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Webinar recording: BIA-ALCL and breast augmentations

18 March 2020


This recording is provided on the TGA's website solely for the purpose of indicating or suggesting what TGA representatives spoke about to the various conferences and seminars to which it relates. The papers are not legislative in nature and should not be taken to be statements of any law or policy in any way.

The Australian Government Department of Health (of which the TGA is a part) advises that (a) the recording should not be relied upon in any way as representing a comprehensive description of regulatory requirements, and (b) cannot guarantee, and assumes no legal liability or responsibility for, the accuracy, currency or completeness of the information contained in the recording.

Recording of online webinar

  • Webinar date: 14 February 2020
  • Webinar summary: A panel discussion was held in Sydney to talk about BIA-ALCL and breast augmentations. The recording of this discussion is below.


Sophie Scott Hey, welcome, everybody. My name is Sophie Scott. I'm the medical reporter for ABC. I'm gonna be your host today. Thank you for tuning in and watching. Today we're gonna talk about breast implant...associated anaplastic large cell lymphoma. Now that's a bit of a mouthful, so we're gonna call it ALCL for this debate. We wanna make sure that everyone out there watching is up to date with all the latest information about this condition. Now before I introduce our panel, we've already received lots of questions for the webinar which is fantastic! We'll try to get through as many as we can. You can also ask questions as well and they'll come up on my iPad. The briefing will be recorded so you don't have to take notes. You can play it back and watch it later and we'd love you to share on social media because this is such an important topic.

If you're on Instagram or Twitter, we'll put it out through those and my Instagram and Twitter handle is @sophiescott2 so I'll be posting it there after the event. So let me introduce our panel right now. We've got Professor Anand Deva, a plastic surgeon from Macquarie University, Dr Anna Loch...Wilkinson, a plastic surgeon from Queensland, Dr. Ron Bezic, a cosmetic surgeon from Sydney, Anne Marie Sage is our consumer representative on the panel today, and Miranda Lauman from the Therapeutic Goods Administration. So thank you all for being here and I want to start by saying that the information that we'll be talking about today is general in nature and if you have any specific concerns that you wanna raise, you should raise it with your own physician, but you'll be hearing lots of good information today. So before we start, let's just set the scene with a couple of slides with Dr. Deva maybe taking us through just where we're at when it comes to breast implants and this condition. So, Anand, just take us through the issue of breast implants. How common are they? And when were they introduced in Australia?

Anand Deva Sure, so look, they've been around for a while, introduced since the 1960s. They're used for both cosmetic enlargement of the breast and reconstruction and they can vary considerably, based on the shell, texture, smooth, what's in them and what shape they are. We've known a little bit about I'll just advance this...

Sophie Scott Sure.

Anand Deva We've known about breast implants and they're quite highly regulated. They're classed as Class III, so all the devices, they're that ones that carry a risk and they have to balance the risk versus the benefit. Now it's really important for all Australian women to know that these devices are now tracked through a registry. Around 20,000 Australian women get these devices each year and the Australian Breast Device Registry is set up by the Federal Government, monitors long-term safety and performance. So it's critical that if you're getting an implant, that your implant's placed in the Registry and it's endorsed by all societies and surgeons. It's free. And certainly, seek a surgeon that uses the Breast Device Registry. And then, about ALCL, this is a tumour that was first reported back in 1997 and certainly in the last 10 years, numbers have been increasing. There have been 33 confirmed deaths from this cancer and currently there are at least 838 cases confirmed worldwide. And the reason we're here today is because Australia has reported quite a large number of these cases, 107 as of 31 January this year.

Sophie Scott OK, excellent, so we'll just fix... flick through the rest of those. OK, so let's get cracking on our questions. One of the most common questions that patients have asked is, if someone has breast implants and they're worried, what should they do? And let's talk to the doctors on the panel. For a start, what are the symptoms that women should be looking out for if they have breast implants? So we'll just go through our three doctors here.

Anand Deva Well, I think that anything that changes, another shape, size, pain or a pebble of mass would alert you to go and seek medical attention.

Sophie Scott And Dr. Loch-Wilkinson, what should women be looking out for?

Anna Loch-Wilkinson So one of the things if you have breast implants, in for what we call late seroma, so it's having a collection of fluid, usually more than 100ml but generally a significant collection of fluid and usually presents in a delayed fashion.

Sophie Scott And when you say delayed, what do you mean by that?

Anna Loch-Wilkinson Usually on average every six to eight years, roughly.

Sophie Scott OK, and Dr. Bezic?

Ron Bezic Yeah, it can be anywhere between 3.5 to about 14 years, I guess. The other thing, the key, often it occurs on one side most commonly so any asymmetry, so any difference in size of the breast that slowly develop might be a key pointer. It's usually painless.

Sophie Scott OK, and so if if women do have any of those symptoms, what is the next step, then? What should they do, in terms of getting those symptoms checked out? Who'd like to take over?

Ron Bezic First, see your original operating surgeon will be your first port of call and an ultrasound is the first valid test that you do and that's non-invasive. It doesn't have any radiations, easy test to access. And they can see if there's any fluid around the implant or if there's any masses that are obvious on the ultrasound and they can test that fluid if there's enough there.

Sophie Scott OK, so and then what about so the, if there's - we'll go into some of these issues a little bit more in detail in a minute but if women don't have any symptoms and are concerned, what should they be doing?

Anand Deva So I think there's no indication today, if you've got no symptoms and normal examination either physical exam or ultrasound exam - that you need anything done apart from ongoing surveillance. So I think that's key and so I think initially, a good assessment ultrasound, if required - and if everything comes back OK, I think women can take heart that they're unlikely or probably don't have this cancer.

Sophie Scott And so, some women though, some patients might want to have the implants out even if they don't have symptoms. Is that something that you're finding with some of the women that are speaking to you, that they do feel anxious and they want to have the implants out?

Anne Marie Sage Yes, absolutely. So what we we get a lot amount of women, they are sort of very anxious and they're thinking, oh my goodness, what am I gonna do? I'm reading all of these articles. I'm seeing all these things in the news. And I think that with that fear comes that uncertainty and I think having that check and really getting the facts about what to do is so important.

