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The biggest lesson from the vaginal mesh saga? Doctors must listen to women.

June 7, 2018

The Guardian , Melissa Davey

 

There needs to be recognition that women have been let down – by doctors, regulators and pharmaceutical companies. 

How many women need to be ignored, harmed or maimed before women can be confident their health issues will be taken seriously?

According to a professor of gynaecological surgery, Dr Jason Abbott, more than 60% of women suffering from crippling endometriosis are told their symptoms are “normal”. (javascript:void(0)) Diagnosis can take a decade, at which point women often undergo invasive and unnecessary surgeries on their reproductive organs at the behest of their doctors. It’s a tragedy that led to Australia’s health minister, Greg Hunt, issuing a national apology.

A study published in the British Medical Journal in 2014 (javascript:void(0)) found that interventions that are ideally reserved only for complicated childbirth cases are also performed on women with low-risk pregnancies and labours. These procedures include episiotomy, where a surgical cut is made in the perineum to enlarge the opening of the vagina, and which in rare cases can cause rectal tissue tearing and ongoing pain.

Women are tired of being told they are making up pain. They are traumatised from living with catastrophic consequences of surgeries they were not adequately informed about, or were not necessary.

Which is why a well-intentioned statement, issued on Wednesday by the UroGynaecological Society of Australasia in response to the transvaginal mesh scandal, comes across as paternalistic and ill-worded. In the statement, the head of the society, Dr Jenny King, correctly points out that mesh surgery has a low complication rate for treating incontinence. And mid-urethral slings – which are different from the problematic meshes now banned in Australia for treating prolapse – are also usually safe and sometimes medically necessary for treating prolapse, she says. It’s important women are aware of this.

But where King goes astray is in her comment that women are shunning evidence-based treatments involving slings and mesh because of “the fear generated by adverse publicity, social media and the Senate inquiry”.

The vast majority of women who contacted Australia’s Senate inquiry into transvaginal mesh procedures reported severe complications such as bladder perforation, excruciating pain and recurring infections. The inquiry found: “… most of these women have experienced great difficulty finding medical practitioners who would accept that the symptoms they were experiencing were as severe as they claimed… their struggles to find support and treatment have had far-reaching and devastating impacts on their lives”.

King says because of the inquiry and subsequent negative publicity, “I am performing prolapse procedures without mesh which I know have an extremely high chance of failure – simply because of patient anxiety”.

“This is poor practice but what else can we do,” she says.

But there is a lot specialists like King can do, and it starts with listening to and informing women. Her comments echo those made in a piece published in the New Zealand Medical Journal that said the media “have over previous years done great harm to the reputation of mesh abdominal wall and groin hernia repair”. 

What should also be prominent in these statements is recognition that doctors, regulators and pharmaceutical companies have failed women repeatedly. There needs to be a renewed and meaningful commitment made to listening to women and to making sure they give informed consent. There have been reports that pharmaceutical companies who manufactured transvaginal meshes began heavily promoting them to doctors, and that doctors and regulators continued to promote the devices to patients in the face of a growing body of evidence that efficacy was lower and complication rates were higher for pelvic organ prolapse.

Why didn’t regulators demand stronger evidence? How many women were told that there was little robust information on the success of the procedures in the long term, and that complication rates could be significantly higher than those typically reported in clinical trials? (javascript:void(0)) How many regulators and surgeons failed to scrutinise the evidence pharma presented to them, and to keep on top of new research?

Complications may be rare but given transvaginal mesh operations accounted for nearly 25% of prolapse interventions in some countries by 2010, this still equates to hundreds of thousands of women who have experienced bad outcomes.

Mistrust of excellent doctors like King is worrying. It leads women to unproven, useless and ineffective treatments. But the way to win women back is not to point towards media scare-campaigns or government inquiries. Let’s not forget where this sorry saga began – with dodgy clinical data and regulatory failure. Women are fed up, and they have reason to be scared. They have a right to think twice, ask questions, and demand to be heard. The transvaginal mesh saga is only the latest in a series of examples of women being let down, with devastating consequences.

It’s up to the regulators and the medical profession to regain their trust. • Melissa Davey is Melbourne bureau chief for Guardian Australia Guardian Newspapers Limited