Last September Emma-Louise Lucas, a mother of one from Manchester, at just 31 received the shocking news that she had a rare type of cancer, caused by her breast implants.
Called breast-implant associated anaplastic large-cell lymphoma (BIA-ALCL), it’s a form of Non-Hodgkin’s Lymphoma, which affects immune cells.
The disease has been linked to implants manufactured by Allergan. While the US medical company has made no admission of liability, in 2019 it issued a voluntary global recall of these types of implants.
Now Emma, a manager of a civil-engineering company, is facing not just a shocking diagnosis, but learning she is the latest victim of a vast legal injustice.
For she had her implants inserted in March 2014. That time gap, of just over a decade, means that under UK rules she is barred from taking a legal case against the makers.
This is because there is a ten-year limit on making medical-device injury claims, even though it often takes more than ten years for patients to start suffering symptoms of harm.
It is a different situation in Europe, where the legal limit for such claims is being raised to 25 years.
‘On top of going through all the trauma of cancer, it is even more upsetting to learn that my case is timed-out for product-liability compensation in Britain,’ she told Good Health.’
In fact currently many thousands of UK patients who have suffered severe harm from implanted medical devices are the victims of this injustice.
This unfairness is highlighted by the fact that last August, in a landmark case, 140 women in the UK won an undisclosed sum from three companies, Johnson & Johnson, Boston Scientific and Bard after suffering years of misery caused by mesh, or transvaginal tape (TVT).
The total sum is expected to run into millions of pounds.But thanks to the ten-year legal snare, thousands of other UK women such as Gail McCourt, who have the exact same type of injuries caused by the same mesh, aren’t allowed to pursue the same claims.In a similar scenario, hundreds of British women are now pursuing compensation for harm they say was caused by a contraceptive implant called Essure.
Yet thousands of other women – with the same injuries from the very same devices – are legally barred from doing this.,And it’s the same for women such as Emma-Louise Lucas with cancer related to breast implants.
To add insult to injury, it was revealed last Friday that mesh-damaged women who fall outside the time cut-off are still yet to hear anything about the redress scheme to compensate them – a year after it was recommended by Dr Henrietta Hughes, the patient safety commissioner.
For all these women who are barred from pursuing compensation claims, the problem boils down to the fact their medical implants simply have earlier dates of manufacture on the label than the exact same implants surgeons put into patients who can pursue legal claims for damages for life-changing injuries.
Campaigners point out that this is despite the fact that harms caused by implants may not appear for ten years or more after their implantation.
What’s more, some surgeons and manufacturers have flatly denied any link between a patient’s crippling symptoms and their implant, delaying the start of their legal claim further.
And in the case of implants such as vaginal mesh, patients are often not told that the devices were ever implanted in them. Only years later do they discover the truth.To stop this injustice, the EU is issuing a legal directive to extend the injury-claims deadline from ten years to 25 years – to cover cases where symptoms are slowto emerge.
Gail McCourt, 64, from near March in Cambridgeshire, is one of the British women affected by this legal mess.
In 2003, the married mother of four had TVT implanted to treat the urinary incontinence she’d developed post childbirth. Gail, then 43, had issues the moment she woke from surgery.
‘I went in for a day operation and stayed a week as I couldn’t pass urine and had to learn to self-catheterise,’ she says. She’s lived with chronic pain ever since and had to give up her job as a carer. She’s dependent on painkillers, and suffers with constant urine infections.
‘I was back and forth to hospital with problems for the next 20 years. But they never said it could be the mesh – in fact I was repeatedly told it definitely wasn’t.’
Eventually it was recognised that the mesh was the problem and she underwent two arduous operations at a specialist centre at University College Hospital London to remove it, in 2020 and 2022. The first failed to get all the mesh, which had broken up and invaded her hip bones, ligaments and nerves. Her agonies persist.
‘I can hardly do anything without being in pain even though I wear a morphine patch all the time and live on tramadol,’ she says.
Gail was among the first women in the UK to have pelvic mesh inserted and is effectively being punished for suffering the longest – because of the ten-year limit, lawyers have said she has no case.
‘Because my op was an early one this implant isn’t even on my official records,’ she adds.
‘The NHS system didn’t have a reporting code for it back then.’Kath Sansom, who herself has been harmed by mesh, founded the campaigning action group, Sling The Mesh, in 2015. It now has around 10,000 members – many of them, like Kath, victims of this arbitrary ten-year cut-off.
As she told Good Health: ‘All these plastic-mesh devices are date stamped with the time of manufacture. My mesh was inserted in March 2015, but I’m out of date to claim because my mesh kit would have sat on the shelf at my local hospital for a few months before it was inserted inside me.’
The 140 mesh-injured British women who are to be compensated by the manufacturers were the fortunate ones – their implanted mesh had date codes within the ten-year limit.
Lisa Lunt, a partner at solicitors Pogust Goodhead, which brought this case, told Good Health: ‘People are often shocked to discover that limitation starts to run not from the date of implantation, but from the date that the product is manufactured.
