What’s the latest on BIA ALCL?
As of June 2024 the U.S. Food and Drug Administration (FDA) has documented 1380 cases of Breast Implant Associated Anaplastic Large Cell Lymphoma. This rare form of lymphoma is mainly linked to textured breast implants, with 73% of BIA ALCL cases involving textured implants, while only 3% involving smooth breast implants. Allergan Biocell breast implants were involved with 86% of the reported cases. 64 deaths relating to BIA ALCL were reported.
https://www.fda.gov/medical-devices/breast-implants/medical-device-reports-breast-implant-associated-anaplastic-large-cell-lymphoma
In the UK, as of December 2023, 106 confirmed BIA-ALCL cases were reported, with an estimated incidence of 1 in 14,200 implants sold. One death was associated with these cases.
https://www.gov.uk/guidance/breast-implants-and-anaplastic-large-cell-lymphoma-alcl
On average, symptoms of BIA ALCL occur 7 to 10 years after the implantation. The most common symptom for people with BIA ALCL around breast implants is fluid collecting around the breast implant, what is known as a ‘seroma’. You might notice a painless, sudden swelling of one breast , usually over a period of weeks. Very rarely, BIA ALCL has been found when a lump develops next to the implant or implant capsule.
Q: What is BIA ALCL ?
A: BIA ALCL stands for Breast Implant Associated Anaplastic Large Cell Lymphoma. It is a rare type of lymphoma (cancer of the immune system) that develops due to breast implants, specifically the capsule around the breast implants.
Q: Is it breast cancer?
It is not cancer arising from breast tissue, but a cancer (lymphoma) developing around the implant.
Q: What causes BIA ALCL?
The exact cause of BIA ALCL is poorly understood. There are however, several factors that are strongly associated with the development of ALCL.
Textured breast implants
This is the most significant risk factor. Over 90% of BIA ALCL cases have occurred in individuals who have macro-textured breast implants ( those with a rough surface like Allergan’s Biocell implants)
Chronic inflammation
Inflammation may result from the friction between the breast implant and surrounding tissue or from microscopic shedding of implant particles.
Bacterial Biofilm
Some studies suggest that higher bacterial load in the film that grows on the implant surface, may correlate with a higher BIA ALCL risk
Genetic susceptibility
Research is ongoing to see if some individuals carry genetic mutations that make them more susceptibile e.g. mutations in the JAK1/STAT3 pathways.
Q: What is the risk of getting BIA-ALCL if I get breast implants?
The risk of developing BIA ALCL depends largely on the type of implant, especially the surface texture of the implant. As of 2024,
Textured implants 1:3817 to 1:30,000
Smooth implants Extremely rare (Less than 1:1,000,000)
Reconstruction patients 1:355
Q: How do I know if I have BIA-ALCL?
A: By far the most common presentation of BIA-ALCL is a sudden swelling (seroma) of the breast, occurring in 70% of patients. This can occur anywhere between 2 to 28 years after the insertion of the breast implants, with the median average occurring at 7 years after the breast implants have been inserted.
In 20% of patients, BIA ALCL presents with a mass or lump that is fixed to the implant capsule. You may feel this as a lump in your breast which does not improve after a month, and may be growing.
In the remaining 10% of patients, BIA ALCL can present as enlarged lymph nodes in the armpit, spread of the cancer to other organs (metastasis), an aggressive capsular contracture or a breast rash.
Q: If the breast implants are removed, can I still get BIA -ALCL?
There are a few reported cases of patients who had their textured implants removed without replacement, who subsequently went on to develop BIA-ALCL.
Q: How is it treated?
A: When caught early, BIA ALCL is treatable and curable by means of removing the breast implant and the implant capsule. If the disease is advanced, chemotherapy or radiation may be required.
Q: I had an ultrasound or MRI which showed a small amount of fluid – is this BIA-ALCL?
Patients with BIA ALCL tend to present with a large volume (>100cc) of fluid around the breast implant. Trace amounts of fluid around a breast implant can be common finding but is usually benign. However, if there are clinical concerns, you need to see a qualified plastic surgeon and repeat imaging by means of an ultrasound +/- MRI and close monitoring is essential in 3-6 months.
Q: How do you test the fluid for BIA ALCL?
In patients presenting with a fluid collection around the implant (seroma), at least 50mls of fluid from around the implant must be taken to test for the disease. The fluid is then tested (immunohistochemistry) for ALK and CD30 markers.
In patients presenting with a breast mass, in addition to an ultrasound, mammogram (if aged above 40 years) and MRI scan, a core biopsy should be performed of the mass which will then be analysed for BIA ALCL.
Q: Are breast implants safe?
BIA-ALCL is mainly associated with textured surface breast implants.
Allergan implants, particularly those with a textured surface like Biocell, have been linked with BIA ALCL. This connection led to a recall of certain Allergan implants and a global recall in 2019.
Q: Could I die if I get BIA ALCL?
As of 2024, there have been 64 deaths related to BIA ALCL globally.
Q: Risk of BIA ALCL if I remove my implants and do not replace them?
The risk of BIA ALCL is estimated to be 1:30,000. Importantly, BIA ALCL has been seen in
Textured implants across all implant manufacturers, and while the vast majority of cases occur in people who still have their implants, there have been a few rare reports of BIA-ALCL developing after implants have been removed without replacement. This is thought to be due to the presence of remaining scar tissue (the capsule) around the implant, where the disease can still arise. Removing your implants may reduce your risk over time, but it does not eliminate it completely if any capsule tissue is left behind. There are no confirmed cases of BIA-ALCL in patients who have only ever had smooth implants. If you are considering implant removal, it is important to discuss the benefits and risks with your surgeon, including whether to remove the capsule as well, to make the decision that is right for you
Q: Should I have all of my breast implant capsule removed (total capsulectomy)?
Having a total capsulectomy may lower the risk of BIA-ALCL but there is no data to confirm the future risk of developing the disease. A thorough discussion with your plastic surgeon is recommended as a total capsulectomy can compromise the blood supply to the skin of your breast leading to necrosis of the skin, delayed healing, bad scarring and implant loss (if you have had implant exchange).
A thorough consultation with your plastic surgeon is vital for you to make an informed decision that is individual to you, your body and your health.
Q: Should I have my implants removed ‘just in case’?
The recommendation from the FDA, MHRA, BAPRAS and BAAPS advises that there is no need to routinely remove implants if patients remain symptom-free.
If you have any change in your breast shape, present with breast swelling or a mass in your breast or armpit, you should seek an examination and further imaging with a certified plastic surgeon.
Q: Why then would my surgeon have recommended textured breast implants?
Textured breast implants have historically been recommend in certain situations because of specific clinical benefits, not because they are inherently safer.
1. Reduced risk of capsular contracture
With the insertion of breast implants, it is normal to have a soft layer of scar tissue form around the implant. This is normal and your body’ way of protecting itself from the foreign object. Capsular contracture happens when the scar tissue thickens, hardens and tightens , squeezing the implant and causing a change in breast shape, hardening of the breast or pain.
Textured breast implants are associated with a lower rate of capsular contracture than smooth implants
2. Reduced risk of implant rotation
Due to the textured surface, textured implants ‘grip’ the surrounding tissues better and this can help the implant to ‘stay put’. This is particularly relevant if you have chosen a teardrop-shaped implant where movement of the implant – implant rotation/ malposition/flip – can lead to a change in breast shape.
If you are seeking breast implant- related surgery, it’s very important to consult with a BAAPS-certified plastic surgeon, who will discuss your options and make recommendations based on your body and goals.
