In case you missed it, we had a Facebook Live session with Dr Mark Magnusson and he gave us all the most up-to-date information on ALCL. This is a great source of info for anyone concerned about the link between breast implants and cancer.
There are a lot of uncertainties, a lot of concerns by patients and the information that came out last week certainly portrayed things in a way that created a lot of anxiety. The information that came out last week is not new; it was actually released initially in May. Our paper, which looks at all of the cases of ALCL related to breast implants in Australia and New Zealand, was collated from all of our patients and the data was stopped collecting at that point for that study in August. By the time it went through the peer-review process, was checked and double checked, it was released in May. So this recent information is certainly not new.
Firstly, there’s nothing new that we have to be anxious about. However, obviously this is a lymphoma and as such it is important that we don’t trivialise it because it will affect some patients. Rarely, in fact very rarely, some of those patients may even succumb to the disease. We want to have a discussion about what this is. Realistically about what the rates are, about what can be done, what you should do if you have implants, what you should ask about if you’re considering implants, how this disease this illness is diagnosed, how it’s treated, and what the outcomes are. That’s perhaps one of the most important things, is what the outcomes are. Because with our current knowledge, although this is a rare disease with less than 400 identified patients worldwide, with only a small number of deaths from this disease, many of those deaths were before we understood the full way we should manage this disease at the moment. Some of those patients succumbed before we really had a handle on this process.
People are certainly having much better outcomes now, anyway. But a recent paper was published in the last couple of months in the Aesthetic Surgery Journal. Now that’s the official journal of the United States, so the American Society of Aesthetic Plastic Surgeons, which is the sister society to ours. I’m fortunate to be on that editorial board. The paper looked at what your life risk is of dying from ALCL if you have textured breast implants. Of course we know that to date there are no cases identified worldwide who have developed ALCL who have only been exposed to smooth breast implants. But if we look at the worldwide figures, and it’s hard to really get a strong grasp on how many of these implants go in worldwide, but last year there were about one and a half million textured breast implants that went in worldwide.
We conservatively estimate that there are 30 million women with textured breast implants for cosmetic reasons. There are many others for reconstructive reasons. If we look at them as most of them, the cosmetic ones, having two implants, that’s conservatively 60 million textured breast implants worldwide. Around 400 cases of ALCL. So this is still a very low risk disease. It’s a rare disease. But on top of that, less than one in 20 or about one in 20 patients who get this disease actually succumb to it. So we’ve got 12 confirmed reported deaths of this disease worldwide. So that’s certainly something to consider, because if you get 30 million women over a period of many, many years, certainly a much, much larger number of those women are going to be succumbing to other things.
As I said, I don’t want to trivialise this disease. But I want to put it into perspective. It is two and a half times more dangerous to drive a car an hour a day than it is to have a textured breast implant. When it comes to if you’re only looking at your percentage or your likelihood of dying of this disease. Now we don’t think about driving our car, because it’s just become part of our life. If you ride a bike for something like 30 miles, which is less than 60 kilometres, you’ve already increased your risk of death by more than having textured breast implants for your entire life. So certainly, as I said, I don’t want to trivialise it. But I want to put it into a little bit of perspective.
What is breast implant associated ALCL? It was diagnosed as its own entity in the beginning of last year by … Well, it wasn’t diagnosed. It was categorised as its own specific entity by the World Health Organisation last year. We’ve known about it for a number of years. The first case described in the literature was 1997. In Australia, we’ve had cases … The first report in the literature of cases was a collection of five cases, written by authors, plastic surgeons in Melbourne. They collected those cases and reported that in 2007. Australian surgeons have been well aware of it, plastic surgeons have been well aware of it for a very long time. But what we knew at the outset was that this is an incredibly rare disease, with an incidence of one in the millions. Then slowly as we’ve learnt more about it and we’ve pursued the diagnosis to make sure we’re capturing all of the patients to make sure everyone gets the right treatment, we’ve found that the incidence is more than anticipated. In our study, which came out in May, it is the strongest study of its type worldwide. The reason for that is we have a relatively small group of people who put these implants in, and a relatively small group of people who see patients with problem implants. So we’ve got a fairly small group that we can collate the data from.
Plastic surgeons, breast surgeons, and cosmetic surgeons have been joined together in collecting this data, at least until now. On top of that, being a lymphoma it’s reportable, so pathology companies have to report it. Also we are quite fortunate, we don’t always think we’re fortunate with Medicare, but we are quite fortunate because what that means is this can be investigated at a relatively limited cost to patients when there’s a suspicion. What I mean by that is the way we diagnose this … Well, firstly let’s talk about how it presents.
