The Scottish Mail on Sunday - You
It was hailed as a qu ick and easy solu tion to birth control. instead, hu ndreds of women claim Essu reru ined their liv es. Lorraine Fisher reportson a modern medical horror story
Waking up once again with her face lying on a wet pillow stained with the tears of agony she’d cried in her sleep, Tracey Pitcher felt a familiar throbbing coursing through her lower body. It had been barely noticeable at first, just a slight ache in her hips. But gradually, over the following weeks and months, the pain had intensified, radiating into her knees and stomach, becoming a raw, jagged torture.
Everything good in her life juddered to a halt. Days working at the preschool she’d once loved became a trial. Evenings were spent on the sofa with a hot water bottle, unable to move. Adventurous trips away with her Guides and Rangers troops were unbearable.
Most distressing to Tracey (pictured above right), though, was that she couldn’t be a proper mother to her five children any longer. Instead the elder girls learned to parent their younger siblings, ripping the heart out of the then 40-year-old.
And even after two years in agony – despite many GP and hospital appointments and scans – still no one could tell her what was causing the pain. It wasn’t until the beginning of July 2019 that Tracey, from Southampton, saw a report on the local news about claims of problems with a sterilisation implant called Essure.
‘I’d had it in 2016,’ she says, ‘but never thought it could be responsible as the pain didn’t start immediately – it came on slowly over the next year. But this woman on the news was describing everything that was happening to me.’
Tracey, now 44, went straight online to research the claims and discovered a 21st-century horror story.
Essure came on to the US market in
2002 when it was hailed as a revolution in birth control. Until then, if a woman wanted to be permanently sterilised, she needed an invasive procedure called tubal ligation, which was carried out under general anaesthetic in hospital and had a long recovery time. But Essure could be implanted in less than half an hour with just pain relief, and the patient could go back to work immediately afterwards.
Or that was the theory. In practice hundreds of British women now claim it is to blame for gut-wrenching pain, impossibly heavy periods and even their hair falling out and teeth crumbling. In short, they say, it ruined their lives.
Tracey had had Essure fitted in May 2016 after deciding her family of five girls – now aged from seven to 24 – was complete.
‘I had a chat to my GP about sterilisation,’ says Tracey, who is married to postman Daniel. ‘Then I had a flu jab with a nurse who recommended Essure, so the doctor booked me in to the clinic where she’d had it done.
‘I looked it up on the internet and the NHS website to find out as much as possible but there was nothing.’
Unknown to Tracey, concerns had been raised about Essure as far back as 2013, although they weren’t widely reported. So at the time it just seemed like the answer to her prayers.
‘I didn’t have any worries when I went in to have it fitted. They gave me some ibuprofen and I lay on the bed with some gas and air. It hurt, but it was a lot easier than an operation and it only took 20 minutes.’
Essure is a small coil, just a few centimetres long, inserted through the vagina and uterus up into the fallopian tubes. It works by creating scar tissue that blocks the tubes, thus preventing sperm reaching the ovaries. ‘Afterwards I felt good,’ says Tracey. ‘But then I started having niggles – joint pain that I put down to exercising. My periods started getting heavier and more painful and I started flooding.
‘It all got more painful over time and within a year I would wake up to find I’d been crying in my sleep as my hips hurt so much. In 2004 I’d had Hodgkin lymphoma and the pain was so severe I thought it had come back again.’
But while scans showed she was still clear of cancer, they didn’t reveal the reason for her pain. Instead, doctors diagnosed irritable bowel syndrome and recommended she take ibuprofen.
‘After that I was in constant pain and had no energy. It affected all my family’s lives. I’d go to work, come home, make tea then sit on the sofa with a hot water bottle unable to move. I didn’t want to do anything.
‘Daniel was very understanding – I couldn’t fault him. But I felt guilty. I wanted to be the person he and the children needed but I couldn’t be his wife or their mum.
‘I couldn’t get up and run around with the children or go camping – anything we used to enjoy. I missed out on so much.
‘My youngest daughter got used to going to her older sisters instead of me when she needed something – it was heartbreaking, but thank goodness I had them or I wouldn’t have known what to do.’
Finally, in 2019, Tracey saw that local news report. ‘The relief was overwhelming – I’d finally found out what was causing all my problems.’
Simply removing Essure is not generally possible – it can fragment, leaving tiny metallic pieces behind – so instead most women have to have their fallopian tubes removed or, as in Tracey’s case, a hysterectomy that left her ovaries in place so she wouldn’t go into the menopause immediately.
‘I went to see my doctor thinking I’d have to fight for it, but he put me on a waiting list there and then. Six of the longest months of my life later, I’d had the operation and was walking on air.’ Tracey says the pain stopped immediately. ‘Now I can sit on the floor playing with my children, enjoy the adventure trips I go on with my Girl Guides and Rangers groups and I’ve qualified as an early years practitioner. Removing Essure was the best thing I’ve ever done.’
In Bolton, nearly 250 miles from Tracey’s home, laboratory technician Karen Tonge (pictured on previous page) tells the same story. She had Essure fitted in 2014 on the recommendation of her family planning clinic. ‘I had it done at the local hospital then went back to work the same day,’ says the 46-year-old, who is married to engineer Craig and has a son, Aidan, 21. ‘I had period-type pain and cramps but nothing I couldn’t deal with.’
