Two hundred women in the UK who say they were left in “excruciating” pain after having a permanent contraceptive device fitted can now take legal action against the manufacturer.
The Essure contraceptive device is a flexible metal coil placed inside each of the patient’s fallopian tubes. Over a period of three months, scar tissue forms around the coil - creating a barrier which stops sperm from reaching the eggs, thereby permanently protecting against pregnancy.
Launched in 2002, Essure was marketed as a simpler alternative to sterilisation by surgery. However, some women have reported suffering constant pain after having the device fitted, as well as various complications, such as heavy menustrual bleeding, allergic reactions, immune-type reactions, and performation and migration of the coil.
Some had to have the device removed, while others ended up undergoing hysterectomies (surgical removal of the womb). There were also reports of women becoming pregnant, despite the fact that Essure was supposed to be a permanent form of contraception.
Lawyers in England began legal action against manufacturer Bayer in 2020. On Tuesday (5 September), the BBC reported that they now have permission to bring a group claim on behalf of 200 women, who they allege have suffered “irreparable damage physically and mentally” because of Essure.
Manufacturer Bayer, a German pharmaceutical company, has refuted the allegations. Speaking to the BBC, 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 vigorously defend itself from these claims.”
They added that the device had been tested in 10 clinical trials and more than 70 real world observational studies involving thousands of women. “While all birth-control products and procedures have risks, the totality of scientific evidence on Essure demonstrates that the benefit-risk profile is positive,” the statement concluded.
On the website page for Essure, advice reads: “Pain (acute or persistent) of varying intensity and length of time may occur following Essure placement. This is also more likely to occur in individuals with a history of pain.”
Essure was withdrawn from sale in 2017, but the UK Medicines and Healthcare products Regulatory Agency reported that this was “a commercial decision” and “not related” to any concerns about its safety or effectiveness. Women were also advised that there was no need to have their device removed.
However, a study published in the British Medical Journal in 2017 found women using the Essure contraceptive device had a significantly heightened risk of needing further surgery due to complications than those using more traditional laparoscopic procedures.
Bayer is already facing legal action in other parts of the world in relation to the device. In the United States, it has paid out more than $1.6 billion (£1.3 billion) to resolve claims from nearly 39,000 women - but admits no wrongdoing or liability.