So I want to thank you all for joining us for our Insights from Industry webinar, Integrating Innovation in Full Bloom, the Next Evolution in Tissue Expanders, Motiva Fluor and Silk Smooth. Tonight, during our presentation, we'll have Dr. Hamm talking to you. I will give an introduction to him. And in the meantime, I want to let everybody know that we will have his presentation followed by a Q&A. The Q&A feature is open at the bottom of your screen during the entire webinar. You can submit your questions in there, and we will get to as many of them as possible at the end here. And we also want to let you know that we will be recording this tonight. Everything that we are recording will be posted onto our EdNet page for the ASPS members. If you're not a member, you can always message us. There's the email there, the membership at plasticsurgery.org. And with that, I want to give a quick introduction to Dr. Hammond, who will be speaking with you tonight. We're going to be taking an in-depth look at the evolution of two-stage breast reconstruction and the Motiva Fluor Smooth Silk Tissue Expander. This webinar will feature Dr. Dennis Hammond, who will discuss his experience and insights using Fluor, the first and only single-port, magnet-free, and MR conditional breast tissue expander in the United States. Dr. Hammond is a board-certified plastic surgeon in Grand Rapids, Michigan. He received his undergraduate degree from the University of Michigan in Ann Arbor, Michigan. Dr. Hammond completed his residency in general and plastic surgery in Grand Rapids, Michigan, followed by two year-long fellowships. The first was in aesthetic and reconstructive breast surgery in Nashville, Tennessee, under the direction of Dr. Pat Maxwell and Jack Fisher. And the second was in hand and microsurgery at the Medical College of Wisconsin in Milwaukee, Wisconsin. Dr. Hammond has published numerous specific papers, book chapters, and has authored his own textbook entitled Aesthetic Breast Surgery. Dr. Hammond has been an invited speaker at innumerable meetings and conferences around the world and has performed live surgery demonstrations on nearly every continent. Dr. Hammond has been in private practice for 28 years and continues to operate a busy aesthetic and reconstructive breast surgery and body contouring practice. With that being said, I'm going to pass it over to Dr. Hammond to talk with you tonight. Wonderful, really a great pleasure to join everybody tonight and talk about some of the new innovations that have been taking place in plastic surgery. And I'll go to share my screen and we'll go here and then we'll go here. There we go. Is that good for everybody? Looks good on our end. All right. Good. Wonderful. Well, greetings, everyone. It's really a pleasure to be here. I've been thinking a lot about this topic and I look back at my own history as a plastic surgeon. I've been in practice for 32 years. And I remember when I was a medical student at the University of Michigan, the very first tissue expander conference that ever took place happened in Ann Arbor. And I was standing outside the door as a third year medical student. And Chetamere Radovan was presenting this brand new idea of using a device to stretch the skin. And it went on from there. I was working with, as was stated, I worked with Pat Maxwell and Jack Fisher, who are two real giants in plastic surgery, each of whom had developed their own tissue expanders and really pioneered the use of these devices for breast reconstruction, went through on to now here we are with the next step, really, I think, in tissue expander technology. What we'll talk about tonight is the FLORA, the Smooth Silk Motiva device, which has a lot of features associated with it, including a non-magnetic port. And so we'll spend some time talking about that and how I think that's really an advantage moving forward. You'll see some concepts here related to some of my companies I work with, including the Motiva company. So if you take a look at this device, what are the options or the advances that have taken place here? We've incorporated a lot of the changes and advancements that we've had over the years, including the creation of an anatomic shape. The unique thing about this device is the shape resists rotation because of the way the shoulders have been built into it by design. It's got an integrated valve, which I think is one of the advances that has taken place over the years, and a protective skirt, which guards against inadvertent puncture, so you can stick a needle through this and you don't necessarily damage the expander. Something that I was actually involved with early on, I actually developed the first tabbed tissue expander way back in 2000, and now all devices have fixation tabs to hold them in place, including the six tabs that are incorporated into this device. A low inflammatory surface, what's called a silk surface, smooth silk surface that we'll have a chance to talk about, been really one of the advancements associated with the Motiva technology that we're very accustomed with in South America and in Europe, as I've been working over there and will soon become familiar with that here in the United States. It's got also a very soft feel built into it, which is really important for expander reconstruction. Expanders can't feel firm or hard or uncomfortable when they're in place, and so this addresses that as well. And then really the most exciting bit is the MR conditional, MRI conditional, meaning that the patient can have an MRI and can undergo radiation therapy planning with this port in place, really the first time that's ever been possible. And I really have to give a shout out to the CEO of Establishment Labs, he was almost like a Steve Jobs kind of personality with this, was not going to allow expander to be released until this problem had been solved. And really a testament to the engineers back in Costa Rica that were