Webinar recording: BIA-ALCL and breast reconstructions

Sophie Scott Hey, welcome, everybody. My name's Sophie Scott, I'm the medical reporter for ABC and I'm gonna be your host for this webinar. So, today we're gonna be talking about, breast implant associated, anaplastic large cell lymphoma. It's a bit of a mouthful, so we're gonna shorten that to ALCL, so that's what we're gonna be talking about today. The idea is that everyone will get good information and be up to date about the latest information about ALCL. Before we introduce the panel, we've had lots of questions already, they're all on this iPad and I'll aim to get through as many of the questions as we can. So, if you still wanna ask questions, please do so and we'll aim to get through as many as we can. The briefing will also be recorded, and you can play it back later, so there'll be a link posted on the TJ website. We would love you to share this webinar with as many people as possible on social media. If you're on Instagram or Twitter and you'd like to follow me, my handle is @sophiescott2. So, I'll be posting the link in the recording when it's up.

So, without further ado, I'd like to introduce our panel. We have professor Anand Deva, plastic surgeon from Macquarie University. Dr Anna Loch-Wilkinson, a plastic surgeon from Queensland. Dr Sanjay Warrier, breast surgeon who works at Lifehouse. Monique Bock is our consumer representative and Miranda Lauman from the Therapeutic Goods Administration. So, thank you all for being here and taking time to do this really important panel. I will just mention to you briefly that the advice and the information that you'll be hearing in this discussion is general in nature. And if you have any specific concerns, we do suggest that you discuss that with your own personal physician. But you'll be hearing lots of great stuff today. So, before we get underway, let's just briefly take us through a couple of stats about breast implants. So, I might start with Dr Deva, so talk us through breast implants, you know, when were they introduced in Australia, what do we and what are they generally used for.

Anand Deva Sure, so breast implants have been around for some time. Introduced first in the 1960s and they're used for either cosmetic enlargement of the breast, or reconstruction after women have had cancer.

Sophie Scott And that, that'll be the discussion today, this webinar will be for those, that second group of women obviously both can listen, but will be particularly addressing women who've had a reconstruction.

Anand Deva Absolutely, implants can vary in terms of what's on the outside. So broadly speaking, rough texture versus smooth, what's on the inside, which is whether they are saline or silicone gel and the way they're shaped, whether they're round or teardrop. And they've, they're highly regulated. So, you can see here that they sit on the top of all devices in the class three devices. The benefit has to be balanced with risk.

And we, we should hear more about that. It's very important for women to know that in Australia we've led the way with registries in breast implants, around 20,000 Australian women a year choose to have a breast implant. And all of these women are encouraged to ensure that their device is placed on the ABDR. It tracks and monitors longterm safety and performance and it's endorsed by all the societies, all the surgeons, all my colleagues, and by the TGA.

It's a free service, so please ensure that if you choose a surgeon that they use the ABDR. And briefly about ALCL, our focus obviously is to talk about that. It was first reported back in '97, so once again a long time, but it's really in the last decade that we've had a rise in number of cases with 33 confirmed deaths from this worldwide. And currently we, we know that there are at least 838 cases, and the reason we're here today is that Australia actually has a disproportionate number of these. We stand at 107 cases arising from women implanted in Australia as at 31 January this year.

Sophie Scott OK, well, we will unpack some of the numbers and risk a bit further into the discussion, but I think we might just start off talking about... even before we get to women having implants, what considerations need to be taken into account for women who are having or thinking about augmentation after cancer treatment. Maybe we'll start with, Dr Loch-Wilkinson.

Anna Loch-Wilkinson So there's a lot of different factors that go into what type of reconstruction you have, but particularly with implants, you know, whether you're gonna have chemotherapy or radiotherapy, is important and that's sort of guided by our breast cancer surgeons and oncologists. Whether you get to have a reconstruction straight away or delayed, again, there's a lot of factors that go into that, but, you know, the type of implant that you use, the timing of it has many, many factors. So, it's really important to go to, you know, well qualified surgeon, if you're not happy to seek a second opinion and really get all the information before you decide which path you're gonna go on with your reconstruction.

Sophie Scott So, maybe Dr Warrier, can you take us through what you would take a patient coming to you who's been diagnosed with breast cancer? What do you, what are the things they need to weigh up when they're thinking about either having a reconstruction, you know, what sort of things they need to think about?

Sanjay Warrier So, when we talk about, with the diagnosis of breast cancer and it can be quite a complex time to be having a discussion about reconstruction traditionally like Anna said, we used to do just delayed reconstructions, with time what's happened is, there's been an increased shift towards immediate reconstruction, which is trying to preserve the skin envelope, with the whole benefit of that being that you're preserving the skin. So, really you're just replacing something in the middle, which will either be an implant or their own tissue.

And ultimately it is nice, there are certain types of breast cancers, where we can actually start with chemo first. And then if the patient already needs chemotherapy and it's part of their package by sometimes, by giving the chemo takes that pressure away, from making a decision immediately and then I can look at their options and then proceed following that, that treatment, or targeted treatments, to immediate reconstruction and, but the whole premise for us, why we moved away just from doing delayed reconstruction was primarily what it looks like at the end and...

Sophie Scott So to get a better result.

Sanjay Warrier Yeah, just aesthetically when they're looking in the mirror and also not going through that phase, where they may, from a quality of life indicator, where it's not just their survival outcomes, but it's also how they, when they're looking in the mirror, how they feel, yeah.

Sophie Scott Are implants the only option if you, if you're having a mastectomy or? Dr Wilkinson?

Anna Loch-Wilkinson No, not at all actually. We've got some really good options to use your own tissue. And you know, it's important that you get at least offered all the things that are on the reconstructive menu and at least have the chance to talk about that. And you may or may not be suitable to use your own tissue for different reasons, but the option is certainly there and there's, there's plenty of really well qualified surgeons in Australia that can, can talk to you about that, you know, the pros and cons versus the implants, the timing. Again, whether you have delayed or immediate. And I think it important that, you know, if you're not suitable for an immediate recon, you can still get some really good results with a delayed reconstruction. And if that's more suitable in terms of the cancer timing and that and you know, it's better to go that way, so...

Sophie Scott So, just so if women do decide to go down the implant road, what considerations should they take into account when deciding on what type of implant that they might have? What do I need to weigh up? Who wants to... Dr Deva?

