How do we decouple BII and capsulectomy?

Can we, and indeed,should we?

This isn’t an article about BII, nor is it an article about capsulectomy. What it is, is a series of thoughts about why these two highly charged, contentious issues need to be addressed separately, and not conflated.

The prompt for this article is two-fold. Firstly, I was amused and annoyed in equal measure by a recent forum thread on the American Society of Plastic Surgeons website, which started with a mildly hysterical rant from a plastic surgeon questioning the science behind BII (admittedly,poor) and then rapidly seeking to demonise any surgeon who might consider capsulectomy. Secondly, in the latest issue of Plastic & Reconstructive Surgery (one of our trade rags) there is yet another article considering the topic of breast implant safety. This article is fairly balanced (fortunately),but falls into a seemingly perpetual trap of considering arguments for and against capsulectomy to be inextricably linked to whether BII is real or not.

Right, so, allow me to offer my perspective on this, and why I think the two issues can, and should be dealt with separately.

Let’s start with capsulectomy. I don’t need to bang on too much about this, having written a lot about it in the past.

I think the point that is worth making is this: capsulectomy is, in my opinion, a procedural step in any explant procedure that is necessary to allow patients to achieve good outcomes. Not only do we have to contend with the consequences of poorly done explant surgery to support this argument, but we have to think about what we are trying to achieve when an implant is removed.

I have outlined in the past my contention that the repair of the pectoral muscle is a vital step to preventing post-explant deformity (and hence, explant regret). I have also outlined why I think capsulectomy is required to allow reliable outcomes from this muscle repair. This is obviously important when the implants to be removed are under the muscle.

I also consider the muscle repair (and by inference the capsulectomy) to be steps that allow me to treat my patients without the use of drains, and as day case procedures. Go figure, but the relief most patients express at not needing drains, and not having to stay in hospital, is significant.

Even in cases where the implant is above the muscle, the capsulectomy assists in the reshaping and restoration of the breast, allowing greater flexibility in the manipulation of the breast tissue, removal of the irritating elements of the capsule which cause breast pain associated with capsular contracture, and a complete restoration to a normal “baseline” anatomy.

So, considering this, one thing I find myself saying a bit is that I do capsulectomy for my own reasons. What you will notice is that I have not mentioned BII once in those reasons for doing capsulectomy. That does not mean that I don’t consider BII a condition worthy of our concern and attention. Rather, it means that I consider BII to be a totally separate consideration to the idea of capsulectomy.

I do capsulectomies in ALL of my explant patients, not just those ladies presenting with BII.

So what about BII then? How does capsulectomy relate to BII,and is there any overlap?

Well, yeah, there is, but perhaps not how you would expect.

So, I do capsulectomy for my own reasons (relating to better outcomes functionally, and aesthetically). But it is a happy coincidence that patients with BII concerns WANT capsulectomy to be done, and done properly.

This then leads us to interrogate the question of WHY BII patients want capsulectomies.

This is where it gets tricky.

Patients with BII want capsulectomies because they are worried about the implant (ruptured or otherwise) being an intrinsically “toxic” or “infected” product. They want the implant removed with the capsule that surrounds it because they think this will “contain” those toxic/infected elements and thus, this will allow a better/safer outcome after explant surgery.

Fair enough in a way. There is a certain sense to that argument. Especially so for ladies whose implants have ruptured.

The trouble is that we can’t really demonstrate that implants are in any way intrinsically toxic. Various culprits for toxicity include heavy metals, bacteria and/or “mould”, silicone itself as well as silicone particulates (from implant shells), and more recently the pervasive concern regarding “cancerous” cells (in the form of anaplastic large cell lymphoma).

Now, that gives us a mix of issues, some of which are logical, some of which are less so. The evidence we have suggests that we can toss out the heavy metals argument – there is just no science to back that up.

The question of bacteria is a vexed one given that we know bacteria exist around the implant and represent a purported cause of capsular contracture and ALCL both. If a capsule is opened though, is it possible that the bacteria can escape the capsule and "contaminate" the breast at the time of explant? Probably not in all honesty. The bacteria in a capsule exist in a sessile form known as biofilm. The biofilm is a surface dependent bacteria population - that is, the bugs can't leap from the capsule into the breast tissue. This is why, once the capsule is removed, we don't need to determine what bugs live in that biofilm, and nor do we need to treat them. Leave the capsule behind though....perhaps that is a different issue.

“Mould” is something else, and seemingly a popular concept in the USA, where more women had saline filled implants in the past. There are cases where the fluid filling those implants appears brown or even black and this has been suggested to represent “mould”. In reality, that normally is a consequence of surgeons injecting saline with betadine in it, and the idea of “mould” being a cause of BII is probably best considered a moderately loopy fringe theory perpetuated in social media forums.

Silicone itself is an inert substance which is amongst the most studied substances in the history of medical devices. Silicone is not considered to be an allergenic substance, and it isn’t something your immune system “targets”. However, silicone particulates (the tiny fragments shed from textured implant capsules) are something else and have been looked at over the years as possible triggers for the variably named ASIA (autoimmune syndromeinduced by adjuvants) or SSBI (systemic symptoms in association with breast implants), both of which are just ways of surgeons avoiding saying BII. The silicone particulates do travel through your lymphatic system and do accumulate in lymph nodes. These particulates are responsible for the finding some women will have of “silicone” in their lymph nodes on ultrasound studies for example. Do they actually mean anything? We’re not entirely sure. However there is some contention that the particulates (as foreign bodies) are a stimulus for immune activation which may be involved in the pathogenesis of ALCL. What I will say is that "silicone" in lymph nodes is almost never an indication for a surgeon to go removing said lymph nodes.

That then brings us to ALCL and the fear that has been generated by implant withdrawals from market over the last few years. There is now a relatively common concern that normal breast implants in asymptomatic patients could be surrounded by “cancerous” cells. Whilst this is refuted by accepted science, the concern is understandable. The data surrounding ALCL continues to evolve and in some ways is becoming less clear as we understand more - a dilemma that often exists prior to developing a more complete understanding of any new medical condition.

Suffice to say, in the absence of symptoms (such as swelling of the breast due to fluid around an implant), the already rare condition of ALCL is even more unlikely. I can’t say the risk is zero, but it would certainly be close to it. That non-zero risk is why every capsule that I remove is assessed for ALCL.

At the end of the day, removing a patient’s breast implants is an elective procedure, with both a functional and a cosmetic focus. I think treating explant surgery any differently to any other cosmetic procedure (whether that be a rhinoplasty, a face lift or a breast reduction) is disingenuous and self-serving on the part of plastic surgeons.

We owe our patients the right to choose an explant, just as they would choose another aesthetic procedure. We then own them a duty to perform that procedure to the best of our ability, with the same expectations as they might have of any other aesthetic procedure.

To the surgeons out there who still want to argue about whether patients have a right to ask for explant surgery, and in particular to ask for capsulectomy, I say: stop doing the operation. Go and do other things.

I don’t do facelifts, because I don’t want to. If you don’t want to offer a capsulectomy, maybe just stop doing explant surgery. It’s pretty bloody simple.