Sophie Scott And we might just go to Miranda from the TGA, Miranda Lauman. So what's the TGA's advice about whether women should get the implants out if they don't have any symptoms?

Miranda Lauman So certainly, the ongoing advice we've had from our expert clinician advisory group is that where there's no symptoms, where there are no clinical reason to have implants removed, then that shouldn't be pursued. There are risks with having explant procedures as there are with all surgeries and so that risk benefit is something that people really need to weigh out. But we encourage people to stay informed and definitely to keep up regular self-checks and to be engaging with their surgeon.

Sophie Scott Because this was a question that came through in the patient questions. It was, why is it OK for women to now not get implants that have been recalled but it's OK if you've already got them to keep them in? And so we might just get the doctors to refer, to really talk about that risk and benefit of keeping the implants in.

Anand Deva So I think it goes down to the relative incidence of this tumour. So, as Miranda said, there's no indication to preventatively remove these implants if there's nothing wrong. But going forward I think the decision by the TGA was to try and limit new cases going forward. So there's this sort of this gap between what to do with women who have these implants. And I think the explantation surgery is not without its risks. So as practitioners, we have to advise patients, Look, there are considerable risks to having a explant done. And those risks currently don't weigh the benefits of ongoing surveillance.

Anne Marie Sage I think, too, just to add on to that, Annand, is that we get a lot of women and they, they ask, Look, what are some of the long-term consequences of living, you know, with these implants and am I going to, is the risk going to increase with time going on? Or you know, also, if I do get to get them taken out, will there be some kind of a Medicare or you know, anything that can sort of support me along that way?" Cause a lot of women don't have the money to get them removed.

Sophie Scott And that is obviously a consideration as well, isn't it, for patients to see whether they can get the implants out. So, and we might as talk about the recall of the implants. Miranda, can you just, I know it's quite complicated as an extensive list, but can you just take us briefly through which implants have been recalled by the TGA? Just in general terms.

Miranda Lauman Sure, Sophie. So the decision was made to recall eight models of breast implants that are produced by four manufacturers. But that each of the manufacturers does produce multiple models. So essentially of the eight products, eight of those, sorry, seven of those microtextured and one, microtextured. But the TGA is aware that this is something that we're continuing to learn about. We don't know everything about ALCL and the causes of it. It's also a latent disease so there is quite a lag before it's presented. And so, in order to take a forward leaning approach, we've imposed conditions on all breast implants that remain available in Australia, to increase reporting and also really support consumers to have more information about the devices that they're having implanted.

Sophie Scott And I guess a question might be, so Miranda for you is, why aren't all textured implants off the market now?

Miranda Lauman So in looking at the review of all the breast implants, it was a range of information taken into account. The TGA undertook quite extensive laboratory testing on the surface texture of devices and looked at the manufacturing techniques involved. We also looked at a range of clinical information presented by the manufacturers themselves and took into account advise from our working group and from the consumers as well. The reality is that breast implants have an important place and removing all breast implants from the market would have adverse consequences. So in looking at the decision, what we're trying to do is benefit-risk analysis and consider what is the point at which that benefit tips. It's a very hard decision to make and it's one that people have many views on. At its base, the decision to make suspension decisions has based on where clinical evidence is, has some gaps in it. And that's a condition we've put on the suspension. And also, where those particular breast implants have specific links to cases in Australia. Or where they have claimed equivalence to breast implants that have specific links. So their manufacturing technique is the same, or their surface texture is the same. So there are lots of similarities between the products.

Sophie Scott So that might be a good point now to talk about risk because it is, the risk does differ based on the type of implant. So maybe, can I ask our panel to take us through the different grades of implant and how the risk changes with those different grades?

Anna Loch-Wilkinson So we sort of classify that roughness and that this surface area into four things. So it's Grade I, II, III, and IV. And so, particularly the Grade III and IV implants that are, have a bigger risk. Can be as high as about 1,900 for some of them. And then for the lower textured implants, the risk that we have is anywhere between one in 15,000 to one in 36,000. But there are other implants out there that haven't been on the market for long. We just don't have the data on those yet. So, it's probably important to ask if you're gonna consider breast implants. Ask your surgeon which type of implants they use and they can give you the numbers that we have based on our data so far.

Sophie Scott And so, what exactly should patients be asking in terms of the, when they are, if they're thinking about implants? What are the questions that they need to ask so that they can then make a decision about whether they want that particular implant?

Ron Bezic We would have basically have an in-depth conversation with your surgeon about why you want, why you're choosing this particular implant. What is the benefits of it? What is the risk that we know so far of developing ALCL? If it's as, an implant with a slightly higher risk, why are you using that as opposed to a smooth or a microtextured implant, you gotta go for that discussion with them. There are benefits to using them in certain cases. You know, in terms of textured implants, to improve capsular contracture rates and migration, which are two big areas of complications who are much more common than ALCL.

Sophie Scott And Anne Marie?

Anne Marie Sage Look, I think that point here is that, when anyone goes and sees a surgeon or a specialist, of course, you're always gonna listen to them. And what I like to see is that women are informed but they do research. They do research in a way where you really look at, OK, so what is it that I would like to have? Why I'm going to have this implant? But not only that. What are the benefits? And ask informed questions. So OK, these are the implants that you'd like to, you know, have me have. But why is that? What's the difference between this implant and this one? And be OK with, you know, asking some, what are some of the experiences that you have as an individual surgeon in this area? So do that research before you make up your mind.

Sophie Scott And another thing we'll touch on now is also about follow-up care. Because that's very important as well, isn't it, with breast implant? So it's not, it's not just something that you go and have and that you forget about it. So how important is, what sort of follow-up care should women be getting when they get breast implants?

Anand Deva So I've been advocating that, you know, breast implants are not lifetime devices. And in fact, the longer they stay in you, the more risk of things going wrong. So I agree. I don't think it's good enough to put an implant and then not offer some sort of ongoing surveillance. Now, so is the argument is to, what the frequency of surveillance is. And so you could do a clinical exam each year or every second year, but you need to match it sometimes with an imaging as well. It varies from surgeon to surgeon. But I do think, we need to start offering. This is part of a standard.