Most people who develop this disease will develop a swelling of the breast. You’ll have a breast implant that will have been stable for many, many years. So in our study it shows that the average time is eight years after your breast implants that you develop symptoms. We have had one patient as early as two years. Most are between three and 14 years. The breast swells for no apparent reason. That’s due to fluid collecting around the breast implant. Occasionally, less frequently, and that’s about one in 10, there’ll be a lump either associated with the swelling or on its own. Most people are presenting with either a lump or swelling or both. The vast majority with swelling. The first step is an ultrasound. That ultrasound, the radiologist can say, “Yes there’s fluid present,” or there’s a lump present. Then those need to be assessed. The lump will be in association with the breast implant rather than in the breast, or it may be a lymph node in the armpit.
This is not breast cancer. For all of the women viewing tonight, the risk for you of breast cancer is one in eight. If you get seven girlfriends in a room, one of you is likely to develop breast cancer through the course of your life. That’s far, far, far more common. In our study, we found that with Allergan textured breast implants, that rate was one in 3,880. You would need to get 3,880 women all with the same breast implants for one lady to develop this disease.
We looked at silimed polyurethane implants. Their rate in the study was one in 7,000. That’s a little bit difficult though, to fully assess those figures, because the polyurethane implants have only been on the market since about 2008, and that was in small numbers. Then they really became more prevalent in the marketplace a bit later than that. So they hadn’t been around for a very long period of time. So we may not have a really accurate assessment of that incidence, but it’s likely to be in the same sort of figures as the Allergan implants, around one in 4,000 or something like that.
Mentor Siltex textured implants; one in 60,000. So you have to fill a football stadium, everyone with the same type of implants for one lady to develop it during the course of her life. On top of that, so you’ve got one football stadium for one person to get it. You need 20 football stadiums for one lady to succumb from this disease with a Mentor implant. So, again, I don’t want to trivialise but if you fill 20 football stadiums with people and then watch them over a couple of years, we’re going to have a number of people succumbing to many other very standard type of problems, whether that be car accidents or other types of issues. It is a rare disease.
Once we’ve found this disease with the ultrasound, the next test to is to put a needle in it and we suck out some of that fluid. The radiologist does that with the ultrasound so that the implant is not damaged. That fluid is taken out and it is tested. The correct testing needs to be done. That testing is looking at the cell type originally, and that there needs to be a consistent type of cell. In other words, it’s not one or two cells, the whole lot has the same type of cells. Those cells are then tested to make sure that they’ve got the right surface markers on them. Then we can definitively say, “Yes, this is it,” or, “No, this is not.” The test can then help put everyone at ease, is the key. From there we go onto treatment.
Now I’m just going to pause, because there’s a couple of little questions. Okay, the first question is screening options. Well as I said, ultrasound is your go-to tool. Essentially if you don’t have changes in your breasts and you’ve had implants for a long time, then this is not a disease that you will have. Because there are changes in the breasts. If you’ve got textured breast implants and you haven’t noticed changes, then there is no urgency for you to do anything or so forth. But for those with concerns, the first port of call of course is your surgeon, or your GP. But an ultrasound is a good screening tool. Certainly the TGA had an expert panel, which I was on, and we were talking about what we should do with screening, what we should be doing with routine sonography. The consensus was that routine ultrasound is not necessary unless there are changes that can be detected either by yourself or on examination with someone who is used to looking at the breast.
Now I’m just going to look again at a couple of these questions, quickly. “Knowing the statistics, which appear quite low, would you still recommend if it were you, your wife, or daughter with these implants that they adopt a wait-and-see approach?” Absolutely. I would not be telling anyone to have these out routinely, even if it was my wife or daughter. Now, I’ll tell you why. Firstly, there’s another bit of research which was published this week, where I’m a co-author on with eight surgeons worldwide. This was in the Plastic and Reconstructive Surgery Journal. What we’ll get to in a little bit is that we know that the ALCL appears to be the response from the body in relation to bacteria on the implant. Bacteria get on an implant when you put them into the body. That’s probably inevitable. Every body, every implant, has bacteria on it. So it’s not so much about bacteria, it’s about managing the number of bacteria. There’s a thing called the 14 Point Plan, and many of you have probably heard about that. It’s been in the literature, it’s been online, it’s all over the place at the moment.
The 14 Point Plan, if you’re wanting to look up the website is www.saferbreastimplants.org I think. But if you Google breast implants 14 Point Plan you’ll get it. Basically it outlines 14 different steps, or 13 at the time of operation and one later on, that can be undertaken when they’re appropriate, to help reduce the likelihood of bacteria or the number of bacteria getting on an implant. These can be done by the surgeon at the time of operation. So what makes this study that was published this week, what makes this study interesting, is that we have collected eight surgeons, we’ve collected 42,000 breast implants, so that’s about 21,000 women, of the Allergan biocell variety and eight surgeons. What’s happened with those and what makes it different is each of these surgeons is someone who looks at the literature, follows the literature, and has employed those steps of the 14 Point Plan as they’ve come out. What we’ve looked at is we’ve almost 12 years of follow up of these 42,000 breast implants. We should have 10 cases of ALCL. But with the use of the 14 Point Plan and good surgical technique, there are zero. This is encouraging.
