IT is the Facebook post on October 29 that shocked women around the world – of pelvic mesh campaigner Christina Lynn Brajcic in a hospital bed saying “This is insane. To almost be on your death bed at only 42 because of mesh, it’s not right.”
One month later the outspoken Canadian and mother of two was dead.
Australian pelvic mesh campaigner Caz Chisholm advised the Therapeutic Goods Administration on Friday, in an email demanding it extend last week’s targeted ban of some pelvic mesh and sling devices to become a total ban on all pelvic mesh devices, even those regarded as “gold standard” for stress incontinence.
“Chrissy was sick for many years. She fought hard. She was 42 years old and leaves behind two very young sons and a husband. It was a Johnson and Johnson stress incontinence midurethral sling that destroyed her life and finally took it forever,” Ms Chisholm told TGA deputy secretary John Skerritt.
“Women who are permanently injured by these devices do not consider them to be the gold standard. How can they be when the risks can be so catastrophic?”
Danny Vadasz, of consumer health group Health Issues Centre, said there were “ample reasons” to support a total ban on all pelvic mesh devices. He was scathing of a system that accepted permanent and incapacitating injuries to a minority of women because the devices helped treat some women’s incontinence.
“What does it have to take before the penny drops, before we treat this seriously enough?” Mr Vadasz said.
Mrs Brajcic’s death – which is not the first recorded death of a woman experiencing pelvic mesh complications – was “way beyond the discomfort and inconvenience” that some doctors referred to when questioned about mesh risks, he said.
“How many deaths before the regulators and other health bodies are shamed into doing their jobs?” Mr Vadasz said.
Mrs Brajcic died in hospital on Thursday, Sydney time, after emergency treatment in late October for sepsis – a life threatening response to infection that can lead to organ failure. Her husband Tony said “her heart stopped”, but the coroner is yet to provide a formal cause of death. In Facebook posts in November she described some days as “really bad”.
Mrs Brajcic was implanted with a mesh midurethral sling in 2013 for incontinence after the birth of her youngest son. Versions of the midurethral sling remain on the market in Australia, despite the TGA’s targeted ban of all transvaginal – surgery via the vagina rather than abdomen – prolapse mesh devices, and a group of incontinence mesh slings.
Mrs Brajcic experienced immediate severe pain after the 2013 surgery that only worsened with time. In a Canadian news report in September she said her surgeon dismissed her complications as the mesh settling in.
The formerly vibrant and active interior designer had the mesh removed after searching for surgeons who would do the risky procedure, but spent much of the past four years confined to a wheelchair and on constant antibiotics, painkillers and anti-nausea medications.
Her death prompted an outpouring of grief from mesh-injured women around the world, including many in Australia who had regular contact with her via Facebook.
“Everyone in the mesh world knew her,” said Ms Chisholm.
“No-one can believe she’s gone. She helped all of us and now she’s dead. It’s just so shocking. She was so unwell but now it’s happened. It’s really happened.”
Sydney mesh campaigner Gai Thompson, who had a different Johnson & Johnson transvaginal mesh device in 2008 that Australian surgeons have told her cannot be removed, said Mrs Brajcic “drew attention to the cause because she wanted to get this stuff banned”.
“Doctors talk about the thousands of women who’ve had mesh without complaint but they don’t talk about the women who are left with this crap in them that destroys their lives, and that’s what people don’t understand,” Mrs Thompson said.
In a complaint to the TGA in 2011 Mrs Thompson said she was “living a nightmare”, with constant urinary tract infections leaving her resistant to some antibiotics, chronic and severe pelvic pain, chronic bowel problems, incontinence, multiple areas where the mesh had eroded into her vagina, she was unable to have sex with her husband, unable to work and the couple had been forced to sell their home.
“I’ve still got all my mesh in and I’ve got constant infections I can’t get rid of. I’m on the strongest antibiotics I can be on and it’s doing nothing. It’s been in there for nearly 10 years. The long term consequences of putting polypropylene mesh into women’s bodies is unknown, and yet doctors, manufacturers and the TGA say it’s all ok,” Mrs Thompson said.
In one of her final posts, that echoed evidence by Australian women at recent Senate inquiry public hearings in Perth, Sydney, Canberra and Melbourne, Mrs Brajcic said she experienced “anger that my life was taken away from me”.
“I feel neglected by the medical system. That we have to fight so hard to get even an ounce of help is just not right,” Mrs Brajcic said.
In her October 29 Facebook post from a Canadian hospital bed after she was transferred from an intensive care unit, Mrs Brajcic told supporters: “How do I go from an infection to heart failure? I’m 42. It was the scariest experience of my life. I’m so lucky to be alive.”
In a Facebook post circulated to mesh groups in Australia, America, New Zealand, England, Scotland, Ireland and Europe, Mr Brajcic said his wife was “a very strong fighter right up to the very end”.
On November 28 the TGA moved on a final eight transvaginal prolapse mesh devices and certain incontinence slings on the Australian market, ordering their cancellation or that they not be implanted via the vagina.
It followed a review that found the risks outweighed the benefits of the prolapse devices and there was a lack of adequate scientific evidence backing the incontinence slings. Since 2013 the TGA has cancelled 43 mesh devices and their multiple variants.
In October the TGA moved to upgrade the classification of all implantable pelvic mesh devices to high risk.
In a statement on the “gold standard” midurethral slings, where there is accepted research supporting their use, the Royal Australian and New Zealand College of Obstetricians and Gynaecologists in May acknowledged complications “may become intractable”.
“In some women these long term adverse outcomes have had severe effects on everyday activities and their quality of life. The mesh is a permanent material that can result in mesh exposure and infection which may occur soon after surgery or many years later,” RANZCOG said.
“This can result in the need for mesh removal which may be difficult, may have complications and may not completely resolve chronic pain or other adverse symptoms.”