Twenty women in the UK are taking legal action after they developed a rare cancer that is possibly linked to breast implants.
Textured implants are thought to cause breast implant associated-anaplastic large cell lymphoma (BIA-ALCL) in some patients.
More than 50 women have been diagnosed with the condition in the UK, with hundreds more suffering worldwide.
Many are taking legal action against both their doctors and the implants’ manufacturers to cover removal surgery, as well as personal injury and ‘distress’.
The long-term safety of breast implants is unclear, prompting one surgeon to say women are being used as ‘guinea pigs’.
The Medicines and Healthcare products Regulatory Agency (MHRA) estimates one in every 24,000 implants sold in the UK could trigger the rare form of cancer.
Twenty women in the UK are taking legal action after they developed a rare cancer that has been linked to textured breast implants (pictured). The ‘rough’ surface is thought to trigger a reaction that causes breast implant associated-anaplastic large cell lymphoma (BIA-ALCL)
At least 688 cases of BIA-ALCL had been diagnosed worldwide by March, according to the International Consortium of Investigative Journalists.
The number is believed to be much higher in reality, with the US’ Food and Drug Administration reporting 660 cases and nine deaths by September last year.
In the UK alone, 57 confirmed cases were diagnosed after 2012, according to the MHRA. At least one of these women died.
Textured implants are thought to trigger BIA-ALCL due to the way the surface disturbs living cells or the chemicals the implants are coated in.
They are said to be be the preferred type of implant because the texture helps create a natural shape.
Among other expenses, the women taking legal action want the cost of their initial surgery paid for, with some also seeking compensation for ‘potential financial loss’ as a result of the procedure.
Their lawyer Zahra Nanji, of the personal-injury firm Leigh Day, told the BBC: ‘I really do believe strongly the manufacturers, producers and distributors of these implants need to take responsibility.’
The firm is building a civil court claim against the pharma giant and implant manufacturer Allergan for around 250 women.
Although not all have developed cancer, some feel they should not have to pay to have their implants removed given the risks.
Consultant plastic surgeon Professor James Frame claims there is not enough information about the potential complications that can arise from breast implants.
WHAT IS BIA-ALCL?
BIA-ALCL is breast implant-associated anaplastic large cell lymphoma.
It is a rare but treatable cancer that develops in the immune system around breast implants.
By September 2018 the US Food and Drug Administration had received reports of 660 BIA-ALCL cases and nine deaths.
Per its latest statistics, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has recorded 57 cases of BIA-ALCL since 2011.
The cancer most commonly occurs among women who have had breast implants with a textured surface.
The disease is a type of T-cell lymphoma, which means it affects lymphocytes, more commonly known as white blood cells.
These can start a cancer when one mutates to become abnormal or out of control, then divides into more cancerous cells which spread.
BIA-ALCL is a relatively treatable cancer and many patients are declared cancer-free after having the implants and surrounding tissue removed.
The survival rate for patients with BIA-ALCL is 89 per cent for five years after being declared cancer-free.
It is considered to be a rare illness but estimates of its incidence vary – the MHRA believes it to be one case of cancer per every 24,000 implants.
This leaves doctors unable to communicate the risks to patients.
He added women in the UK are not being ‘appropriately warned that breast implants are not for life, necessarily’.
‘There are unknowns with any implant, but it does mean we are using our entire population as human guinea pigs, almost,’ he said.
The MHRA, which regulates medical devices in the UK, is collecting data on the number of women who have developed BIA-ALCL.
When combining both textured implants and other types of the prosthesis, it estimates one in every 24,000 sold puts a woman at risk of lymphoma.
The MHRA issued a statement last month saying it is ‘essential’ surgeons warn patients who are looking to have the surgery.
Nonetheless, breast implants undergo a rigorous risk assessment before they can be used, it added.
Women who have textured implants should consult their doctor if they have any concerns, the MHRA said.
France banned four types of textured breast implants in April.
These were made by the pharma companies Allergan, Eurosilicone, Nagor and Polytech.
ANSM, the French agency for the safety of health products, also refused to renew the European certification, CE mark, for the implants made by Allergan.
Authorities in the UK and US, however, claim they have reviewed the evidence and deemed there is not a strong enough case to stop the implants being used.
