Facts associated with BIA-ALCL

1. It is a cancer of lymphatic cells and a form of Non-Hodgkin’s Lymphoma

2. It is not a cancer of the patient’s breast gland

3. It occurs in association with breast implants and to date exclusively with exposure to textured implants (no reported cases with exposure to smooth implants alone)

4. It occurs in women who have had implants for both cosmetic and reconstructive reasons

5. It takes an average of 7 – 10 years after implant insertion before it develops

6. The commonest presentation is a fluid swelling around the breast implant, in the space between the implant capsule and the implant scar capsule.  This is called a seroma. The diagnosis of the tumour is made by examination of the seroma fluid

7. Early stage disease (Stage 1) is confined to the seroma fluid and is cured with surgery alone in over 99% of patients. In fact, all patients known with Stage 1 disease have been cured. These patients with Stage 1 disease only require removing the prostheses (and possibly replacing) with total en-bloc removal of the scar capsule with a margin of normal tissue. No chemotherapy or other treatment is indicated

8. Disease which has spread through the capsule forming a mass, or which has spread to local lymph glands, may carry a worse prognosis and require other treatments such as chemotherapy and radiotherapy

9. It is essential that any patient with a breast implant who notices any change in a breast, such as (but not limited to) swelling, discomfort or a lump, must bring that to immediate medical attention for appropriate investigation

It is important to note:

1. Anaplastic Large Cell Lymphoma has been described in all parts of the body well before breast implants existed

2. ALCL has occurred in the breast without any implant present

Risk

The most accurate published data to date showed that the risk for implants with high surface area texture (Biocell, Allergan, and polyurethane Silimed) was around 10 times higher (1 in 4,000 to 1 in 7,000) compared with implants with lower surface area texture (1 in 60,000 for Siltex Mentor). The risk was calculated only for companies that complied with a request for provision of sales data. ALCL arising from other implant manufacturers was also seen, but risk was unable to be calculated due to their refusal to supply data for analysis.

The study also identified clusters of multiple cases arising from the same practice. These clusters are currently under investigation, and there is insufficient evidence presently to comment as to likely causative factors.

Dr Perkins:             

I have not personally had a case of BIA-ALCL in my practice.
I have never used polyurethane implants.
I now only use microtextured implants like Siltex Mentor (low risk) and smooth implants. The factors that need to be considered for implant selection will be discussed against the background of each individual’s circumstance to decide the most appropriate implant fit for purpose.

Causation

A unifying theoryproposed by the ANZ epidemiology paper has been accepted as a working model as the best explanation for factors that cause BIA-ALCL. This is not universally accepted.

The unifying theory cites four inter-related factors:

1. Textured implants (with a higher risk for high surface area textures)
2. Some biological factor causing chronic inflammation. This may be a bacteria or other substances not yet identified
3. Patient genetic predisposition
4. Time – for the process to develop

Bacteria have been identified in association with these tumours. It is unclear whether they are causative or coincidental bystanders.

Breast implant surgery in Australia

The exact numbers of breast implants in women is hard to define, however in 2020 about 1.6 million were inserted worldwide (International Society of Aesthetic Plastic Surgery, ISAPS) and about 207,000 had implants removed.

Implants should not be considered lifelong devices and may need revision in due course.

The most common reasons for revision are capsular contracture, implant migration, changing aesthetic outcome, size change and rupture.

Different types of implants perform differently, give different outcomes and have different relative risks of these complications.

Conservatively there are 30 million women (60 million implants) in the world with textured implants. There are 993  independent confirmed case of BIA-ALCL as of January 2021. At least 112 confirmed cases in Australia up to 2019. There have been 32 deaths worldwide, with many of these occurring before treatment principles were better understood and the disease entity was widely recognised. 4 of these deaths were in Australia.

The risk for Australian women of breast cancer of the glandular native breast is about 1:8. These are separate diseases.

Allergan has voluntarily recalled existing Biocell implant stock that has not been used. This is a business decision by the company going forward. Currently all macro textured implants have been removed from the Australian market (not international markets) under a moratorium by the Australian TGA.

SCC and other lymphomas associated with breast prostheses

The Food and Drug Administration (FDA) of the USA in September 2022 published a “Safety Communication” regarding squamous cell carcinoma (SCC) and other lymphomas (other than BIA-ALCL) in association with breast prosthesis capsules. They report their awareness of 20 such cases of SCC, and less than 30 cases of various lymphomas. These SCCs and other lymphomas associated with breast prosthesis capsules have been reported with both textured and smooth implants, and for both saline and silicone filled implants (all implants have a silicone shell). The TGA of Australia is aware of one such case.

It appears that BIA-SCC and other lymphomas, compared to BIA-ALCL, may have a longer latent period before presenting of up to 20 years.

Recommendations

Implant selection will take into account what the patient already has, what the goals are, the patient’s lifestyle and the risks relative to various implant options.

Mammography is not an appropriate test for BIA-ALCL. Ultrasound is better at detecting fluid (seroma) around a prosthesis and can be used for both screening and as part of diagnosis. Other tests such as MRI may be indicated in specific circumstances. Mammography and MRI are the tests of choice for screening glandular breast tissue. Ultrasound for the breast tissue is complementary in most.

Implant specific risk will be discussed in the context of overall benefits of a particular implant type and/or texture.

Routine implant removal is not indicated for asymptomatic women with breast implants, including textured implants. All significant worldwide regulatory bodies, including the TGA of Australia, have clearly stated this.

Anti-bacterial strategies (known as the 14 point plan) have been recommended to mitigate against the risk of bacterial contamination of implants at the time of implant insertion. These steps have been shown to reduce the risk of capsular contracture and re-operation. They may also (as supported by the unifying hypothesis) reduce the risk of developing BIA-ALCL. They can certainly reduce the risk of infection and the need for prothesis removal.

All women (with and without prosthesis), who notice changes in their breast of any nature must seek expert medical advice and be appropriately assessed and investigated. Very few will have BIA-ALCL. Sadly, more will have adenocarcinoma of the breast, which is far more common and sinister. The majority will have neither, but these need to be excluded.