Anne Marie Sage And I think, too, on that Annand, is that when you start getting that relationship with your surgeon, that you are OK to reach out if anything comes to mind or if all of a sudden it doesn't quite feel right. I think that in the past, there's been a bit of shaming about having implant, but we know there's thousands and thousands of women a year that gets breast implants. It's not uncommon. If you were to have any, let's say, hip replacement or anything like that, and something was wrong, you'd go to your doctor, you'd go to your surgeon and say, Hey, you know, I'm not feeling quite well around that." And I think it's normalising that... Breast implants is something that a lot of women do get for certain reasons and individual reasons, as well. Have that relationship with your surgeon where you can reach out and ask any question without feeling like, is this OK, and not have that shaming feeling around it, as well.

Anand Deva There are two benefits, Ann Marie, as well, I think, and benefits for the patient, because every year when you come back, information might change and so there's new information that you - there's an opportunity to discuss with the patient. As women get older, there's also a risk of breast cancer so having implants and screening for breast cancer is something that's really important. We found that they may not be getting breast cancer screening if they were worried about implants. But I think the other benefit is actually to the surgeon because you really get to see your own results (LAUGHS) at the time and you learn that what you do today can change significantly as time goes on. So I think I'd encourage clinicians to follow up patients cause you learn from your patients and you learn from your own data.

Anne Marie Sage And I think too, that when you do get a lot of paperwork, which you do with any surgery, is that you really sit with your surgeon and go through that step by step. And if any question comes up, be OK with asking those questions at that point in time because they're there to support you and it's a partnership. It is a relationship that's built on trust and that will take a lot of the fear away, as well.

Sophie Scott So one of the common questions that we've had from people who've preregistered for this webinar is, for women who have breast implants, can you test for ALCL with a blood test? So who'd like to address that?

Anna Loch-Wilkinson No, you can't, (LAUGHS) simple answer.

Sophie Scott Why not? Take us through why can't you test it for - why can't we do a blood test to see if you got ALCL?

Anna Loch-Wilkinson Because the disease itself actually sits usually in the fluid around the implant or in the capsule around the implant. It's not until potentially later, it can spread further - but generally most women present with very early stage of the disease, about 87% and that's confined - which is good because it's very treatable at that stage but you just won't pick it up on a blood test.

Sophie Scott So let's with the fluid, how much fluid do you need to take, to test properly for ALCL?

Ron Bezic Generally, the amount has to be enough so you can safely remove the fluid without damaging the implant cause you use a needle to remove the fluid. So about 50ml is what they generally say is a safe amount that you can easily drain to test.

Anand Deva I'd like to add that the majority of women that we're seeing with this, it's not a little bit of fluid. It's a significant amount of fluid. It's not something you would ignore. You'd wake up and one breast would be quite swollen and difficult to get in the...

Anne Marie Sage Yeah, and we get a lot of questions from women that, what are some of the symptoms? Is it just fluid or is it that my breast is hardening or I've got a rash, could that be it? So what are some of the symptoms other than fluid?

Sophie Scott Yes, so when patients come and see you again, what are you generally seeing or what are you commonly seeing as symptoms that would lead you to think this patient might have ALCL?

Anna Loch-Wilkinson It's usually a seroma. So a collection of fluid happens without any necessarily proceedings with trauma or anything like that.

Sophie Scott And what does that sort of look like? Could you just sort of take us through what that might look like on the patient?

Anna Loch-Wilkinson It looks like a swollen breast that's - we don't have many cases of disease in both breasts at the moment, so it's generally on one side. And that breast would look a lot bigger and swollen, more swollen.

Sophie Scott And, Ron, does that fit with what you've ...

Ron Bezic Pretty much, I mean it's usually painless. It's not associated with any temperature or redness, purely like a swelling without many symptoms, apart from just the swelling itself.

Anna Loch-Wilkinson I think... RON BEZIC: Some of sorry, you go. Alright, so a lot of women get their implants, ultrasound and that because they might have had some other issue and they'll detect a small amount of fluid and that's not abnormal around a breast implant. So when it's a bigger volume generally but if that fluid does build up to something more, it's important to go and see your doctor to get that tested.

Sophie Scott Is that why it's so important to go back and have checks to see if that fluid is building up?

Anand Deva So I think the moment a woman presents with a seroma, my feeling is it really should be properly worked out. It can't be ignored and when possible, as both of my colleagues have said, you need to sample it and test it. There are many other causes of fluid swelling but you need to really exclude ALCL in that setting.

Sophie Scott And, Ann Marie, is that happening with patients that are coming to you? What are they saying to you about their experiences, in terms of if they have fluid or they have some concerns, are they getting proper follow-up care and getting those tests done?

Anne Marie Sage I would say yes, some, absolutely and that's a fantastic thing because we do have some amazing surgeons in Australia. There are a big group that they might go to the doctor and they don't know what to do and I think it's being downplayed a lot. Some surgeons, they no longer are active so they can't find their past surgeon. Sometimes the information of the implants and the details are no longer there because it might be past the seven-year period. So I think that there is a big, large amount of women that do feel like that it's being downplayed. You'd be alright because it's fairly rare and so, yes, I think it's a bit of a mix.

Sophie Scott So we might just follow up that point about what should women do if, for example, they don't know what kind of implants they have, their surgeon might have retired and they can't get that information, what should they do just to find out more about what's going on with them?

Anand Deva There's a few ports of calls. Clearly if your surgeon is retired... then one option would be to go to the hospital where you had the original surgery. A lot of hospital records are kept a lot longer, as we found. Actually, Anna did a lot of the work (LAUGHS) in terms of finding out which implant types are involved. So that's one port of call. And then there are registries now. So prior to the ABDR there was the Breast Implant Register and you can contact them and ring them and say, this is my name, my date of birth, am I on the register? And that's another way you can find it. And then, actually go through a lot of paperwork at home cause often women say, "I don't know" when I say So do you have a file with medical stuff?" And just go and rifle through that and sure enough they've been given a little card. I had one patient that brought in, I think, a 30-year-old card of a Dow Corning implant and says, I didn't even know this was at home." So there are different ways of getting that information.

Anne Marie Sage And we do get questions quite often. So how do I know if my surgeon is going to be the best one? How do I know if this surgeon is exposed to a lot of experience? How do I really know other than, perhaps, asking questions, looking at their website and looking at some of the credentials? So what should I answer to that?

