Mesh implants: Government issues national apology over ‘agony and pain’ caused by device

Health Minister Greg Hunt has issued a national apology to the many women whose lives have been ruined by the debilitating effects of pelvic mesh implants.

Speaking as he released details of the Government’s response to a Senate inquiry into vaginal mesh, Mr Hunt said he wanted to acknowledge the pain and suffering of those at the centre of the medical scandal.

“On behalf of the Australian Government, I say sorry to all of those women with the historic agony and pain that has come from mesh implantation which have led to horrific outcomes,” he said.

“My message to them is your voice has been heard, and not just heard but acted upon.”

The ABC has obtained details of the Government’s response to the inquiry, which is expected to be tabled today.

Mr Hunt said the Government would work with states and territories on setting up a voluntary national register of women who have had mesh devices and anything that went wrong.

“I would like to see it (the register) set up by the end of 2019, if not the middle of the year,” he said.

Patient groups had wanted it to be made compulsory for all health practitioners to report side-effects of any implantable device.

Mr Hunt said while his Government supported such a move, it was outside federal powers to do so.

“We will encourage the states and territories to adopt mandatory standards,” he said.

There’s been a mixed response from women and consumer health groups who continue to lobby for all mesh products to banned.

At the moment many items have been pulled from shelves and only select products can be used by qualified surgeons.

Mother of two Joanne Villani said she had witnessed some reforms by regulators, but many problems she experienced more than a decade ago still persisted.

“Women are still not being believed by their doctors,” she said.

“Doctors are still implanting mesh and telling women it’s new mesh and it is the same mesh.

“I would like mesh to be banned until it’s been shown to be safe. If it’s not shown to be safe, then it should never be used again.”

Senator Derryn Hinch pushed for the Senate inquiry, calling mesh “one of the biggest medical scandals” in Australian history.

Among the other actions the Federal Government will take are:

• Permanent Medicare payment items for the removal and treatment of pelvic mesh
• Asking states and territories to conduct an audit of pelvic mesh

Mr Hunt said he would raise the issues with his counterparts at the next health COAG meeting.

“I would be surprised if any state or territory resisted the steps that we have taken,” he said.

“Too many women have suffered too much for too long.”

‘I’ve friends who probably won’t make it’: patient

For Ms Villani it was not that pelvic mesh stopped her being able to have intercourse with her husband, it was the broader impact it had on their relationship.

“We actually split up for quite some time. It’s nothing my husband did or thought,” she said.

“It was very hard when he felt guilty and I felt guilty. It caused strain.”

The mother-of-two left the family home for some time because of the problems mesh caused in her relationship.

She has now returned to her partner because they “just want to be together”, but said their partnership would never be the same.

It is just one way Ms Villani said mesh has “totally altered my life” after her doctor suggested it to treat prolapse and incontinence following the birth of her son.

She recalled her surgeon seemed quite excited about the product at the time and believed he was on the “cutting edge” of new techniques.

“It didn’t quite work the way they expected,” she said.

“I went back to the surgeon on a number of occasions to discuss problems I was having and I was basically told it was in my head.”

Eleven years on, she said her situation had improved little.

“I have pain all the time,” she said.

“I’ll have to give up my job eventually. My financial future is also affected. I’ve been extremely depressed and anxious.”

Ms Villani said the worst part was that she was “not the only one”.

“Some women are expecting to die from their complications,” she said.

“I’ve friends who probably won’t make it.”

Patient advocates call for regulation of devices

And while Ms Villani welcomed the Government’s reforms to regulation and reporting, she said it did very little to help women who were continuing to struggle with debilitating side-effects from the product.

“I have friends who are talking about suicide. So we all need help,” she said.

“I would like to believe the Federal Government is serious about reform but what I see is a lot of this comes down to money.

“Money isn’t the issue, we are the issue.”

Patient advocates had been hoping for much tighter regulations of implantable devices, so that a scandal like pelvic mesh could not happen to other patients in the future.

Health Issues Centre chief Danny Vadasz said the Minister’s apology would provide much-needed validation to women who had long been told their problems were in their heads.

He welcomed the push for mandatory reporting, but said it relied on doctors listening to their patients.

“What we found in a lot of cases [was] women believed they had an adverse outcome but their practitioners didn’t,” Mr Vadasz said.

“You can only effectively mandate something if there’s an agreement on what constitutes an adverse result.”

He said the states and territories, to date, had not made an audit of past mesh cases a priority, but “hopefully with the Minister’s encouragement they will put this on the front burner”.

Mr Hunt said discussions were also underway to include implantable devices on the My Health record, if a patient chose.

But he said it would not be mandatory and the Government wanted to make sure that the My Health record system “was an entirely voluntary system”.

Mr Vadasz did not think the My Health record was an adequate avenue for a registry of devices because it had “sufficient problems of its own”.

“Complicating one problem by introducing the problems of another isn’t a way of coming up with an overall solution,” he said.

The Health Issues Centre was also hoping to see stricter credentialing around which surgeons were allowed to implant mesh.

“I haven’t heard anything yet that suggests there’s going to be tighter control of clinical trials that would enable a high degree of confidence in products that find their way to market,” Mr Vadasz said.

“I think people still need an explanation about why the various regulatory systems that are supposed to protect the public failed.”

(Source: ABC News Australia)