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Made from fibres of the thermoplastic polymer resin known as Polyethylene Terephthalate (PET), titanium and nickel, the Essure is a small coiled spring which is inserted through the womb into the fallopian tube to prevent eggs from reaching the uterus and becoming fertilised, as they break up upon contact with the device.
Essure has mainly been used by women aged 40 or over who already have between one and three children or who have never wanted to become mothers.
Bayer described it as 'harmless', of a 'hypoallergenic composition', with 'practically no side-effects' and does not require surgery to fit.
About 80,000 women in Spain are thought to have had one fitted, although the Plataforma Libres de Essure ('Free from Essure Association') have 1,400 members who have gone through unpleasant and life-changing ordeals as a direct result of the coil.
Internal bleeding, sciatica, hair loss, inflammation of the abdomen, joint pain, cramps, itching and stinging, unwanted – and even ectopic – pregnancies, and weight gain, in some cases over 20 kilos (44lb, or 3st 2lb) are just a few of the effects Association members have suffered, and many say they are in so much pain they need morphine to control it.
They found each other by googling their symptoms and finding a direct link between the coil and their ill health, but all the women in the Association say their doctors do not believe the Essure coil is the cause – and many say they have been dismissed as 'mad' and 'making it all up'.
Essure first came into use in 2002, but since then, 'nobody has ever figured out how to remove it', says Elisa Fornés of the Association – the only way to get it out is for the fallopian tubes or even the entire womb to be removed, and some of the women have not had it fitted properly, meaning bits have since broken off inside them.
The Essure was designed as a permanent contraceptive device, and was recommended to women seeking to have their fallopian tubes tied or otherwise sterilised.
Elisa Fornés says the Essure left her, at 'little more than 40 years old', with an early menopause and 'practically an invalid' – four years on, unable to bear it any longer, she had her fallopian tubes removed, complete with the coil, and started to feel better.
María de Prado needed a full hysterectomy to remove hers, having had it fitted in July 2013 – an experience she described 'more painful than giving birth' and which left her in pain and bleeding profusely.
Nani, now 46, said she was in so much pain 10 days after her Essure was fitted that she went to A&E, where it was found that the 'head' of the device in her right-hand fallopian tube was sticking out into her abdominal cavity.
As the Essure cannot be removed, the doctors decided to tie her tubes with it still inside her, provoking an early menopause at age 42, stomach pain, dizziness and sciatica.
She has already had four pieces of it taken out on separate occasions, but remains of it are still inside her pending yet another laparoscopy.
Waiting lists for removing tubes or broken-off parts of the Essure can run into six months as they are not considered 'urgent'.
Other women report digestive system problems, back pain, extreme fatigue and even 'a constant ringing noise' in their ears, as is the case with Olga, who also piled on 25 kilos (four stone) between having the Essure fitted at 43 and now, aged 50.
She was told her problems were due to her 'age, menopause and being overweight'.
The affected women say they were all 'perfectly healthy' until they had their Essure device fitted, and those who have had it all successfully removed – normally by taking it apart inside them in several laparoscopies, by full or partial hysterectomies or having a fallopian tube taken out – say they stopped suffering their extremely painful symptoms, even though, by then, lasting damage had been caused.
A law suit is now under way, and the women are calling for compensation likely to run into millions of euros.
Bayer, who withdrew the Essure from circulation in September 2017, has denied doing so is in any way linked to safety concerns about its use.
Yet similar testimonies have been seen all over the world, and other major lawsuits, particularly in the USA are due to be brought.
Photograph: Essure Victim Advocates, in the USA
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