Sophie Scott And what should people do? I mean, because often looking at a website would be not necessarily a good indication of someone's expertise or qualifications or - is it a matter of going and actually just having a consultation and asking the right questions, asking about their experience, asking about what sort of follow-up care they might offer?

Anand Deva I better take that one. I think that don't forget your GP cause general practitioners have a wealth of information about a lot of stuff that happens out there whether it's good and bad. So I think the GP should be included in this process. I mean I know a lot of... That would be one piece of advice. The other thing is a lot of it depends on how comfortable you are. I mean, I've been a patient a few times and it's that level of comfort and trust as you say. I think that's really important and I think that people are pretty good at sensing that. I hope they are anyway.

Sophie Scott So Dr Bezic, what would you say to women who might be thinking about breast implants? What sort of questions should they be asking doctors before they go down that track?

Ron Bezic Well, there's also their level of experience so how long have they been in practice? Have they done this procedure many times before? What type of specific training have they obtained doing this procedure and also looking at feedback from other patients, maybe talking to other patients. If you couldn't find any other information, that's often a useful source.

Sophie Scott And one of the big issues because I've done lots of stories on medical devices including breast implants and others is the issue of informed consent and whether patients really understand what they're having implanted inside them. So I just wanted to touch on what's being done to improve informed consent both from doctors and also maybe from a regulatory point of view?

Anand Deva Can I suggest we use the term informed


Anand Deva The reason why educated I think is important is that different patients have different levels of ability to take in information so giving a detailed bit of information to someone who perhaps may not get most of that, you need to then give it another avenue in which they can clearly understand it. So I think informed consent is more than just a bit of paper or a tick box. It's actually connecting with that patient on a level that they can understand and you can educate them and they can make a real decision based on what they know.

Anna Loch-Wilkinson Agree and you should, for a lot of these surgeries, it's a big decision so you probably want to go back to your surgeon more than once to actually go over things again because you're only going to take in so much on one consult. So I tell my patients go home, write down all the questions that you have because when you come back, hands down, you're always gonna forget something when you're actually in the room so if you have this list, you can go through it and if you're not happy or comfortable with your surgeon, you can ask for a second opinion or ask your GP to refer you to someone for a second opinion.

Anne Marie Sage I think that cooling period is really, really important because it's an emotional thing and it's a big thing for women so having that cooling off period just to deflect and maybe even bring your partner or bring a good friend to that meeting to ask some other questions that you might not have thought about at that point of time just so that you can come from different angles because it is an emotional thing for a lot of women.

Ron Bezic I was gonna say the onus on us as healthcare professionals is to make sure they understand the nature of the surgery that's part of the informed educated consent.

Sophie Scott And Miranda, what from a regulatory point of view, what is being done or can be done to help empower women so they can make that educated informed consent when they're sitting in a doctor's surgery?

Miranda Lauman So as part of the review, all products were given new conditions and that was to enhance information in two different ways. One was to enhance the instructions for use which go to surgeons so that helps health professionals stay up to date with what's evolving knowledge. Also, to introduce what's called a patient information leaflet which helps consumers understand information about the product at a consumer level so not at a technical, scientific level but the kind of questions that normal people like us might have. And that's a really important part of educating both key groups here. In fact, the condition comes into effect today so we've been working very closely with manufacturers and sponsors to ensure that those products are available. We've also got a really great breast implant information hub available on the TGA website which goes through some of those questions you might want to ask and it's keeping an evolving timeline of what's happening with the knowledge of ALCL so certainly a resource that we'd recommend to people whether they have implants or they're considering getting them.

Anne Marie Sage And I was going to ask would that be in the future, building on getting some services around Australia? Like we've got breast cancer clinics where women can come and get their breast implant checked and screened and just have someone that's really knowledgeable in that area without having to make too many big appointments.

Sophie Scott Dr Deva, do you just want to just talk about the clinics that you've set up and that you're helping to roll out.

Anand Deva Yes, I think that, once again, it's impossible to deal with this demand. I mean, certainly since regulatory action. There are a lot of anxious women out there and I think I understand people are finding it difficult both to get access and also from an affordability point of view to present for assessment and then potentially treatments. So don't forget your GP so I want to go back to that before we start talking about the clinics. They're a great resource and actually we're working very actively to try and educate general practice about breast implants because a lot of them don't know about them so there are articles that we're publishing and information I'm sure that will be available so that your regular GP will know what to do so I think that's the real solution rather than opening more clinics. So have a level of expertise at that level. Now the clinics, look, there are public hospital systems which Anna can speak about so there is a public hospital avenue for explantation surgery on Medicare and then what I've started and it's still a long way to go, is to try and work in the not for profit sector so working with universities, working partly with government funding but then also, increasingly, they're leaning on the social responsibility of companies to say, look, you've got to help solve this problem. But it's still early days and there's a lot more work to do.

Sophie Scott Now, we've just had an interesting question come through because I think we talked earlier about the breast implant registry and the question was does the breast implant registry cover implants that were put in like decades ago and also what about if you have your implants put in overseas? So can we just cover that for a moment maybe? Who'd like to take that?

Miranda Lauman So we were just trying to pinpoint earlier the exact date that the ABDR came into effect and it was around 2015 and it does have a really high subscription level amongst surgeons. It's 90% plus so that's encouraging for people who've more recently had implants.

Sophie Scott Does that include all types of surgeons so like plastic, cosmetic, no matter what type of surgeon?

Miranda Lauman That's that whole sphere, it's about a 90% take-up rate which is really encouraging. Historically, there has been less record-keeping in that regard so people, certainly 30 years ago, may not have and it's certainly not a default for people who may've had implants overseas but there are options for someone who did travel and have surgery overseas or had surgery before the registry was stood up to register their own details and there's some very accessible patient information pages on that ABDR website.

Sophie Scott OK, so that's obviously and we can put links to that.

Miranda Lauman We can make them available.

Sophie Scott Along with this as well.

Anna Loch-Wilkinson I think this database is really valuable for us as scientists too because then we can actually look at that data long term just like they have in orthopaedic joints too and actually assess these implants over time which is... And time is one of those things. You know, what's on the market now you don't know how that's gonna behave until you get long term data on it. So, again ask your surgeon if they're a part of the registry and also ask them about what long term they're gonna offer. You know, as we alluded to with the you know, if you are gonna get implants overseas it's one of the things you need to factor in and any surgeon that you see what are they gonna do if something goes wrong? Because surgery is not a 100% guarantee that nothing's gonna go wrong even if everything is done right on the day there's always gonna be a risk.

