Episode 56: Thursday October 27
Patients have always had two options for breast augmentation: saline implants, or silicone implants. Is there now a third choice for patients?
Guest Gabe Walters, Vice President for US Sales for the IDEAL IMPLANT Inc., speaks on the 3PlasticSurgeryPodcast about the IDEAL IMPLANT, a structured saline breast implants that gives "the peace of mind of saline" AND " the more realistic look and natural feel of silicone gel."
Dr. Sam Jejurikar @samjejurikar, Dr. Salvatore Pacella @sandiegoplasticsurgeon and Dr. Sam Rhee @bergencosmetic discuss the origin of the IDEAL IMPLANT and what makes it a third option for patients seeking breast augmentation.
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#podcast #plasticsurgery #cosmeticsurgery #plasticsurgeon #beauty #boardcertified #aesthetic #3plasticsurgeonsandamicrophone #bergencosmetic #bestplasticsurgeon #beforeafter #aesthetics #realpatientrealresult #boardcertifiedplasticsurgeon #njplasticsurgeon #njplasticsurgery #nyplasticsurgeon #nyplasticsurgery
(Please note that Drs. Pacella, Jejurikar, and Rhee have no financial interest in IDEAL IMPLANT, Inc., and none have received compensation or other consideration for discussion of IDEAL IMPLANT on their podcast.)
2022.10.27 S03E56 GABE WALTERS IDEAL IMPLANT
[00:00:04] Dr. Sam Jejurikar: Four of yous Today we're gonna be talking about a new breast implant that some of you may not have heard of. We wanna make it clear that none of us have any financial relation whatsoever with this company or any other new technologies we may be presenting.
We also are not promoting this product. Instead of other products or that might be available, but we recognize as as listeners to this podcast, you have an interest in newer technologies and this is our way to get that message out to you.
[00:00:30] Dr. Sam Rhee: As plastic surgeons, all three of us have debated what do we do in terms of showing off new technologies or having people who have interest in other products in plastic surgery and showcasing them on our podcast.
Seemed like a big commercial for these products. We basically decided if. Don't have a financial interest and we let you know about that. We want you just to take a look at these products because we think they might be interesting, they might be part of the future, or they might be something that you might be interested in.
We think that's worthy enough for us to include in our podcast, as Sal and Sam has said to me and as we've discussed, If we don't ever want you to think that we're doing this to be compensated for it, or that we have a bias for these products regardless of what other people may say or do out there, what we really care about in our podcast is to show you an unbiased, if possible and informative.
Look at what might be interesting to you. we'll just start the podcast. And hope you found it informative and enjoyable. Thanks.
[00:01:34] Dr. Sam Jejurikar: Good morning everyone, and welcome to our latest edition of Three Plastic Surgeons and a Microphone. I'm Sam Jejurikar, and as always, I'm joined by my compatriots, Dr. Salvato Pacella from La Jolla, California, who is at San Diego Plastic Surgeon, and also Dr. Sam Re. From Paramus, New Jersey, whose Instagram handle is at Bergen Cosmetic.
Good morning, gentlemen. Today we are very fortunate to be joined by someone I've known very well for more than a decade. Gabe Walters, who has extensive experience with breast implants that will highlight our topic today is gonna be talking about, about about. Both silicone and saline breast implants.
Gabe is currently the vice president in charge of US sales for the Ideal implant, which is a really special implant that our, our our listeners will get to hear more about. But he also prior to this position actually worked with a, a major implant manufacturer of silicone implants, Sientra as well.
And so he's gonna be able to highlight some of the things about, about this. So, before we get onto this exciting topic, I'm gonna let one of my compatriots talk about the nitty gritty legal details that we have to say before every podcast. All right, that's me up.
[00:02:46] Dr. Salvatore Pacella: This show is not a substitute for professional medical advice, diagnosis, or treatment.
This show is for informational purposes only. Treatment and results may vary based upon the circumstances, situation, and medical judgment. After appropriate discussion, always seek the advice of your surgeon or other qualified health provider with any questions you may have regarding medical care. Never disregard
[00:03:06] Dr. Sam Jejurikar: professional medical
[00:03:07] Dr. Salvatore Pacella: advice or delay seeking advice because of something in this.
[00:03:13] Dr. Sam Jejurikar: All right. And with that, Gabe, welcome to the podcast. So, you know, as I sort of mentioned, I have known you actually first when you were with Allergan, then when you were with Citra and now with the ideal implant. And, and I know you to know a lot about breast implants. I've come to you about a lot of information about data, about various implants in the, in the past.
So maybe you could start off by just telling our listeners what the ideal implant actually is.
[00:03:37] Gabe Walters: Yeah, for sure. And thank you for that. And thanks for having me guys. That's quite the introduction. I'll try to live up to it. . Yeah, so the ideal implant is a, is a really novel idea. And it is the confluence of some really good engineering and some good luck honestly.
