There has been much in the media about breast implant associated anaplastic large cell lymphoma (BIA-ALCL). Whilst headlines grab attention, it is important to remember that these headlines will have an impact on patients and will spark fear and concern about their risk of developing this cancer. There seem to be many opinions and many “experts” who are ready to jump in with their 2 cents worth. Some comments are helpful and others are simply wrong and may well be motivated by either trying to underplay risk (so as not to impact on their practice) or overplay risk (to use attention to get more women to have implants removed). Unfortunately, with breast implants and cosmetic surgery, commercial considerations always cloud the truth and draw away from what should always be our prime goal in medicine – to look after the patient.

Fortunately, through a global collaborative effort, we are in a good position to outline some facts associated with BIA-ALCL. These facts have emerged through painstaking research and what is often good about science is that when you have consistent findings across a number of different research studies, then you are more confident of arriving at something that is true.

This article will outline a list of facts that all women should know about BIA-ALCL. It will also outline a list of questions that remain to be answered – hopefully in matter of months, by ongoing collaborative research. Finally, it will lay bare some clear untruths that have been perpetrated through media and social media.

Facts

  1. It is a cancer of lymphocytes – the immune cells that ironically protect against infection and cancer
  2. It occurs in association with breast implants and to date only after exposure to textured implants
  3. We have shown that high surface are textured implants (i.e. Polyurethane coated and salt loss textures) carry a significantly higher risk as compared with textures that have a lower surface area
  4. It takes 7-9 years to develop
  5. It can occur following aesthetic and post cancer breast implant surgery
  6. The commonest presentation (over 85%) is a late seroma (collection of fluid around the implant and distending the capsule around the implant). Usually the fluid is over 100cc and occurs over weeks
  7. Less commonly (10-15%) it can present as a mass attached to the breast implant capsule with or without spread to local lymph glands or invading into surrounding tissue in the chest
  8. The detection and incidence is increasing worldwide
  9. There are significant racial and geographic variations reported around the world
  10. At present, we have around 560 confirmed cases worldwide and 16 deaths from BIA-ALCL through both cancer spread and early in the experience of treatment from complications of cancer therapy.
  11. The majority of cases around the world are now being diagnosed early and present as early stage (1a) disease. This is where the cancer cells are limited to the fluid (effusion-limited) and the tumour behaves in a very slow growing manner. The treatment of this stage is by removal of the implant and capsule and to date is completely curative.

Remaining questions to be answered

  1. What is the risk?
    We have completed two studies on the risk of BIA-ALCL in Australia and New Zealand. Through cooperation and good reporting, we have shown that the risk for high surface area/roughness implants is now in the order of 1 case per every 2800-3300 implants used. This risk drops to 1 in 86,000 for implants that have a lower surface area/roughness texture. A new grading system for implant surfaces will be published in October in Plastic and Reconstructive Surgery Journal and scores implants from 4 (highest surface area/roughness) through to 1 (smooth/”nano” textured implant). BIA-ALCL is essentially a disease associated with Grade3/4 surfaces. Other studies in the UK, Canada and the Netherlands have confirmed these numbers. In the US, due to the large number of unknown implant types and the variability of reporting of early stage disease (due to cost of testing and fear of litigation), there is a skewed pattern of more advanced disease.
  2. Are there two types of BIA-ALCL
    We believe that the stage 1a (effusion limited) disease, which is now emerging as the commonest presentation of BIA-ALCL in all countries representing up to 80% of patients in most series, is naturally held at this early stage for some time. Whether this can then progress to more advanced mass type disease is still a matter of debate. There is also ongoing work to also look at whether there is a spectrum of early stage BIA-ALCL with a more benign form of lymphoproliferation (LPD). More research on the differences in tumour mutations, bacterial contamination and immune system (HLA typing) will give us answers as to whether effusion limited is a different form of disease as compared with mass type disease or whether there is a moveable line with LPD.
  3. What causes BIA-ALCL?
    Apart from a few lymphomas that are caused by virus infection and scrambling of oncogenes, all others arise from chronic inflammation. For T cell lymphomas, the initiating source of inflammation has to be a biologically derived antigen – i.e. Bacterial proteins, gluten (in coeliac disease) and less commonly auto antigens from autoimmune disease. These antigens bind to the surface of the T cell and cause them to change into a premalignant precursor before finally mutating into a full-blown cancer cell. We published the unifying hypothesis of BIA-ALCL last year. We believe that the combination of bacterial infection on a highly textured implants (allowing the bugs to grow in the various nooks and crannies to a higher level) stimulate the lymphocytes of patients with some genetically predisposing mutations over time to produce BIA-ALCL. There is increasing evidence from both basic science and patterns of disease (including the documented clusters of cases around a single surgeon) that point to this theory being true. Other sources of inflammation e.g. friction, particles and metals/silicone have been put forward but do not explain how these process can talk directly to the T cell to cause cancerous change. More work is ongoing into the interaction of bacteria, implant particles and surfaces with BIA-ALCL tumour cells and will be reported in the coming months.
  4. Why is there such a variation in cases reported around the world?
    There has only been one case reported in a woman of Asian descent. This points to racial and genetic differences and is currently the subject of a large collaborative study. Clues from the various immune signatures (HLA type) and underlying genetic mutations will give us answers.
  5. Does prevention of bacterial attachment at time of implant insertion reduce the risk of BIA-ALCL?
    A large study of 42,000 high grade implants (3/4) followed up over 8 years in surgeons using reported strategies to reduce bacterial attachment at the time of surgery (the 14 point plan) has reported ZERO cases of BIA-ALCL. Whilst this is not definitive proof, preventing bacterial contamination of implants simply represents good surgical practice and has been proven to reduce the risk of capsular contracture and reoperation. You can find out more about the 14-point plan at saferbreastimplants.org.