Let’s say we’ve got 21,000 women out there with these implants, with a risk of one in 42,000 for each implant that they’ve got, what would be the rate of risk and complication of performing 22,000 routine operations for concern to save one diagnosis? Because there’s another paper that came out about two months. This paper I’m involved with, it hasn’t come out yet but what it does it looks at patients who’ve come in with advanced disease, so that’s disease that’s beyond the breast, or it’s gone to the lymph nodes. Compared to patients who have breast implant only disease. So it’s around the fluid or confined by the capsule. Eight out of 10 women diagnosed with disease has disease completely contained by the capsule and around the implant. Every one of those women survives this disease as long as they have the appropriate operation. So when the diagnosis is made, and the surgery is appropriate, that early stage patient survives this disease. Of the remaining two out of 10, they might have a lymph node or something like that, or more advanced disease in the breast. But if we can still get around this disease and get clear margins around this disease, those patients survive as well. Those patients will also need chemotherapy potentially, but the ones with only breast implant disease are not going to need chemotherapy if their surgery is adequate.
Not only can we modify the outcome, and make it even less likely to occur, so it’s one in 40,000 for the implant that was reported last weekend, or two weekends ago, as the worst one, the Allergan implant. It’s still rare, it’s one in 3,880 or around one in 4,000 of the figures that we gave. That’s still rare. But we’ve shown that with this study, we’ve been able to modify that by using good technique and using the 14 Point Plan to one in 40,000 or thereabouts.
So would I suggest to my daughter or my wife to have these implants removed? No. Because I know also that as long as you’re aware and you observe patients for, or patients observe their breasts for change, again if we look at those with advanced stage disease compared with those with early stage disease, the women who came with early stage disease had on average eight months between the onset of change that they noticed and their surgery. Eight whole months. They had early stage disease which was curable by surgery alone. Those patients who had more advanced stage disease on presentation had waited on average almost two years between the onset of symptoms that they noticed and getting definitive treatment. So there’s another reason there. I would be telling my wife and daughter, don’t panic. It’s still rare. If you’ve had the 14 Point Plan utilised, it’s rarer still. On top of that, if we find changes early, the literature and the science and all the data we’ve got so far says this is going to be curable by an operation to remove the implant and the capsule. That’s it.
Now if you have a capsular contracture, which is not a cancer, around an implant it’s exactly the same treatment. You remove the capsule and you remove the implant. This is another reason to re-operate. But again, I don’t want to trivialise it being a lymphoma. But it is rare, we seem to be able to modify the incidence according to our understanding of the disease and applying standard techniques, the 14 Point Plan, to make it rarer. If we’re observant and aware and notice changes, this is diagnosed at an early stage where it is curable. So the likelihood of dropping through that safety net and being one of the advanced cases if you’re aware of problems, is very, very rare.
Okay, so in the scheme of things, no. I would be comfortable with my wife, my daughters … I’ve got three daughters, except one’s quite young so she shouldn’t have implants yet. But my two elder daughters are in their 20s, and they could choose to have them. I would support that choice. I would make sure they saw the right surgeon, someone who I know is going to diligently apply the 14 Point Plan. The other thing is that I would be saying there is no one implant for every patient. The implant selection has to be appropriate. Even though we’ve shown that the incidence of this can be modified by good technique and the 14 Point Plan, it doesn’t mean we have to use a large surface area breast implant, or a macro textured implant. But there are some patients in whom these are still going to be the best implant. But it needs to be on the back of a discussion that outlines the risks as we know them. We know more about it now than we ever have. We don’t know everything, but we’ve got more information coming.
There’s a whole stack of research that’s going on; I’m on a collaborative group with guys at MD Anderson in Houston in Texas, with Anand Deva in Macquarie in Sydney, with a haematologist Miles Prince who’s at Peter Mac in Melbourne. Amongst others including others from the Mayo Clinic and from New York University, and so forth. There’s big units looking at this and investigating this in a collaborative fashion, which is why with such low numbers as 400, we’ve been able to learn a lot but we’re still learning more.
The first message I would say is it’s not to be trivialised, but panic is not the right thing. Routine removal of implants is not the safest thing. But if you have implant problems, whether it’s capsular contracture, movement out of position, changes to the breast over time such as droop, and things like that, then there might be other reasons to consider an exchange or a removal or whatever. There are a group of women who get over their implants; while implants are usually very comfortable for most women, it’s not for every woman that they’re comfortable. Some will get symptoms that are just aches and uncomfortable or they just feel they’re too big or whatever. It’s okay to have them removed if you want them removed.