‘We’ve had to turn away thousands of women because their claim was out of time due to the ten-year rule. These are not only victims of pelvic mesh, but also victims of a contraceptive implant device called Essure.’
This was launched in 2002 as a form of permanent sterilisation. The small coil, made of nickel and polyester fibre, was inserted into each of the two fallopian tubes to trigger inflammation.
This causes scar tissue that eventually blocks the tubes so eggs cannot pass into the womb.
However, the Essure device was found to cause intense pain –possibly as some women reacted to the nickel and plastic – and the manufacturer Bayer stopped its sale in the EU in 2017.
This was four years after the device had been implanted into Katy Alderson, 36, a mother of three from Thirsk, North Yorkshire.
As the care support worker, now divorced, explains: ‘In 2013, I’d had difficult delivery with my third son and decided I wasn’t going to go through childbirth again. My GP recommended Essure and said the hospital procedure to insert it would be quick and painless.’
Indeed it took just 20 minutes. But afterwards Katy suffered severe pain.
‘I felt awful, sick with a headache. I went to bed, and things seemed to have settled when I woke again,’ she remembers.
However, she began to suffer back pain that has intensified. This, along with stomach pain, has now become chronic.
‘Over the years increasing fatigue has also become a big problem.
‘More recently my elbows have become really painful and I have bad knee pains,’ she says. ‘Some days I’m all right, but others I’m like a stricken 90-year-old woman. I get such terrible brain fog that even simple daily tasks can be a real challenge, thinking what I have to do next.’
Katy adds that none of her doctors ever suggested her problems could be caused by the Essure. Then five years ago, she was looking online to find anyone with similar symptoms, when she found Jan Faulkner complaining of her own problems with Essure.
Jan was fitted with the device in 2008 – within months she began developing debilitating symptoms including incontinence and fatigue. She eventually had the implant removed in 2016.
‘After that I felt like a different woman,’ Jan, 52, a legal dispute adviser and mother of five from Warrington says.
‘I got my old life back and it felt like such a relief.’
But Katy still has the device inside her. ‘I don’t have the money to have it removed privately. Also I worry it would be a very invasive op, because it’s so tangled in my tissues.’
The way the coils attach to the fallopian tubes means these have to be removed too, and in some cases, the uterus as well.
Jan Faulkner is similarly timed out from suing Bayer – she’s launched a campaign, Raise The Limit, calling for the time-limit to be extended to the EU’s 25 years. Kath Sansom is joining forces with her.
Meanwhile, Emma-Louise Lucas, who is engaged to be married, bitterly regrets the implants. At the time – she was 20 – she was ‘unhappy with the shape of my breasts and worried that one was significantly larger than the other’.
‘I had a private operation and thesurgeon recommended Allergan TSF implants. Two years later, I gave birth to my daughter, Isla. I had some pain with the implant just afterwards, but that settled down,’ she recalls.
‘Then in 2019 I started to have recurrent abscesses in the milk ducts of my right breast. Antibiotics wouldn’t clear it and I had two milk ducts removed.’
Last March, Emma-Louise was leaning over the bath when she noticed that her chest felt ‘really tight’.
‘The implant in my right breast was really weird-looking. I left it for a couple of weeks and it went back to looking quite normal. Then it flared up. It became hard and bulging. My GP thought that the implant might have ruptured.’
But after a scan which suggested ‘a potential rupture’, in August surgeons told Emma-Louise there was no imminent problem so that they planned to leave it alone.
She persisted, saying that her breast had tripled in size and was causing her serious pain. ‘Two days later I had surgery to remove the implant. There was a lot of fluid, so the surgeon first thought that it was truly ruptured.’
But analysis of the fluid revealed the presence of lymphoma cancer cells. The cancer, BIA-ALCL, can develop in the scar tissue around breast implants – the most common symptom is fluid collecting around the implant and an increase in breast size, usually over weeks.
Emma-Louise has since had the other implant removed and she’s been referred to an oncologist.
‘It has massively affected my daughter, because I’ve had to tell her what’s going on,’ she says.
‘On top of all this, it is even more upsetting to learn my case is timed-out for product-liability compensation in Britain.’
Sarah Moore, a partner at Leigh Day solicitors, told Good Health that her firm has been approached by about 50 women who have developed BIA-ALCL after receiving Allergan breast implants.
‘About half of them are timed out under the current ten-year cut-off rule,’ she says.
This is deeply unjust – even the UK watchdog, the Medicines and Healthcare products Regulatory Agency itself says in its online advice for patients, public and health care professionals: ‘Most cases [of the implant-related cancer] have happened years after surgery.
’The ten-year rule favours the manufacturer, says Sarah Moore.
‘No amount of compensation would get my life back,’ says mesh-victim Gail McCourt.
‘But it would help practically for some things. I don’t think there should be a time limit. If a device goes wrong, it goes wrong.’
A spokesman for the Department for Business and Trade told Good Health: ‘Our current laws enable people to seek compensation for damage caused by defective goods, and we keep these under constant review to ensure they do right by consumers.’
