Women are in danger of losing a perfectly safe and effective device for urinary incontinence, as the scandal over transvaginal mesh catches mid-urethral slings in its wake.
Early last year the Senate in Canberra launched an inquiry in response to women coming forward with reports of serious side-effects from mesh implants.
While many have welcomed the opportunity to address problems around mesh, leading gynaecologists expressed concern at last week’s RANZCOG Annual Scientific Meeting in Adelaide that the commission had bundled slings into the same category.
“There’s not a gynecological operation that’s been studied more than mid-urethral slings for stress incontinence,” former AMA president Dr Michael Gannon told The Medical Republic.
If the new regulations were well-considered, perhaps resulting in a more carefully selected group of patients being given transvaginal mesh for pelvic organ prolapse by a smaller group of highly trained gynecological surgeons, that would likely be a positive, he said.
“But one of the messages that the Senate Committee didn’t get was that mesh for transvaginal prolapse and midurethral slings for stress incontinence are two completely different processes.”
As such, it would be “a great shame” if the backlash led to a whole new group of victims who would be denied “a very safe and very effective treatment for a very disabling condition”, he said.
In Australia, an estimated 30,000 to 40,000 procedures using mesh for the treatment of vaginal prolapse have been performed, and more than 100,000 procedures using tape for stress urinary incontinence have been conducted.
Quality-of-life questionnaires had found that women with urinary incontinence sometimes score as badly as those with neurodegenerative conditions and cancers, and the reality for many women with the condition was constant toilet mapping, avoiding social situations, declining invitations and becoming more and more housebound, Dr Gannon said.
But already this year, the TGA removed the listing for transvaginal mesh for prolapse and single incision slings and asked for updates on the Instructions For Use (IFU) that resulted in the shipment of the most studied sling being for a few months, Melbourne urogynaecologist Associate Professor Anna Rosamilia told the audience in Adelaide.
In the UK and the US, regulations have already restricted the use of slings for stress urinary incontinence, with doctors in England unable to perform the procedure until March when more vigilance measures will have been established.
One of the reasons for this broad alarm was the impact that the personal stories of victims had on the senators, Dr Gannon said.
“They saw a group of very brave, injured women, and I think came up with some recommendations that, while some of them are appropriate, some of them have the potential to harm a future cohort of women who’ll be denied appropriate treatments.”
Community activism has been a powerful driver of action on this front, with passionate groups emerging on Facebook in Australia, New Zealand and globally. During the recent launch of the TGA’s Facebook page, early posts quickly filled with comments of women complaining about the adverse effects they attributed to the mesh.
Professor Steve Robson, president of RANZCOG, said there had been extraordinary hostility levelled at him after posting a video apologising to women harmed by transvaginal mesh on the college’s website.
In the time it took him to fly from Canberra to Perth following the post, he said he had received 203 personally vitriolic emails, one saying: “Your practice is not a medical practice. You run an abattoir, and you specialise in butchery.”
While he said it was “devastating” for the college to be accused of “having a problem with women”, Professor Robson said he also recognised that this issue highlighted the need for the profession to not uncritically accept the assessments and processes of other organisations, such as assuming the devices were safe because the TGA had approved them.