Transvaginal mesh made headlines for all the wrong reasons. The fallout continues.
Many surgical mesh manufacturers have not met upgraded TGA standards, leaving women with fewer options for prolapse repair and urinary incontinence surgery.
The regulator has now almost finished reclassifying all the surgical mesh implants remaining on the market, after debilitating complications led to high-profile lawsuits here and abroad.
The ARTG listing for transvaginal devices solely used for pelvic organ prolapse was cancelled in November 2017. But sponsors of urogynaecological mesh devices, used mainly for pelvic organ prolapse and stress urinary incontinence, had until 1 December 2020 to meet safety, quality and performance criteria. Devices used for other conditions will be evaluated in the coming weeks.
Many didn’t make the cut.
Since 2013, when complaints first escalated, 45 products have been removed from gynaecological use by the TGA. There are currently only eight urogynaecological mesh devices that have met the Class III regulatory requirements.
“After the profusion of mesh kits and tapes that were available … we’re now down to just a small number,” said Professor Steve Robson, past president of RANZCOG. “And of course, with covid manufacturing issues, there’s a big logistical problem with even getting some of them.”
This lack of devices was “a massive problem”, said urogynaecologist Dr Salwan Al-Salihi, from the Royal Women’s Hospital in Melbourne, because despite the fear around surgery for prolapse and incontinence, many women have exhausted all other alternatives.
“We routinely start with conservative management,” said Dr Al-Salihi. “All women who come to our clinic are offered non-surgical options until they are proven to be ineffective, or they don’t improve their quality of life. Surgery is the last resort.”
While mesh is no longer employed vaginally, it is still used abdominally.
Dr Al-Salihi had observed mixed feelings about surgery among women since the issues with mesh were first raised and highlighted in the media.
“We have a lot of women who come and say, ‘Look, I want this. I want something that will work for me. I don’t mind what it is’.
“And then other women say, ‘I don’t want anything permanent. And if the trade-off is that it will come back again and I need more surgery, can I do it again?’.”
He is concerned that there are now many women who are afraid to seek help even though they need it.
“Take incontinence, for example. After incontinence surgeries using slings were restricted in Europe and the United States in 2011, there was a 50% reduction in incontinence surgeries in the first year,” he said.
“That’s 50% more women going through life persevering with incontinence, which is tragic.”
Professor Robson told The Medical Republic he understood why women might now find it difficult to have confidence in this type of surgery following the issues with transvaginal mesh procedures.
“My sense is that trust has been broken. Many women, with some justification, feel that they’ve been experimented on. I heard the term ‘guinea pig’ used many times, and I understand why people feel that way,” he said.
“There’d be nothing more frightening than saying, ‘Have a procedure. And by the way, we’ve got all these pages of detailed legalese go through’. That alone must be extremely intimidating.”
But he added that there had been “a complete evolution over the last 10 years”.
“Part of what happened at the height of the mesh craze was, I think, a lot of people were misled into thinking that they would have this risk-free outcome.
“Now it is about helping people understand the condition, think about the right options, optimise their own health, understand that’s it’s a long-term thing and that there is no perfect solution,” said Professor Robson. “We can try to find something that will give them as good a result as we possibly can, but no one’s guaranteeing anything.
“If anything, the mesh crisis has made people go back to basics and take a broad approach to trying to make people’s lives better, not just concentrating on fixing an anatomical thing.”
Professor Robson said some of the women who had experienced terrible suffering from vaginal mesh complications had been operated on when they had no symptoms from the prolapse.
There are many alternatives in that scenario, he pointed out, such as referring a patient to a skilled pelvic floor physiotherapist, changes in diet, exercise, quitting smoking, and estrogen treatment.
Some would still need surgery, though.
But all the options currently on offer had limitations, said Dr Al-Salihi.
Even native tissue repair, using the woman’s own tissue, may improve quality of life for several years, but unfortunately the longevity of such options was not great, he added.
Nonetheless, Dr Al-Salihi continued to encourage women to seek care.
“It’s well known that women do put themselves last on the list when it comes to their family,” he said. “This is a quality-of-life issue. You really need to look after yourself. And we’re here to help.”