Anand Deva Well, I think broadly speaking, implants come in all different shapes and sizes and surfaces. Australia as a rule, has always tended to prefer textured implants, and that's kind of the discussion, you know, why we're here today, because textured implants have been linked more commonly with this, with ALCL. So, in terms of what type of implant really depends on the anatomy of the patient, depends on the shape of the other breast. So, we're trying to match as much their normal anatomy, with the reconstructed anatomy. And then as we've said many times, that's the time where if you're choosing an implant reconstruction, it's really, really important that you get all the facts and you're allowed time to digest them. And perhaps at least two occasions if there is time, you know, pending a cancer treatment to go through these with your treating doctor.

Sophie Scott And we might just go through the, the different grades of breast implants and, and the risk that correlates with those, those different grades. So, can you take us through that?

Anna Loch-Wilkinson So, so broadly speaking, we have differences, the differences in grade related to the, the roughness and the surface area of the implant. And we grade them one, two, three and four, and it's the grade three and four implants that are, are rougher and have a higher surface area. And they're the ones that we, we now know through scientific evidence have a higher risk of getting anaplastic large cell lymphoma.

Sophie Scott Are you able to quantify when, when you look at the numbers, what is the risk in terms of like one in how many cases are at risk of getting ALCL?

Anna Loch-Wilkinson So, roughly for a, for a great or textured implant, again, it depends on whether you've had one implant or multiple, but it's anywhere between 1 in 1000, 900 to 1 and 2500, so it's the highest. And then some of the lowest series textures, so the grade twos will be, you know, between 1 and 15 to 36,000. So, it's quite different, statistically speaking, quite different.

Sophie Scott And so, so some of the, the textured implants now have been recalled and they're not on the market anymore. And I guess this might be question for, for Miranda Lauman from the TGA. Can you take us through this in very broad terms, the ones that have been recalled?

Miranda Lauman Sure, so there's eight products that have been recalled, it represents about 6% of the breast implants used in Australia using the 2018 data is a bit of a measure. So, this is a smaller section of the market. Seven of those products are the macro-textured products and one is a micro-textured product and that's been done on the basis of clinical evidence provided by the manufacturers of laboratory testing undertaken by the TGA and also looking directly at this statistical correlation between individual implants and cases of ALCL in Australia as well as where the same devices are produced by the same manufacturing will have the same surface texture as those that are linked directly with ALCL.

Sophie Scott And I guess a question that the audience might have is if there, if them all... if the risk goes up compared to how textured the implants are, why aren't all the most textured implants or all the textured ones off the market?

Miranda Lauman So, I think part of the assessment that needed to be made was looking at the risk versus the benefit of devices. And there are certainly benefits associated with textured implants particularly in a reconstruction context. More textured implants can prevent movement and are linked with less incidence of capsular contracture. And so ensuring that there are options for women who need to undertake reconstructive surgery and wish to have an implant, was an also an important part. So, the TGA's role is to ensure safety and quality, but also to ensure that Australians have access to quality medical devices. So, it is a balancing act.

Sophie Scott And I'll just might get one of our physicians to comment on that as well, because some... from the outside someone might say, well, if the textured implants are more risky, why don't we just not use them? what are the benefits from still using the textured implants from an outcomes point of view and how they look like, what are the reasons that some doctors and patients might decide to still keep to use them?

Sanjay Warrier Yes, so with regards to, when we're talking about reconstruction, we've talked about removing all the breast tissue. And with that there'll be variation in the anatomy of the body and having the ability to have varying devices that provide a sort of mimicking a more natural look. is an advantage potentially for patients. So there will be patients that are appropriate for round devices, which tend to be the grade one devices. But it's nice to have the option of potentially other devices. And on top of that we also use temporising expanders in certain cases and that provides options where we can not necessarily get the complete reconstruction right at the first sitting, but allows us to grade our results to the point where we then do an exchange down the down the track. So what that means is that at the end of the day, we're giving that again, that quality of life result for the patient.

Sophie Scott Yes, Dr Deva.

Anand Deva Can I just add, so broadly speaking, the grade one devices are smooth, so there's no stickiness, whereas the grades threes and fours stick. So if you're, if you're recommending a device for whatever reason, you wanna minimise the long-term reoperation as well. So, there are times where we would recommend a textured device and that's why it's not as simple as they get rid of texture. You might be committing this woman to having multiple revision surgeries. So, the factor here is time. We can make a decision today that might say ALCL is gone, we're just gonna to use a grade one device but we might be inadvertently then subjecting our patient to multiple revision operation. So this is the balancing act.

Sophie Scott So it's complicated isn't it? So, we are just gonna go to Monique. So what, what are the sort of... it is complicated for women then to weigh up all these different factors. What are they saying to you when they come and talk to you.

Monique Bock It is, I guess the feedback I'm getting is that they've already had breast cancer. They don't really want to have another risk of another cancer. So why, why even consider that? The ones that have had the BIA-ALCL after having breast cancer, had they known there was a risk, they wouldn't have taken it.

Sophie Scott So it's difficult then, for them to weigh up all this to things.

Monique Bock It is and I think they are emotional, there's a lot going on as well. and now they are gonna be making an informed decision at the time as well?

Sophie Scott So we can we can talk about that. Let's talk about the idea of informed and educated consent. Did you wanna add something Dr Loch?

Monique Bock As you know, yes, I think that's why it's important to actually know what other options are out there and, and patients aren't always told. And that can sometimes come down to financial reasons, but you know, if you're not happy, go and go and seek a second opinion because there are some fantastic other options. You may or may not be suitable, but you know, getting informed, If you're informed and educated about all the choices, then you can weigh up the risk and benefit and make the right choice for you. And just 'cause you have one type of reconstruction doesn't mean that that precludes a different type of reconstruction down the track.

So, you know, again, staying in touch with your surgeons and you know, cause your body changes over time too. Or, you know, if you choose to have an implant, you know, maybe years down the track you might want to get that change for your own tissue or something. So you might know what your options are. so you know, consumer choice, this is really important.

Sophie Scott Monique?

Monique Bock I also want... we did discuss about, perhaps in future that someone brings along a support person with them as well, so that they've got someone there that's going to be listening and taking in everything so that they're not on their own, helps them to be a little bit more informed.

