IN Canberra on Wednesday two groups will meet – the health regulator that approved pelvic mesh devices a decade ago without clinical evidence, and the women dealing with the catastrophic consequences.
The women, members of the Australian Pelvic Mesh Support Group, will tell senior Therapeutic Goods Administration (TGA) representatives many of their members can no longer work or have sex, are in constant and shocking pain, suffer debilitating infections, or have been told there is nothing doctors can do for them.
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“We are the physical evidence of what’s gone wrong and they need to see and hear from us,” support group founder Caz Chisholm said.
The TGA approved transvaginal (surgery through the vagina rather than the abdomen) mesh devices from 2005 for prolapse surgery in women after pregnancy and childbirth.
In 2014 the TGA admitted its assessment process for mesh prolapse devices was not “mature” and lacked “rigour”. In August that year the TGA announced there was “little evidence to support the overall effectiveness of these surgical meshes as a class of products” and moved to deregister devices that could not provide clinical proof of safety and efficacy.
“We want the TGA to suspend all mesh until the safety and efficacy of it can be proven, and if it can’t be proven mesh should be banned,” Caz Chisholm said.
Australian Medical Error Action Group founder Lorraine Long said she supported the mesh women, and it was “disgraceful” that women were forced to campaign for answers because of regulatory failure.
“It’s always left to the patients to fight for answers or take legal action when things go wrong,” Ms Long said.
“There’s no one there to fight for the patient, which is the main reason I established my group. When things go wrong the regulators don’t get hold of the issue and help people deal with the consequences or prevent things from happening in future.
“There’s vast bureaucracies, but when things go wrong people are really on their own.”
Mesh women to meet Australian health regulator in Canberra during campaign for Senate inquiry | photos, video, poll
JOANNE McCARTHY
The Newcastle Herald
May 23, 2016, 6 p.m.