I’ll just have a quick look again at some of these questions. “Silimed polyurethane, yes that’s one of the ones with higher risk. Considering having them removed and replaced with a smooth implant to minimise. Do you think this is necessary as a precaution?” If you’re unhappy with your result, then it’s worthwhile considering having them removed and replaced. That’s the way I would consider this at this point, is you’re far more likely … Everyone with breast implants is going to need a revision because implants aren’t life devices. But they don’t have to be removed if there’s nothing new happening.
“What are the type of changes we should be looking for?” We had a chat about that.
“My surgeon uses the 14 steps and is a registered surgeon with Safer Breast Implants.” Almost every plastic surgeon that uses breast implants in this country is registered as a surgeon on the 14 Point Plan. Plastic surgeons know this stuff. We’ve been talking about it for years. So that’s certainly something I would give you all a little bit of reassurance about in that regard.
“How big a part does the surgeon play in contributing to implant infection?” Very good question. But, if you are following these steps, and taking all of the precautions, then that’s going to be minimised. The more anal your surgeon is, and surgeons can be pretty anal, but the more anal and control-freakish your surgeon is, it’s probably actually to your benefit. It may not make him as pleasant to chat to, but it probably makes him a good personality type for this sort of procedure, because I know in the operating room I have a very low threshold for telling people what they should and should not be doing, because at the end of the day regardless of what happens it’s the surgeon who carries the can. I am responsible for my patients’ outcomes. I will not have anyone else tell me that it’s alright, don’t worry. These steps need to be followed diligently and it works. We’ve shown that.
“If you’ve had a prior rupture should you have the capsules removed?” You had PIP implants and now have textured Allergan. That’s a very good question. What do we do with capsules now that we know about this disease? My own approach to capsules is if the capsule is contributing to the reason we’re re-operating, then I like to take the entire capsule. I have some patients who’ll come in and some of you may have read online about on-block capsulectomy, that’s taking the entire capsule out. That’s certainly what I would do for a lot of patients. But the problem is that is a more destructive operation than a lot of people need. For instance, if you’ve got very thin skin and thin breast tissue, and then you go and take out the capsule, then you lose control of the implant pocket. The implant is more likely to move out of position. You might remove some of the important blood vessels to the residual breast, particularly if you’ve got very thin breasts like a breast reconstruction, it could actually interfere with healing. You could have skin healing issues and so forth.
It’s not always appropriate or practical or safe to just go in and take all the capsule. There are other techniques that you can use to stabilise implants, but it starts to then become quite a more complex procedure. But nonetheless, it’s a procedure that some of us perform … May not be completely regularly, but certainly from my own side I mean I do these much more complex operations once or twice a month, where we’re putting other products in to stabilise the implant in association with taking out the capsules and so forth. But for me, as I said, if the capsule is part of the disease, like in capsular contracture, certainly for this problem if you’ve got a thickened and solid capsule then I think it needs to go. But if you’ve got a very flimsy capsule that’s gossamer thin, you can see through it, then it’s not contributing to the disease. For a lot of people, we’ll do what we call a neopocket, where basically if this is the capsule you operate by going just outside the capsule, you squash it flat and you put the implant over the old capsule. The old capsule is clamped shut with some sutures.
The old capsule is closed off; the implant isn’t in the old capsule. But the old capsule might still be there. That’s how a lot of the capsules will be managed in those circumstances. If I have a patient with a ruptured implant, for me that’s a different kettle. I would take that capsule out. I’d put in a new implant that was in a fresh pocket.
“How can we find out which doctors do the 14 Point Plan?” There is a list on that website saferbreastimplants.org. If you go to that website, there is a list of doctors who have taken the pledge. There’s a couple of doctors, a few doctors at the top who are what we call “concept champions”, who teach people about the 14 Point Plan, we try and spread the word I guess, and then underneath that are a list of surgeons who’ve gone there, who’ve said I know about the 14 Point Plan, and when I do my surgery I consider these steps when I do the operation. You’ll be able to find plenty of guys there. Not just Australian. There are many, many surgeons from around the world on that website who’ve taken that pledge. So although it started here, there’s been a groundswell of support. Partly because there’s such a collaborative nature about this disease. Where we find that there are benefits, the information about those benefits is shared around the world through the classic surgery societies. We all work very closely together on this sort of thing.
Excellent, so the next thing is treatment. As I said, most patients are going to come in with a swelling of the breast. The largest group, so six out of 10 women, is going to have the lymphoma in the fluid around the implant and it’s not even involving the capsule. This is an interesting group, because there’s scientific discussion at the moment is does this stage actually mean it’s lymphoma? Is it actually lymphoma at that point? Or is it another condition that we call a lymphoproliferative disorder, which may or may not turn into ALCL? So that’s something that’s being discussed.
