Controversial pelvic mesh devices banned in Australia by medical watchdog

Friday, 1st December, 2017

Carina Anderson, a member of the class action, outside the Federal Court in Sydney. Photo: AAP

VAGINAL mesh is to be banned in Australia after the medical regulator found the risk posed to patients by the device outweighed any benefits.

The Therapeutic Goods Administration announced the ban this week after an investigation which followed widespread complaints from women who said the implants left them in debilitating pain.

The mesh device implants were used to treat common problems after pregnancy, birth and hysterectomies.

"The TGA is of the belief that the benefits of using transvaginal mesh products in the treatment of pelvic organ prolapse do not outweigh the risks these products pose to patients," a statement read.

The authority also said there was a lack of scientific evidence to justify the risks of the mesh products for the treatment of stress-related incontinence.

Changes to the register will take effect from January 4, 2018.

Women who were fitted with the implants said they had been left in excruciating pain and with chronic infections. In some cases they were no longer able to have sex.

"We've lost so much that I can't believe in this day and age this can happen to women, that our lives are being destroyed and no one cares," Mrs Thompson told Fairfax Media last year.

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A selection of pelvic mesh devices cleared for release in Australia and overseas for use in women. Photo: Supplied

In an incident report to the TGA, Mrs Thompson 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 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.

She was unable to work and as a consequence she and her husband had been forced to sell their home, Mrs Thompson said.

It's understood the banned mesh products were only used in a minority of prolapse cases with tape products still well regarded by urogynaecologists for treating urinary stress incontinence.

Health Issues Centre CEO Danny Vadasz welcomed the announcement but said it was disappointing some devices would still be available under a special access scheme.

"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.

"What does this decision mean for women with stress urinary incontinence, for which mesh is still recommended?"

He also congratulated the women who courageously campaigned for the ban, calling the TGA decision a "historic move".

Caz Chisholm, who set up the Australians Pelvic Mesh Support Group, said doctors, regulators and the manufacturers of the mesh devices had catastrophically failed women. 

"We were guinea pigs, we didn't know until it was too late," she told Fairfax Media in March.

Ms Chisholm said many women were not told the risks of transvaginal mesh surgery and so did not give informed consent.

"Current systems still don't allow the true extent of this disaster to be known," she said.

"For so many women, you're left feeling you're the only one experiencing these extreme consequences.

"It's only when women join the group they are able to say 'Oh my God, it's not just me. I'm not going crazy'," she said. 

In America tens of thousands of mesh victims have taken manufacturers and doctors to court and been awarded damages of as much as $12.5 million.

More than 700 Australian women launched a federal court class action against medical giant Johnson & Johnson in August, with the decision expected to be handed down by the federal court next year.

Calling for a senate inquiry into transvaginal mesh products, Senator Derryn Hinch told Federal Parliament the devices rivalled Thalidomide as one of Australia's worst health scandals

The Senate inquiry heard how victims unable to have vaginal sex after mesh surgery "repeatedly" reported that their doctors suggested anal sex as an alternative.

More than 40 mesh devices were cleared for use by Australia's peak health regulator, the TGA, without clinical evidence of safety and efficacy, and despite strong warnings from three Australian specialists as early as 2003, including Newcastle gynaecologist Alan Hewson, that some surgical mesh procedures "cannot be recommended".

With Joanne McCarthy

The Sydney Morning Herald

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