able to design that. And so this is part of an implant-based reconstructive strategy, which is the most common way that breast reconstruction is performed now here in the United States. And stage one has evolved now into a skin sparing and usually a nipple sparing approach, oftentimes supplemented with a placement of a tissue expander at that first stage to hold that space open and prepare for then what becomes stage two, the placement of an implant coupled with what I think is really an important part of implant-based reconstruction, fat grafting. And Dr. Pat Maxwell has coined this term, the bioengineered breast. And I think with the kind of work that we can do now, coupling all of these advances together, it's the aesthetic bioengineered breast, or what we're going to call aesthetic breast reconstruction, is we can get that good at this. And I'll show some examples of this at the end. But here's just an example, just to show what's possible. This is a patient that's undergone a bilateral mastectomy. I've incorporated a lift into the overall reconstructive strategy. Ultimately, then the implant was added and she underwent a couple of rounds of fat grafting. And here she is eight years later, really looking better after a bilateral mastectomy than when she started. And this is just amazingly exciting, to be able to provide these kinds of results for patients after bilateral mastectomy. Here's an example from the side view. Almost looks as if she's had a breast augmentation, or in this case, an augmentation mastopexy. So this is the degree of control that we can provide using these kinds of techniques. So the advances that have taken place over the last 20 years or so are truly performing these procedures as an immediate reconstructive process, using a skin and nipple sparing approach with fat grafting. Where have we gotten really better at this? Something that's really helped us is we have better implants and expanders now that we can use to accomplish these tasks. Now, like I said, tissue expansion goes all the way back to Chetermule Radovan in the early, late 70s and early 80s. And this was stimulated by observations that were made on tribes in Africa that used expansion to physically adorn themselves. And this led to the placement of expanders under the scalp to help in scalp reconstruction and in facial reconstruction. And this was just groundbreaking back at the time. Like I said, when I was a medical student at the University of Michigan, the ability to do this kind of work was just stunning. And it didn't take really much imagination then to say, we can do breast reconstruction with this concept as well. So the first tissue expanders were round and had a remote valve associated with them. So this remote valve had to be buried peripherally somewhere in the chest wall. And this is the kind of result that they created from back in the day. It was basically a round object and created a round shape. And this remote valve was seen here. So during the expansion process, there was a fair bit of deformity that occurred as a result of that. And this didn't really set the footprint all that well. So it doesn't take much to think about how can we make those early versions of the tissue expander better. One of the things that happened and what Dr. Maxwell and Dr. Fisher were very good at was they'd started to incorporate the idea of shape in the expansion process. So that during the expansion, the patient had somewhat of a shaped breast, which made the whole process tolerable, but also set you up well for trying to pick your implant then to go into that space that was created by that tissue expander. And so as the technique evolved, the expander was not really set so much as an expander per se, something to stretch the skin, but something to control that implant space. When you're there as an immediate reconstruction, the space is already created by the mastectomy. You want to use the expander to set that footprint so that you could come in later and adjust the volume and prepare for the placement of an implant. By using that expander and gently filling it at first and then filling it to your desired volume later on, you allowed the flaps to develop. So it was a bit of a safer approach that you could use to allow these flaps to settle and then control that space a little bit better so that later on, when you could look at the base diameter and the volume, you could better select your implant. The other thing that that two-stage approach allows now, one of the great advances that's allowed all this to happen, is it allowed fat grafting to be done. So that at the second stage, you could safely now fat graft. It would be probably a bad idea to try to fat graft a fresh mastectomy flap right after the mastectomy is done. But later on, when the tissues have recovered, now you can fat graft really quite aggressively. So it's an important part of the overall process. The other thing is, there's a built-in revision. When you use this two-stage technique, there's a second operation that's planned. So the tissue expander is going to come out, implant is going to go in. No insurance company in the land will ever argue about that. It's very insurance friendly. It's built into the process. I've actually had cases where I've tried to do direct implant and then come back later and fat graft. And that was denied by the insurance company because they said it was cosmetic. So kind of a downside of the direct implant technique. But with the two-stage tissue expander implant technique, it kind of builds into the strategy. So tissue expanders, how have we made them better? We've gotten better shapes. We've gotten more thoughtful with regards to the valve. We've allowed these devices to be fixated into place, and we've allowed them to become much more comfortable. So early on, one of the first alterations or advancements in expander design was in the realm of shape. And several different and