German pharmaceutical giant Bayer has said it would defend itself “vigorously” after 200 women in the UK – who claim they were left in pain after having a permanent contraception device fitted – plan group legal action against the company through the courts.
Bayer has already paid out more than $1.6bn in the United States to resolve claims from nearly 39 000 women, but admits no wrongdoing or liability, reports BBC News.
The Essure coil “has caused irreparable damage physically kand mentally”, said the British women’s lawyers, who started the legal action in 2020 and now have permission to bring the group claim on their behalf. Other woman wishing to join the group action have until 2024 to do so.
The product was withdrawn from sale in 2017 but the UK medicines regulator said there was no risk to safety.
Heavy bleeding
The Essure device is a small metal coil inserted into the fallopian tubes. Scar tissue forms around the coil, creating a barrier that blocks the tubes and keeps sperm from reaching the eggs.
Launched in 2002, the device was marketed as a simpler alternative to sterilisation by surgery.
But some women have said they suffered constant pain and complications afterwards, including heavy bleeding, with some needing to have hysterectomies or have the device removed altogether.
‘Mood changes’
One woman, who had the device fitted after the birth of her third child, said she started suffering from various symptoms, including headaches, abdominal pain, heavy bleeding, rashes, extreme itching and mood changes.
After she woke up one morning, and her face had gone numb, neurologists diagnosed multiple sclerosis.
The symptoms began to affect her daily life, but doctors put the symptoms down to her Crohn’s disease.
Only after a CT scan and the doctor mentioning in passing that the device was in place “did it dawn on me it could also be the root of my issues”, she said.
She had it removed, as part of a hysterectomy, and felt immediate relief. She has had no issues ever 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 … of Essure and will continue to defend itself from these claims vigorously.”
Bayer said the device had been tested in 10 clinical trials and more than 70 real-world observational studies, involving thousands of women.
Lisa Lunt, who represents the 200 women and is head of medical-product claims at law firm Pogust Goodhead, said: “Thousands of women around the world have been fitted with the Essure device, and sadly many of them have suffered adverse effects from it.”
MedicalBrief reported on 15 June 2022 that a team from Lyon, France, had studied the wear debris from these medical devices and their possible toxic health effects, and suggested that tin could be the cause of the implant’s toxicity.
BBC News article – Hundreds of UK women can now take legal action over Essure device (Open access)
See more from MedicalBrief archives:
Bayer: Lawsuit by 200 UK women over Essure sterilising device
Tin in permanent contraception implants most likely behind side effects – French study
IUDs may cut cervical cancer risk by a third — US systematic review