Key Points
- A class action lawsuit is starting against Bayer's Essure contraceptive device.
- Lawyers from Slater and Gordon say the device left women in severe pain and damaged their health.
- Lawyers also allege Bayer failed to warn women of the risks associated with the product.
Georgina Hahn was 32 when she had the Essure contraceptive device implanted in 2002.
She told SBS News she was not warned of any potential side effects, but almost immediately started experiencing severe pain and blood clots "the size of her fist".
In the years that followed, Ms Hahn said she had relationships break down, lost her sex drive, became unable to care for her children, had difficulty working, and experienced depression and post-traumatic stress disorder.
"It's just crippling in every possible way — physically, mentally, emotionally," she said.
"Obviously (you) want to be able to function like a normal person and be able to do those things but you just physically and mentally and emotionally can't."
Some 1,000 Australian women have joined a class action lawsuit over Essure contraceptive devices. Source: Supplied / Andrea Petrie / Slater and Gordon
"For my health but also for my loved ones, I just could not function any longer," she said.
"I couldn't care for my children. (It was) just debilitating, absolutely debilitating, the whole experience."
Ms Hahn is one of 1,000 women in a class action lawsuit against Essure devices and manufacturer Bayer that's starting in the Supreme Court of Victoria on Tuesday.
She described some women's experiences with the device as "torture".
"It's just mind-boggling, the amount of suffering, the amount of relationships lost, the amount of torture that some of these women have gone through, it's just incredible," she said.
"This has been many years in the making, and there's an enormous amount of women suffering every day."
Tasmanian woman Lisa Garner says she experienced symptoms including haemorrhage-like menstrual bleeding, severe pelvic and abdominal pain, and depression after she got an Essure device implanted.
She underwent a hysterectomy at age 35 to have the device removed, putting her into early menopause.
"I am angry on behalf of every woman around the world who has had this device inserted without it being properly investigated, and the harm it has caused us," she said.
What is the Essure device?
Essure is a spring-loaded metal spiral device, which, following insertion into a woman's fallopian tubes, was designed to cut into the soft tissue of the inner walls.
This was intended to trigger an inflammatory response to promote the formation of scar tissue around the device, anchoring it in place and blocking the passage of sperm and egg to prevent pregnancy.
The permanent female contraceptive device was added to German company Bayer’s contraceptive portfolio in June 2013 following Bayer’s acquisition of Conceptus, the manufacturer of Essure.
In 2017, Bayer discontinued the distribution of Essure in Australia for commercial reasons. After 31 December 2018, Essure was not available in any market.
What is the lawsuit about?
Law firm Slater and Gordon, which has brought the lawsuit, claims the devices sold by Bayer also damaged their clients' health.
It additionally alleges the company failed to warn women of the risks associated with the product.
The class action trial, expected to run 12 weeks, is against Bayer and its associated entities who manufactured and distributed the Essure device in Australia between 1997 and 2017.
"Australian group members are frustrated that litigation in the US settled for very large sums of money, for the same device, while no settlement has occurred in the Australian proceeding," Slater and Gordon Class Actions Senior Associate Kylie Trounson said.
Bayer says it stands behind the safety and efficacy of the Essure contraceptive device. Source: AAP / Oliver Berg/EPA
"What we really want is for them to admit they've done wrong," she said.
"I don't think we're going to get that from Bayer and that's probably the hardest pill to swallow ... but we do we just want acknowledgement.
"There's no amount of money that can fix this."
How many women are involved?
Slater and Gordon says it represents 1,000 women who are part of the class action in Australia.
The Washington Post reported in 2017 that Bayer had sold at least 750,000 Essure devices globally before taking them off the market.
In August 2020, the company agreed to pay US$1.6 billion ($2.5 billion) to settle cases with up to 39,000 American women.
The US settlement did not include any admission of wrongdoing or liability by Bayer and the settlement has no impact on the class action litigation in Australia.
Bayer stands behind Essure
A Bayer company spokesperson said the health and safety of the patients is the company's "greatest priority".
"We have great sympathy for anyone who has experienced health problems while using any of our products, regardless of cause," the spokesperson said.
"Bayer believes it has strong defences and will continue to defend itself vigorously in court. We are confident that the evidence in this case will demonstrate the company is not responsible for the alleged injuries."
The spokesperson said Bayer stands behind the safety and efficacy of Essure.
The company says the device is supported by an "extensive body of research" including 10 clinical trials and over 70 real-world observational studies undertaken by Bayer and independent medical researchers, involving more than 270,000 women over the past two decades.
"Women who currently have Essure in place may continue to confidently rely on the device," the spokesperson said.
Bayer says it will continue to support women with Essure and their healthcare providers.
"If a woman with Essure has concerns or questions about the device, she is encouraged to discuss these with her healthcare provider."
'It ruined so many lives'
Jodie Trengrove, from Adelaide, said she had "lost all faith in Bayer" and would “never buy another product they’ve made".
“It’s just wrong what they’re doing. They put this product out there without properly testing it and it ruined so many lives,” she said.
Ms Trengrove said the product should have been removed from the market once the issues became apparent.
“They need to acknowledge what they’ve done and do the right thing by those affected,” she said.
- With additional reporting by AAP.