increasingly severe shapes were developed. We even had these kind of devices here with an expander on top of an expander. This was a differential expander that ballooned out in the lower pole. And what these were preparing for was the anatomic concept, which this was a precursor. For those of you that are on the call that remember, to the anatomic implant concept of the early 90s and into the 2000s. And so setting the footprint with this anatomically shaped device was really an early modification. And this has absolutely been built into the flora expander as well. It's got an anatomic shape, several different heights, as you'll see later on, sets that base diameter, gives you that lower pole expansion, and really prepares that space for the subsequent placement of an implant. Next was the valve. We pretty quickly got away from these remote valves, as you can see here. These were hard to find sometimes, they were prone to flipping when they were buried laterally along the chest wall. And early on, these valves were incorporated right into the anterior surface of the device. Some of these became quite prominent, these could be problematic, but these enlarged reliefs here, they could actually create ischemia in the skin if the mastectomy flaps were quite thick or thin. But early on, here's that magnet, they all incorporated a magnet. And there were these different kinds of magnet finders, there's a whole host of these different magnetic finders to evaluate so that you could find that magnetic valve. So that you could identify that valve, and then go in and fill the expander through that self-sealing valve that's built into the device. So the integrated valve was definitely a step forward. They were fairly easy to locate, they were comfortable, they're a leak proof, and what it allowed was adjustability now to your tissue expander. So you could gradually fill it over time, and you could do that in a gentle way. The tissues recovered after each fill, and then something that is maybe not focused on a lot, but it allowed the patient some input into how big a breast you were actually creating. So they could say when they were happy with the expansion process, so that you could then go on and proceed with your implant placement. Now as we said, all of these valves were magnetic, there was a magnetic component to it. And as a result, they were not really friendly for use in MRI. So there are several different scenarios that developed, I've certainly seen these in my own practice, where they were not suitable for use in an MRI for a host of different reasons. They're MRI unsafe. And several articles have been published, here is a situation where the port became dislodged because of the heavy magnet in the MRI. It interferes with radiation planning, and this was actually a CO2 filled expander here, where the CO2 cartridge actually became activated by the MRI, and became inordinately filled resulting in tissue necrosis. But the real problem with the magnetic ports is it completely distorts the image on the MRI, so you really can't see the tissues, and it's been classed as MRI unsafe. It's really not recommended that you put these expanders in an MRI. So if for whatever reason the patient needed an MRI, say for instance a workup for possible brain mets, say some symptoms that develop after the expander is in place, that's a situation I've been faced with. I literally had to take the tissue expanders out in order to allow a proper workup to be performed. And so not being able to use that modality is definitely a downside. So this is where I think establishment labs really kind of entered the fray. I'd say that as they've been involved in the plastic surgery space now over these last 10 to 15 years, their middle name is innovation. And they attacked this problem head on. And early on, they had a radio frequency identification system that they built into their implants early on, and they were able to take that and modify this so that you had an MR conditional valve now with a unique port locator that they could build into that device. So there is an injection dome that's built in. That RFID coil is built on top of a needle stop. And so this is magnet-free, and it allowed a safe MRI to be performed under specific conditions. So MR, or traditional expanders with a magnetic valve, are actually classified as MR unsafe. And as we said, there are some safety issues with regards to valve dislodgement. Interestingly enough, for patients that actually got accidentally put into an MRI, there can be heat that accumulates at that magnetic port. So there's a burning sensation and a risk for creation of a burn. And then, as we said, the distortion of the MR images. So going back to the drawing board and using that RFID technology here, they were able to build into that expander with a port locator that you can see here. So what happens is that air-wound passive RFID tag is powered by the reader. And then signals are sent back to this port locator that tells you, yes, you're on top of the port. So a lot of technology went into building this, multiple different versions of this. This is a case that I did with my good friend down in Panama, Luis Picard-Ami, where we were using these expanders early on. And here you can see that we've got a delayed reconstruction here with a base diameter 14 fluorotissue expander. We've got it filled partially, and the dressing is on. We're ready to leave the operating room. And this is how it works. You advance the port locator towards the lights. and when you're centered over that valve the green light goes on and that tells you that you're right over that valve you put a little purple dot and it's really very hard to make a mistake here and miss that valve and so you can actually feel it in most instances as well because these flaps are somewhat thin but here we can go ahead and pardon me there we go you can go ahead and fill that that that tissue expander right