Sophie Scott And, Miranda, what's the TGA doing and the regulators in terms of improving informed consent or making sure that the patients as much as possible know what their options are and know what they're getting in for.

Miranda Lauman So, an important part coming out of the review was not only suspending devices but putting a range of conditions on devices that remain available in Australia. And they've been aimed at educating the regulator. So there are some reporting conditions that have been put on every breast device available in Australia. There are also really important measures around informing consumers and informing practitioners. So enhanced information pamphlets for practitioners and a patient information leaflet that's specifically targeted at a patient level. It's accessible language, accessible information to give information about that device so that people can have better conversations, ask better questions and keep informed. And that condition comes into effect today on Valentine's day.

Monique Bock I saw some really good information on reconstruction. The cancer council has you know, one of the breast... they have got little booklets that you can actually go and get a rough idea of different options.

Sophie Scott That's great. So, yes Dr Deva.

Anand Deva I was gonna say having treated, you know, some women who've had this double, you know, breast cancer and then ALCL, I really wanna echo your words Monique cause there's a lot going on, isn't there? So…

Sophie Scott You mentioned you've just got...

Anand Deva Yeah, the struggle is how do we create a framework where, you know, we create enough space and time, when there are big decisions to be made often in a short space of time. So I don't have, I mean you two do way more reconstructions than I do, so, I'd be really interested to hear, you know, if you had thoughts on how to do that.

Sanjay Warrier For us it, it's not just for recon, it's everything. cause when you talk about breast cancer and you're diagnosed with breast cancer, you, it's not just the surgery, it might be, you may need chemotherapy. It just making sure that the treating team, everyone sees the person before they necessarily have an operation and it's just not a captain's call per se and it's easy, in the past it would be easy to potentially feed off the anxiety of the patient and that drive..

Sophie Scott Decision making.

Sanjay Warrier Decision making, whereas we know what is important when it comes to cancer treatments, whether it's recon or not, is having the time to make sure you're getting the right options available. So where that tends to work, it's a lot easier when you're in a larger centre obviously where you've got a multidisciplinary group and where there is good communication between specialists because then it's easy. You can phone your friend, meeting another specialist, and get the patient to see someone else in a timely manner and then come back and see you again. But what I've found with time, it's very important that they see multiple people before they have surgery.

Monique Bock Yeah, you know you've got your radiation oncologist, your oncologist, your breast surgeon, your plastic surgeon. So, if you don't feel that you, you've got all the information, you know, make sure that you say, you know, I wanna see that person.

Sophie Scott So, let's take a patient, for example, that they have decided to have the implants, they've decided to go down that track. And then might be concerned, that they might be having some issues. What are the symptoms that women need to be looking out for? What are the classic symptoms that might suggest that it might be ALCL and they need to get further investigated?

Monique Bock So, the majority of patients present with a spontaneous seromas or a reasonable collection of size question of fluid around an implant. And it usually happens quite a few years after the implant is put in. So on average, every six to eight... or after six to eight years is the average time. But it, you know, can occur anywhere between sort of three to 14 years or even longer. And we're still collecting data on that. But as it stands, you know, six to eight years after the implant has been put in, you get large swollen breasts for no particular reason.

Sophie Scott So no trauma or anything else precipitated...

Monique Bock Very rarely you can present with a mass, that's the other sign. But generally, most patients present with usually with a collection of fluid around the implant when it's generally painless.

Sophie Scott OK, and then just take us through if that's the case and a woman does have symptoms, what's, what's the framework in terms of the treatment that they should get in terms of like the diagnosis, what are the steps that need to happen, so that you can make sure you are picking up anything if it's there or excluding other things?

Anand Deva So I think as Anna said, the majority of women present with swelling and the swelling is due to fluid between the implant and the capsule, which is the tissue around that. So, the first step would be an ultrasound test, where the fluid is drawn and analysed and that will give you the diagnosis and that's by far the majority of cases. And then you need to be worked up with a CT/PET scan, and MRI scan potentially, and then the surgery. So, that's kind of the path which most women would go through.

Sophie Scott And we'll talk about that, Monique did you have something to add there?

Monique Bock How much fluid, do you need where there's patients that don't have enough fluid and then they don't get tested properly because there's not enough fluid?

Anand Deva Yeah, that's a good question, so we've estimated this is based on advice from the ultrasonographer, is around 50cc is usually enough and the issue here is sampling that fluid without damaging the implant. You can sometimes do it on lower volumes, as long as the ultrasonographer is skilled and comfortable enough to draw that fluid out.

Monique Bock And so sometimes you can get false negatives as well?

Anand Deva It's not so much a false negative, if you haven't sampled enough of the fluid, you may not be sampling the whole area, you might miss it. But generally speaking, the early stages of disease is not gonna go away. So, the fluid will re-accumulate, patients will represent in a few months’ time with more swelling and at that point the diagnosis is made.

Sophie Scott So, let's just backtrack for one second, what if you have, we've had a couple of questions that, if a woman has had implants but no symptoms and yet they might be concerned hearing about ALCL and the risk what's, what's the medical advice and then also the regulator advice about whether they should have the implants out if they're concerned, these are for women without any symptoms.

Anna Loch-Wilkinson So, there's no recommendation to remove the implants if you're asymptomatic. Removing the implants, you know, when you don't have symptoms, it also comes with, you know, a certain risk of doing that. So, we don't recommend taking them out but we do recommend, you know, having good GP, you know, continuing to see your surgeon that, you know, has put the implants in and if they've retired or moved on, then get your GP to, to refer you to another surgeon, so that you can...

Sophie Scott So you make sure you got the ongoing care.

Anna Loch-Wilkinson Yeah, it's really important, that's, you know, if patients getting surgery done overseas, they don't necessarily have that option for follow-up. So it's, you know, ask your surgeon what follow-up, you know you're gonna provide, because it's not just doing the operation, you actually need to have some ongoing maintenance and care, so you need access to that.

Sophie Scott And so from a regulatory point of view, Miranda, the TGA doesn't recommend that women who don't have symptoms get the implants out, is that correct?

Miranda Lauman Yeah, no, that's, that's exactly consistent with the advice we're getting from our expert working group. That in the absence of symptoms, there shouldn't be a removal, but certainly people should be trying to get informed, understanding what the symptoms are, understanding their own breasts and self-examination, as well as engaging with their health professionals. So that you know what's going on and you have a really good point of care.

