They say the sterilisation device left them in pain – but the manufacturer defends its safety.
Image source, Deborah ChalkTwo hundred women in the UK who claim they were left in pain after having a permanent contraception device fitted, can now take group legal action through the courts, against its manufacturer.
The Essure coil “has caused irreparable damage physically and mentally”, the women’s lawyers say.
German maker Bayer says it will defend itself vigorously against the claims.
When Essure was withdrawn from sale, in 2017, the UK medicines regulator said there was no risk to safety.
Lawyers in England began legal action in 2020 and now have permission to bring a group claim on behalf of 200 women.
Other women wishing to join the group action have until 2024 to do so.
Heavy bleeding
The Essure device is a small metal coil inserted into a woman’s fallopian tubes.
Scar tissue forms around the coil, creating a barrier that keeps sperm from reaching the eggs.
Launched in 2002, the device was marketed as a simpler alternative to sterilisation by surgery.
But some women say they suffered constant pain and complications, including heavy bleeding, with some ending up having hysterectomies or the device removed altogether.
‘Mood changes’
Deborah Chalk, 39, had the device fitted following the birth of her third child, after talking to her GP, but soon started having all kinds of issues.
“I began to suffer with headaches, abdominal pain, heavy bleeding, rashes, extreme itching and mood changes, to name a few,” she says.
“The Christmas after the device was inserted, I woke up and my face had gone numb, which led to neurologists believing I had multiple sclerosis.”
The symptoms began to affect her daily life – but doctors put the symptoms down to her Crohn’s disease.
“It was only when I had a CT [computed tomography] scan and the doctor mentioned in passing that the device was in place that it dawned on me that it could also be the route of my issues,” Deborah says.
She had it removed privately, as part of a hysterectomy, and felt “immediate relief”.
“I was sat up laughing and smiling – something I hadn’t done in a while,” Deborah says. “My mood just shifted and I have had no issues since.”
‘Benefit-risk profile’
A company official said: “Bayer’s highest priority is the safety profile and effectiveness of our products and we have great sympathy for anyone who has experienced health problems while using any of our products, regardless of cause.
“The company stands by the safety profile and efficacy of Essure and will continue to defend itself from these claims vigorously.”
The company and other researchers had completed 10 clinical trials and more than 70 real-world observational studies, it said.
“While all birth-control products and procedures have risks, the totality of scientific evidence on Essure demonstrates that the benefit-risk profile is positive,” it said. And the claimants would still have to prove the merits of their alleged claims.
‘Unnecessary pain’
Lisa Lunt, who represents the 200 women and is head of medical-product claims at global law firm Pogust Goodhead, said: “Thousands of women have been fitted with the Essure device, around the world, and sadly many of them have suffered adverse effects from this product.”
And she hoped “Bayer agrees to compensate our clients for all of their unnecessary pain and suffering”.
The pharmaceutical company is facing legal action around the world in relation to the device.
It has paid out more than $1.6bn (£1.3bn) in the United States, to resolve claims from nearly 39,000 women, but admits no wrongdoing or liability.
The US Food and Drug Administration says women successfully using the device “can and should continue to do so”.