Breast implant associated-Anaplastic Large Cell Lymphoma (BIA-ALCL)
Facts associated with BIA-ALCL
- It is a cancer of lymphatic cells and a form of Non-Hodgkin’s Lymphoma
- It is not a breast cancer
- 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)
- It occurs in women who have had implants for both cosmetic and reconstructive indications
- It takes an average of 7-10 years after implant insertion before it develops
- The commonest presentation is a fluid swelling around the breast implant, in the space between the implant and breast implant capsule. This is called a seroma. The diagnosis of the tumour is made by examination of the seroma fluid
- 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 only require removing the prostheses (and possibly replacing) with total removal of the scar capsule. No chemotherapy or other treatment is indicated
- Disease which has spread through the capsule, forming a mass, or which has spread to local lymph glands may carry a worse prognosis
It is important to note:
- Anaplastic Large Cell Lymphoma has been described in all parts of the body well before breast implants existed
- ALCL has occurred in the breast without any implant present
The most accurate risk published to date is from a detailed study in Australia and New Zealand. This 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 68,000 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.
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) unless there is a very specific indication not to, and the reason to use other than a microtextured implant would be made clear and discussed preoperatively with the patient.
A unifying theory proposed 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:
- Textured implants (with a higher risk for high surface area textures)
- Some biological factor causing chronic inflammation. This may be a bacteria or other substances not yet identified
- Patient genetic predisposition
- 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.
I have not had a case of infection with an elective cosmetic augmentation in my 21 years of practice.
Breast implant surgery in Australia
The exact numbers of breast implants in women is hard to define, however last year about 1.5 million were inserted worldwide (International Society of Aesthetic Plastic Surgery, ISAPS) and about 150,000 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 457 independent confirmed case of BIA-ALCL. At least 55 confirmed cases in Australia. There are only 21 deaths worldwide, with many of these occurring before treatment principles were better understood. 3 of these deaths were in Australia.
The risk for Australian women of breast cancer 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.
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.
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.
All women with implants who note changes in their breasts should seek advice. The overwhelming majority will not have BIA-ALCL.
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.
My longstanding practice conforms to the 14 Point Plan, and I have not needed to alter my practice to comply with the recommendations.