Sophie Scott Monique.

Monique Bock There, there are also patients that don't even know what type of implants they have, you know, how can they find out?

Sophie Scott That's a good question, so say for example, if a woman doesn't know, where would they, which is probably less likely if they've had a, as a result of a reconstruction, but there may be some who don't know what type, where can they go to find that information out? Dr Deva?

Anand Deva So look, this does happen from time to time, so the first thing I say to them is, you sure you don't have any bits of paper at home that you know, you've collected over the years and sure enough, more often than not there's a card with the implant sticker around that they didn't know they had, so that's a good point of call. If the surgeon is retired or the clinic is closed and you can't go to that avenue, then the hospital where you had the implant put in is another really good place to look. Hospitals keep records a bit longer than the statutory 7 years, so...

Monique Bock Even if they're overseas or some other place?

Anand Deva Overseas is a bit more difficult, but contacting the hospital where you had the implants, they might have some record of your surgery. And then the third, which is an increasingly a great way to know exactly what implant you have, as the other registries. So, the ABDR since 2015, we think has collected and increasingly collecting, you know, up to 90% of implants that are going in now today. And so ringing up and giving your details, may lead to access the information. And prior to that there was a breast implant register, the BIR and that's also accessible through the Internet and once again you could contact them. So, there's many ways you can find that.

Sophie Scott One of the questions that we've had, which I think is worth putting to the panel is, for women who've had implants as part of a reconstruction, why is it OK for, for women not to have these implants that have been taken off the market, the recalled ones now, but that they should keep their implants? So how, and that would, I would imagine cause some anxiety if they are hearing all these implants have now been recalled, yet they've got them and they have to necessarily, they've got to keep them so...

Anna Loch-Wilkinson They recall to try and prevent future cases, but just because you have one of those implants, doesn't mean that you are gonna get ALCL. And again, it comes down to the, the risk of actually removing that implant isn't zero either. So if there's no hard, hard evidence of symptoms and that's not the recommendation agree to go through some unnecessary surgery, but it is really important just to keep you know, the monitoring up and you know.

Sophie Scott And another question is, if you've had implants for reconstruction, are you covered by Medicare for removal or replacements?

Anna Loch-Wilkinson For reconstruction, yes, you are. In the public hospital, the replacement non-reconstructive patients isn't necessary for reconstruction, there is, yeah.

Sophie Scott So, we might just go to a couple of questions from the, that have come through. So a question from Jennifer, she's asking how should a patient respond to a surgeon who says that extensive capsule sampling isn't necessary because the surgeon or pathologist can see where the disease is with their, by looking at it, is that correct? Or what, what should happen if someone is told that?

Sanjay Warrier I would get a second opinion. (LAUGHTER) Like to, when... firstly it depends what the scenario is, but if you've got a thickened capsule and you're asymptomatic with it and you're looking at just, firstly and you've had fluid tested, but you've still got to thicken capsule or you should be seeing someone who... cause ideally to really know what's happening with the capsule, you'd likely remove it.

Sophie Scott There's another question here as well from Amy. What's the current opinion from the panel on textured tissue expanders? Should we be performing complete capsulectomy at the time of tissue expander to implant exchange to negate that risk? It's quite technical, but I think it's... yeah, it's OK, so...

Anna Loch-Wilkinson I don't think we really have the evidence on that yet.

Anand Deva We often use the capsule, don't we? Yeah, so... The capsule is a way of stabilising the implant. So, if you were to remove all that capsule, you'd be starting from scratch. (CROSSTALK) That's a very good question.

Sanjay Warrier I think the risk is we, is generally low, it's not zero when it comes to, you're removing the contact device. By doing that, you're potentially reducing the risk and they expand, it doesn't stay in for a long period of time, but what Anand was saying ultimately it's the pros and cons, when it comes to the aesthetics, cause the capsule acts as a potential interface for lipid filling potentially. And also just providing any area where we can place the implant easily without rotation.

Sophie Scott So we've, we've talked about a little bit about the steps of what women would go through if they had symptoms and to be picked up. One of the questions that often is asked, I would like to get the panel to answer is can you test for ALCL with a blood test?

Anna Loch-Wilkinson No. (LAUGHTER)

Sophie Scott And why, why can't you test it with a blood test? Dos it, does it come with some other conditions?

Anna Loch-Wilkinson Because the disease is in the fluid around the implant or the capsule in the implant itself or for those rare cases that present with a mass within the mass. So, it's not actually hematogenous, so you spread, as I said that, at that early stage.

Sophie Scott Is that something that you get asked quite a bit about the blood test?

Monique Bock Quiet often, and I think they get a bit confused cause they think it's a little bit of a breast cancer. They don't understand the difference and they think that they can go and get a blood test.

Anna Loch-Wilkinson There's a lot of cancers that aren't, aren't picked up on a blood test, you know, particularly breast cancer.

Monique Bock Those are the ones that have those swollen lymph nodes and the rashes, you know, we get a lot of questions, you know, what do we do about that?

Sophie Scott Yeah, so what would, what you suggest if a woman has implants and they have, say for example, swollen lymph nodes and they're feeling tired. Is that enough to get a biopsy or what should that woman do? Dr Warrier?

Sanjay Warrier Yeah, I think ultimately, they need a clinical assessment when they have symptoms. And that includes not just the implant, it includes the breasts, including the lymph nodes. And part of that assessment would include an ultrasound of the axilla and also an MRI potentially. And then it depends what's causing the swelling, is it relating to the implant or is it relating to other things that have come from the breast tissue and it's really then you would, then escalate from there, but they should definitely be seeing a specialist for that.

Sophie Scott And so Monique, what are your findings? How anxious are women in this particular group of women, the women who've had cancer and a reconstruction, and now with these record implants, how anxious are they that they might be effected, what do you do to sort of, to reassure them and make sure they get access to good information?

Monique Bock Well, I guess, I mean they're pretty scared. It's pretty terrifying having, you know, had one round of cancer already and then they've got these, you know, textured implants in. It's just important, I mean, I just tell them that they're just got to get followed up with their doctors and make sure if they're not happy with their doctor, that they need to go to another doctor.

