Two hundred women in the United Kingdom who claim they were left in agony after having a permanent contraception device implanted can now file a class action lawsuit against the device's manufacturer.
The Essure coil has caused irreparable physical and mental harm, according to the women's attorneys. The German manufacturer Bayer says it will vigorously defend itself against the allegations.
When Essure was removed from the market in 2017, the UK medicines regulator stated that there was no safety concern.
In 2020, attorneys in England initiated legal action and now have permission to file a class action lawsuit on behalf of 200 women.
The deadline for other women to join the joint action is 2024. A small metal coil is implanted into a woman's fallopian tubes using the Essure device.
A barrier of scar tissue forms around the coil, preventing sperm from accessing the eggs. In 2002, the device was introduced as a less invasive alternative to surgical sterilization. However, some women claim to have endured constant agony and complications, including heavy bleeding, with some requiring hysterectomies or removal of the device.
After consulting with her physician, Deborah Chalk, 39, had the device implanted following the birth of her third child, but shortly began experiencing a variety of complications.
She mentions headaches, abdominal pain, excessive bleeding, rashes, intense itching, and mood changes. The Christmas after the device was inserted, she woke up and her face had gone numb, which led to neurologists believing she had multiple sclerosis.
The symptoms began to interfere with her daily existence, but doctors attributed them to Crohn's disease. However, it did not occur to her until the doctor mentioned in passing that the device was in place during a CT scan and that it could also be the cause of her problems.
She felt "immediate relief" after having it removed privately as part of a hysterectomy. According to a company representative, the safety profile and efficacy of their products are Bayer's top priority, and they sympathize with anyone who has experienced health problems while using one of their products, regardless of the cause.
The company stands by the safety and effectiveness of Essure and will continue to vigorously defend itself against these claims.
In spite of the fact that all birth control products and procedures carry some degree of risk, Essure has a favorable benefit-risk profile, according to the report. The claimants would still be required to demonstrate the validity of their purported claims.
Lisa Lunt, who represents the 200 women and is the head of medical-product claims at the international law firm Pogust Goodhead, stated that thousands of women around the world have been implanted with the Essure device, and sadly, many of them have experienced negative side effects from this product.
She hoped that Bayer would compensate her clients for all of their needless anguish. Regarding the device, the pharmaceutical company is confronting legal action on a global scale.
It has paid out more than $1.6 billion (£1.3 billion) to resolve claims from nearly 39,000 women in the United States, but denies any misconduct or liability.
According to the Food and Drug Administration, women who effectively use the device "can and should continue to do so"
