Some 200 women in the UK who have reported being left in pain after having a – now discontinued – permanent contraceptive coil fitted (as opposed to the IUD and IUS, which can be removed at any time), are now able to take group legal action against its manufacturer.
The Essure device "has caused irreparable damage physically and mentally", the women's lawyers say, as reported by the BBC.
Meanwhile, its German maker Bayer told Cosmopolitan UK it will "defend itself from these claims vigorously".
When Essure was withdrawn from sale in in the UK in 2017 (and in the US a year later), the Medicines & Healthcare products Regulatory Agency (MHRA) said there was no evidence to suggest any increased risk to patient safety.
The Essure website (a US link) currently states: "As a result of Bayer’s voluntary business decision in 2018 to discontinue the sales and marketing of Essure, the device is no longer available for implantation. There are no changes in the safety profile or effectiveness of Essure."
Lawyers in England began legal action in 2020 and now have permission to bring a group claim through the courts on behalf of 200 women, while other women wanting to join the group action have until 2024 to do so.
The Essure device is a flexible metal coil placed inside each of the tubes to the ovaries, causing scar tissue to form. This tissue then blocks the tubes to the ovaries to prevent pregnancy, according to the NHS.
The device typically did not require an operation for insertion and could be placed through the vagina and guided into the fallopian tube. It is made from a number of materials including synthetic fibres, nickel, titanium, and stainless steel.
Launched in 2002, it was marketed as a simpler alternative to sterilisation by surgery. However, some women claim they have suffered constant pain and complications, including heavy bleeding, with some having hysterectomies or the device removed entirely, the BBC reports.
The Essure website says the coil procedure "should be considered irreversible" but elsewhere states: "Some patients implanted with the Essure System for Permanent Birth Control have experienced and/or reported adverse events, including perforation of the uterus and/or fallopian tubes, identification of inserts in the abdominal or pelvic cavity, persistent pain, and suspected allergic or hypersensitivity reactions. If the device needs to be removed to address such an adverse event, a surgical procedure will be required."
One 39-year-old woman who had the device fitted after the birth of her third child told press she soon "began to suffer with headaches, abdominal pain, heavy bleeding, rashes, extreme itching and mood changes, to name a few".
"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," she added, with doctors also thinking the daily symptoms she developed where due to her Crohn's disease.
It was only when she had a CT scan and the doctor mentioned the device was in place that she thought it could be the root of her issues. She had it removed privately as part of a hysterectomy, giving her immediate relief.
A Bayer official has told Cosmopolitan UK, "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.
"A hearing of a group litigation order application in England in May 2023 relating to Essure dealt with procedural matters, not the merits of the alleged claims, which Claimants still must prove. Bayer believes the claims brought in this litigation are without merit and will vigorously defend itself.
"While all birth control products and procedures have risks, the totality of scientific evidence on Essure demonstrates that the benefit risk profile is positive. Its safety profile is consistent with the risks disclosed since its approval and is comparable to other female permanent birth control options." It refers to the results of 10 clinical trials and more than 70 real-world observational studies, carried out by Bayer and independent researchers over the past 20 years, involving more than 270,000 women.
"The results of several large studies comparing patients with Essure to patients who have had tubal ligation [female sterilisation] consistently show that Essure’s safety profile is comparable to that of tubal ligation."
Lisa Lunt, representing the 200 women and head of medical-product claims at law firm Pogust Goodhead, said of the case, "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."
Lunt hopes that "Bayer agrees to compensate our clients for all of their unnecessary pain and suffering".
The pharmaceutical company is also facing legal action around the world in relation to the device, financially resolving claims from nearly 39,000 women in the US, but admitting no wrongdoing or liability.
The NHS website advises, "The device was designed to be permanent. Removal of the device usually requires an operation. A specialist gynaecologist will be able to advise you of the risks and benefits of removal," but adds: "If the device is not causing significant side effects or complications, the MHRA highlights the manufacturer’s advice. This is that there's no need for women to have their device removed. It advises that there's currently no evidence to suggest any increased risk to patient safety."
Speak to your GP if you've had the Essure device inserted and you're worried about side effects or complications.
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