But it's, that's odd, that's why I guess I think, you know, I'm questioning why, why are we putting textured implants into people that have had reconstruction? They're probably the last person that would want to have another cancer diagnosis.

Sophie Scott Is that something that you would talk to patients about if they'd had a, you know, if they've had cancer diagnosis, having a reconstruction that you might say to them, you know, you do need to weigh up this, this risk, yeah, so what would you say to them?

Sanjay Warrier Yeah, I think it comes back, it's sort of Monique's question ties in what we've, what Anand was saying earlier, when it comes to ultimately any sort of discussion about a surgical option, it's really difficult to do it with one consultation. It needs to take... It's difficult 'cause these patients are going through a diagnosis where often, their feeling is that the quicker you get to the operating theatre, is gonna impact the way that, you know, what sort of result they did in terms of life expectancy, which is not the case often. So, it's very important I think, that the frameworks there for patients that are diagnosed with breast cancer, that they're having time to understand the risks and pros and cons of not just implants, but other treatments. So, that they're doing the right treatment for them.

Anna Loch-Wilkinson We can give you the numbers, you know, if you come with questions and you know, when I can send patients, I will tell them what the numbers are for a particular type of implant. So you know, as, as the scientific data stands today, you know, this is your risk of getting, you know, ALCL, you know, and then that's then for the patient, cause they're educated, then they can weigh up whether that risk is something that they're willing to take or not. Cause it is, you know, for some types of implants, it is quite small, but you know, if, if you're that patient that doesn't want that minute percent, then you know, it's your choice.

Anand Deva Can I say there's actually quite a variation in acceptance of risk? And it's not for us to make that decision, it's the patient's decision. So, you see some patients who you give them the number and they go, fine, OK, I'll take those odds. Others, I'm not gonna take those odds. But that's not the physician's decision, that's the patient's decision. So we need to be very clear on, and also that risk weighed with the risk of other things happening. So, you might have the risk of ALCL might be X, but your risk of reoperation might be, you know, every six, two or three years.

Sophie Scott The best question that we've had from someone saying, Kathy asking for reconstruction patients, why isn't capsular contracture discussed more often? She's, she's a cancer survivor, had a reconstruction, it was discussed briefly, but she said the true statistics of it occurring, she felt it wasn't sort of explained to her, that, that it was an issue. So, is that, is that obviously something you need to factor in with patients as well?

Sanjay Warrier Absolutely, like I think when you talk about implants and particularly in the setting of radiotherapy, we are gonna have a rate of capsular contracture, it is important that women are aware of potential, not just short term risks outside of ALCL, but also longterm sequela of having a device. And ultimately, it's really hard to do it in one consultation for the patient who's diagnosed with breast cancer to absorb everything at that one consultation.

Ultimately often they will believe what the person they see in front of them tells them. Say they really, really are trusting the person in front of them to give them the appropriate advice and with that as well, hopefully consenting them on what one in... relatively important, but relatively low risk of ALCL. So, it is quite a complex area at that time. I do think that it is very important when we think about that, that it's not just the one consultation, these patients when they're looking at reconstruction.

Anna Loch-Wilkinson Yeah exactly, I think it's important to, you know, if it's particularly patients that are struggling with decision making, it's very overwhelming. I think when you get a diagnosis of breast cancer and then you get bombarded with all this information, you know about the cancer stuff, the, you know, the reconstruction or, the most important thing is to get the cancer treated. When you have your reconstruction, you know, whether, whether you have...

Sophie Scott It sort of needs to be say, under that lens of that, and so you prioritise.

Anna Loch-Wilkinson Yes, we can have time. And even if you're suitable for an immediate, if you're not in that right head space, that's fine. You know, we can deal with that down the track. You know, the cancer is the most important thing. But you know, go away, think about it, you know, bring a support person, write down your questions when you get home and you know, cause you're not gonna remember everything and when you come back to see the doctor and people will often then, you know, it's a bit of a deer in headlights sometimes, you know, they might forget. So, if you've got things written down, you know, go for your second consultation, you've had time to think, you know.

Sophie Scott And taking someone with you is a really good piece of advice as well. Someone who's just there to listen and write down the information that the physician is saying so that you can, as the patient, you can just listen. But someone else is actually writing it all down. And yeah, we've got another question here from Lisa, she says she's 56, she chose a double mastectomy and a reconstruction to lessen the increasing risk of cancer. But she has small breasts, so what risks are there to explanting to the nerve, blood supply and it also is a fat transfer. What benefit would that be? So they're quite technical questions, but we're just, what advice would the panel have?

Sanjay Warrier What was the first part of that? (LAUGHTER) just with the...

Sophie Scott She wants to know, she's saying she's small breasted. What risks are there in explanting to, to nerve and blood supply? What risks are there to the nipples and the breast tissue taking them to find out.

Anna Loch-Wilkinson Generally once you're explanting, it's actually less than, and then at the original operation. And then, you know, fat transfers, one option for using your own tissue. But again, you've got to have enough fat. So, some women aren't, you know, suitable for that. But there are, there's different options, there's quite a few different options. Some of them are more complicated than others. But important to go and actually ask those questions and see what your options are.

Sophie Scott OK, there's another, I've got lots of lots of questions coming in, which is good. One question is, if a woman does decide to have surgery, can you explain the difference between en bloc and capsulectomy? Can one of the panel explain that for us maybe? Dr Warrier.

Sanjay Warrier Yes so really, en bloc, an en bloc resection is a cancer principle generally, when we, when we talk about, and that ultimately it stems from other cancers, where we take the tumour rather than cutting it, take it in entirety, with a margin. However, in there, ultimately in the setting of a capsulectomy, when we talk about an en bloc capsulectomy, which is the human tissues reaction to the implant, ultimately it comes with its own risks, I think. So, there'll be patients where it's relatively straightforward to take the capsule if it's on top of the muscle, it's often easier.

But if it's underneath the muscle, that posterior or lower level of the capsule will be sitting on the ribs and it comes with its own, we say comparatively for someone who's, not got a proven anaplastic large cell lymphoma where they're doing it for prophylactic or for preventative reasons, ultimately performing that surgery comes, they need to be aware that it comes with significant risks. And you're balancing that versus potentially, not a lot of benefit I would think.

Sophie Scott Right. And Monique with the women that you speak to, what are most of the women that contact you, what are they having?