A spokesperson for the MHRA said: ‘While most cases of BIA-ALCL have been reported in patients with textured implants, there is currently not enough scientific evidence of a causal relationship specifically between textured implants and BIA-ALCL.’
Nonetheless, the British Association of Aesthetic Plastic Surgeons (BAAPS) advised its members in December to stop using leftover stock of Allergan textured implants.
One source, who has worked in the industry for more than a decade, previously told MailOnline texturing is used more than 90 per cent of the time.
However, different companies may describe texturing differently, which makes it difficult to keep track of the implants being used, the source added.
The MHRA did not reveal what types of implants caused the UK’s recorded BIA-ALCL cases due to commercial confidentiality.
But it did confirm all have been described as ‘micro textured, macro textured or polyurethane coated’ by their manufacturers.
Consultant plastic surgeon Professor James Frame (pictured) claims there is not enough information about the potential risks of breast implants. He added confusion over the procedure’s long-term safety means women are being treated like ‘guinea pigs’
Dr Roberto Viel, a veteran plastic surgeon who runs the London Centre for Aesthetic Surgery on Harley Street, stopped using the implants before BIA-ALCL surfaced.
‘I stopped using macrotextured implants quite a few years ago and personally I would not go back,’ he previously told MailOnline.
‘I used them in the past but I changed because I wanted to use better technology. I want to use the safest for my patient.’
Although Professor Ash Mosahebi, a plastic surgeon at the Royal Free Hospital in London, also does not use textured implants, he added the risk of removing them could be worse than leaving them be.
‘The chances of [BIA-ALCL] are very, very low,’ he said. ‘Surgery has its own risks and the risk of leaving the implants in would be lower.’
Allergan’s products have also been recalled in Canada and the Australian government is considering a wider ban on textured implants.
A spokesperson from Allergan said patient safety is a priority and it will continue to ‘invest’ in increasing awareness of BIA-ALCL.
The company voluntarily recalled its Biocell saline- and silicone-filled textured breast implants and tissue expanders. The latter is a balloon-like device that stretches the skin to make room for an implant.
THE WOMEN WHO ‘FEARED FOR THEIR LIVES’ AFTER DEVELOPING CANCER FROM THEIR BREAST IMPLANTS
A cancer sufferer ‘thought she was going to die’ after she developed cancer from her breast implants.
Linzy Bromfield, now 50, paid to have her chest taken from a cup size B to D in 2005.
The operation seemed to go to plan until, years later in 2016, the mother-of-two noticed her right breast was too swollen to fit in her bra.
Ms Bromfield later had to have her breast drained and was diagnosed with implant-associated lymphoma.
‘I was angry and hurt,’ she told the BBC. ‘I was worried I was going to die.’
Ms Bromfield had both implants removed, with no further treatment being required. She has been disease-free since.
Linzy Bromfield (pictured) ‘thought she was going to die’ after she developed cancer from her breast implants. She was diagnosed when her right breast became swollen
Anna Nightingale is pictured after losing her hair while being treated for BIA-ALCL
A mother ‘feared for her life’ after her breast implants triggered cancer.
Anna Nightingale had Allergan textured implants put in nine years ago at a London clinic to take her chest from a B to a DD cup.
The mother-of-one, now 45, knew something was wrong when she developed ‘eye-watering’ pain in her chest years later.
She was diagnosed with BIA-ALCL last November, which forced her to endure six rounds of chemo.
Ms Nightingale, who lives in Malta, finally had the implants removed in May.
She claims she never would have had them fitted in the first place if she knew of the risks.
Emma O’Connell (pictured) paid to have her textured implants removed
A woman paid £4,000 ($4,832) to have her textured implants removed over concerns they could cause her to develop cancer.
Emma O’Connell, 44, claims she developed migraines, brain fog and hair loss after she had the D-cup implants fitted.
Unable to sleep with worry, she later paid to have the implants removed.
She claims they came out a ‘bright toxic yellow’.
‘One of my surgeons is, I know, still putting these implants in people,’ she added.
Now back to her natural B cup, Ms O’Connell, who lives in Jersey, believes she had ‘breast implant illness’.
However, the NHS and the US Food and Drug Administration deny this exists.
They do, however, provide long lists of potential side effects of breast implants.
Implants are not designed to last a lifetime, according to the FDA.
The longer a woman has the implants in her body, the higher the risk of complications, it added.