As I said, if you can get complete surgical incision, there’s nothing else required. If there are lymph nodes, those involved lymph nodes need to be removed, and for those patients they would probably go on to be treated with chemotherapy. There are newer medications being tested at the moment that are more targeted for chemotherapy, and they’re showing a lot of promise. A great deal of promise, even in extremely advanced cases, as a last resort. Some of those patients who’ve got extremely bad prognosis have responded completely to this newer medication. That’s exciting as well.
That’s what’s involved with the treatment. Where we lead up from the diagnosis with the ultrasound into the operation though, you’ll need a couple of investigations. The first will be what we call a PET-CT, which is a positive emission tomography and computerised tomography, which is a standard way of looking at lymphoma and other diseases. It helps us detect if the disease is confined to the breast. For instance, if you have a lymph node involved it will glow like a little red spot on the images, which allows us to determine whereabouts it is. Then finally we do an MRI scan. The MRI scan then gives us the most accurate picture of the breast.
Now at present, an MRI scan there isn’t a Medicare rebate, but on behalf of the research group I’ve been involved with discussions with the Department of Health in Canberra, only about three or four weeks ago, and it looks like we’re going to get approval for a Medicare item number to perform MRIs to plan surgery for patients with this condition. We’re working not only with the scientists around the world and our colleagues, but we’re also working with the regulators, with the Department of Health, with the TGA, keeping them abreast of all of our knowledge as it improves and increases. Certainly working with the Department of Health when we see that something like an MRI scan should be available for women who’ve been diagnosed with this, then we fight to make sure we get that. It looks likely that we’re going to get that. So that’s very encouraging.
There’s a lot of information there. I’d like to know if there are any questions? I see one. “Will the item number be backdated if you have had it done beforehand?” I doubt it. The government doesn’t give away money easily. But certainly it won’t be something I’ve got control over. I’d love to be able to get that, because we know that there are only 55 women in Australia who have had this diagnosed. There are three others still under investigation to see if that’s confirmed. So that’s 58 women; that’s not a lot of MRI scans over the space of the 10 years we’ve been looking at it in this country, or noticing it in this country. In fact, the process for getting a new item number normally takes 18 months to two years. But at the end of my discussion with the Department of Health, my last comment was, “Can we just remember when we’re discussing this and considering whether it’s worthwhile, we’re talking about 10 new patients each year. We’re talking about 10 MRI scans each year.” So it looks like we’re going to slip it through quickly, because they’ve basically come to the conclusion that it will cost more to explore it more than it will to just pay for the MRIs. Hopefully we’ll know, and they thought that process might take two months. So let’s hope so.
Have you got any other questions? Excellent. I’ve also been doing a little videoing in our practise, and we’re going to be putting a new video up online shortly. I can see there’s another one there, I’ll have a look at that in a minute. You can certainly go to our Facebook page, it’s not there at the moment, it will not be up until next week. But it will be a video and I know Trish usually makes these videos available after the time, so you’ll be able to go back and watch this.
Another one; “Two years ago I got silimed polyurethanes …” I think we’ve gone through that question or something very similar. “Silimeds … Should I get them removed and replaced as a precaution?” No, that’s a repeat question it was up there before. That’s fine, no we’ve already talked about that. If there’s a problem with your outcome then you should see someone who performs revision augment surgery regularly, because it’s much more challenging than the primary surgery. A primary augment operation takes 30 to 40 minutes when everything’s neat and tidy and the patient’s a low body weight. The operations we’re talking about, these revision operations, where there’s a total capsulectomy or a total capsulectomy with replacement or perhaps with a mastopexy or lift, or perhaps even with using these products to stabilise the breast implant, can take up to three hours. So we’re talking about a very different operation. I certainly would be suggesting that you are seeing someone who regularly performs revision implant surgery, because it is more complex. But, would you routinely have them removed? No.
If you have changes in your breasts, if you have other complications or problems with your breast implants, if they’re just getting old. Implants can last a very long time. In the last three weeks I’ve taken out four sets of breast implants; two of them were over 20 years old. In two patients they were over 20 years old. So it’s not something … They can go for a very long time. The bottom line is, if you notice changes with your breast implants … A lot of us will follow patients for quite a long time. I follow my patients for two years after their primary surgery. At that point, if everything’s right, it’s likely to go for a very long time. But the first thing you should do if you feel you’ve got a problem is contact your surgeon. If I have a patient who rings me, our rooms, and it might be five years ago they had their surgery. They’ll talk to the girls and they say, “Look, my right breast implant seems to have moved out of position.” Then we will give advice to you and say, right, get yourself a referral because implant complications at this time in Australia have item numbers for revision and review, so you’ll get a referral, you’ll get an item number for your consultation so you get a rebate. Then you can be referred on for other investigations if required, or you can discuss the options and so forth.