through that valve with no problem and so you can find the valve really quite well this is an example of a patient that's post-operative so she's coming back for a clinic visit the expander sitting right there and we use that same port locator you manipulate it till you get the green ring and there's our our mark and we can access the valve that way so pretty easy to use and the advantages as outlined in all of these papers here when you have an MRI or a CAT scan that's done with that valve in place there's a significant distortion that's occurred and then with the the flora RFID tag coil here there's no distortion at all so here's an example of it here's an MRI that was obtained using this device and you can see there's next to no distortion in the signal here is a clinical example of a patient that's got that valve in place so you can see the tissue expander sitting right here you can fully see the muscle in this case here you can see the mastectomy flap so no distortion in the soft tissue at all so that's a significant advantage so here's an example from a recent paper that was published in 2023 again documenting that the mastectomy has been done so here's the flora tissue expander on a couple of different images t1 and t2 weighted panels for the evaluation of the soft tissue no problem at all with reading the the images and no risk for displacement overheating or damage to any of the devices so a real step forward as far as the need is should an MRI develop need for an MRI develop the other and probably even just as important advantage is the planning then for radiation therapy I'm sure all of you have experienced that situation where you've got your expander in you got everything up and then all of a sudden you get a call from the radiation therapist they want the expander deflated because it's interfering with their ability to plan and that just throws a monkey wrench into the really overall planning or right from the get-go and so this kind of complex planning that's done can sometimes be significantly infected by that metallic valve and so here's an example of recent paper that was published out of Korea where the the radiation delivered to the surrounding soft tissues which much more delivered in a much more controlled manner because the valve was not interfering with that planning so here's the fluorovalve the RFID coil versus a metallic valve so this is a significant step forward here you can be ensured that you're going to be able to do your radiation planning without hindrance and then a very important part of the design of an expander is fixation so early on there was really no attempt to fixate at all and as many of us know textured surfaces were developed and this was a way to with the early on with the macro texture devices you could get this kind of a texture and this would result in ingrowth and here's an example of one of the problems with that particular surface which was the double capsule that a lot of us have seen but here is an example of a device that came out and if you listen you can see that velcro effect that was associated with the macro texture devices like that you can just hear that velcro kind of effect as that comes out like that and problem with that is that ultimately the texture surfaces were associated with significant inflammatory response and ultimately these devices were recalled and removed from the market and so this is where I actually had a chance to participate in the design of these devices and I developed these expanders that had these tabs way back in 2000 and this has gone on now to be a technology that's been used in many of the texture expanders that have been subsequently developed so you can use these suture tabs to now hold the device in place and this was a pretty significant step forward with the placement of these tabs now you can very solidly hold that anatomically shaped tissue expander right where you want it in the mastectomy wound to help set the footprint and this is definitely been incorporated into the design of the flora there are six tabs that are available and I've used these devices and I would recommend that if you can get a stitch in all of these tabs I would do it if it's easy to get I would put a stitch in each one of these tabs I tend to use a permanent suture when I do that but you know what I would want I would want to make the observation and share with everybody is this 12 o'clock tab is actually pretty important so when we first developed the tab concept this was back in 2000 now all of these devices were going under the pectoralis major muscle so the pectoralis was actually our 12 o'clock tab it was holding that down now that we're prepack with most of the placement of our devices you've got to secure the top of that device so that it doesn't tilt forward so that that 12 o'clock tab is one that I'd say is a must if you're going to use these devices and then depending on where your incision is I think you've got to get at least two of the other tabs sutured down and like I said if I can I'll suture all of these tabs down because I want that tissue expander to stay right where it's set and so again I use it to a permanent suture you know an ethabond is a good stitch to use because of the friction from that braided nylon another one good one is a proline or nylon to suture through these tabs and by doing that you can keep the orientation of your device you can set the inframammary fold it positions the valve so it's always going to be right where you think it's going to be and now you don't need that surface to interact with the soft tissue in a velcro type fashion to hold it in place and then lastly something that you maybe not think about a lot when it comes to a tissue expander but comfort during the expansion process is really important I've used some of these other types of devices these expanders they're firm they're somewhat uncomfortable and I've actually been in a situation