A 45-year-old woman with breast implants potentially linked to a rare and deadly form of cancer has been told she can only get them removed if she develops signs of the disease.

Businesswoman Annabelle Baugh, from Birmingham, had textured Biocell implants inserted when she was 24-years-old, opting for ones manufactured by pharmaceutical firm Allergan due to the company’s impressive safety record.

Then five years ago, she learned of the supposed link between the implants and a rare form of blood cancer known as anaplastic large cell lymphoma (ALCL). Breast implant-associated ALCL has already led to the deaths of more than 60 women in the US, the Food and Drug Administration (FDA) says. 

But to get her implants removed by the NHS, Annabelle would have to have symptoms of the cancer – or face spending up to £9,000 on private surgery, with no compensation available – something she cannot afford.

Although UK-based law firm Leigh Day are currently representing 10 women in the UK who have BIA-ALCL, Annabelle fears thousands of other women around the world could be unaware of the concerns raised in the US. 

Annabelle Baugh, 45, from Birmingham, had textured Biocell implants inserted when she was 24-years-old

Annabelle Baugh, 45, from Birmingham, had textured Biocell implants inserted when she was 24-years-old 

Annabelle (pictured) believes there could be thousands of women across the globe living with these implants who cannot afford to have them removed or might be unaware of their link to BIA-ALCL

Annabelle (pictured) believes there could be thousands of women across the globe living with these implants who cannot afford to have them removed or might be unaware of their link to BIA-ALCL

Five years ago, Annabelle learned of the link between the implants — manufactured by the pharmaceutical company Allergan — and a rare form of blood cancer known as anaplastic large cell lymphoma

Five years ago, Annabelle learned of the link between the implants — manufactured by the pharmaceutical company Allergan — and a rare form of blood cancer known as anaplastic large cell lymphoma

The FDA recalled the Biocell implants in 2019 after evidence suggested they were linked to patient deaths, but the UK’s Medicines & Healthcare products Regulatory Agency (MHRA) maintains there is ‘no evidence’ of an ‘increased risk to patients’. 

As of June 30, 2023, the FDA has received a total of 1,264 U.S. and global medical device reports (MDRs) of Breast Implant-Associated ALCL (BIA-ALCL), with 63 related deaths — 59 per cent of these (37) — were related to Allergan implants.

A spokesperson said: ‘We do get a steady stream of people coming forward having just learned about the risk of BIA-ALCL. There isn’t much awareness, there is a certain degree and its growing but they previously had no knowledge about it.

‘Our concern with Allergan Biocell implants is the MHRA guidelines changed in 2018 when there was much more awareness for GPs and doctors to be advising about this.

‘I think a lot of the patients we are seeing were at a time when there wasn’t as much awareness about it and they’re in a really difficult position because who is their recourse about now?

‘Although there is some awareness now it isn’t as widespread as it should be so patients can make informed decisions.’ 

Annabelle believes there could be thousands of women across the globe living with these implants who cannot afford to have them removed or might be unaware of their link to BIA-ALCL because it has not been as widely publicised as, for example, the PIP implant scandal. 

Surgery to remove breast implants is unavailable on the NHS unless a patient meets specific criteria, including if they have recurrent infections, if they rupture, if it is a PIP implant or if someone develops BIA-ALCL. 

This means that people living with these textured breast implants would need to pay privately, which could cost anywhere between £3,000 to £9,000.

Speaking to MailOnline, Annabelle said: ‘It’s leave them in and hope for the best or pay to get them removed or exchanged yourself. That’s the situation and there’s no recourse in any other way.

‘I definitely think I will have them replaced but at the moment I’m not in a financial situation to do that.’

Annabelle cannot get her potentially 'deadly' implants removed on the NHS unless she develops symptoms of BIA-ALCL

Annabelle cannot get her potentially ‘deadly’ implants removed on the NHS unless she develops symptoms of BIA-ALCL 

While Annabelle said she didn’t regret having implants, she admitted the fear of getting BIA-ALCL is ‘always in the back of my mind. It might be a really low risk but it’s the fact that you know you can do something about it.’

London-based plastic surgeon Naveen Cavale told MailOnline: ‘Concerns regarding Allergan textured breast implants are not uncommon among women and I have had new patients come to me with this enquiry.