Most women who come back to see me in this way, whether it’s my own patients or other patients, we don’t have to do anything. We just sit back and watch. Frequently they’re coming because they had a mammogram and an ultrasound for breast cancer follow up, and they were told “We can’t see any breast cancer, but it looks like your implant’s ruptured.” Ultrasound over-diagnoses rupture, and often it’s just a fold in the surface of the implant that’s being picked up and so forth. In those instances we might say, “Let’s get an MRI. If the implant’s ruptured we’ll deal with it. If it’s not, we won’t need to.” Or they might say, “Well, actually I’ve been looking for a reason to do something else because it’s not quite what I wanted,” and then we go from there.
The first port of call is to call your surgeon. We can tell you what the concerns are and everything like that. If you were remote, you call the surgeon and you say, “It’s not easy for me to get there.” We say, “Right go to your GP, say that there’s a problem with your implant. Ask for an ultrasound.” Certainly we can give advice to the GP or whatever about what to look for. This is not well-recognized by GPs. It is something that has to be considered, but if you have fluid around your breast … We’re not talking about two or three mils, we’re talking about 50, 100, 150mls. We’re talking about quite a bit of volume, not just a couple of mils. There’s almost always some fluid around an implant. Most fluid around an implant is not lymphoma; most fluid around an implant is simply a seroma. That’s quite common. In fact, there’s always a little bit. It’s a matter of degree, and that’s why if there’s a significant enough amount for them to put a needle in, it needs to be tested.
Certainly for my patients, I’d be saying come and see me. Or at least call our rooms, but we’d certainly be doing follow ups. I imagine that a lot of plastic surgeons would be doing exactly the same thing.
Okay, yeah. Someone’s asked a question about clusters. Yes, clusters have been found. There’ve been I think five clusters in Australia of interest. These can be for a number of reasons, but they do support the concept that bacteria could be involved. We haven’t been let into try and assess the reasons for these clusters in every instance. However, in one of these clusters especially, we’ve been able to go in and identify that one of the bacteria most associated with this disease was inadvertently present in the water supply of that institution, of the hospital. In that instance, it wasn’t the surgeon it was just that the water and the processes in the hospital were contaminated, if you like. That’s been since addressed, and we move forward from there.
Someone’s asked a question “Do I charge the same for a aug in Brisbane and Toowoomba?” I think I do, because I work in both.
“Is there a brand of implants that’s better than others when selecting which ones to have implanted?” Okay, so this is a good question. One of the things when journalists are interviewing us is they say, “Well, why are you still using textured implants? If it’s not associated with smooth implants, why doesn’t everyone just have a smooth implant?” The bottom line is that different implants have different performances, and they have different relative risks. Lymphoma, ALCL, is one of the risks. But we’ve already talked about how rare it is. But for example, if I use a larger, smooth implant compared to a larger, textured implant, that smooth implant is going to move out of position more frequently than a textured implant. It’s going to undergo migration.
I’m far more likely to operate on a patient for migration than for any other problem, because one of the things that we learnt about before the 14 Point Plan before we worked out that it might be associated with ALCL, was that bacteria are associated with capsular contracture. 15, 20 years ago, we would have said to someone entering into breast implants for the first time, “Within 10 years you’ve got a one in five chance of having a re-operation for capsular contracture.” It’s one out of five patients for capsular contracture. Now what we know is that there are three things primarily that contribute to capsular contracture. One is blood collecting around the implant. Then if that’s not removed or whatever, then that can predispose to capsular contracture. The other is bacteria. The third is time, because you need enough time for these problems to develop.
Stopping bleeding at the time of the operation, that’s one of the 14 Points. Preventing bacteria getting on the implant, or limiting the number of bacteria getting on the implant … With implants bacteria causing problems, basically you start with a very low level of bacteria. As you go along with time, if it stays below a threshold the body doesn’t respond. If you have more bacteria and then with time they grow and they pass that threshold, then you can get one of two responses. You can get an inflammatory response, which gives you capsular contracture, or you can get a transformational response where the body responds to the presence of the bacteria. You get an immune response, those cells can grow and proliferate and in those patients with a genetic predisposition, they may go on to develop lymphoma. I say genetic predisposition, so they’re a patient factors as well that we’re exploring and investigating.
Despite the large number of Asian women worldwide who’ve had breast implants, there is only a single Asian patient, and that includes Chinese patients in China, Korean patients in Korea, and so forth, but also Asian patients in Australia or in America or in Europe, there’s only one identified Asian patient who’s had this disease. Which helps us sort of work out that yes there are likely to be genetic factors as well.
