Sioux Bettiens was at work on Tuesday when she received a text message that made her stomach drop.
“Oh, I’m really sorry about the Bayer ruling,” an old colleague had messaged.
Ms Bettiens is one of the more than 1,400 women who lost a class action lawsuit against pharmaceutical giant Bayer over its female contraceptive device Essure.
Logging online to see the news, the Macedon Ranges woman discovered that a six-year legal battle hoping to prove that the Essure implants caused major health problems had ended in failure.
In his judgement, Justice Andrew Keogh said the evidence did not indicate that the Essure device had been the cause of health issues reported by plaintiffs.
“I have concluded that the biostatistical evidence weighs heavily against causation, and represents a very significant barrier to [the plaintiff] proving general causation … the expert evidence of biologically plausible causal mechanisms is far from compelling,” Justice Keogh said.
Ms Bettiens said the group of women had been stunned by the decision.
“Collectively crushed is putting it politely, a little bit of disbelief, a little bit of anger, a lot of frustration,” Ms Bettiens said.
“So many of us really thought that the evidence was profound. It was fairly straightforward. It was all there. What did the judge not pay attention to?”
More than a decade of health complications
The decision on Tuesday punctuated a 12-year ordeal for Ms Bettiens, who struggled with health complications after having the Essure device inserted.
One main argument of the plaintiff’s case was that Bayer did not provide adequate warnings about the risks of the device, a claim rejected by Justice Keogh.
Ms Bettiens said she was told only about generic risks alongside the help of a pamphlet, with recovery time likened to that of a vasectomy.
Instead, she said felt excruciating pain from the moment the device was inserted.
“I had pain straight away,” Ms Bettiens said.
“At my six week check-up with the gynaecologist, I explained that to him. That’s when he said, ‘Oh it’s all in your head. Don’t get caught up in the media hype’.”
More tests, ultrasounds and specialist appointments followed, as Ms Bettiens said she felt as if she was forced to harass doctors in order to have them take her pain and concerns seriously.
Exploratory surgery was eventually scheduled, where she asked doctors to remove her Essure device if there were any issues.
The surgery revealed that one of the devices had in fact perforated her left fallopian tube, which was removed along with the device. But the device on her right side had been left untouched.
“I was almost crying, partly validated, partly like you still didn’t listen to me. You’ve gone back on the agreement. You haven’t taken the other side out,” she said.
Ms Bettiens said the symptoms continued until she was able to get a hysterectomy via the Royal Women’s Hospital.
She said that she still deals with health complications today, but that her experience in attempting to deal with the Essure device has scared her away from the public system.
“I think you end up losing a lot of faith in the medical system and the medical industry,” she said.
A more gender equitable system
In his judgement, Justice Keogh said the health issues raised by plaintiffs were common to women of reproductive age, where diagnosis was complex.
“Chronic pelvic pain and abnormal uterine bleeding commonly affect women of reproductive age. There is a broad range of potential causes of both disorders,” Justice Keogh said.
It was a statement that Ms Bettiens found troubling.
“It does make me wonder that if it was something that happened to a man …and he had to have his testicles removed because of it, would they still say, ‘oh well, it’s just because of your age and these are things that happen to men’,” she said.
Women’s Health Victoria chief executive Sally Hasler acknowledged the courage of the women who had come forward as part of the class action.
Ms Hasler said there was evidence to show a split between the medical care given to different genders.
“There’s lots of lived and living experience to demonstrate that women’s pain and experiences of pain and trauma are often dismissed, and especially when it comes to pelvic pain,” Ms Hasler said.
“More broadly speaking, women and gender diverse people have not been included in medical research, and this means there’s a systemic bias which can lead to poorer health outcomes.”
Ms Hasler said it was not uncommon for some to lose faith in the medical establishment having their health concerns ignored.
“Cases like these shake women’s trust in devices and in the health system,” she said.
“We will never have a gender equitable system unless women are able to come forward and talk about the problems happening every day.”
Ms Hasler said a larger focus needed to be put on sex and gender in medical research, in an effort to combat “in-built bias” in the health system.
Bayer stands by safety of Essure
In a statement, Bayer said it stood by the product, which was supported by “an extensive body of research” including 10 clinical trials and 150 studies involving more than 280,000 women.
“Bayer welcomes today’s decision by the Court as it is in line with the science-based profile of the safety and efficacy of Essure, a permanent contraceptive device for women,” the company said.
“The health and wellbeing of women who rely on our products is our greatest priority. Women who currently have Essure may continue to confidently rely on the device. If a woman with Essure has questions or concerns about the device, then we encourage her to speak to her healthcare professional.”
Bayer was sued by women who had experienced similar complaints while using the product in the United States, and agreed to a $US1.6 billion ($2.4 billion) settlement. However that settlement had no impact on the Australian case.
Bayer said the Essure product has now been withdrawn from the Australian market for commercial reasons.
Justice Keogh’s judgement is set to be formalised in the coming days, with any appeal needing to be launched early next year.
Ms Bettiens was involved early in the class action run by law firm Slater and Gordon, which began in 2018.
Despite more than half a decade of fighting, Ms Bettiens said she is motivated to keep going.
“I’m absolutely fed up, but I’m also willing to fight it, because there needs to be some kind of accountability,” she said.
“We’re people, we’re parents, we’re partners, we’re not just numbers, we’re not cattle, and I feel like that’s how we’ve ultimately been treated.”