Sophie Scott So, we've had quite a lot of sort of technical questions about women who might have implants and have some symptoms. So, I think it's worth going through some of them with this panel today. So, one of the questions was, some women have had swelling in the breast. The pathologist tried to drain it but there wasn't enough fluid. What advice would the panel have in that situation? What should happen then?

Anand Deva Well, I think clearly there needs to be ongoing surveillance just because there wasn't enough to sample today may not mean there would not be enough in six months. So, I think it's just another reinforcement that if something is wrong and you're worried about it just to keep going back and getting regular checks.

Sophie Scott And is that something that some of your patients are coming to you saying as well Anne-Marie, that that has happened? That they may have had some symptoms but it wasn't enough to get a diagnosis?

Anne Marie Sage Yes, and I think because it does take quite a few years you know, to get ALCL that if you do have that fluid keep getting checked, keep getting checked. But I think it's just ask questions and be OK to reach out because we all know that if you live a life full of fear of the unknown, it can be very stressful for a lot of women. So, be OK with having a strong voice. Be OK with asking experts. Be OK with researching and you know, it might not be the part of the fluid part of it and as we know it can be natural to have a little bit of fluid around your implant but with ALC seems to be quite a lot more fluid, is that right?

Anand Deva Yes, I think if let's say a woman has had a bit of fluid but it's not enough then the clear message should be look, this is not normal so you have to come back. And in fact, some sort of record to make sure not everything's fine because it might be fine today but it may not be in six months or 12 months. I think linking back to regular surveillance is key.

Sophie Scott And we might just mention that fact about anxiety. So, with the women that contact you, how anxious are they about this, how worried are they particularly when there's stories in the media about this condition?

Anne Marie Sage Well, if you look at anxiousness and feeling stressed on a scale from one to ten, I would probably see it say most of them around 11. And I think it's just that it is a very big topic. Breast implants are a big part of society and a lot of women they have implants because of different reasons. I mean they might even have had breast cancer and so forth, so there's a lot of different kind of fear factors. The fear goes down with having information like we're doing right now. Being able to have more kind of a fact-based evidence with it.

And I think that women are starting to go OK, I need to reach out to my Dr or GP, I need to go and see the surgeon. I need to find out who's the expert in this area, what are some of the recent research about it? And the fear tends to go down. So, my advice is don't live at home in fear because you feel ashamed. Don't think that it's not OK to reach out. Don't to be afraid of being vulnerable because it is a big part of our life and it's not something that you want to keep having on because the stress doesn't get better. It will get worse with time. So, be OK with getting the support.

Anand Deva Can I also say that we are in a very good position in Australia I think. I think that's a message of reassurance. We're all sitting here, we're collaborating, we're collegiate, we share data and research, and we work with the regulator openly. So, I think women should take comfort in the fact that there are some very good people working to get answers and to come up with the right decisions to help them. And I think Australia can be rightfully proud for actually you know, leading the way in some ways, don't you think?

Sophie Scott Well, certainly with the collection of data we've been able to have good data and sort of pick this up relatively early on. We've got some other set of sort of technical questions that have come in but I think it's important to get these questions answered as well. If women decide to have surgery, I might just go to Dr Loch-Wilkinson to explain what's the different between an en bloc and a capsulectomy? Can you talk to us through those and...

Anna Loch-Wilkinson Yeah, so an en bloc resection refers to taking out the tumour and all the surrounding tissues in one unit whereas a capsulectomy itself can be partial or total and that's taking out that capsule. So, the scar tissue that forms around the implant but not necessarily things like the breast tissue or the ribs or anything around it. So, for ALCL we recommend a total capsulectomy. So, taking out the whole thing. But you may if you don't have ALCL, doing a capsulectomy you know, we have them for different reasons and whether you need the whole capsule out or not depends on the type of capsule it is, whether it's very thick, inflamed, how plastered down it is to the ribs and things like that.

Anne Marie Sage We get a lot of questions about OK, so if I do get my textured implants removed, is it OK to get then smooth implants put in?

Sophie Scott Ron, what would you say to that question?

Ron Bezic It depends on the individual factors. If they required another teardrop implant I mean it's probably you would be looking at another textured implant. It depends what they sort of need for their look. If they're adamant on having smooth implants then you might have to adjust your surgical approach to them.

Sophie Scott We might just explain that a little bit for the audience. Some will understand the difference between smooth and textured and why you know, the benefits versus risk of smooth versus textured. Because some people might think well, if the textured are more risky why don't we just stop using them? And it's not really that simple though, is it? So, who would like to address that?

Anand Deva I can speak to that. So, as Anna said we've looked at a grading system based on actually measurements of surface area, surface roughness. And it goes from one which is smooth all the way through to four which is very rough. And so for the grade three and four implants the ones on the rougher scale there are benefits. I mean if the implant is rougher it will stick to tissues and it's less likely to move. The other benefit of a textured implant is they come in an anatomic shape. So, the benefits of those is that if you've had children and there's a bit of loose skin that will actually...

Sophie Scott So, they're more likely to, do they give you a better...

Anand Deva Yeah, and the thing is a bit woolly because once again in this space there are a lot of claims but there's not a lot of data. So, this is where I think we get into you know, as Miranda was saying it's very difficult to tease out what the real benefits are when there hasn't been this perspective in comparative data to say well, this is better than that. But never the less we in Australia have used textured implants for a long time for that reason. Smooth implants don't have that capacity and so they do tend to move around if there are less tissues or if you need fixation.

Sophie Scott OK, so another question we've had coming was what should women do if they, and we've sort of addressed this, but I think it's worth going into a bit more, if they have the recording implants and they're having symptoms, and they don't feel supported by their doctor or surgeon that they have the moment. So, they might go back and feel like the doctor or the surgeon is not taking them seriously and sort of dismissing them. What should they do to make sure that they're getting good follow-up care and to put their fears at rest?