Is there a brand of implant that is better? Well, for me … If I’m using a very small implant, then I would use a smooth implant. Because if I’m using a very small implant, it’s not really pressing against the breast enough for the texture to really actually be effective anyway. Plus a small breast implant is less likely to respond to movements and so forth, and it’s less likely to move out of position. If I’m using larger than a small implant, I’m going to use a textured implant still. The reason I’m going to use a textured implant still is because I like its performance characteristics in terms of minimising other reasons to re-operate, and I know that I apply the 14 Point Plan and therefore am making this as low-risk as possible. But I have this discussion with my patients and we choose an implant together.
I still use the Allergan biocell implant where I think it’s adding something that the others don’t. There are a number of things about the Allergan biocell implant. It has the firmest gel on the market. What that means is, if I need that implant to shape a breast, particularly if I’ve got someone with a short distance between the nipple … So if we’ve got a breast like this and we’ve got a very short distance between, so the nipple’s down here and there’s a short distance here. If I want to expand that up to give the right shape with the nipple on the top and a nice fold like this, so we get a good shape to the breast, in some patients I need an implant to do that. Because the breast won’t. In those patients, I’ll still be using or considering a high-surface area implant with a firm gel so that I can get maximum shape change where I need it.
But if I don’t need it for that particular reason, I will default to other options if we think that they’re going to be of more benefit. If you’re using a shaped implant, so that’s a shaped implant rather than a round one, they’re all textured. If we look at the low surface area texture compared with the high surface area texture, the low surface area textures have a slightly higher chance of rotation. There’s another reason to re-operate. So for some patients that may or may not be worthwhile. You can see that the different implants act and perform differently, and they have different relative risks. Patients come with different amounts of breast tissue, different shapes of breast tissue, different amounts of looseness to the breast itself. They have different goals; some want a rounder shape, some want a natural shape. Some want bigger, some want moderate. Everyone has a different goal. We have different amounts of activity, because activity affects implants.
What we have to do is choose an implant based on requirements and risks and benefits and goals, and what you already have, not just, “This is the implant for you.” So that’s one of the biggest things, I think. You start off with reassurance. This is rare. There are things we can do, we can use the 14 Point Plan at the time of surgery. The disease presents with symptoms that are identifiable. When treated early, this disease is cured by implant removal and capsulectomy. Patients need to be aware of it. They need to be informed about it during the process of consent. Finally your implant selection needs to be based upon your specific … What you have, what your goal is, what your breast tissue is doing, how active you are, what your lifestyle is, and then the relative risks and benefits of different choices that are available to you to get your outcome with your body.
If someone says to me, “I only use this implant now, because that’s the safest.” I don’t believe that. I don’t agree with that. I think that’s narrow-minded, and that means that it’s not necessarily applying intelligence to implant selection. If a patient says to me, “I’m fearful of lymphoma.” Of course, I’m going to use a smooth, round implant. Because otherwise they’ll be anxious. Not because I think we’re substantially controlling risk, but anxiety is not something you need because you want breast implants. So we will minimise that, because there are always options. A woman’s risk of lymphoma is one in 50 if they live to 80. We’re talking about a disease process here which is a far, far, far lower rate. A risk of breast cancer is one in eight. Lymphoma one in 50. We’re talking about one in 4,000 for the biocell implant, and as I said with our current research, we’re pushing that out to one in 40,000.
So it is real, I am not trying to trivialise it, but it’s identifiable. When it’s picked up and treated early it’s curable with surgery alone. Even for women who present with more advanced cases, and as I said those patients generally have symptoms for almost two years before they have treatment. But even for those ladies three out of 10 of them are going to be cured as well. The likelihood of succumbing to this is extremely rare, and far rarer than many of these other problems that we encounter everyday in our general life. We choose to go to the beach and get skin cancer … Well we don’t choose to get skin cancer, but it’s a consequence. We choose to ride bikes and some people have accidents. We choose to drive cars. We like to go skiing. We do all of these things because they’re fun and that’s called living. This doesn’t mean you shouldn’t live. This just means you need to be aware, you need to be observant. But you don’t need to be paranoid. If you’ve got concerns, you call your surgeon and you have a chat. Then you can understand what your own personal risk level is.
If there are other reasons to consider a re-operation, then you might take all of this onboard and you might choose a different option next time.
Here’s another question. “Do you think the numbers of infections would be higher in countries like Thailand where the standards are not as high as in Australia?” Well that’s going to be very interesting to see, and it’s too early to tell. Because the number of women going to places like Thailand and Malaysia has increased, especially … I think it’s pretty stable at the minute, but certainly over the last four or five years there’s been quite a large increase in it. As I said, the average time to onset of this disease is eight years. I think that’s a question we’ll answer later on. There is no doubt that some of these places have good quality surgeons.
