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.
“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.
“We will be there representing the thousands of Australian women who are suffering in silence because these products were put on the market, and shouldn’t have been.”
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.
This was despite no evidence of their safe use in prolapse cases, and clear warnings of the need for controlled trials on related incontinence mesh devices.
The Australian Safety and Efficacy Register of New Interventional Procedures warned in 2003 that there was “no peer-reviewed, good quality evidence available to determine the safety and efficacy” of incontinence mesh devices used to support registration of mesh for use in prolapse surgery.
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.
Ms Chisholm said her group’s campaign for a Senate inquiry into how and why mesh devices were approved, and the acceptance of mesh by doctors despite the lack of clinical evidence, would continue despite being put on hold because of the Federal election.
“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,” she 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 noone 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.”
Port Stephens MP and former health lawyer Kate Washington said a Senate inquiry into mesh devices “is certainly warranted”, and might provide a forum to get answers about how to help women.
“Potentially the Senate inquiry process may allow experts in the field to at least be identified,” Ms Washington said.
Ms Chisholm and a number of other women have travelled to America to have mesh completely removed because Australian doctors refused to operate because of the risks.
For some women surgery to remove mesh was not possible, she said.
She will read the TGA representatives a letter written by Stella, who does not want her surname made public, and had pelvic mesh devices implanted in 2011. Two pieces of mesh sit between her rectum and vagina and six arms secure the mesh to points in her pelvis.
The mesh has damaged muscles and nerves and is eroding into her vagina, and is close to breaking through her rectum.
“I feel like I’m dying a slow painful death,” Stella wrote.
”Before mesh I was a strong, resilient person. I cannot sit down at all, I can only stand for a few minutes at a time and I cannot walk very far as every step I take increases the pain horrifically. I am desperate.”