where I had to actually remove these devices because this hard plastic rubbery kind of feel that's built into some of these devices it was actually uncomfortable for the patient and so when we build into the flora was the concept of making it soft and pliable and comfortable during the expansion process and this is where I didn't want to take a moment to talk about the surface the silk surface that's incorporated into these devices what that was right there was a shell and the way that the silk surface is created is it's basically turned inside out so you've got this silk surface imprint that's on the device that's got a relief of about four microns and what's been shown is that the way that this surface interacts with the overlying capsule is such that it's a low inflammatory surface it doesn't really trigger the same kind of inflammation that you get with some of the other textures so as a result you get reduced inflammation and reduced friction and studies have shown now with the use of this these kinds of surfaces in Europe and in South America that you really control the way the capsule forms around these devices and this is a paper that was published in 2023 out of Austria taking a look at the way that this textured surface interacts with the soft tissues and as well the comfort level that was associated with these devices and it was noted that it was an enhanced comfort feel associated with the device likely at least partially related to the fact that the capsule that formed around this device was so friendly it was so patient friendly as far as its elasticity and the lack of capsular contracture that was developed around this thing and so the surgeons reported higher satisfaction with their expansion that was created as well as control of footprint and also enhanced comfort scores so there is less breast pain less discomfort during the expansion process and less sensitivity that's something that I can actually confirm it's very soft during the expansion process so you don't have to worry about dealing with pain and discomfort during the expansion process so the perfect tissue expander if we were going to sit down and design that it would have an anatomic shape it would have an integrated valve it would have a way to fixate it in place it would have a way that it would create low inflammatory reactions with regards to the capsule it would have a soft feel and it should be MR conditional so it should allow an MRI to be performed and that device I think is what the flora represents as we said it's got an anatomic shape that's built into it this little shoulder modification here helps resist rotation it's got the integrated valve with the skirt it's got the fixation tabs including that very important 12 o'clock tab the silk surface is that low inflammatory surface that's built into it I think that as time goes on in the United States you'll become more and more familiar with the whole Motiva concept and that will become a lot more understandable it creates a soft feel and really importantly it's MR conditional so at the end of the day you've got that RFID identification port that allows one and a half and three Tesla systems to be used the four micron biocompatible surface is a relief that controls that reaction resulting in high patient and surgeon satisfaction so that's the device when you start to think about how you want to construct that now I've long felt that if it was just in centimeter increments as far as the base diameter is concerned that would meet the needs of most patients so you can choose the base diameter you can use biodimensional planning with this and notice here with the full height devices it goes all the way up to 16 centimeters so even larger patients you can get up to 995 cc's of volume so basically there's an expander for anybody that's going to be you know so be presenting for this kind of device clinical results this is the patient again that I did with my my good friends Picard on me Louise Picard on me down in Panama this was a delayed reconstruction so the way that we do this is we measure the base diameter or the opposite side and then we just duplicate that on this side so we choose our 14 centimeter base diameter device so there's our 14 centimeter base diameter device it's got a height of 13 centimeters and an overall fill volume of 605 cc's so we just mark that here on the patient that's our sort of our marching orders if you were very similarly that we do our breast augmentations so we identify where's the medial border of that opposite breast here and so then what we'll do is we'll just duplicate that then here on the opposite side so that's our no-go zone as you can see right here and then we just stretch that out 14 centimeters that's going to be the lateral definition of our pocket and then we note that the height is 13 centimeters so we go ahead and measure up 13 centimeters from the inframammary fold that we very carefully want to control so we'll control that with the way that we dissect but we'll also control that with the suture tabs that are on the tissue expander so that we can hold that device in place using the tissue expander to set the footprint of our reconstructed breast so I think it's pretty easy to see then that sets where we want that footprint to sit and that's what's determined outlined here in orange so we've got very precise control over all of the elements of the footprint where we want that implant that expander to set that means our expander will set right here in the upper hole of the breast and so we can go to the operating room we can get that set so here's another example this particular device had a base diameter 14 and a height of 12 same process we set the no-go zone we set the base diameter at 14 we set the height at 12 that means our expander will sit right here and our valve will be positioned there fixation tabs down below so here she is at the time of surgery we've gone ahead and identified