Breast Implants: latest news as of Summer 2017.
Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) and Breast Implants: latest news as of Summer 2017.
There is a lot of media reporting just recently of the possible link between a rare form of immune system cancer, known as a lymphoma, and breast implants. The tumour is called an Anaplastic Large cell Lymphoma and is normally an extremely rare form of cancer. It comes in two types and one type appears to be associated with breast implants, appearing in the tissue immediately surrounding the implant (known as “the capsule”: a term used to describe the fibrous layer the body forms around a breast implant).
The French health agency concerned (l'Agence nationale de sécurité du médicament (ANSM)) has recommended that this risk be discussed with every woman having breast implants and that these implants essentially now come with a warning in France (http://www.lemonde.fr/sante/article/2015/03/17/l-institut-du-cancer-alerte-sur-une-nouvelle-maladie-liee-aux-protheses-mammaires_4594751_1651302.html).
The corresponding American agency, the FDA, has also made some important observations more recently (https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/ucm239995.htm).
Those interested in more detail may consult the American Society of Plastic surgeons website (authored by Dr Clemens, an acknowledged expert in this field) which has an excellent (if technically dense ) summary of the current state of our knowledge https://www.plasticsurgery.org/for-medical-professionals/quality-and-registries/bia-alcl-by-the-numbers
In order to try to help women who have breast implants or are considering breast implants with the choices they face, I have written this brief article and a list of things I think women should know at the time of writing (summer 2017). This is a rapidly developing area of knowledge so please check for latest updates through the web, through search engines, and if you want by discussion with me or your own surgeon.
BIA-ALCL is a new tumour, either not previously existing or not previously recognized, and is a special form of the more prevalent tumour ALCL (the BIA- tag referring to the fact it is found in Association with Breast Implants
Reports of this condition began to emerge in the first years of the 21st century but only in 2011 did the FDA recognize a firm link with the presence of breast implants. ALCL itself is a form of lymphoma, an uncommon cancer of blood cells. The full name of the tumour is Anaplastic Large Cell Lymphoma. The term “large cell” refers to the appearance under the microscope, and “anaplastic” refers to the cell type as being rather primitive in appearance and behavior, that is to say not appearing to have developed into a more specific identifiable cell type.
ALCL itself can develop at various sites around the body, and probably affects about 1500 people a year in the USA alone. The rare type of ALCL associated with breast implants appears to be very specific in its genetic make-up and so is now identified as BIA-ALCL (Breast Implant Associated Anaplastic Large Cell Lymphoma).
So, to summarise before moving on, lymphoma is a rare form of blood cancer and ALCL is a rare form of lymphoma, and BIA-ALCL now appears to be an even rarer form of ALCL, specifically occurring in women with breast implants.
Now here are ten things you might like to consider about this disease.
How common is BIA-ALCL? It is hard to be precise, but in the USA there appear to be fewer than 400 cases in total with 9 deaths, and that figure itself may be a substatial overestimate because some cases are misreported or reported twice. In the UK recent reports suggest there have been 23 reported cases with 2 deaths. Each of these reports may be subject to some errors but are the best estimates to date. An interesting thing is that when these are translated into an estimate of the risk each woman with implants faces, the current estimate in the USA is about 1:30,000 lifetime risk. That means that for 30 thousand women spending a lifetime with breast implants, only one will contract this disease. However, in some parts of the world the risk appears higher (Australia for example) and in other parts almost zero (India). We do not know whether these differences are due to reporting errors, genetic differences or environmental differences. But to put these risks into some perspective, for every eight or nine women in the UK one will develop conventional breast cancer in their lifetime.
What do we think causes it? This is conjecture at the current time, but it may be that something to do with the way the body reacts to alien objects inside it, or to long standing sub-clinical infection, may be part of the story. This is strengthened by the observation that some cases have appeared associated with metal implants used to repair bone. I anticipate that progress in understanding this field will be rapid in the years to come so watch this space!