Ron Bezic I would suggest see your GP. Look at seeing possibly someone else that they would recommend to and they could possibly have a better, more comfortable relationship with a new surgeon if that was the case.

Anna Loch-Wilkinson Yeah, yeah, I agree with Ron. You know, a good GP is worth their weight in gold. So, get a good GP, see them regularly, and they would know who to refer you onto.

Sophie Scott And we talked about this earlier but what if some women might want to have an MRI scan and Medicare won't cover it for a ruptured implant, for example? If they can't afford it, what can they do to get that resolved?

Ron Bezic So, the ultrasound is affordable and is a relatively good screening tool for picking up rupture. It's not always the case but most of us, based on clinical findings and an ultrasound that shows a rupture, would say this is ruptured. So, it's not necessary to get an MRI for every potential rupture and ultrasound. So, that's the first thing. And I do know that the government has now introduced a rebate for MRI for proven ALCL for part of the work up. And I guess, you know, if this demand continues to increase, we could lobby government to provide some sort of support for imaging.

Sophie Scott What about if it's for a patient? We had a question on this if a woman has swollen lymph nodes, for example, and feels tired. So, she might feel like she has some of the symptoms. Could she get her lymph nodes by up seed or do you need to be further down the track?

Anna Loch-Wilkinson It kind of depends on what the other symptoms are because there's a lot of causes for swollen lymph nodes. So, again, you know, getting your GP to do a good and thorough work up for that, you know.

Sophie Scott To sort of exclude other possible causes?

Anna Loch-Wilkinson Yeah. I think if you have isolated lymph nodes, then that might be an indication to go and test further. But yeah, it depends on a lot of the clinical history and other things.

Ron Bezic Also, the ultrasound will have a, if they looked a bit worrying, have a specific appearance, a swelling that they might be reactive which is fairly benign and you wouldn't want to biopsy that necessarily.

Sophie Scott Is that something that, Anne Marie, that some of the women contact you about? That they might have these symptoms like lymph nodes or feeling tired, or and then they're concerned it might be the implants.

Anne Marie Sage I think that pre all of the information about ALCL, people would just go you now what, I'm tired because I work really long hours, I've got children, I'm doing a lot. And you know, maybe I'm a little sore in my lymph node because you know, like I went to the gym and I worked out really hard. But now, we've got this information and all this data and I think it's all of a sudden, this is why I'm tired. This is why I've got thin hair or this is why I've got a rash. And that's not always the case as we know. But I think that it's, you know, like yes, lymph nodes is a big thing. The rash is a big thing. Having the fluid. Tired, perhaps thinning hair, those are sort of the things. But like we've been saying, go to a good GP. And if you go to a GP that has no idea and that doesn't know or maybe you don't feel really good, then go and see another one. I mean there's lots and lots of choice out there. And the same with your surgeon. If you can't find a surgeon and if they're not really wanting to support you in that way, well, there's lots of other surgeons out there.

Sophie Scott So, we might just talk to the audience a little bit about and we sort of touched on the breast implant-associated illness. Could one of the physicians take us through what that is and how seriously is that taken by the medical profession?

Anand Deva OK, I'll take that. Look, breast implant illness is one of these things that is emerging but it's an old story. It's not a new story.

Sophie Scott And what would be some of the symptoms if a woman has breast implant-associated illness?

Anand Deva Sure. So, it's an emerging entity in that in the 90s, a lot of women linked autoimmune disease to breast implants. That actually led to you know, legal action in the US. So, there's just been this link potentially between chronic illness and breast implants. It's been out on the literature for a long time. And if you look at the data as I said, there's some that support and some that don't. So, I think that we're starting to think about processes that start to be triggered by implants. It's not just breast implants and it's inflammation.

Sophie Scott It's more inflammatory processes that might be switched on by having an implant?

Anand Deva Exactly, and so the short answer is do we believe that some women, you know, get chronic illness from implants? I think the answer is yes. But we just need to have more information, more research, more data, tease out what symptoms are related to chronic inflammatory processes from the implant, or chronic inflammatory processes from something else. And that's really difficult. It's not easy research. But we're starting it.

Anne Marie Sage And I think we hear a lot of women saying so, they have contacted their GP or they have contacted their surgeon. And look, it's very, very unlikely that that's it. It's very rare or we don't see that, you know, ever. And so it's a lot of women don't feel that support because it's being downplayed. So what's your advice when you see that?

Anand Deva I think you need to keep an open mind. I mean a lot of people can be dogmatic about things and then proven wrong once the research and the evidence comes out.

Ron Bezic Yeah, that's true.

Anand Deva So I think if a patient is seating in front of you and has a problem, then as a doctor, a, you've got to listen to them. Take their complaint seriously and do some proper investigation. And that's part of being a good doctor.

Anne Marie Sage And as you know, most, when we're dealing with the unknown, a lot of the time your mind will go to oh, my goodness, that's it, I'm done. I'm going to die. So, what's your advice when it comes to that?

Sophie Scott Reassure people.

Anand Deva Anna, do you want to go ahead?

Sophie Scott Anna?

Anand Deva We defer to you. I think it's very difficult. (CROSSTALK)

Sophie Scott Knowledge is power. So, you know, you need to go, you know, you have a right to go back to your doctor, you know, ask them these questions. You know, make sure your GP has ruled out causes. But you know, if you really strongly feel that way, then you can have your implants out. But whether, you know, that can be done in the public or the private, you know, that's sort of the catch. So, you've got to think about the implications of that too, you know, financially, you know, the risk of having explanation surgery itself.

Anand Deva My play in that setting is that there is a golden opportunity to capture data. So, it'll be really good to know, you know, about these women, about why they're proceeding with explantation. And more important, actually, analysing some of the tissue that comes out. Maybe looking at some blood tests. So, there is a framework for a really good research project which can be done and hopefully provide answers.

Ron Bezic And for us surgeons as well. We should remember we're removing implants. We need to actually fill out the (INAUDIBLE) to say with explant and not reinserted.

Anand Deva Yeah.

Sophie Scott We've got a couple of questions which we want to get through about late-stage ALCL. So, we've got a question saying what research, this is from Terry. What research is being conducted on late-stage disease and treatment options? Can we cover that?