The next two or three years passed uneventfully but, in 2017, Karen’s periods began to get very heavy. ‘For two weeks before, I felt awful – sick and with horrendous headaches. I’d be stooped over in pain – even my colleagues noticed I couldn’t stand up straight. Then my period would happen and it would ease off only to begin again a fortnight later.’
Like Tracey, she became unable to do anything, spending every evening on the sofa in agony, and her relationship with her family suffered. ‘I got snappy with my son when I didn’t mean to and also with my
‘I DIDN’T KNOW WHATWAS WRONG WITH ME. I LOST FIVE YEARS OF MY LIFE. YOU THINK YOU’RE DYING’
husband – I was overly moody and took my pain out on him. He was very concerned about me.’
After about a year, Karen was in so much pain at work one day, she took herself off to A&E. The doctors couldn’t find anything wrong and referred her back to her GP who booked an ultrasound. It was there that the problem was revealed. ‘The guy doing it pointed at the screen and said, “That doesn’t seem to be where it should.”’
He was talking about her Essure implants. One had moved away from the fallopian tube it had been placed in, causing the problems. She had both tubes removed in April 2019. ‘The pain went immediately,’ says Karen.
Both she and Tracey eventually found the Facebook support group Life After Essure UK and Ireland that had been set up by Jan Faulkner (pictured top right) after her experience with the implant. There are now 1,300 members.
Jan, 49, had hers fitted in 2008 after giving birth to her fifth child. As with the others, she wasn’t warned about any side effects. ‘I was fine at first,’ she says.
‘Then the third year after I’d had it, my body shut down and I didn’t know what was wrong with me. I lost five years of my life.
‘You think you’re dying. You wonder, “Why’s my back gone, why don’t my legs work?” but doctors can’t give you an explanation.’ Like Tracey, Jan’s nightmare began with pain in the hip area. ‘Then I’d have anxiety attacks that would knock me for six, brain fog that left me unable to think straight and an exhaustion so severe I couldn’t even pick up a cup.’
Eventually she couldn’t walk and had to give up her job as a dispute advisor for a water company. ‘I lost friends, I couldn’t go out, I don’t know how my husband Lee coped with it,’ says Jan, from Warrington. ‘It got to the stage of me thinking, “How can I carry on like this?” It put me in such a dark place.’
She had MRI scans, brain scans and was wrongly diagnosed with several conditions including osteoarthritis and fibromyalgia.
It was while researching the latter that she stumbled upon a US website about Essure problems. Finally she felt she had her answer. And, after her fallopian tubes were removed in June 2016, she says life was back to normal within days.
She’s since dedicated her life to ensuring other women know about her experience with Essure, first setting up the Facebook page then teaming up with lawyers suing the manufacturer Bayer (which bought out Conceptus, the company that developed Essure, in 2013), which has already settled a similar case in the US.
They’re being led by solicitor Lisa Lunt of law firm PGMBM, which served documents on the defendant in February. ‘It’s the very first step in the litigation process,’ she says. ‘We have cases from Brazil and Holland and represent just over 200 women in the UK.
‘They’re suing because this was advertised to them as a quick and easy noninvasive surgical procedure but it has caused all sorts of damage and ruined their lives. The device has migrated and attached itself to internal organs, they’ve got pain and bleeding and changes to their menstrual cycle. ‘There are huge amounts of hypersensitivity – in some women their hair has fallen out, their teeth are crumbling… and these are young women.
‘The basis of our case is that there wasn’t sufficient research and pre-market testing and that it was defective. The safety of the procedure wasn’t what you’d be entitled to expect.’
Essure has also been blamed for allergic reactions and organ perforation. Bayer withdrew it from the UK market in 2017, citing commercial reasons.
A spokesperson told YOU magazine: ‘Patient safety is the greatest priority at Bayer and we investigate reports of side effects of all our medicines and medical devices thoroughly.
‘We stand behind the positive benefit risk profile of Essure, which is demonstrated by an extensive body of research undertaken by Bayer and confirmed by several independent expert reviews. The research includes results of more than 40 clinical trials and real-world observational studies conducted pre- and post-approval over the past 20 years and involving more than 270,000 women.
‘The US settlements have no impact on pending litigation in other countries, as Bayer’s decision to resolve these cases is based significantly upon factors that are specific to the US legal system. We do not routinely comment on individual cases nor discuss ongoing litigation.’
Whatever the outcome, it won’t be enough for Debby Gordon (pictured left). Like many women who’ve had Essure removed, her pain hasn’t gone, although it’s not known why. The 44-year-old had the implant fitted in 2014 and says she was in agony right from the start, spending the next four years going back and forth to various doctors, having different tests and being told it couldn’t be the Essure. ‘I lived on painkillers,’ she admits. ‘I thought I must be imagining it.’
So when her mother saw a news article about Jan’s Facebook group, she secured an appointment with her gynaecologist who agreed to perform a hysterectomy which she underwent in May 2019. ‘I woke up and the pain had gone,’ says the mother-of-two from East Sussex. ‘But six months later it came back. I was beside myself and messaged Jan who said I was the second person in two days to say that.’
Debby still believes that the implant was the source of her pain. ‘I thought Essure was going to be the answer to our prayers
– but it’s wrecked our lives.’
‘I LOST FRIENDS, I COULDN’T GO OUT. I DON’T KNOW HOW MY HUSBAND COPED’
If you have concerns about an Essure implant, consult your GP immediately. You can also visit the Life After Essure UK and Ireland Support Group on Facebook or email essurelitigation@pgmbm.com