'Historic' targeted ban on pelvic mesh devices does not go far enough, say women and health groups

Journey: Jan Wise's life spiralled out of control after she was implanted with pig-based biological mesh in 2012.
Journey: Jan Wise's life spiralled out of control after she was implanted with pig-based biological mesh in 2012.

A TARGETED ban of Australian pelvic mesh devices this week is “too little, too late”, say women and health consumer groups calling for a total ban on all pelvic mesh devices.

The Therapeutic Goods Administration’s ban on some prolapse and incontinence sling devices from January 4 because of the risks involved is “a step towards recognition of the suffering of so many women”, but “the battle to ban all mesh continues”, said Australian Pelvic Mesh Support Group founder Caz Chisholm.

Health Issues Centre chief executive Danny Vadasz said there was “ample reason” for a total ban on all pelvic mesh. The implanting of more than 100,000 devices in women over more than 20 years was a tragedy and catastrophe that exposed a health system “not accountable to the people it was built to serve”.

The TGA announced on Wednesday that a final group of prolapse mesh devices implanted through the vagina would be banned from January, along with a group of problematic mesh slings to treat incontinence. In both cases a TGA review found little or no evidence to back their safe use in women, despite many devices being on the Australian market for years.

The move follows damning Senate inquiry public hearings, a long-running legal class action by more than 850 women against mesh manufacturer Johnson & Johnson, numerous confidential settlements and complaints against doctors, and a campaign led by the Newcastle Herald.

The TGA said it had removed 45 devices from the Australian market – with multiple variants – since a review in 2013, prompted by the growing global scandal about pelvic mesh and action by America’s Food and Drug Administration.

Consequences: A photo of Ms Wise taken in the months before she had pelvic mesh surgery which left her with devastating complications.

Consequences: A photo of Ms Wise taken in the months before she had pelvic mesh surgery which left her with devastating complications.

The decision came only weeks after the TGA announced plans to upgrade all remaining mesh devices to high risk.

Ms Chisholm and Mr Vadasz said they struggled to see why some stress incontinence devices remained on the market. Although there was long-term evidence supporting their use, the complications experienced by some women were severe, permanent and incapacitating, they said.

“We think there are ample reasons for a total ban. We can't imagine which surgeon would still want to use mesh in the absence of evidence and with so many injured women,” Mr Vadasz said.

Australian Pelvic Mesh Support Group member Andrea Walter said a survey of members showed 70 per cent had severe complications after surgery using “gold standard” incontinence devices that would remain on the market after the latest ban comes into effect.

The TGA’s action was “the start of validation mesh can cause terrible complications”, Ms Walter said.

Mesh campaigner Gai Thompson, who suffered catastrophic injuries after she was implanted with a Johnson & Johnson Prolift mesh device in 2008, said the ban was “too little, too late”.

In a complaint to the TGA in 2011 she said her life had become “a living nightmare”, but it was simply filed and not taken seriously.

“Why has it taken so long? The TGA treated us with complete disdain. A group of us met with them in May last year and they were so dismissive, just like the doctors have been dismissive. For years we’ve been saying these devices have destroyed women’s lives, and no-one was listening,” Mrs Thompson said.

“The only reason this is happening now is because of the publicity. They have been so condescending. How many women have had their lives destroyed because these people didn’t act when they should? Why were these devices ever let on the market when clearly there was no evidence they could be safely used?”

Victorian woman Jan Wise, who said she was “rotting from the inside” because of the pig-based biological mesh implanted in her in 2012, said the ban showed women should have been believed.

“This journey has been very hard and very long for many of us coming forward, but it needs to remain out in the open so that human beings are no longer treated with the utter contempt and disrespect shown to so many women,” Ms Wise said.

“This was done by people we had so trusted to help us.”

Mr Vadasz said the pelvic mesh device exposed Australia’s health system.

“Nobody has taken responsibility for the pain and suffering of countless women and that leads to the ultimate tragedy of the mesh debacle – if there is no one to accept accountability then there is no one to validate the experiences of all those injured women with the simple acknowledgement ‘sorry’,” he said.

“The ultimate tragedy of mesh is that it demonstrates that our world class health system, as unarguably great as it is, is not accountable to the people it was built to serve. We need to make it so.”