melbourne from 9.15am before a second hearing day in Perth on August 25. Committee chair Senator Rachel Siewert, Senator Hinch and three other senators will hear from women who have had mesh surgery, doctors groups, university researchers, consumer health groups and regulators.
In a submission to the inquiry the Federal Department of Health estimated about 150,000 pelvic mesh devices for incontinence and prolapse have been supplied in Australia since the first meshes were cleared for use in 1998. Because it is common for more than one device to be implanted in women, the number of women who have had mesh surgery is estimated at 100,000.
The breakdown is about 106,000 devices for incontinence, where randomised controlled trials have supported the use of mesh in some circumstances, and more than 31,000 devices for prolapse, where mesh implanted via the vagina is not recommended as a first line treatment for any prolapse.
I don’t know where this is going to go, but I’m just bloody determined to find out how this happened.
- Victorian Senator Derryn Hinch.
In its submission the Therapeutic Goods Administration, which is Australia’s peak medical device regulator, said the “safety signal for urogynaecological mesh devices was relatively slow to emerge”, with the first adverse event report to the TGA not until 2006.
But internal working group documents for the TGA show it knew in 2013 that manufacturers were not reporting adverse events, despite being mandatory reporters, and doctors had a low level of awareness of the adverse event reporting system.
In 2013 the TGA conceded internally that it was only receiving 10-20 per cent of complaints about pelvic meshes. Although the TGA had only received 226 adverse event reports by May, more than 1000 Australian women have registered for class actions against two major mesh device manufacturers, and more than 2200 have responded to a survey by a Victorian consumer health group.
Australian Pelvic Mesh Support Group founder Caz Chisholm, whose meeting with Mr Hinch in 2016 led to the push for a Senate inquiry, said it would allow women to be heard.
“The trust between patient and doctor has been lost on mesh injured women,” Ms Chisholm said.
“The patient needs to be heard, acknowledged, empowered. At a minimum, the patient deserves these rights.”
She has called on the inquiry to recommend that doctors are obliged to report mesh complications, after years of doctors dismissing or minimising women’s complaints of serious complications.
In 2013 there were about 100 pelvic mesh devices on the Australian market, with variations on 42 registered devices. After a review following global recognition of major problems with mesh, the TGA and mesh manufacturers cancelled 23 devices.
There are now 14 registered mesh devices in Australia, with variations of the 14 taking the final number of available mesh devices to 29.