Anand Deva So, this is, I spoke to Miles Prince actually, whose Professor of Haematology in Melbourne. And so the standard treatment is still CHOP which is chemotherapy and prednisolone. And then, if they fail that, there's brentuximab which is a monoclonal antibody. Conjugated with a chemotherapy engagement which has got amazing results. And then unfortunately for some women who failed that then it's bone marrow transplants. So, that's kind of the sequence. Now, the really good news is that there's very few women that get to that point. And that may be because we're picking it up early through awareness, so that's terrific.

Sophie Scott So, Anna, what was the statistic you quoted earlier about if it's caught early?

Anna Loch-Wilkinson So, it's about 87.5% of patients present with stage one disease in the fluid or in the part of the capsule. And to date, we've had no deaths in this patient group and the five year survival is 100% in those patients.

Sophie Scott Which is good and I guess that's good also to keep in perspective in relation to other forms of cancer that don't have anywhere like that success rate and survival rate. So, we've covered the point about pertuzumab and I just wanted to go back to Anne-Marie for a moment. What struggles are you seeing in your patients that contact you, the women in terms of the struggles they're facing in relation to testing and diagnosis and treatment? Are there some common things that pop up with those patients, those women?

Anne Marie Sage The common theme seems to be the lack of knowledge from perhaps the GP or when they're going to get their fluid tested. So, there's been a real kind of unsureness about how many mls need to be tested to kind of get the accurate outcome.

Sophie Scott Well, let's be quite specific. So, how many mls of the fluid do the Drs need to take out to do that proper testing?

Ron Bezic Well, we nominated about 50mls before but it's essentially what the ultrasonography's comfortable removing without them damaging the implant. And as Anan said this usually presents with a lot more fluid than that so it's not usually an issue and if it's a small amount of fluid then we monitor it to see if it progresses. But that's where you get the patients worried about is this an early stage but you've just gotta reassure them and make sure you get them back and not neglect them.

Sophie Scott But there's another question here. This is from Gina, thank you Gina. Have there been any cases of ALCL with textured implants where the seroma fluid was negative but the capsule or the scar tissue tested positive? Has that ever happened or is that unlikely to happen?

Anand Deva I don't think in our series that we had any that are a negative fluid and then a positive tap. We certainly had a few the other way around. So, a positive tap and then negative pathology and that's because the tumour cells are just in the fluid alone. So, we think that there's actually two distinct versions of this. One where it's mainly fluid and held at that stage thankfully, and there are a few that bypass that and go to more advanced disease. And there's a lot of genetic work. I won't go into the details but we're looking at genetic risk as part of it as well.

Anne Marie Sage Another one that comes up quite often is that is it OK if I just get an ultrasound? Would that pick it up?

Anand Deva It's clinical examination and ultrasound so you need both.

Anne Marie Sage So, does the person need a PET scan and a breast MRI?

Ron Bezic No, only if it's proven and you're working them up towards more treatment.

Sophie Scott Why don't we be quite specific. Let's just step us through the exact steps that you would like that a patient needs to have if they've had breast implants they concerned, what would you do step by step to sort of either rule in or rule out ALCL? So, what needs to happen?

Anna Loch-Wilkinson So, I think your first port of call is either your original treating surgeon or your GP to do a work up. If you do have that fluid then an ultrasound with a tap of the fluid and that gets sent off for some special tests that we look for certain markers and that with you know histochemistry to define whether it is ALCL or not. And then if you do have ALCL we do an MRI and PET scan as well.

Sophie Scott So, that's the standard work up that women should get. And is that happening Anne-Marie, from the women that are coming to you? If they're having symptoms are they generally going down that pathway of...

Anne Marie Sage I think there's definitely been a big change in exposure of information and it's happening more where there's been a big gap where that hasn't happened. And that's created a lot of confusion because people reach out and then information on social media is being shared and it's creating a lot of fear kind of like, oh my goodness, I haven't ticked that box. And that's where I think it's really important, have that list, make sure that if you're seeing the GP so that you can kind of follow a procedure there.

Sophie Scott And so just with that, how satisfied are you that the regulators are doing enough to keep women safe and to keep track of what's going on with this condition? From the women that come to you do you think enough is being done or would you like to see more being done?

Anne Marie Sage I would absolutely love to see more being done and in a way where the information is just becoming common knowledge. And I think that you know, so that women don't have to go and search for it and really work hard to find that information. It should be something that is right in front of us and that's in terms of GPs knowing exactly what process they need to do, the people that's testing the fluid needs to know exactly what to do, the surgeons as well have the same procedure so it doesn't matter if I'm seeing this person or that person I know I'm gonna get the best practice every time. Have those clinics around Australia where you know, I can go there, I don't have to talk about intimate people. I can go there and they know exactly what it is that I'm dealing with and I can have that... it makes it more of a sort of normalise it.

Sophie Scott And so, from the regulators point of view, what's being done? Is there anything else being planned for the future to improve what's happening for women who might have these implants and be worried?

Miranda Lauman So, I think certainly Anne-Marie, we have seen a positive change that information's starting to get out there and that's 'cause we're leveraging some really great consultative groups we've stood up. So, we're working with the major colleges through our advisory working group on breast implants, so that helps us not only get information about what's happening at the cutting edge of research but also find avenues to push information out to more surgeons and to look at opportunities to do that with GPs as well. We've also established a consumer working group. So, we have women who have had an ALCL diagnosis speaking with us so that we have that very human element about the questions that are asked and the best way to communicate that. And the patient information leaflets have all been approved with key input from that consumer group. So, it's not a scientist saying yeah, I think that's consumer language, it's women who've been through ALCL who've reviewed those and given some really excellent feedback about the level of language, the way information should be structured and even you know, that's a really good point about how much information. Sometimes too much information you start screening out, so getting that balance right. We also work very closely with the Commission on Health Safety and Quality and with the jurisdictions and so those dialogues are beginning. But I think it's a good start, but there's certainly more to be done.

Anne Marie Sage And I agree. Less is more when it comes to that information, and I think it just makes it more simple.

Sophie Scott So with the patient information sheet, at what point, or should every woman going for a consultation be given that sheet, or how do they access that information?