So, Dr. Robert Hammus was a plastic surgeon in Dallas for about 37 years. I practiced contemporaries with like John Tets and some of those guys. So you know, right there in the meat, in the heart of rest implants and ingenuity and implants changing. And the market changing. And of course, if you recall in the early nineties, we had.
The moratorium on silicone gel implants, and that was right in the meat of Dr. Hamas' practice. And he had used both saline filled as well as silicone gel implants. And so when the FDA pulled gel it was, you know, it was undetermined how long that period would be until they came back, if they ever came back.
And so, Dr. Hammus had you know, not no formal training in engineering, but certainly viewed himself as kind of an architect and an engineer, and has a. Mindful you know, thought process and, and art and just looks at things differently. And so, you know, he has several patents in other medical areas.
Orthopedics breast had one of the original texture devices, implants back with Dow Corning actually. So, you know, he is kind of always had that process of coming up with new ideas and ingenuity and so he was interestingly. Plane to Aspen with his wife for a ski trip. And this was right after the moratorium had had started on gel implants and they were flying over the mountain and he had a scotch on the rocks and his wife had a cup of water.
As you often do, going over the mountains in the smaller planes, hit turbulence in his wife's cup of water sloshed and spilled. And his scotch did not. And he started thinking, Well, why did my scotch not spill? And it was because of the ice inside of the glass. And so it's got him thinking as they were descending, that if we could put something inside of a saline implant, then it would mitigate that, that sloshing that you get that undesirable.
Water hammer effect, so to speak, that you would get from a saline implant. And we would have a more desirable aesthetic outcome because maybe we're gonna be stuck with saline for, for in perpetuity. So, as his wife says, they landed and they went straight to a store and he started buying water balloons and marbles and other material and proceeded to ruin the entire ski trip cuz he spent, he spent the whole time.
Designing what eventually became the ideal implant. And so the ideal implant trademark name is structured saline implant. And so, although it is filled with typical saline sterile saline, it does not act or perform like the old water balloon or the traditional saline single lu and back saline because.
It's multilayered, it's got two lumens. So you've got an internal lumen surrounded by an outturn excuse me, external lumen. And then in between are multiple layers, depending on the size of the implant of what we call baffle shells. And not many people know what a baffle is unless you were perhaps in the Navy.
And you know, if you're on a boat and the whole of the boat. Partitions for layers of walls. So if you were to take on water, the whole ship doesn't sink immediately. It slows the flow of the fluid. Fuel tanker trucks utilize similar technology, so if you see like a gas truck going down the highway, there's partitions inside.
So if they turn too fast, the water or the fuel doesn't all ship to one side and turn the truck over. So, basically the layers inside the ideal implant control, the fluid dynamics. And so you get. You get a slower movement of the saline cuz they gotta move through the multiple layers of baffle shells.
And what resulted is a saline filled device that certainly doesn't act like traditional saline. So it looks better, feels better. Wrinkling is mitigated. Certainly. And you know I said part of this was luck as well. The data has beared out just tremendously. We've got 10 year data, which the other three manufacturers roles subjected to the same tenure, pma and the deflation rates are extremely low.
So about a third of the current implants on the market and contractual rates are about half. And so that's the luck factor. So, you know, he designed an implant cuz he wanted to create a better outcome with the current product. And ended up getting really good data as well, which he wouldn't have known until it was all, all said and done.
So we've been very pleased so far with the results. We've got about 1200 board certified plastic surgeons in the United States that have currently experienced the product and have used it and are currently using it. We sell in Canada as well as Puerto Rico. And we just started selling outside the US as well.
And. Actually, so, product is done well. We certainly are still kind of at the beginning phases of getting it launched. Even though we've been out since 2016, breaking in into this market could be tough, but we're, we're pleased with the progress so far.
[00:08:28] Dr. Sam Jejurikar: Okay. So, yeah, I, I've, I have not put in many, but I have finally put in one pair of, of ideal implants.
And it is, it is definitely very different, like you say, from traditional saline implants. It looks and feels way better than traditional saline implants. But you know, the question I would ask you is someone who has extensive experience with silicone implants as well it still feels different than a silicone implant.
So in your mind, who is the ideal candidate for an ideal implant versus someone who you know, might want, might be wanting a silicone implant? How should patients, or how would you advise a friend that's asking you like, which implant should I get in which situ?
[00:09:06] Gabe Walters: Yeah, that's a great question. And, and yes, cuz I did silicone gel implants for about four years.
I launched the Citra Dallas Market in 2012, and I think that device did very well. I think it's a great product. And I think that the current silicone gel implants, especially the, the new generation, more cohesive gel implants. Provide a very good outcome for patients. I think it's about having opportunity for, for different selections and different products available to the patients so that they can pick and choose to tailor to their needs.