the valve like I said you can oftentimes just palpate this valve if the mastectomy flaps are thick enough and this was her she'd been inflated three times and we got her completely expanded by 21 days and this is due to a couple things with the way that the textured surface the silk surface interacts with the soft tissue it creates that low inflammatory relationship so that there's no hindrance there's no scar formation with the traditional capsule which allows that expander to just pop right out and you can see that we've been able to reclaim that skin envelope really pretty readily and here we are 21 days already fully expanded so what we'll let that we'll do here is we'll let that set whatever that all the swelling go away and so she's set up very well for her second stage where the expander will be removed replaced with a permanent implant and then back grafted so that's really the description of this this new device that incorporates I think all of the available innovation that we can build into it what I wanted to try to do was to just demonstrate where we're at now with our aesthetic breast reconstruction concept so here's a patient that's going to present for a mastectomy there's all of the planning that I just outlined with the taking into account the base diameter where we want that footprint to sit the height is 11.9 centimeters in this case there's our no-go zone we're going to use an inframammary fold incision to do our mastectomy through and then here she is with the pre-pectoral placement of her tissue expander filled at this point here to 350 cc's we've gone on to allow that all to settle and here's our planning for our second stage we'll take a look at the base diameter and the volume of our expander we'll choose an implant that fits that we'll harvest some fat and add that then to the mastectomy flaps at the second stage and this is her result at a year and this is what I was talking about when we first began this presentation we have the opportunity at this point to make patients look better after a bilateral mastectomy than when they started we can almost make it look like they've had a breast augmentation utilizing that staged approach so controlling all of the variables at the first stage so that at the second stage when we place the implant and do our fat grafting we can really fine-tune that result creating a very soft reconstruction with no animation because of the pre-pectoral space here's just a little video clip sometimes the pictures just don't do it justice this is an outstanding reconstruction by any stretch of the imagination this this new concept of aesthetic breast reconstruction I think is revolutionizing what we can do in the reconstructive process for these patients basically all as an outpatient procedure with COVID we got very good at doing these reconstructions first stage where the tissue expander is an outpatient and then of course the second stage is outpatient as well and you can see what the incision there in the inframammary fold and then because she's prepack, no animation. That is a significant step forward being able to do this without any of the animation that we've seen in the past. Just another quick example of this, a lady that's had a bilateral mastectomy with reconstruction looking for all the world as if she's had a breast augmentation and here again an example here rotating her from side to side. You can really see the quality of that reconstruction with the peripheral contours having been softened with the fat grafting. I don't want, I can't stress that enough. The fat grafting is an integral part of this overall process and here another example 18 months. This is a lady that was actually fat grafted twice which is very common for their colleagues over in Italy and in Europe. Fat grafting is something that can be done multiple times and it really creates along with everything else we've been talking about just really outstanding results. So at the end of the day when it comes to this device, the flora silk surface tissue expander, it's got the anatomic shape, it's got that integrated valve with a protective skirt and the fixation tabs that hold it in place. There's an orientation stripe that you can feel and the lower pole, a low inflammatory surface really controls the interaction with the overlying soft tissue creating that soft feel that allows expansion to proceed in a very comfortable way and really amazingly, I don't know if any of us would ever thought this was possible, MRI compatible. It's really an amazing thing. So at the end of the day, stage one skin sparing approach with the tissue expander, strategically choosing the implant and then fat grafting stage two, the aesthetic bioengineered breast. So I like this slide because it shows here we are heading off into the future. It's going to be really interesting to see what the future holds as we continue to move forward with these concepts but I think that now in the United States we're just so fortunate that we've been able to get this through the FDA and get it into the hands of reconstructive surgeons now. It should be really exciting to see what we're able to do moving forward. So that really concludes my remarks I think on this new technology, this new innovation with this device and what I do is open it up to any comments or questions that anybody might have for the rest of the time that we have available. So I guess what I'll do is I'll manage the chat here. I see there's chat and there's Q&A. I'm just going to go ahead and read this. The first question that I see here, there is word out there that in Europe some reconstructive centers have stopped using an ADM because of the surface of this expander. I think what they're referring to is the fact that this is such a low inflammatory surface that one of the reasons for using an ADM has actually been obviated and you know I actually think that that's true. Now depending on the thickness of