‘My advice mirrors recommendations from plastic surgery regulatory bodies such as BAAPS, BAPRAS, and ISAPS: while there’s no need to panic, it’s crucial not to disregard any concerns. Regular self-examinations for lumps or abnormalities are advisable. This should be standard practice for all types of breast implants.’

Annabelle said: ‘I knew I wanted implants from about the age of 15 when I first saw Pamela Anderson on Baywatch and realised you could have them because my mother and my sister are both small busted so I knew it wasn’t very likely I was going to have a big bust.’

While Annabelle said she didn't regret having implants, she admitted the fear of getting BIA-ALCL is 'always in the back of my mind'

While Annabelle said she didn’t regret having implants, she admitted the fear of getting BIA-ALCL is ‘always in the back of my mind’

A year-and-a-half after her first procedure, Annabelle spoke to her surgeon who was working with the pharmaceutical company Allergan on a new teardrop implant. 

She ‘jumped’ at the chance of having the implants and said: ‘I had it done. I was really happy, I finally looked in the mirror and thought ‘yeah, they’re the size I want’. It was a huge relief because after the first and second one I was a bit disappointed.

Symptoms of anaplastic large cell lymphoma (BIA-ALCL) to watch out for

Swelling – This is the most common symptom and is caused by a build-up of fluid in the area of the breast implant. People can notice an increase in size of the affected breast over a few weeks.

Lumps – In some cases there might be a lump next to the implant’s surface or in the armpit, although this is rare.

Enlarged lymph nodes

Skin rash

Fever

Weight loss 

BIA-ALCL symptoms tend to develop on average, over seven to 10 years, but they can develop sooner. 

Source: breastcancer.org and Gov.uk

‘I chose Allergan because they’re one of the top manufacturers of breast implants. They have excellent safety records. 

‘They’re commonly called gummy bear implants because if you cut them open they’re like jelly, so they can’t leak and you haven’t got the worry of them rupturing and leaking into your lymph nodes.’

Before surgery, Annabelle measured at a 34A cup, but is now a 34F. At the time they cost £1,200 plus the cost of surgery, which came to around £3,000. 

Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) is an uncommon type of non-Hodgkin lymphoma.

The most common symptom of BIA-ALCL is fluid collecting around the implant or an increase in size of the affected beast. In very rare cases, a lump has developed next to an implant.  

FDA Principal Deputy Commissioner Amy Abernethy, said in 2019: ‘Although the overall incidence of BIA-ALCL appears to be relatively low, once the evidence indicated that a specific manufacturer’s product appeared to be directly linked to significant patient harm, including death, the FDA took action to alert the firm to new evidence indicating a recall is warranted to protect women’s health.’

Dr Janine Jolly, MHRA Deputy Director of Benefit/Risk Evaluation, said: ‘Patient safety is our top priority.

‘Based on our analysis of the latest evidence and expert clinical input, our advice remains unchanged. There is no need for people with breast implants who do not have any signs or symptoms of BIA-ALCL to have them removed.

‘If you 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.

‘It is important anyone undergoing breast implant surgery discusses the risks and benefits with their surgeon and following this discussion understands the relative risks involved.

‘Detailed guidance on BIA-ALCL for patients, healthcare professionals and the public is available in our website. If you have experienced an issue with a breast implant, please report it to our Yellow Card scheme so we can investigate further.’

Allergan issued the following statement in 2019: ‘Allergan plc today announced a voluntary worldwide recall of Biocell textured breast implants and tissue expanders. 

‘Allergan is taking this action as a precaution following notification of recently updated global safety information concerning the uncommon incidence of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) provided by the U.S. Food and Drug Administration (FDA).

‘Biocell saline-filled and silicone-filled textured breast implants and tissue expanders will no longer be distributed or sold in any market where they are currently available. 

‘Effective immediately, healthcare providers should no longer implant new Biocell textured breast implants and tissue expanders and unused products should be returned to Allergan. 

‘Allergan will provide additional information to customers about how to return unused products.

‘Patient safety is a priority for Allergan. Patients are advised to speak with their plastic surgeon about the risks and benefits of their implant type should they have any concerns.’

Allergan has been contacted by MailOnline for a further comment. 

Annabelle has collated resources for men and women who are concerned about BIA-ALCL. To find out more, visit cosmeticsurgeryadvancements.com.

Anyone who has received a diagnosis of BIA-ALCL is asked to get in touch with Leigh Day on 020 4502 3777 or by emailing [email protected].

Post source: Daily mail

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