TEIGAN was 22 in 2008 when she was implanted with a “gold standard” pelvic mesh sling device for incontinence, less than two months after the birth of her second child.
Nine years later there are times when she has to lay flat on her back in a shallow warm bath to urinate because of the pain of “strangury” – an inability to void caused by the interaction of the mesh and her bladder. Urinary tract infections are frequent. The boundaries of her life are marked by the availability of toilets no more than an hour from her Hunter region home.
“This is what I have to do now. I’m scared of what I’m going to have to do in 10 years. I’m scared, especially because I haven’t reached menopause and people are saying the complications can get worse with menopause. That’s a long way away for me,” said Teigan, 31, who agreed to speak about the devastating consequences of mesh surgery on her life, but asked that her surname be withheld because of their intimate nature.
I’m scared of what I’m going to have to do in 10 years. I’m scared, especially because I haven’t reached menopause and people are saying the complications can get worse with menopause. That’s a long way away for me.Teigan, 31, who had pelvic mesh surgery at 22
On Thursday Australia’s peak drug and medical device regulator, the Therapeutic Goods Administration, quietly announced on its website that from December, 2018 all new pelvic mesh devices will be classified high risk requiring evidence of safety and efficacy, while currently available mesh devices will have until December, 2020 to meet new evidence standards.
The changes were announced as a Senate committee prepares a final report into how mesh devices were approved for use in Australia despite serious questions about the evidence used to support them, and as women in countries including Australia, the United Kingdom, America and New Zealand have initiated more than 100,000 legal suits, in a global push where claims are estimated to top more than $20 billion.
Teigan is one of more than 800 Australian women registered in a Federal Court legal class action against Johnson & Johnson that started in July and will continue into 2018. Another 500 women are registered in a class action case against a second mesh manufacturer, American Medical Systems.
The Gold Coast specialist who implanted her Johnson & Johnson TVT device, Dr Malcolm Frazer, is scheduled to give evidence at the class action in early November as an expert witness engaged by legal firm Clayton Utz, which is representing Johnson & Johnson.
In a statement in June the Royal Australian and New Zealand College of Obstetricians and Gynaecologists said the use of slings to treat incontinence was “a safe and effective treatment and regarded as the ‘gold standard”’ for incontinence surgery. A Senate inquiry in September was told complication rates after sling surgery ranged from 2–5.6 per cent.
Teigan’s GP referred her to Dr Frazer in 2008 after she complained of “annoying” incontinence when she coughed or tried to move quickly following her second baby’s birth.
Her hospital notes show she was in pain and unable to urinate after surgery to implant the device, was “very uncomfortable” a day after surgery because she was unable to void, was “in tears” while trying to catheterise herself, and went home after four days with a catheter in place and a urine bag strapped to her leg.
“I was pretty miserable as I only had a new baby. I felt like an old woman. It wasn’t what I was expecting at all,” she said.
“In hindsight I probably just needed time to recover from the pregnancy.”
Teigan moved from the Gold Coast to the Hunter and did not see Dr Frazer again after a six-week post-surgical check up.
She described the following years as a gradual increase in regular urinary tract infections and pain, incontinence, increasing difficulty urinating and going to general practitioners who did not connect the complications with the TVT sling tape.
In September Royal Australian College of General Practitioners representative Dr Magdalena Simonis told the Senate inquiry there was “no excuse” for the experiences many Australian women had had when they sought help from doctors because of mesh surgery complications.
Those complications were “a new issue” for general practitioners “in terms of making the association” with mesh, Dr Simonis said.
“It has not been in our heads up until relatively recently, unfortunately.”
In April this year Teigan had a third baby by caesarean because of the TVT tape.
“The pregnancy was difficult because it was really painful to walk and I’d get shooting pains up my groin at times,” she said.
By June an ultrasound showed why she experienced serious pain if her bladder filled, but also why she often cannot sit to urinate if more than an hour passes between toilet breaks. The ultrasound showed the TVT sling was “the likely cause” of “kinking” of the bladder over the mesh sling – like a kinked garden hose - resulting in “strangury”, which both increases the urge to urinate and restricts the ability to do so.
“I get the stinging urge to go but nothing comes out. That’s when I have to lie in the bath,” Teigan said.
“I feel quite limited. I don’t go anywhere because I need to find a toilet before it reaches that point.”
Dr Frazer said he could not comment on an individual patient.