your mastectomy flaps of course. Now there's other reasons to use ADM. So the ADM can be there to help support the space, help set the footprint. The ADM also does actually facilitate back grafting later on. But I do have to say it is very possible with the low inflammatory silk surface that's built into the floor expander, one of the reasons for using an ADM may well be obviated. And so that's really one of the I think the research directions that will go in as this expander is now being made available here in the United States. Another one question is what experience has been studied with flora for patients undergoing radiation? And so a couple things. First off just the very process of administering the radiation as we were talking about is it allows the radiation planning to go in a much more uncomplicated way. So you're never going to be faced with that situation where you have to bring a patient in and completely deflate the expander which is like I said something I had to deal with or even a more draconian situation where we have to take the expander out. So that will obviate that, it will allow the planning to be done in a much more friendly way. It will allow superior dosimetric results as far as the heart and the lungs is concerned under the area where you're trying to deliver the radiation. And it will make that I think a lot more user-friendly. Next question, are there any cases of BIA-ALCL related to this device? And what that's related to really not just necessarily this device but in particular the surface, the silk surface. And there are no cases of proliferative disease ALCL or BIA squamous cell SCC or B-cell lymphomas associated with silk surface. And that includes 3.2 million silk surfaces globally over the last 14 years. So not really a worry with regards to this particular surface. I don't necessarily worry about that. I still adhere to the idea that as of now there's not been a case of ALCL with a smooth surface device or a silk surface device as well. And one of the questions here now, what kind of a surface does the flora have? Like we said, that's the silk surface. So it's created by the mandrel. It's a four micron surface. It's got a four micron relief to it. So then what happens is that shell comes off the mandrel is just simply turned inside out. So in that regard, it qualifies under the imprint type of surface. As this has been introduced in Europe and South America and in Asia actually, a lot of discussion has been bandied back and forth about whether or not this qualifies as a round or a smooth surface versus a textured surface. And there are different bodies that have classified these devices based on how many microns they are with regards to the relief. It's considered smooth by ISO standards. But I think that's more accurate to say it's got a four micron surface, which really is not very much. And it interacts with the fibroblasts and the capsule in a very low inflammatory way. I think most everybody would agree that that's really not in dispute. And it's been shown that the inflammatory response to that surface is really well controlled. So it functions almost like a smooth device. It says here in the study from Austria, what was the comparison of the fluoride expander that showed higher patient comfort? It was compared against another device and it was graded as with regards to really a Dolores Wolfram, who is the one of the authors of that study is a very a well-known and renowned immunologist as well as plastic surgeon. And so she studied that interaction between the silk surface and the capsule. And it was found according to a number of inflammatory investigation methods that there was a low inflammatory component to that, which translated into a much more comfortable device during the expansion process. Now that's also I think related to just the way that devices is manufactured. I actually have one here. It's just, it's a very soft construction with way that the shell is made. So it sits very comfortably within the soft tissue framework and that as much as anything also contributes to its comfort during the expansion process. Is it FDA approved, available in the United States? Yes, it's actually gone through the FDA approval process and been given a green light. And I think I'm allowed now to use that device in my own reconstructive process or practice here as well. And there's another question here. Appreciate your contribution to breast reconstruction, but shouldn't we be looking at direct to permanent implant immediate breast reconstruction as a better approach than continuing to approach reconstruction as a two-stage journey? That's a great question. And listen, a lot of my friends around the world do great work with direct to implant reconstruction and that can't be disputed. But I would say this, and I very candidly quizzed a lot of my friends around the country, do any of your patients ever come back for fat grafting? I mean, is this truly a one and done kind of situation where you get everything done, mastectomy and implant in one stage? And so that can happen. I think that it's a bit dependent upon the quality of your mastectomy surgeon and how thick your mastectomy flaps are. I know from where I live here in Grand Rapids and where a lot of my colleagues around the country are faced with fairly thin mastectomy flaps. So it's not at all uncommon for these direct to implant people to come back to have fat grafting done. And like I said, I've been faced with that situation where the insurance company actually denied that. They called it aesthetic. And it's almost like a bit misleading if you do direct to implant and then take them and bring them back for fat grafting. I mean, that's a two-stage operation. From my standpoint, I'm just very much a control enthusiast. And I think that if we can break this concept, this process down into two very definable steps, do the mastectomy, control that space with a temporary