Protecting Patient Safety
Updated 18 May 2021
Breast implant associated-Anaplastic Large Cell Lymphoma (BIA-ALCL)
The Australian Society of Plastic Surgeons urges women with breast implants to be vigilant in monitoring for any changes or swelling in their breasts and to contact their doctor if this occurs.
Breast implant associated-Anaplastic Large Cell Lymphoma (BIA-ALCL) is a rare cancer that can be effectively treated if detected early.
The ASPS is concerned there may be confusion in the community surrounding BIA-ALCL and therefore seeks to clarify the key known facts.
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 textured breast implants
- It occurs in women who have had implants for both cosmetic and reconstructive indications
- In most cases the disease develops 3-14 years after implant insertion
- The most common presentation is a fluid swelling around the breast implant and in the space between the implant and breast implant capsule. The diagnosis of the tumour is made by examination of the seroma fluid
- Other possible solutions include pain in the breast, a rash on the breast or a lump on the breast, in the armpit and elsewhere
- Early stage disease is curative with surgery alone
- Disease which has spread through the capsule, forming a mass or which has spread to local lymph glands carries a worse prognosis
The most accurate risk published to date is from a detailed study of numerator and denominator 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 4000 to 1 in 7000) 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. We did see ALCL arising from other implant manufacturers but were not able to calculate risk 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, with the consent of the center and/or surgeon, and there is insufficient evidence presently to comment as to likely causative factors.
As at March 2021 the Therapeutic Goods Administration (TGA) is aware of about 76 cases of BIA-ALCL in Australia.
The level of risk depends on the type of implant and is estimated to be between one in 2,500 and one in 25,000. The risk is highest for the most textured implants.
A unifying theory was proposed by the ANZ epidemiology paper and has become widely accepted worldwide as the best explanation for factors that cause BIA-ALCL.
The unifying theory cites four inter-related factors;
- Textured implants (with a higher risk for high surface area textures)
- Bacterial contamination at the time of surgery to reach a threshold to cause inflammation
- Patient genetic predisposition
- Time for the process to develop
Bacteria have been identified in association with these tumours, similar to the association between gastric lymphoma and Helicobacter pylori.
Detection and Treatment
When BIA-ALCL is suspected, imaging by ultrasound and CT scan or MRI of the breast is performed. A mammogram is not useful for detecting the disease.
Most cases of BIA-ALCL are cured by surgery with the removal of the implant and the surrounding capsule. If there are implants in both breasts then both implants are removed even if symptoms only appear on one side.
If there is a solid lump or the cancer has spread, chemotherapy, radiotherapy or additional surgery may be required.
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 are not life devices and all will need revision in due course.
The most common reasons for revision are capsular contracture, implant migration, poor aesthetic result, size change and rupture.
Different types of implants perform differently, give different outcomes and have different relative risks of these complications.
Conservatively there are 35 million women (60 million implants) in the world with textured implants. There are just over 500 confirmed cases of BIA-ALCL. There are 16 deaths worldwide with many of these occurring before treatment principles were better understood.
The risk for Australian women of breast cancer is about 1:8. These are separate diseases.
We support the maturing of the Australian Breast Device Registry as the best way to prospectively collect outcome data following breast implant surgery.
All patients undergoing breast implant surgery must provide informed consent that includes a discussion of risks of BIA-ALCL.
Implant selection should 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 should be discussed in the context of the 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 women with implants who note changes in their breasts should seek advice. The overwhelming majority will not have BIA-ALCL.
It is always recommended that you self-examine your breasts regularly to check for any changes.
It is recommended that you have your implants checked every 2 years to check for any ruptures.
We recommend the use of anti-bacterial strategies 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.
A list of recalled, cancelled and suspended implants can be found on the TGA breast implants hub at https://www.tga.gov.au/hubs/breast-implants