Do implants cause it? The strong association with breast implants suggests some sort of link here but quite rightly the international agencies are being cautious in identifying a definite cause. We can say the disease is associated with breast implants and further that the FDA have identified from research sources that …”at this time, most data suggest that BIA-ALCL occurs more frequently following implantation of breast implants with textured surfaces rather than those with smooth surfaces.” This may prove to be important and at least one surgeon has called for an end to using textured surface breast implants. Some have gone so far as to claim that the disease is not seen with smooth surfaced implants (see below). Some manufacturers are making claims about their implanst having less risk than those of other manufacturers. This may or may not be the case, but the commercial issue sat stake are clear.
How does it appear, that is to say what should women with implants look out for? It seems the disease first appears in the thickened tissue (capsule) that the body creates to surround an implant. It then makes fluid, and so the breast swells and becomes tense and hard. Some fluid and some tension are normal but a sudden change occurring at any time (months or years) after the implant has settled down initially, and causing one side to swell, should immediately be reported and expert advice sought. Any woman with settled implants who develops new swelling in just one breast should immediately seek advice. Some agencies have recommended routine scanning or mammography screening but that is not currently the advice in the UK. Again, your surgeon is an appropriate person to advise you.
How is it treated? Pleasingly, the way forward in treatment is becoming clear and the results are reassuring. The key thing appears to be that surgical excision of the tumour is essential, and this can often be achieved by simply removing the capsule that surrounds the implant. Where the disease is reported early and is appropriately treated when still confined to the breast, 93% of women have no further sign of the disease 3 years later. This is of course no cause for complacency, but is reassuring for those women affected. Other means of treatment include chemotherapy or radiotherapy for disease that cannot be removed.
Should I insist on smooth implants, or have mine changed to smooth implants? I can only give a personal view as at the moment I do not believe there is a right and wrong answer to the question. The reason most surgeons in the UK have preferred textured implants is that there is evidence to show they are less likely to harden with time (capsular contracture). Given that hardening can spoil the result, and is quite common, and given the risks in general of surgery (small but real), and the very small (but again real) risk of BIA-ALCL, it is a difficult balance to decide whether to use smooth implants and whether to change implants. The only reasonable answer to this question is that the patient and the surgeon should put time aside to discuss these issues prior to surgery, and be clear about what is covered in the aftercare and what is not under the terms of the surgery. As the FDA puts it “before getting breast implants, make sure to talk to your health care provider about the benefits and risks of textured-surface vs. smooth-surfaced implants. If you have breast implants, there is no need to change your routine medical care and follow-up”.
Should this put me off having breast implants? Let me answer this as I do for all my patients: there is no such thing as totally risk free surgery. All surgery can cause health problems, and carries risks which can range in frequency and in severity. For this reason I have never accepted that breast augmentation is simply a life style issue. Patients should only undergo aesthetic surgery to address distress about appearance, and the degree of that distress should be sufficient to warrant the risks a procedure entails. For breast implants the risks remain either infrequent but important (e.g. B IA-ALCL) or more frequent but less severe (e.g. scarring or loss of sensation etc: see other advice on this site). In other words, patients requesting breast augmentation face the task of balancing risks and benefits as they do for any procedure and your surgeon should help and guide you objectively in this matter. Often it helps to consult more than one health care professional before reaching a decision which should in any case never be rushed or impulsive. Breast implants can be greatly life enhancing and in the past this has not, I believe, been adequately recognised. But they also carry potential consequences which must be understood.
I am very willing to consult with any patient who is worried by this development. If you are worried it is perfectly reasonable to schedule an appointment with your surgeon or GP, and you should certainly do this is you have any of these symptoms:
Increase in size of one breast
Progressive hardening of one or both breasts
Pain in one or both breasts
A lump found in a breast
Discharge from a nipple
As always, women should be vigilant about their breast, examining them monthly, and reporting any change. One in eight women will develop breast cancer in their lifetime, compared to the roughly one in thirty thousand women with implants who may develop ALCL. So check your breast whether you have implants or not please. (see http://www.breastcancer.org/symptoms/testing/types/self_exam/bse_steps)
Simon Kay Summer 2017