Two women given scandal-hit textured breast implants call for them to be BANNED after one developed a deadly cancer and the other was left in agony
- EXCLUSIVE: A mother ‘feared for her life’ when she got cancer from her implants
- Around 700 women worldwide have developed the highly specific blood cancer
- One brand has been taken off the market but others are still being used in the UK
- Two women affected by textured implants said they should all be banned
- Textured implants vary in the UK but account for more than 90 per cent of usage
- Health officials and surgeons say there isn’t enough evidence to stop using them
Breast implants linked to a rare cancer should be banned in the UK as they have been in France, according to two women made ill by them.
Emma O’Connell and Anna Nightingale both had their macrotextured breast implants taken out earlier this year because of health problems.
Ms Nightingale, 45, got the cancer authorities are telling women not to worry about – 57 women in the UK have developed it so far.
While Mrs O’Connell was afraid she would get the disease after she developed breast implant illness which left her in pain, exhausted and losing her hair.
Both now believe surgeons should stop using textured implants and said it was ‘hideous’ to use something the French government has deemed unsafe.
They are among hundreds of women demanding action over the newly discovered danger – around 250 are considering claiming compensation from one manufacturer, Allergan.
Surgeons themselves, although still using other types of textured implants, admit they would no longer want to use the ‘old technology’ of those taken off the market.
Anna Nightingale (left) and Emma O’Connell (right) have both had their textured breast implants removed because of health concerns. Ms Nightingale developed a rare form of cancer because of hers, and Mrs O’Connell said she developed a poorly-understood condition called breast implant illness and was afraid it could lead to cancer later on
‘I know it’s rare but for the implants to give you cancer is severe,’ Ms Nightingale told MailOnline. ‘It’s not like “oh they hurt so let’s take them out”.
‘I feared for my life. You think “I’m going to die”. It’s a proper cancer, a blood cancer and it will spread.
‘All textured implants should be banned – just go back to smooth ones.’
Ms Nightingale now lives in Malta but is from Cheshire and had her implants put in a by a surgeon in London in 2008, increasing her breast size from a B-cup to a DD.
She had Allergan textured implants and was diagnosed with breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) – blood cancer – in November.
After six cycles of gruelling chemotherapy which made her blonde hair fall out and grow back grey, she was finally allowed to have the implants surgically removed in May.
The mother-of-one, who only realised something was wrong when she suffered agonising pain in her breast, has now been told she’s cancer-free.
Ms Nightingale said the painful lump she developed at the start was ‘eye-watering’ and added losing her hair was ‘terrifically hard’.
Macrotextured breast implants – the same as those Ms Nightingale was given – had been available in the UK for more than two decades.
Ms Nightingale was diagnosed with cancer in November last year (left, before her diagnosis) and could not have her implants removed until May after six cycles of chemotherapy which caused her long blonde hair to fall out and grow back grey
But in recent years increasing numbers of cases of BIA-ALCL have been cropping up around the world, all believed to be linked to textured implants or those coated in a substance called polyurethane.
BIA-ALCL is a form of non-Hodgkin lymphoma – a cancer of the immune system’s lymph nodes.
It’s rare, with an estimated incidence rate of one case for every 24,000 implants, but is known to have affected around 700 women in the US, UK and Australia and killed at least 14.
For this reason the French agency for the safety of health products, ANSM, in April banned the use of four brands of textured implants.
Those made by the companies Allergan, Eurosilicone, Nagor and Polytech were affected.
And it refused to renew the European certification – the CE mark – for the implants made by Allergan, meaning they are now unusable anywhere in Europe.
But other brands still have textured implants on the market in the UK which are being used by plastic surgeons.
One source who has worked in the industry for more than a decade told MailOnline texturing is used more than 90 per cent of the time but the way implants are classified does not have a defined standard.
So different companies may describe certain levels of texturing with different names, making it difficult to keep track of variations among them.
Ms Nightingale, pictured with her partner and her son, six, before she was diagnosed, said she was angry she had never been warned her implants could give her cancer and said ‘I feared for my life’
And the UK regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), refuses to reveal what types of implants have caused the 57 recorded BIA-ALCL cases because of commercial confidentiality.
It will only say that all have been described as ‘micro textured, macro textured or polyurethane coated’ by their own manufacturers.
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.
Allergan’s products have also been recalled in Canada and the Australian government is considering a wider ban on textured implants.
Authorities in the UK and US, however, have reviewed evidence and said they do not believe there is a strong enough case to stop them being used.
‘If you’ve got a choice between products why would you keep using the one which might cause cancer?’ Mrs O’Connell, 44, said. ‘I couldn’t sleep at night.’
