Hundreds of women in the UK are taking legal action against medical giant Bayer after they were reportedly injured after being fitted with ‘sterilisation’ devices.
The German Pharma company has now removed Essure devices from market, amid claims of “excruciating pain, abnormal bleeding, nickel poisoning and illness” from users.
Around 200 women have been given the go ahead by a court in the UK to proceed with their multi-million-pound case against Bayer.
The Essure device - a small metal coil - was inserted into the fallopian tubes to permanently prevent pregnancies, designed as a simple path to sterilisation.
It was reportedly promoted as an easy, non-invasive, non-surgical procedure aimed at women who had decided they didn’t want any more children, or who did not want any at all.
Manufacturers said the metal coil would cause scarring inside the tubes, thus blocking them and preventing pregnancy – but was less intrusive than sterilisation surgery.
The device was available on the NHS and was fitted in hospitals around the UK in little over 15 minutes.
But lawyers acting for the women launching legal action against Bayer say the Essure device “caused irreparable damage physically and mentally”.
Many women who had the device fitted have subsequently had either hysterectomies, or are awaiting procedures to have the device removed.
Among those taking legal action is mum-of-three Deborah Chalk, 38, who had to undergo a full hysterectomy after complications while she was fitted with an Essure device.
Mrs Chalk was told after her third child she should not have any more children due to her Crohn’s disease, and opted for Essure after being told “how easy it was”.
“After a brief discussion with the [GP] I was told to take two co-codamol, and half-an-hour later the devices were inserted,” said Mrs Chalk, who is represented by law firm Pogust Goodhead.
But Mrs Chalk soon began to suffer with headaches, abdominal pain, heavy bleeding, rashes, extreme itching and mood changes.
“The Christmas after the device was inserted, I woke up and my face had gone numb which led to neurologists believing I had MS,” she said.
“Three years later the symptoms were becoming more frequent and affecting my daily life. I was taken to hospital because my blood pressure dropped dangerously low yet still no one had any answers as to why this was happening.
“It was only when I had a CT 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.
“I then went privately and within days was booked in for a removal. The safest way to remove it was a full hysterectomy so that is what I did. I had been keen to avoid such major surgery in the first place but now I had no option.
“As soon as I came round after the operation it was immediate relief. Obviously, I was in pain but it was so different to the pain I had been in before. My husband said he noticed the difference immediately. I was sat up laughing and smiling – something I hadn’t done in a while. My mood just shifted, and I have had no issues since.
“I really feel strongly that Bayer need to be held accountable. Their device has left hundreds of women all around the world with years of pain and suffering. I got involved with the legal case because I just couldn’t stand to say nothing and let it go on and to raise awareness for other women who are in the same position I was.”
Mum-of-two Victoria Wright, 42, from Merseyside, was left suffering “migraines, irregular bleeding and hip pain” after having the Essure coil fitted.
She was forced to take time off work as a care assistant as the symptoms persisted. In 2016 she had the device and her fallopian tubes removed.
“From then on the pain, headaches and irregular bleeding stopped,” she said. “It was such a relief.”
Representing Essure clients Lisa Lunt, head of medical product claims at London-based global law firm Pogust Goodhead said: “Thousands of women have been fitted with the Essure device around the world, sadly many of them have suffered adverse effects from this product.
“Whilst the Essure device has been withdrawn from sale in the UK and Bayer have settled claims against them in America, the case continues to be defended in the UK.
“Our clients have suffered years of pain and complications from a device that ought to have provided them with a safe method of permanent contraception. We hope now that the court have agreed that a Group Litigation Order is appropriate in this case that Bayer agree to compensate our clients for all of their unnecessary pain and suffering.”
The group litigation order was signed this week which allows the group litigation to progress through the civil court system.
Anyone harmed by the Essure device who would like to join the class action has until 2024 to get in touch with lawyer, says Pogust Goodhead.
Bayer has been approached by the Standard for a comment.
A company official told the BBC: “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.”