device, which in this case we're going to call the floral tissue expander, control that space, let everything heal, be gentle with the way that you put your fluid in at first. And then later on, you can become a little bit more aggressive, add fluid to the expander such that secondarily later on, you can look at the volume that you have in your expander. You can look at the base diameter of your expander. You can go to your implant selection tree then and pick an implant that's going to precisely fit that space. I think with much more consistent results, you also have the opportunity at that second stage to adjust the pocket. I am almost always adjusting that pocket, either doing a little capsulotomy or elevating the fold or opening the pocket up medially or laterally, doing something that allows me to create that beautiful result that we're getting at the second stage. And then really, most importantly, I aggressively fat graft at that second stage. I get 200 to 250 cc's in a typical patient, which is a massive amount of fat, if you actually stop and think about it. I don't think there's any way you could safely do that with a direct implant approach. So I very much am pushed back, I guess, a little bit, that the control that's provided by that two-step approach just gives you, I think, a more predictable and controlled result that really is just an amazing thing to be able to provide for patients. So yeah, I get the direct implant thing, but I'm very much a two-stage guy. So let's see, the ADM creates the same internal breast geometry as a subpectoral implant, reducing the need for fat grafting. Again, I'm going to push back on that because for me, the thing that makes implant-based breast reconstruction go, especially in the pre-pectoral plane, is the ability to fat graft. You've got to be able to soften those mastectomy flaps so that you don't see wrinkles, you create smooth contours as the device comes off of the chest wall. And so fat grafting is really a critical piece in this overall strategy. And so anything that facilitates that, for me, is going to be a real important part of the process. So again, that's one of the reasons why I'm pretty much a two-stage guy, trying to set myself up for that second operation in the most controlled way that I possibly can. And so that is what I'm seeing here. I don't know if I'm seeing, if I've got this correct here. I don't see any other questions. Am I good with regards to this? Am I seeing everything I'm supposed to see? I don't see any of the other Q&A there. All right. Well, we've got seven minutes left. I'm just going to, maybe if I could, I'd just like to editorialize a bit. I'm an old flap guy. I mean, I was trained to do tramp flaps by Dr. Maxwell and Dr. Fisher back in the day. And I was trained to do latissimus flaps. I've done probably thousands of those procedures. I have transitioned at this point to almost completely an implant-based breast reconstruction process. And that's because of some of the advantages I've tried to outline this evening. The move to the nipple-sparing mastectomy has allowed us now to not really have to use the expander as an expander. The expander functions really more as a footprint setter. It controls that space for us and it allows that soft tissue to heal around that space. When you go into that space right after a mastectomy, that's a really challenging environment. A lot of the blood supply to that skin has been cut down. And so you want to try to be as gentle with those flaps as possible. So the ability to put that expander in, partially inflate it, let the skin recover over the next couple of weeks, which it will do, and then later fill that expander to the desired volume is a huge advantage. Then, secondarily later on, you can use the information you have using the volume that's in your expander along with the base diameter to intelligently pick your implant. And then at that point, to fat graft as aggressively as possible is just a huge advantage. And I think that it really sets you up for success in the overall process. And so that's why at this point I still have tram flaps, latissimus flaps, deep flaps, muscle sparing pre-tramps. I've got all that in my back pocket, but I rarely have to use those with my immediate breast cancer situation. There is one question that hasn't been asked that I think that I can think of, and that's what do you do in the face of radiation? So we'll place the expander and we'll blow it up as much as we can, and then we'll send the patient off for radiation. They've got to have it. So we'll go ahead and let that radiation take place. We'd like to think that we're controlling some of that radiation damage with the way that the surface interacts with the overlying soft tissue. I think that research work is going to have to be done in that regard. Thus far, it looks promising based on the papers that have been published, but we go ahead and we let that radiation take place. And then postoperatively, we try to wait as long as we possibly can to let the radiation injury settle. And then we just come back and we do what we do. We take out the expander, put in the implant, we fat graft as much as we can. As I think everybody knows, there's a thought process that the fat, the stem cells that are in the fat helps at least a partial recovery from that radiation injury. Thank you guys so much for participating tonight. Again, as we mentioned in the beginning, if there's any questions about membership or any additional questions that you have, you can reach out to the ASPS membership or go to our website. Thank you so much for joining us tonight. And again, this was all recorded, so we will have this available on the ASPS EdNet website for all of our members. Thank you.

Motiva Fluor Silk Smooth Tissue Expander

Dr. Dennis Hammond

breast reconstruction

MRI compatibility

two-stage reconstruction

plastic surgery

fat grafting

capsular contracture

ASPS EdNet