Monique Bock With regards to... I think a bit of both, and I think that the questions that they say are that, you know, how do I know I've had all my capsules removed. You know, I've had an explant and I've had textured implants, and they don't know.

Sanjay Warrier I think you'd hope, you'd really hope that the person that's treating you is honest and that they have been completely but, what some people have been doing, is they've been asking for photos of actually, of the actual capsule and also...

Sophie Scott They wanna actually see evidence.

Sanjay Warrier And it's probably a reflection of and these guys will agree a reflection of mistrust in the, in the medical community from patients, so that they want proof that the surgeon is saying something, they are doing what they're saying essentially.

Anand Deva That is sad actually in some ways, isn't it?

Monique Bock There is also though that the ones, that they've had the explant and then the surgeons have said, I couldn't get all the, all the capsular as well. I would at least, the surgeons at least being honest, which is positive there.

Sophie Scott That was a question that says, some women have said their surgeon recommends, removing the implants but not the capsule. Saying the body will absorb it. Is that OK, or not OK or?

Anand Deva So, I think the Sanjay says it's important to be honest with the patients. And I think in the setting of ALCL, is absolutely critical.

Sanjay Warrier Absolutely.

Anand Deva That the implant and the capsule are removed in its entirety. I mean, we have had recurrences of the cancer, when bits have been left behind. So, the stakes are very high there, and you would hope that anyone undertaking that surgery is absolutely committed to doing that. If they're not, they're properly treating the cancer.

Sanjay Warrier They need... just to interrupt, someone's doing known ALCL case and they're excising, they should be going to a specialist, someone who is doing...

Anand Deva Yeah, and often we actually do cases combined, right? But then let's move away from ALCL, and so you might have someone with a capsular contracture or you might have someone with another non-cancerous... Problem around an implant. That's where I think you need to be honest with the patient. I will try and take this capsule out. But in the setting, as Dr Warrier says, where the capsule is very tightly stuck to your ribs, then my ability to take that out is gonna cause a huge risk of bleeding, puncturing your lung, et cetera and you can list these complications. They're not minor.

So it's really a balance between, you know, benefit and risk. So when you move away from the cancer sphere, the term 'unblock' is not...Yeah, I don't think it's quite appropriate. So I talk about a complete capsulectomy or a partial capsulectomy in those benign cases but I'm very honest with the patients. I will do a hundred percent of my effort to try and get it all out but if I can't get it out there'll be a reason and the reason is to keep you safe.

Sophie Scott And what, you talked about some distrust in the... the medical profession with surgeons of maybe patients wanting photos to make sure that it's all out. What should women do if they...if they don't have a good relationship with their surgeon and they don't feel supported? Where can they go for help? What should they do?

Anna Loch-Wilkinson They can always get a second opinion, get a good GP, get rereferred to someone that you are happy with cause, you know, someone...there's a lot of factors go into it. Someone technically might be good but you may not gel with them well on a personality point, find that you can't approach them and talk to them. So, you know, go and find someone that you can go and see comfortably, feel like, you know, you're being heard.

Sophie Scott Monique?

Monique Bock I guess I get a lot of questions is that the people, they don't know who to go to. The surgeons are too expensive, and they can't afford it, so that there's a lot of desperate women out there. The one alternative, you know, when are we gonna have more clinics opened up in the country and, you know, more support for people. You know there's not enough surgeons to go around that aren't gonna charge the earth and look at it as a money-making exercise.

Sophie Scott So that...I mean that is a factor as well for women, isn't it? To weigh up whether they can afford to have the treatment that they need and if they need to have them out. What do we need to do...

Anand Deva Well, affordability...

Sophie Scott Yeah, affordability.

Anand Deva ..is a problem across health care. We've spoken about this, Sophie. I think that in the setting of breast implants, you've got to remember that we're talking about recon here and that a lot of these women are older They've got more means. They've got access to their health funds which will cover some of their revision surgery but there are also a lot of women who don't. So I think that capacity is a big issue.

There are only a limited number of surgeons and we're all getting busy and full with women wanting their implants assessed. So my real solution for this is to upscale primary care to get general practice much more aware of implants, breast implants complications. We're working on a number of assets, so publications, education. So that every GP, you know, has got some level of awareness and some more than others. And so that's the only way we're gonna deal with this. And people that really have a problem can then get sent quickly and effectively and affordably to a surgical service.

Sophie Scott Yeah, Monique?

Monique Bock It would also be good to have a document that people could take with them, you know, when they've got some symptoms or...

Anand Deva Of course.

Monique Bock ..some issues, you know. If we could standardise something and have something like they'd, you know, have the NCCN Guidelines in America or have something where people can also take, and the surgeons are gonna listen to it and follow the guidelines.

Sophie Scott And is that something that the TGA could develop or what would be of use to patients do you think, Monique? So what would you want on that...on that list?

Monique Bock Oh, something that we could hand out because a lot of doctors don't even understand what this is. It's taking a long time for GPs to understand that it's not a breast cancer. That it's a totally different type of cancer.

Miranda Lauman And certainly that's...that area of both health professional education as well as consumer education is something that we're firmly working on. We've been... Out of the consumer workshops that we've had already and that we'll be continuing to have into the new year, looking at those real questions that women have and ensuring that we're reaching back into the health community to ensure that that information is available so that people can respond to those questions.

I think one of the challenges, of course, is that the health care network, you know, there are lots of people who have a little bit of skin in the game and coming together is a really important part of moving forward. And we're really starting to see that through both our work with health professionals and our work with the States and Territories, our work with consumers and also partnering with the Commission on Safety and Quality in Health Care. But it does require a number of people to come to the table to keep moving forward.

Sophie Scott Dr Lock, was there something you want to add there?

Anna Loch-Wilkinson Oh, no, just listening. (LAUGHTER)

Sophie Scott So we've got some...a couple of, sort of, fairly technical questions but I think for the audience for this particular webinar they'll probably wanna hear answers. So one of the questions is... There's been several articles on this to indicate that an excision or biopsy rather than a needle biopsy is necessary to rule out ALCL in a suspicious lymph node. Does the panel agree with that or not?

Anand Deva That's a difficult one, yeah.

Sophie Scott You can say no.

Anand Deva I think that the diagnostic capability of a needle versus an open biopsy is probably, you know, and particularly with ALCL, which is quite uncommon. Generally speaking, seroma disease, like the fluid disease is the fluid test.