One of the things we have in Australia that unfortunately makes our surgery less competitively priced, is that accredited facilities cost money because they’ve got a lot of hoops they’ve got to go through to maintain their accreditation. Without accreditation, they don’t get any relationships with health funds, they don’t get paid for anything, and obviously they don’t exist. To maintain those levels of accreditation, they have to have whole procedures about infection control and so forth. In Australia, we have minimum standard wages, or minimum basic wages. So we have higher paid employees of the facilities. To provide the right level of care preoperatively, during the operation, and post-operatively, they require more staff numbers. So all of these things add up. The implant companies sell implants to Australians at a higher price than the same implant in Asia. The reason? The companies have told us; Australians will pay for them.
There’s a whole bunch of reasons why surgery in Australia is not as cheap as it will be elsewhere. But it’s what you get from your treatment. It’s one thing to say that’s cheaper, but the other side of the coin is what’s better value? Value is not the price. Value is what you get for the price. Does having the surgeon live nearby so you can see them again if there’s an issue or a question or a concern, does that have a value? If you have a problem two weeks, six months, two years, five years and having the surgeon accessible, does that have value? The problem with this is if you have an appendicitis and it’s ruptured. A successful outcome from treating that is that you don’t die, your appendix is removed, and you’re functionally normal. You can still run and jump and whatever. That scar might be puckered, it might be stuck down on the muscle, it might be wide, you might have had a wound infection. But you’ve still had a successful outcome because you’re alive and breathing.
When we’re talking about breast implants, a poor outcome is a complication. If the implants are like that (pucker noise), that’s not good. If you’ve got a poorly planned procedure, if you’ve got a poorly performed procedure, if you’ve got a breast that’s droopy, you’ve got differences in size, you’ve got a whole range of things, those things you might have healed without an infection, without bleeding, without anything like that. But it still may not be your goal and your best outcome. At least when you’re having your surgery at home, you can ask the surgeon. You can re-approach that. That’s I think an important thing; value is not the price. It’s what you get for the price.
My patients as for many, many of my colleagues, my patients pay for their surgery and I see them for two years and it costs them nothing else. If their problem, if they develop a problem and it’s not a recognised complication that has a low risk but due to something I’ve performed, then that operation doesn’t cost them a cent if they need one. You get value out of safety. That’s what I’d argue. I’m not alone with those sorts of policies. I’m not trying to say I’m the best of the best or anything like that. Many, many, many others will be doing something very similar. But that’s something you should also be asking when you actually see someone to have this surgery; what happens if there’s a problem? How is that going to be managed? Because that’s why you pay to see someone that’s not the cheapest person. Because you’re getting value out of every other part of the treatment, whether it’s their knowledge, whether it’s their training, whether it’s because they do a lot of them. Whether it’s their outcomes. But more likely it’s a combination of all of this. Because that’s how it should be done. From your point of view, your safety is the most important part. Then on top of that your outcome. They’re the things that we need to focus on.
Excellent. Any more questions? Now, I’ve got a question here which is I feel for this person, who has anonymously asked a question. A surgeon who is not associated with any of the associations or societies had a bad result and wants to get them replaced. If you have a complication from the surgery, then you will get assistance with the procedure from Medicare and health fund if you have one. Now, in some instances, this is an interesting point. In some instances, you have a complication that’s non-urgent. A capsular contracture, for instance, is a reason that Medicare and health funds would assist with surgery. That means, the health fund pays for the hospital, the health fund pays for the new implant, and between Medicare and health fund they assist with the cost of the surgeon and the anaesthetist. If you have a non-urgent problem, one option is to get health insurance, wait 12 months so that you’ve done your waiting time for pre-existing conditions, and then you can get assistance. That saves a lot of money.
Revision augmentation from a hospital’s perspective could be $3,000 even. The implants could be $1,000 a piece or thereabouts. Just on the implants and the hospital, if both were applicable, you’ve got $5,000 in your pocket from your health fund. Health insurance is a good thing for these types of problems. But if it’s just … I don’t say just, just is not the right word, but if it’s a poor cosmetic outcome with no complication related to the implants, then the way Medicare stands is there’s no item number. But it’s certainly something that could be assessed and you could be given advice if you see someone.
Okay. Thank you everyone. We’ve been going for an hour, I’ve been doing all the talking. It’s time to have a glass of water. Okay, thanks so much. Look, Trish knows how to contact me if you’ve got any questions. As I said, we’re putting up a video on our own Facebook page soon, or on our websites or something. If you need information, we know a lot about this disease. This disease is something that is supported by Medicare and health funds. You are never left on your own in this country when you’ve got a malignant or a lymphoma or any other cancer. There is always Medicare assistance with the management of cancer. Okay? That’s not a problem. Thanks everyone.