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Women suffering from daily agony and horror symptoms after having the Essure contraceptive coil fitted can’t claim compensation from pharmaceutical firms because of the ten-year liability limit on medical devices.
Currently, women in the UK only have ten years from the date of manufacture to make legal claims against pharmaceutical companies if something goes wrong with an implant, coil or other device – regardless of when it is actually fitted.
Legal firm Pogust Goodhead, which is representing women affected by the product, has been forced to turn away more than 1,000 would-be claimants affected by the ‘permanent’ contraceptive, manufactured by medical giant Bayer, who say they have had their lives destroyed by symptoms they attribute to the metal device.
Upon hearing she had missed out on the window to join the legal claim by just two weeks, one woman told MailOnline: ‘I was devastated. It’s not about compensation for me, it’s about the fact this is so wrong.’
Bayer have consistently maintained the coil is safe and effective and stressed it went through ten separate clinical trials. The metal device, which is inserted into a woman’s fallopian tubes to permanently prevent pregnancy, was withdrawn from the UK market in 2017.
But women have told MailOnline how they experienced a ‘nightmare’ after having the device fitted, and say they cannot even try to claim compensation for their ordeal. Now they are campaigning to change the law.
Under the current UK Consumer Protection Act (CPA) 1987, no action can be brought against a manufacturer if a device is defective ‘after the expiration of the period of ten years’.
This is regardless of how long the device was meant to last and of when it was actually fitted inside a patient.
Jade Jordan begged doctors for years to remove her Essure coils, but by the time the operation took place and medics had informed her of their model number, she was two weeks two late.
Mother-of-four Mrs Jordan, who is married to an Afghanistan veteran and works at a local school, told MailOnline she had problems from the day she had the coils fitted in 2014.
She had just given birth to her fourth child and wanted a permanent means of contraception without the trauma and recovery period of a hysterectomy.
‘It was sold to me so well, I thought it sounded amazing’, she said. ‘I wasn’t told it was non-reversible and that the only way they could be removed was a full hysterectomy.
‘I collapsed in the lift on the way out, I had problems from the get go.’
Soon afterwards, Mrs Jordan began experiencing crippling periods which were so severe she described experiencing ‘a waterfall of blood’ and ‘birthing large blood clots’.
‘It would be like a waterfall of blood. It was really painful in my back as if I was going into labour,’ she said.
‘Within a few months I went back to the doctor and was told it was just the device settling in. I thought I shouldn’t go back to a doctor to pester them about a period.
‘It sounds terrible when you’re in that much pain, but as a mum you put up and shut up because you have so many things going on. My husband was away for months, being ill wasn’t even on the agenda.’
Mrs Jordan soon began losing so much during her periods that she began passing out on the floor. She said her children, who were aged nine, eight, five and just months old at the time she had the device fitted, soon got used to stepping over her as they waited for her to come round.
As well as having awful periods, Mrs Jordan said she became exhausted, depressed, had chronic pain and brain fog.
When she finally got a hysterectomy in August to have the coils removed, all these symptoms immediately disappeared.
After hearing about a group of women placing legal claims against manufacturers Bayer, Mrs Jordan spent six months chasing her medical records to find her coils’ batch number so she could join the claim.
But when she finally received it, she found out she was too late: the coils were ten years and two weeks old.
‘I could have cried,’ Mrs Jordan said. ‘I was devastated. It was just awful. It’s not about compensation for me, it’s about the fact this is so wrong.
‘I’ve had so much time off work, times I’ve been in bed, I’ve missed out on huge sections of time with my children.
‘I’ve just had to survive through it. You just get on with it because you have to because you’re a mum.
‘I didn’t realise how much pain I was in until it was out. Now I feel amazing.’
For her, giving patients longer to make claims would mean one thing: ‘Justice.’
She added: ‘It would mean everything, This law is wrong on so many levels. If those devices are not fit for purpose, that’s not that person’s fault. It’s not their fault their life has been turned upside down.’
Jan Faulkner, 51, was also affected by the rule and is now campaigning to raise the claim limit from ten to twenty years.
Ms Faulkner, from Warrington, was fitted with an Essure device in 2008. She began developing debilitating symptoms including bladder incontinence and eventually had it removed.
She first became aware of the legal case in the UK against manufacturer Bayer – after reading online about women who had been fitted with the same device and had the same symptoms.
She also looked into legal action – but after meeting with lawyers from global law firm Pogust Goodhead, was told she was ‘out of time’ to pursue a claim.
She said: ‘First, I started getting a lot of pain in my hips and back, and I became tired really quickly. The fatigue was awful, especially when you have five kids to look after.
‘I couldn’t drive my car, do the school run or even tie their shoelaces! My blood pressure was constantly raging too. It took over my life. I just couldn’t function.’
Ms Faulkner claimed doctors ‘dismissed my pain’ for eight years, until a sports therapist suggested she might have fibromyalgia.
It was then, when researching the condition, that she read about other women who had had the Essure coils removed and immediately returned to her GP to demand hers were taken out.
Ms Faulker felt like ‘a different woman’ after the procedure. ‘I got my old life back and it felt like such a relief.
‘People don’t realise that, in Britain, if you use a faulty medical product or device, you only have ten years from the date of it is manufacture to hold its company to account.
‘It matters because it can take years for a woman to find out why her body is reacting badly to something. It could take another decade just to gather the medical evidence and get doctors to properly test.
‘By that time, you have lost your opportunity to take your case to court and get compensation for the damage it has done, not only to your body but to your life.
‘I know one thing – I am grateful that I could connect with other women to learn about their symptoms and share our stories. We bonded together over our ordeal. None of us could have taken on a billion-dollar pharmaceutical company by ourselves either – in that sense group litigation has been a godsend.
‘We need to see this law changed. I’m calling to raise the limit because I couldn’t take Bayer to court.
‘There are thousands of women like me who have been denied justice because it has been more than a decade since their Essure device was manufactured. We are denied justice. That is unfair to us, and possibly hundreds of thousands of British women and men with other devices in similar situations.
‘How can it be right to say you only have 10 years to know a product is not working properly, gather the medical evidence and join a court case? It can take decades to get the medical evidence by itself!
‘I am determined to have the law changed so that women like me don’t face the same problems again.’
Lisa Lunt, partner at Pogust Goodhead and head of medical product liability, said:
‘The Consumer Protection Act needs to be changed to remove the current 10 year longstop limitation which protects industry, not the trusting patient.
‘Sadly, some pharmaceutical and manufacturing companies are selling medical products without proper testing, leaving women and men vulnerable.
‘If they can’t take those companies to court, because the product was manufactured more than 10 years ago, they have no access to justice. It’s an absolute scandal and that’s why I support Jan’s campaign to extend the statute of limitations to 20 years.
‘It can take years for the patient and their doctor to realise that the medical device or product is responsible for their problems, years to gather medical evidence and potentially the same to be on a waiting list to have it removed. By that time, it can be too late to claim.’
The company behind the coil, Bayer, previously told MailOnline: ‘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.’
They continued: ‘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.’
Bayer has been contacted for comment.
Robert Johnson is a UK-based business writer specializing in finance and entrepreneurship. With an eye for market trends and a keen interest in the corporate world, he offers readers valuable insights into business developments.