Sophie Scott So you need the fluid. ANAND DEVA: Yeah. In the less common situation where a mass has developed in some, usually a lymph node, usually a mass attached to the capsule or a mass, you know, within other parts of the body, and that's where, in my experience in the few patients that I've treated, a needle biopsy would be sufficient in order to get the diagnosis. Now, if the needle biopsy came back 50-50, you might move to an open. So jumping to the most, you know, invasive way of making a diagnosis is not always the best way. No?

Anand Deva I think it's important to also realise when it comes to lymph node enlargement, that it's not just ALCL. There are things like silica granulomas that form within the lymph nodes from latent implants potentially. And ultimately what we tend to do is we would biopsy one to prove that that's what is and you could start with ultrasound. And the option is the fMRI as well and regular surveillance. But often moving towards anything that's operative comes with its own risks. So we tend to leave them alone.

Sanjay Warrier I think it's important to also realise when it comes to lymph node enlargement, that it's not just ALCL. There are things like silica granulomas that form within the lymph nodes from latent implants potentially. And ultimately what we tend to do is we would biopsy one to prove that that's what is and you could start with ultrasound. And the option is the fMRI as well and regular surveillance. But often moving towards anything that's operative comes with its own risks. So we tend to leave them alone.

Anna Loch-Wilkinson I think you gotta marry it up with your clinical history too 'cause there's many reasons your lymph nodes could be enlarged. And so, you know, getting a, doing a thorough history examination, that's really important. And I think that's where our GPs would be really valuable as well.

Sophie Scott Another question we've had is the symptoms of a late-onset seroma. So will a woman with a late-onset delayed seroma always notice a change in the breast or can it sometimes be only detected with imaging?

Anna Loch-Wilkinson Generally for ALCL, the seroma's large enough for us to have had clinical suspicions. So, you know, if you went out and screened everyone with implants, you'll find that, you know, there often is a little bit of… Some very small amount of fluid. But it becomes significant when it's in larger volume and you tend to see that clinically.

Sophie Scott I think we talked about this in the early webinar but what sort of...how much fluid do you need to be able to test properly for ALCL?

Sanjay Warrier It's often about 50.

Anna Loch-Wilkinson 50ml.

Sophie Scott So that's quite a lot. So it's usual for women to have some fluid, isn't it?

Sanjay Warrier Yeah, it's very...

Sophie Scott Very, very small amount.

Sanjay Warrier Yeah. It's common to have a rim of fluid. Where there is, you know, a little bit more fluid, if possible, we would recommend - if it's 50ml - aspiration. Otherwise, you could always follow-up with a progress ultrasound to see whether it's stable or not.

Sophie Scott And there's a couple of other questions about symptoms. Will a woman who've got the late-onset seroma always have the skin that's grey or would she have pain or anything like that?

Anand Deva No.

Anna Loch-Wilkinson Generally, not. No.

Sophie Scott And other things like a change in the breast size, you know, asymmetry I think we talked earlier about. It often just presents in one breast rather than both. Are they the sort of things that you would look for?

Anna Loch-Wilkinson Yeah. So to date we haven't seen any cases where it's affected both breasts at the same time.

Anand Deva Not in Australia.

Sophie Scott We have seen them in our group and overseas, yeah.

Anand Deva Have you? Yeah?

Sophie Scott But generally, in most cases it'll just be in one breast,

Anna Loch-Wilkinson But if you do notice a big change... So, you know, that's...you always say, you know, whether it's one side or two, you know, go and see your treating surgeon.

Anand DevaI think it's also important if a woman's getting an implant for whatever indication, that they're well-informed as to what to look for, you know? So it's not just swelling 'cause there are other things like in people with implants, rippling visibility, dropping of the breast, hardening, lumps, pain. These are all things that should prompt an assessment. Now whether or not it's ALCL is unlikely but being aware of this is important.

Sophie Scott We do have a question on that. It says... Is it true that not all women with ALCL present with the most common symptoms like of a large delayed seroma? What about from other potential symptoms such as a rash, itching, fatigue, fever, hardening of the scar capsule? How much are they red flags that you need to be looking into, in what's going on?

Sanjay Warrier Well, I think if you have a symptom that's new, the simple...I think the simple way is to actually approach your GP and then potentially see - particularly in the setting of breast cancer, you'd be seeing a specialist who would assess it. And then you're both getting your own clinical assessment on it. But you're also getting a specialist to assess it. But then from there, commonly redness is not… redness is often a reflection of fluid underneath. So I think...

Anand Deva There have been reports of skin rashes...

Sanjay Warrier As well, yeah.

Anand Deva ..as well. It's difficult 'cause it's not uniform. And so skin rashes may be related to something else. Or maybe to immune activation. So I think that... I think the rule is that if anything changes, then there's a pathway to get clinically assessed quickly.

Sophie Scott And Monique, so, what do your patients, your women that come to talk to you, or come to your page for advice, have they noticed your symptoms like these? And generally, when they go to the doctor, have they been getting good advice and help?

Monique Bock It varies. Some get good advice, some doctors tell them it's in their head, and that it's not really anything to do with it. So I guess that's where it gets a bit confusing for them. You know, some will have a rash, some have swollen lymph nodes, some have swelling, you know, there's a whole variety of issues going on. And I guess that they're scared too because you can be diagnosed, you know, from the capsule. You know, without any symptoms. But...

Sophie Scott How often does that happen though, that you would be diagnosed without any symptoms?

Sanjay Warrier Not very often. So I think in less than 15% of women with ALCL present with a non-swelling, whether it's a mass or something else. So... or lymph nodes. So, yes, I mean, I think be aware of your breast, be aware of your body. And if something doesn't feel quite right, get a medical assessment. And if you're not happy with that medical assessment, get another one.

Sophie Scott That's definitely good advice. I might just go back to you, Monique, in terms of what's being done to help women feel that they are being supported in this area? What else do you think needs to be done, so that women have access to good information and good health that they need? What would you like to see?

Monique Bock I like to see more clinics around, and I'd like to see more documentation that people can take to their GP to inform themselves and start information that we can hand out. But also more surgeons, more surgeons that aren't going to charge the earth for people and are going to generally look after them. This is not enough here.

