AMERICAN pharmaceutical giant Johnson & Johnson has withdrawn its “gold standard” incontinence pelvic mesh slings from the Australian market after devastating evidence from women at a Senate inquiry and Federal Court civil case, and action by Australia’s medical device regulator.
The move this month has been described as “extraordinary” and “fantastic” by consumer and women’s health groups which campaigned strongly for their removal, but a backward step by doctors who said the “gold standard” TVT incontinence devices had helped tens of thousands of Australian women since they were introduced in 2004.
Johnson & Johnson withdrew before a January deadline to meet new Therapeutic Goods Administration (TGA) guidelines announced in December requiring companies to warn that devices could lead to complications including severe and chronic pain, groin pain and bladder perforation.
On Tuesday the TGA released an updated list of pelvic mesh devices available in Australia which showed only two companies still marketing 13 devices, down from about 100 devices and multiple companies in 2013. The Johnson & Johnson mesh slings can continue to be implanted in Australian women until supplies run out.
The TGA in November banned all prolapse pelvic mesh devices implanted via the vagina because of little or no evidence backing their safe use. In December it banned a small group of problematic incontinence slings and issued new guidelines requiring remaining incontinence devices, including the “gold standard” slings, to clearly warn of the risks to women.
Johnson & Johnson’s decision to withdraw surprised women and consumer health groups after the TVT devices – whose prototype and early procedure were developed in Australia – were strongly backed by doctors giving evidence at a Senate inquiry and Federal Court case brought by more than 800 Australian mesh victims against Johnson & Johnson.
The Johnson & Johnson devices have repeatedly been described as the “gold standard” slings to treat incontinence because of recognised trials supporting their use.
But Robyn Ramster, Lynda Garlinge and Hunter woman Teigan – who experienced severe and extreme complications after she was implanted with a Johnson & Johnson incontinence sling when she was 22 – said the slings were just as capable of destroying women’s lives as the more recognised problem devices used to treat prolapse.
“We’re paying the price for their experiments on women,” said Mrs Garlinge, 68, who spent nearly a decade dealing with severe and disabling complications after surgery for incontinence in 2004 without knowing she was one of the earliest cases to receive a TVT mesh sling.
Her doctor was dead by 2014 when she read surgery notes saying she had been implanted with a Johnson & Johnson TVT sling without her consent.
“I felt like I’d been raped. That’s how I felt,” she said.
I’ve lost the best years of my life and now I’m going to lose the rest. I get so angry. How could this have happened?Lynda Garlinge
Mrs Garlinge said Johnson & Johnson’s withdrawal from Australia was “good news, but they would have kept on putting these things into women if they hadn’t been found out”.
“I’ve lost the best years of my life and now I’m going to lose the rest. I get so angry. How could this have happened?” Mrs Garlinge said.
Robyn Ramster, 64, lived with chronic pain and urinary tract infections after she was implanted with a Johnson & Johnson TVT mesh sling for incontinence in 2005.
When she sought help from doctors she was told her problems could not be linked to the TVT device “because it was known to have worked so well for so many women”, she said.
In 2017 she had surgery which a doctor described as “scraping the mesh off your bladder”.
She was pleased on Wednesday to hear that Johnson & Johnson had withdrawn its devices from Australia but “the sad thing is it took so long for people to listen to us”.
“It was only because of the publicity that women like me started hearing other women describing what was happening to them, and suddenly thinking ‘That’s me. That’s happening to me’,” Mrs Ramster said.
She said the rapid uptake of pelvic mesh devices and slings in Australia, without doctors, doctors’ groups and regulators properly scrutinising the research manufacturers were relying on, was “disgraceful”.
Consumer Health Issues Centre chief executive Danny Vadasz described Johnson & Johnson’s withdrawal as “an extraordinary decision”.
“It suggests they have concluded that a withdrawal from the Australian market is preferable to continued scrutiny,” Mr Vadasz said.
“Under such circumstances it’s extraordinary that some health professionals are calling for stock still in circulation to be used up rather than withdrawn and are focussed on finding equivalent substitutes. When will the penny drop?”
A TGA spokesperson said Johnson & Johnson withdrew supply of its mid-urethral sling devices to enable them to consider their options in response to the TGA’s request from December.
“From 17 January 2018, Johnson & Johnson had decided to withdraw supply. Use of devices supplied prior to the 17 January date is at the discretion of the medical practitioner and the individual patient,” the spokesperson said.
Royal Australian and New Zealand College of Obstetricians and Gynaecologists president Professor Steve Robson said Johnson & Johnson had made a commercial decision not to import TVT devices to Australia but “fortunately there are other similar devices still available to women in Australia and New Zealand”.
“It is true that there is strong evidence to support the use of mid-urethral tapes in women with genuine stress incontinence, particularly when relief from distressing symptoms through methods such pelvic floor exercises is not successful,” Professor Robson said.
“Again, the Johnson & Johnson decision is a commercial one and the reasoning behind this is unknown to me.”
Johnson & Johnson did not respond to a request for comment.