Mrs O’Connell, who lives in Jersey, paid £4,000 to have her textured implants removed because they were making her ill and lethargic.
She said she developed breast implant illness and believed it would have progressed to cancer if she didn’t have them removed.
Her concerned surgeon even took a biopsy during her removal surgery and sent it off for ALCL testing – the result hadn’t been confirmed at the time of writing.
Mrs O’Connell said she was left with aching muscles, hair loss, vision problems, migraines and brain fog, and the implants were a ‘bright toxic yellow’ when removed.
‘One of my surgeons is, I know, still putting these implants in people,’ she said.
‘They were sold to me as the best and safest on the market. We were never told about cancer when we had them put into our bodies.
‘Of course, they won’t stop because they’re still making money and I don’t trust any of them now.’
At least 688 cases of BIA-ALCL had been diagnosed worldwide by March, the International Consortium of Investigative Journalists found.
This number is believed to be much higher in reality, with the US’s Food and Drug Administration reporting 660 cases and nine deaths by September last year and the Australian authorities recording 78 cases and four deaths so far.
The MHRA confirmed 57 cases of BIA-ALCL have been diagnosed in the UK since 2012. At least one of those women has died.
The debate about the safety of the implants continues, however, as plastic surgeons in the UK toe the MHRA’s line.
Mrs O’Connell said her implants were a ‘toxic yellow’ when they were removed and her surgeon was concerned so sent a biopsy to be tested for ALCL – the result hadn’t been returned at the time of writing
Mrs O’Connell, pictured before having breast implants in 2009, said she was happy to be back to her natural B-cup and added: ‘The thought of them is just hideous. I’d never go back’
A spokesperson for the government agency 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.’
It added patient safety is its ‘highest priority’, that women should see their surgeon or GP if they’re concerned, and medics should report any cases of BIA-ALCL.
Law firm Leigh Day is building a civil court claim against Allergan – a market-leading manufacturer in the UK for decades – for around 250 women.
Some of the women have been diagnosed with BIA-ALCL themselves, while others are angry they have to personally pay to have implants removed after finding out about the cancer risk.
Mrs O’Connell’s removal surgery cost her £4,000 and others could face similar costs – money they are trying to recoup from the US-based company.
WHAT ARE TEXTURED IMPLANTS AND WHAT IS THEIR STATUS IN THE UK?
Textured breast implants are still used in the UK for the majority of enlargement operations.
There are different levels of texturing used – macrotexturing, microtexturing and nanotexturing – which denote how rough the surface of the implant is.
One source working in the industry told MailOnline what actually falls under each category varies among manufacturers.
And they said textured implants are used in more than 90 per cent of operations in the UK.
Texturing allows the implants to grip to internal breast tissue, creating a more natural shape and reducing the risk of the capsule rupturing or moving out of place.
Macrotextured implants made by the US-based company Allergan, named Biocell, are no longer available because the French government took away its CE mark, which is necessary for them to be used in Europe.
These are the implants most associated with cases of BIA-ALCL cancer, although the UK regulator, the Medicines and Healthcare products Regulatory Agency, will not reveal exactly which implants have caused the 57 cases and one death from the disease in the UK.
The MHRA has also implicated implants classified as micro-textured in cases of the illness.
The British Association of Aesthetic Plastic Surgeons (BAAPS) advised its members not to insert Allergan textured implants from December 2018.
But it says there is not enough evidence to ban or withdraw textured implants in general – a view shared by the MHRA.
Allergan implants have also been withdrawn in Canada.
France’s authorities also banned textured implants from three other companies – Eurosilicone, Nagor and Polytech.
The types of implants these companies are selling in the UK is not clear – the companies did not respond to MailOnline’s requests for information and other sources were unable to confirm the details.
Solicitor Sarah Moore said: ‘There’s a wide group of women who have had the implants but have no recourse to remove them unless they pay.
‘It’s a cosmetic treatment, not a medical one, and people accept there are benefits and risks.
‘But in these circumstances it’s arguable that the benefits do not outweigh the risks and therefore we believe they should not be on the market.’
Ms Moore added there is a ‘real lack of transparency’ around what data the Medicines and Healthcare products Regulatory Agency (MHRA) are collecting.
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 told MailOnline.
‘I used them in the past but I changed because I wanted to use better technology.
‘Using them now would be like going back to the past, but other surgeons are free to use what they want. I want to use the safest for my patient.’
The exact range of implants on the market in the UK is unclear but a source said almost all of those used are textured.
