By Aisha Dow
A group of Australian women who underwent hysterectomies after reporting severe side effects from a permanent sterilisation device has lost a class action against pharmaceutical giant Bayer, with a judge noting that chronic pelvic pain was common for many women.
Victorian woman Patrice Turner led the case against Bayer Australia and five other companies involved in the design, manufacturing and marketing of the Essure, a coil-like device inserted into a woman’s fallopian tubes.
Patrice Turner (centre) arrives at the Victorian Supreme Court in 2023.Credit: Simon Schluter
Turner had the Essure fitted in 2013 after seeking out options for permanent contraception following the birth of her third child. However, in the years that followed, she began to experience long and heavy periods and sharp and debilitating pelvic pain that worsened over time.
The problems stopped when, aged 32, she had a hysterotomy to remove the coils.
Other women who had the Essure fitted have told similar stories. Sydney woman Monique Emmett said that after she was fitted with the Essure in 2007 following the birth of her third child, she was in so much pain she was sometimes unable to walk.
About 1400 Australian women had joined the class action.
On Tuesday, Victorian Supreme Court judge Andrew Keogh knocked back claims by Turner and the other class action members that the Essure was defective. He said he was not satisfied Turner had established the Essure device caused chronic inflammation in some women, resulting in chronic pelvic pain, painful periods and abnormal uterine bleeding.
Keogh said chronic pelvic pain and abnormal uterine bleeding commonly affected women of reproductive age.
“There is a broad range of potential causes of both disorders. Diagnosis is complex, and causation is often multifactorial. It is not uncommon that no causal pathology is identified. This context is relevant to Turner’s attempt to attribute causation of CPP [chronic pelvic pain] and AUB [abnormal uterine bleeding] to Essure,” Keogh said in his judgment.
“The evidence supporting general causation in the histological and corrosion studies, and the expert evidence of biologically plausible causal mechanisms is far from compelling. ”
The judgment said Turner’s treating surgeon had diagnosed adenomyosis (when tissue from the lining of a woman’s uterus grows into the uterine wall) as the cause of her gynaecological symptoms, although the surgeon was not called to give evidence.
During the trial, Turner’s lawyer, Fiona Forsyth, KC, said that while adenomyosis was an early suspected diagnosis given by her doctor, it was not confirmed post-surgery.
Tanya Davidson wants recognition that her experience after being fitted with the Essure was real and not “in her head”.Credit: Jason South
Victorian woman Tanya Davidson, who blames the Essure for her ongoing symptoms of “excruciating” pelvic and back pain, hair loss and cognitive decline, was in court to hear Tuesday’s judgment.
“It kind of felt very similar to what I’d heard all along via my male doctors, [that it’s] all in the head,” she said.
“But at the same token, the whole time, I prepared myself for such an outcome. I only ever wanted our day in court.”
Davidson, a mother of four from Bendigo, said she had the Essure fitted in 2010. She said that soon after, she began having periods that lasted more than 20 days a month. Before that, she said, her periods had lasted only three days each month, and she had never experienced pelvic pain.
“There’s no normal about that,” she said.
“From my personal point of view, it’s like everything points to Essure … from those first few months of insertion, that’s when my symptoms began.”
While Bayer has paid out about $2.5 billion to settle lawsuits involving the Essure in the United States, the company has continually denied there are widespread problems with the device. Bayer stopped distributing the Essure in Australia in 2017, citing business reasons.
In a statement, Bayer welcomed the court’s decision.
“Bayer stands behind the safety and efficacy profiles of Essure, which is supported by an extensive body of research (including 10 clinical trials and over 150 studies, undertaken by Bayer and independent medical researchers, involving more than 280,000 women over the past two decades),” a spokesperson said.
“Women who currently have Essure may continue to confidently rely on the device.”
Slater and Gordon Lawyers, which represented Turner, said it would carefully review the judgment.
“We are profoundly grateful for the courage of lead plaintiff Patrice Turner in giving evidence in this proceeding on behalf of the group. We want to thank the 1400 women who stood with Patrice in bringing the class action,” a spokesperson said.
Slater and Gordon previously said more than 500 of the women it represented had a hysterectomy (removal of the uterus) or removal of fallopian tubes to remove the Essure.
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