Sophie Scott And Miranda, what... you talked briefly, but what are you hoping to roll out to really make sure that patients are getting the help and the information that they need to address this?

Miranda Lauman So the TGA website has a breast information hub, which has a multi-tiered approach. So consumer-focused information, health professional-focused information. The most important thing about that hub is it is continually being updated. So I think it would be fair to say that we're all still learning about ALCL. There are things we know, there are there things we don't know. And we're getting more cases which will help inform that. So keeping that up to date, and pushing that information out is a really important thing.

Within that hub recently, there's been some very specific information for health professionals that have been not only just put on the web, but pushed out directly to the colleges to engage with them to ensure that surgeons and practitioners have access to that information. And certainly there are opportunities for us to continue to partner with the broader health professionals like GPs, to increase that level of information. But it is a bit of a moving feast, and keeping it up to date is therefore really important focus.

Anna Loch-Wilkinson And there is this ongoing data collection with that. So, you know, the more numbers we get, you know, the more information we have.

Sophie Scott We had a question here, about... (INAUDIBLE) who is asking. So, with the implants that have been recalled, who was notified about that, so say, are women notified? Are surgeons notified? Or is that up to the individual doctors and patients to go to the website and have a look? So what's being done in a proactive way to actually let people know that these are the ones that have been recalled?

Miranda Lauman So when the decision was made, an interim decision was made in July, and that information was made publics. There's then an opportunity for manufacturers to provide additional information, and then the final decision was made in September. That information was broadcast quite broadly, with a lot of media coverage as well as on our internet, and the full list of all breast implants available in Australia at the moment, and what regulatory action has been taken, whether they've been suspended, or had conditions imposed, is available on the TGA website.

But in addition to that, any of the suspended products were recalled from the shelves. Which means that within a few weeks of the decision, those products were no longer available for use going forward. And then each company has various means of communication with surgeons and supply lines to ensure that that is communicated, and they work hand in hand with the TGA to design and push out that communication.

Sophie Scott So with those recalled implants, so would any doctors be using them now, within, like would they have old stock that they could still be using, or would it be your hope that they're not being used in Australia?

Miranda Lauman So I recall officers worked closely to ensure that that product has been removed. To reduce that risk that there's potentially something sitting on the shelf that that could be used.

Monique Bock I had been made aware of someone in particular that was still using them once they were recalled.

Sophie Scott So that would be, probably an exceptional, like, using up old stock or whatever. So they can't get any new stock of these recalled implants, can they?

Miranda Lauman So there is a special access scheme that allows health professionals to... Well, it's a general scheme that allows health professionals to access products that are not otherwise available in Australia...

Sophie Scott But that's designed only for very specific (CROSSTALK) isn’t it?

Miranda Lauman That's right. and it's designed where there is an individual patient who they think will benefit specifically from that device. So it's not to say, as a surgeon, I want to use this product more generally, it's a one-on-one basis. And there's a lot of assurance around that process, and requirements for particularly heightened informed consent, where the device is no longer available in Australia.

Sophie Scott So we've only got about three minutes left, it's flown by, yet again. It's flown by. And I will, before we wrap up, I will say that if there are questions that haven't been answered by this webinar, that people can contact the, the Breast Cancer Network have a hotline that you can call, in case there's any specific questions that we haven't had a chance to get to today. But I will... just wanted to go around to the whole panel, and really just get you to... we've got a couple of minutes left, about three minutes, so, just to wrap up, particularly for women have had a reconstruction, who might be concerned about ALCL, what messages would you like them to take? And just to keep in mind with what we know now and sort of going forward.

Miranda Lauman So I think from the TGA's perspective, the best thing women can do is be informed and keep up to date with emerging knowledge, keep up to date with their own checks, their self-checks and their doctors'. And I think from our perspective, the best thing we can do is continue to partner with health professionals and with affected women, so that we're informing you. And this is a really great opportunity to continue that collaboration. So thank you, everyone who's come along today.

Sophie Scott And Monique.

Monique Bock The same thing. I think people, patients need to be informed. I think they should also be, you know, having, you know, annual checkups. And if you're not happy with your surgeon or your doctor, go see someone else. But I'd also like to send a thank you to, you know, for having the consumer representative be able to talk and you're filing, you know, listening to us. And change is happening. It's happening slowly, but it's happening. So that's a good thing.

Sophie Scott And what does it mean for you to be... to be able to have an event like this, or a webinar, so that you can, so that people can actually feel like they're getting the best information, the latest information from the people who are right in the centre of dealing with this issue?

Monique Bock Well to know that you're listening to our questions and our problems and what's going on out there, because there's just so many people not knowing what to do. And we're not doctors or surgeons, we are just patients and patient advocates, and we don't have all the answers either. So, you know, we do need the support. Thank you.

Sophie Scott And Dr Warrier.

Sanjay Warrier Yeah, I think messaging this pretty similar, that, be empowered. So have an idea if you can, about what type of implant you have. And with that information, that will potentially hopefully de-escalate how you feel when you know, OK, this is a risk. And part of that is then be, the empowerment comes with the annual surveillance assessment, which would be with a health professional, hopefully, a general practitioner, and then escalating from there. But there are varying ways to deal with risk. One way is removal, but there are other ways, and that includes assessment. And you've gotta weigh the pros and cons when it comes to anything in life. And that's what we'd recommend.

Sophie Scott Good advice. Yeah, Dr Wilkinson.

Anna Loch-Wilkinson Just know that there are potentially other options besides implants, so, ask to speak to your friendly plastic surgeon.

Sophie Scott Dr Deva.

Anand Deva Well, as I said in the last one, I think this is a really good example of collaboration. I think going forward, we have, you know, a real desire amongst all the stakeholders here, patients, researchers, the regulator, and our colleagues, media, to ensure that, you know, we all work together for a common cause, which is for the benefit of the patient.

Sophie Scott Well, thank you very much. And thank you out there for watching and listening. And thank our panel for all their amazing information that they've imparted today. As I mentioned at the start of the webinar, this is being recorded, it will be put on the TGA website. It'll also be going out on social media. So if you're on social media, on Twitter, or Instagram, if you wanna follow me, which is @SophieScott2 I'll be posting out the links, or the TGAs and other great resource. Again, also, you can contact the Breast Cancer Network hotline for any specific questions that we may not have covered today. But thank you for watching.