Texturing varies widely and may be more of less aggressive than that used on the Allergan implants implicated in the BIA-ALCL cases.
Although its causes are poorly understood, BIA-ALCL may be linked to the way the texturing disturbs living cells, or the chemicals the implants are coated in.
Textured implants are preferable because they’re better at creating a natural shape. They’re less popular in the US, where surgeons use more smooth ones.
Professor Ash Mosahebi, a plastic surgeon at the Royal Free Hospital in London, said: ‘I wouldn’t want to use this [macrotextured] type of implant.
‘You can use them for a natural shape so there’s a role to play, but there is less aggressive texturing that can be used.
‘There’s a need to change the way textured implants are made.
‘But the chances of [BIA-ALCL] are very, very low. Surgery has its own risks and the risk of leaving the implants in would be lower.’
Both Ms Nightingale and Mrs O’Connell said they would never have got breast implants if they’d known about a link to cancer.
And they argued women should be warned more clearly about the risks.
Ms Nightingale admitted she knows people who have had implants but didn’t know about the disease until she told them.
Ms Nightingale, pictured with family since recovering from her BIA-ALCL, said women should be given more warning about the risks the implants carry and that textured implants should be banned altogether
Speaking about her diagnosis she said: ‘[My partner and I] were told they thought it was ALCL from the implants, which I’d never heard of.
‘I was very shocked and terrified. The implants made me feel good but I didn’t know they could give you cancer and if I had known I wouldn’t have done them. That made me very angry.’
WHAT DO BRITISH AUTHORITIES AND SURGEONS SAY?
The Medicines and Healthcare products Regulatory Agency (MHRA) and surgeons in the UK and implicated manufacturer Allergan acknowledge that implant texturing carries a risk of causing the blood cancer anaplastic large cell lymphoma (ALCL).
But the MHRA says there is not enough evidence of the link, nor enough cases, to withdraw the implants from use.
A spokesperson 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.
‘If you have any questions or have breast implants and notice any changes such as lumps, swellings or distortions in your breasts, neck or armpits, please speak to your surgeon or GP.’
The British Association of Aesthetic Plastic Surgeons (BAAPS) agrees with the stance and says it has told its members not to use Allergan’s macrotextured implants.
But in a statement BAAPS said: ‘Not all textured surfaces are manufactured in the same way and they appear to convey different levels of risk, hence it is difficult to draw definite conclusions at this time.
‘Texturing of an implant surface also offers advantages, particularly with more anatomically shaped implants.
‘Hence many surgeons in the UK still advocate the use of textured implants for their patients.
‘It is vital however, that the risks of using textured or smooth surfaced implants are fully discussed with all patients prior to surgery so that patients can make informed choices.’
She had her implants removed for free by the health service in Malta after her chemotherapy.
Mrs O’Connell, meanwhile, didn’t get cancer so had to pay £4,000 for her D-cup implants to be removed, sending her back to her natural B-cup.
The textured implants had already been a replacement which cost her £3,500 after the first ones she had were involved in the PIP scandal in 2014.
‘If I’d been more educated and had more time I would have had them out completely the first time.
‘I have nothing now and the thought of them is just hideous. I’d never go back.
‘My niece talks about having a boob job done and I say never, ever do it. The good feeling you get from having two extra cup sizes is nothing compared to the hell you could go through.’
The British Association of Aesthetic Plastic Surgeons (BAAPS) in December 2018 advised its members to stop using leftover stock of Allergan textured implants.
But it says there is not enough evidence to ban or withdraw textured implants in general.
A statement on its website says: ‘Not all textured surfaces are manufactured in the same way and they appear to convey different levels of risk, hence it is difficult to draw definite conclusions at this time.’
BAAPS says women should be made fully aware of the risks of textured implants before having them and that any who have concerns about existing implants should discuss them with a healthcare professional.
An Allergan spokesperson said: ‘It should be noted that BIA-ALCL has been reported in textured breast implants from a number of manufacturers, not just Allergan.
‘The company continues to collaborate with clinicians, societies and worldwide regulatory authorities to advance research, understanding and awareness about breast implant effectiveness and safety, as well as the importance of appropriate technique.
‘As with all Allergan products, the company is committed to strict adherence to all regulatory requirements, to the most rigorous scientific evidence and to the highest industry standards for its breast implant products.
‘Allergan encourages patients to speak regularly with their surgeons and/or physicians as access to early diagnosis and intervention is crucial to optimal patient outcomes.’
It invited patients with specific questions about their Allergan implants to contact the company on 0808 238 1500 or [email protected]
Source: Read Full Article