SENATOR Derryn Hinch says his fight for justice for women victims of “one of the biggest medical scandals in history” – many living in the Hunter – will probably end up being “the most important thing I do here”.
The former journalist once known as the “human headline”, who won bipartisan support for a Senate inquiry into how pelvic mesh devices were sold in Australia, said he had clear goals for what he wanted to achieve when he stood for politics: “Hoping to rewrite or scrap some old laws and bring in some new ones”.
He added a new goal after meeting women left to deal with catastrophic injuries following pelvic mesh implant surgery to treat common pelvic organ prolapse problems after pregnancy and birth.
“I said in my speech to the Senate that it was one of the greatest medical scandals and abuses of mothers in Australia's history,” he said.
“People accused me of hyperbole when I made that speech. If anything, I understated the situation. When a woman gets on the red-eye from Perth so she can see me the next morning, or when another woman drives from Port Pirie to tell me what she’s been through, you know the situation is extreme, and it is.”
The Senate inquiry, established on February 15, has called for submissions from affected women and any related individuals or groups with knowledge of devices known as transvaginal mesh. Submissions should be received by May 31.The Senate community affairs references committee will hold public hearings across the country to hear evidence about the consequences of mesh surgery and hear from regulators about how the devices were approved.
The Newcastle Herald has previously revealed that mesh devices were approved for prolapse surgery in Australia without clinical evidence of safety and efficacy.
This was after the American Food and Drug Administration (FDA) in 2001 approved the first prolapse mesh device for surgery through a woman’s vagina based on it being “substantially equivalent” to an existing device used in surgery to treat women for urinary incontinence.
Any differences between the devices “do not raise new questions of safety and efficacy”, the FDA stated, so a new prolapse mesh kit device was approved without the rigorous pre-market testing required of new devices or Class III high risk devices.
The decision, which provided a treatment option for gynaecologists in a difficult area where up to 50 per cent of women seek help for prolapse and incontinence problems over their lifetimes, opened a door and manufacturers responded.
Within a few years up to 40 companies had more than 60 surgical mesh kits for prolapse patients on the American market stating they were “substantially equivalent” to other mesh products, and all reliant on the 2001 FDA approval. They included biological or “natural” mesh products as well as polypropylene plastic devices for vaginal access, or transvaginal, surgery.
By 2012 there were 47 prolapse and incontinence devices on the Australian market.
The only problem was the FDA’s decision process was flawed, said leading Australian urogynaecologist and Queensland University Associate Professor Chris Maher in a paper in 2013 headed The Transvaginal Mesh Decade.
People accused me of hyperbole when I made that speech. If anything, I understated the situation.
The device approved in 2001 was subject to high complication and infection rates when used to treat prolapse, and was modified and gained a new clearance seven years later.
But the genie was out of the bottle.
The first mesh kits with tools to insert the mesh through incisions in a woman’s vagina were on the market in America in 2004. By 2010 more than 300,000 mesh kits a year were being used for prolapse surgery.
But by that stage adverse event reports were also being logged, with a five-fold increase in adverse reports to the FDA between 2005-2007 and 2008-2010.
The adverse events included mesh erosion and extrusion into the vagina and urinary tract, bleeding and infections, organ perforation, severe and chronic pain, nerve entrapment and urinary problems.
In a passionate speech to the Australian Senate in November, Senator Hinch said Australian medical watchdogs like the Therapeutic Goods Administration (TGA), which registered mesh devices for use, had let women down.
The TGA 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 used for incontinence surgery cases.
The women – many from the Hunter – were then “treated like mushrooms: kept in the dark and fed bullshit by doctors, hospital administrators, the drug companies and even the TGA”, Senator Hinch said in his November speech.
His background as a journalist who championed the victims of child sexual abuse, and his recent health battles leading to a liver transplant, meant he was more aware than many politicians of how betrayed and abandoned women left with catastrophic injuries felt, he said.
“You trust your doctor. I know how desperate you can get when you need treatment. When people say they have cures for you, you’ll listen to them. Doctors are some of the most respected people in the community. Doctors are gods. We need to find out how this happened. How the trust these women placed in doctors and our health system was so betrayed,” Senator Hinch said.
”Here we have a situation where you have one device approved and you can use that approval to get another device approved for a different problem. It seems crazy to me.
“I want women to make submissions. This is the chance for their voices to be heard.”