Some misleading statements

  1. BIA-ALCL can regress/resolve.
    A recent report has suggested that on the basis of 2 case reports, that BIA-ALCL can disappear. They cite “epidemiological evidence” to support this claim. Responses published by leading researchers have questioned the validity of this claim because of improper reporting of pathological examination and the lack of sufficient time to prove that the tumour can disappear. In order to prove regression or resolution, a patient with a positive diagnosis will need to be subjected to years of observation without surgery – this is both unethical and potentially dangerous. There is also a real danger is trying to downplay the risk of this disease as it may lead to potentially mistreatment or under treatment. We have shown that in the case of delayed diagnosis or treatment and/or inadequate resection of the implant/capsule, that in some patients, disease can progress and be fatal.
  2. Textured implants should be banned
    Whilst it is true that no cases have been reported in association with smooth implants alone, the call to ban all textured implants does not understand what Science is now telling us – that there is a variation in risk depending on what the textured surface is like. Certainly, the choice of using a higher grade (3/4) implant surface will need to be both justified on clinical need and will need to have informed educated consent given by the patient to justify the higher risk of developing BIA-ALCL. Furthermore, if these implants are banned, what will then do with women who have these implants in place? The incidence of this disease does not justify putting patients at risk of implant removal and/or exchange as yet. None of the regulator worldwide, have yet called for this to happen. The move to a grade 1 surface may also be associated with a higher risk of contracture and/or reoperation. Things are not often so black and white in medicine.

What should happen next?

We have called for a number of important changes in the way we approach breast implant surgery going forward.

  1. All women should be offered regular ongoing surveillance following implant insertion. I see all may patients each year for life and have comfort in knowing my exact complication/reoperation rate (which is very low) and also am confident that to date, I have no reported cases of BIA-ALCL in my practice. A new not for profit breast implant check clinic has recently opened in Sydney and is due to open on other states in 6-12 months.
    You should see your original surgeon for ongoing check ups but if this is not possible, consider booking in at muh.org.au/breastimplantcheck
  2. All breast implants inserted in Australia should be recorded on the Australian Breast Device Registry (ABDR). If your surgeon does not participate, consider going to one that does. The ABDR will eventually give us real prospective outcome data on the risks and benefits of breast implant surgery
  3. Any commercial arrangements that provide a surgeon with financial incentives to choose one particular implant over another should be disclosed openly. Transparency in financial disclosure will encourage
  4. All new cases of BIA-ALCL should be reported immediately. It is through ongoing monitoring that we will keep ahead of this disease and eventually understand what causes it and more importantly how to prevent it. There may be some surgeons who are trying to brush their true incidence under the carpet for fear of either litigation or potentially impacting on their practice.

For too long, commerciality has trumped patient care in cosmetic surgery. We see the result of this in news reports, class actions and more recently in terrible price gouging by unscrupulous doctors intent on putting profit before patients. The best doctors serve the patient and put his/her needs first and above all else. Here’s hoping we can drive a change for the better and achieve the highest outcomes in breast implant surgery for any indication. Let us #PutPatientsFirst.

Anand Deva

Professor Deva is head of Plastic Surgery at Macquarie University and Director of the not for profit Integrated Specialist Healthcare Education and Research Foundation – committed to ensuring safety, quality and affordability in healthcare for all Australians. Follow him on Twitter @saferimplants and visit www.saferimplants.org

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