Miranda Lauman So the concept behind the information leaflet is it is given before surgery, and it is a material to help that informed consent discussion. Down the track, more generally, for implantable devices there will be a requirement that's being slowly introduced for people to also have an information card, which is more their ongoing reference about the model, the type, so that people have that information as well. But the information leaflet is specifically to inform those choices up front.

Sophie Scott Anand Deva. ANAND DEVA: So I was gonna say that look, we focused a lot on women and ALCL that I think we should really be looking forward to women who are thinking about having breast implants. I think it's a great opportunity to learn, and as Marie says, up until recently, it was a little bit all over the place, but we're now putting structures in place, and so I think a lot of this information shouldn't just be about women that are worried an implant that they have. It's about women who are thinking of getting an implant.

Anne Marie Sage That's right. ANAND DEVA: So to go forward to the younger person, also young women coming for surgery and looking at really patient focused resources for them so they make an informed, educated... And I think that the point there is that it's not because implants are bad. It's just having the education so that you can make an informed choice, you've done that research, and there isn't any nasty surprises that you weren't aware of.

Sophie Scott And one of the questions we've had is from Deva, who wants to just cover the issue of, first of all, I think we refer to it in the slide, but we can go over it again, how many cases there are in Australia, New Zealand at the moment, but also what is your prediction of the numbers and risk going forward for that group? So that women who might be thinking about implants can sort of weigh that out.

Anand Deva So the total, as of end January, is 107 women have had ALCL with implants from Australia, and additional five that have had ALCL who are Australian, but had implants overseas, so it's interesting, so the total's a bit more.

Sophie Scott So would that indicate that the rate is higher?

Anand Deva So we've got three snapshots. Anna was involved in two of those. And each time, we've looked at, so from 0.1 to 0.2 is a 40% increase. From 0.2 to 0.3 was a 56% increase. So we're looking at 0.4 soon enough, and we expect that those numbers will continue to rise.

Sophie Scott So you will expect that more cases will come forward.

Anand Deva Of course, 'cause a lot of textured implants have gone in. There's a lot of...

Anne Marie Sage Yep. ANNA LOCH-WILKINSON: I think we have a social responsibility too cause there's a lot of stuff on social media about young women and their bodies. It's that Kardashian effect. They all wanna get plastic surgery these days, and a lot of these girls, a lot of them are young and impressionable. There's different groups that get implants. There's the purely cosmetic group. Then you have the groups that have maybe congenital deformity, and then you got our breast cancer group. Then also the mommy makeover type of groups. The women are a little bit older and have had their kids, and I think particularly that first group can be really impressionable, so I think it's really important to find ways to get them to be informed as well. Everyone needs to be informed, but I think at that age, you are really impressionable with your social media, and us as doctors have to be responsible for what we put out there as well.

Anand Deva Do you think, Anna, that perhaps they're also a bit vulnerable as well, in terms of being a little

INSECURE ABOUT THE WAY THEY LOOK? Anna Loch-Wilkinson Absolutely. And there's been fads in plastic and cosmetic surgery too, and the decisions you make when you're 19 are gonna be different to the decisions you make when you're 40, so...

Anne Marie Sage And I think with those different groups too we see that you will have that group that will want to show it off. Look what I've just had done, and look at me. And then you get that other group where they don't go and say, "Hey, did you realise I just had my breasts done?" If you've got glasses, and then you get surgery on your eyes, and all of a sudden you don't wear glasses, people go, "Oh, what's happened? You've changed. Something different." OK. "Oh yeah, well, I had my eyes done." But breast implants is a little bit different because it's not something you go out and actively talk about. Hey, let's have a cup of coffee and tell you what I've gotten done. (LAUGHTER) So it's a different way of thinking here and connecting and communicating with.

Sophie Scott So we've only got a couple of minutes left, so the hour's just really flown by. What I wanna do is quickly go around to the whole panel, just very briefly, just in case there's anything we haven't covered or what you'd like to sum up your thoughts, a key message that you'd like the audience to take away from our discussion this morning. So do you want me to start with Anand or start with Miranda at the other end?

Anand Deva Let's start the other way, because I feel like I'm in the hot seat. (LAUGHTER)

Sophie Scott (INAUDIBLE) we've only got two minutes left, so very short and snappy.

Miranda Lauman Well, I think the hashtag for today speaking about social media said it all. Be informed. It's the best thing you can do. Ask questions, whether you've got implants or you're thinking about them.

Sophie Scott OK, and Marie? ANNE MARIE SAGE: For me it's about informed, educated consent. Do your research, but spread awareness. Don't hold back. If there's anything that's on your mind and you're sitting and watching this, make sure that you reach out and get that thought that you're holding onto answered.

Ron Bezic I'd say that make sure you're comfortable with the surgeon you're choosing because you're gonna have a long-term therapeutic relationship with him, so you have to be comfortable. If you're not comfortable, go back to your GP and source someone else, possibly.

Anna Loch-Wilkinson I think important to think about the potential risks and consequences of your medical device cause it's gonna be in your body for, potentially, a long period of time, and like any car part, it's gonna wear out eventually, so even if you don't...

Sophie Scott Wait a minute, when we spoke, you were saying, so when a woman gets breast implants, is it a one-off decision, or how often do you need to get them replaced, say if you get them in your 20s?

Anna Loch-Wilkinson So it varies. But probably on average, every ten years you might need another operation. So particularly for younger women, that's a long time of life time of surgeries that they're signing up for, so you really gotta think about what happens long-term, as well, and potentially short-term too. There's always a risk, and you need to make sure that you're educated about that risk.

Sophie Scott And Dr. Deva.

Anand Deva For me, I think this is wonderful. I think it's a message of collaboration, and so the power of collaboration across this table between patients, doctors, colleagues, regulators, industry, perhaps as well. A lot can be done when humans band together. I think we forget that sometimes. (LAUGHS) So I'm really grateful that we're all working together on this.

Sophie Scott Well, look, our time's almost up, so I just wanted to thank our panel, Dr Anand Deva, Dr Anna Loch-Wilkinson , Dr Ron Bezic, Miranda Lauman, and Marie Sage-Lowman. Thank you so much for tuning in as well. We got to most of the questions, so it's been great, and as I said, it's been recorded, and we'll make sure you can watch it back on social media, on the TJI website, on Instagram and Twitter, so if you've missed a of bit today, the links will be there. So thank you very much.