It's a bit of a setup question when you ask me who is the, the ideal patient. I sell the product. My answer is gonna be everyone is the ideal implant patient. Because it, I think the implants all. Basically the same thing. So they enhance the breast, they augment the breast. It's just what you are looking for in some of those ancillary or secondary benefits of the product.
And so, you know, in a, in simple terms, silicone gel looks and feels. I, I, I guess we would say natural, this whole feel thing is a subject subjectivity thing. And I can go down a long rabbit hole with that and get into some philosophical discussions about it. But I think the patients. Decide.
What feels right to them inside their body. And I think that we, we tend to or at least I feel like in consultations, that patients tend to get the table, the table test, so they feel the implant outside the body. Perhaps they put it in a bra and feel it under a shirt, but it, it never really mimics the, the true effect that you get inside the.
And so I think you're right. I think they feel slightly different, but I think you could also make the argument that all the silicone gel implants feel slightly different as well especially with the different levels of cohesivity that all the manufacturers are offering at this point, that you could make distinguishing differences between all of those as well.
So I think it really comes down to what the patient wants and what they think feels best for them. You know, the one thing I would say about Ideal implant is that it does feel really nice in the body. That's not me saying it. That's the, the 1200 plastic surgeons that have experienced have said that it feels great and that the patients think it feels great.
I think that's the most important thing. But it's all the secondary benefits that the product provides. As I mentioned, the lower deflation rates. The lower contracture rates, and then of course the fact that it's filled with just saline. And I think inherently, if you ask most patients, and we have data to support this actually, Most patients, everything being somewhat similar or equal would always choose saline over silicone gel.
And I think most plastic surgeons, at least the ones that I have pulled, if I asked, you know, if you were gonna put an implant in your wife or your daughter, what would you prefer to do? And the answer almost always is, Well, I prefer to do saline. Now there's other reasons. Silicone gel gets chosen, and perhaps it's because of a feel that the patient wants or maybe it's profile or base diameter or projection.
So there's obviously other reasons why people would choose different products, but I think at its core, the ideal implant provides a somewhat natural look similar to silicone gel, but with, with the peace of mind of knowing that it's just water inside. So when it does break, The body absorbs it, drinks it up and you gotta replace it, but you know, you know about it and you don't have to monitor it, obviously with MRI or ultrasound.
Okay.
[00:12:24] Dr. Salvatore Pacella: Question, couple questions for you. So, how is it, how is the implant different than say the. The traditional Becker implant for our viewers out there are listeners that the Becker device is similar but dissimilar. It, it was a silicone implant surrounded by a saline shell. And throughout the years there have been numerous permeations of this.
They kind of swapping sailing silicone shell with a saline internal section. And so, so maybe from the outside in, can you describe exactly how the device is?
[00:12:57] Gabe Walters: Yeah, it's a great question. So, the Becker, Dr. Ella was, was slightly before my time. But if I recall, the problem was that it had a pretty high deflation rate.
Is that correct? That's my understanding, yes. Yeah, failure, failure rate was pretty bad. So it was a design flaw with the Becker. And just to tell you the differences between silicone gel and saline they both. The same silicone dispersion to make the shells and, and, and funny, all four manufacturers actually source that silicone from the exact same place.
A company in California called New Cell. So it's the same, same core product that's being used to make the shells. However saline filled implants, the shells have to be cured differently. They're cured through a process called rtv, which is room temperature. Vulcanization and silicon gel implants use a process called high temperature vulcanization.
And the reason is, is that high temp vulcanized shells filled with saline they abra on themselves so, They will rub and eventually get a crease and fail. And so that was the problem with the Becker implant is that you had an HTV filled shell, so the silicone core surrounded by saline, and so that shell eventually failed.
And then the outer shell was actually made HTV as well. So that, that's one main difference. The way current saline products and then the ideal implant alike are made, It's through the vulcanization process called r. Other difference is that obviously we are sailing all the way throughout, so the inner core or the inner lumen is filled with saline and not silicone gel as well as the outer.
And it is it is
[00:14:29] Dr. Salvatore Pacella: a smooth
[00:14:29] Gabe Walters: device, correct? Yes. A hundred, a hundred percent smooth, which no, there's no
texturing.
[00:14:34] Dr. Salvatore Pacella: Not, not even an option for.
[00:14:38] Gabe Walters: No, there's not. And you know, so when, when the product was first designed and and brought to market, smooth, round was king, smooth round was the majority of what was being used in the us.
And of course we, we could add an option, a textured option at some point, but. As Asate would have it texturing has certainly taken a dip in its usage. Yes. And I don't really see that there, there's value in us spending the resources to come out with the texture device. At least currently, there's
[00:15:05] Dr. Sam Jejurikar: no market demand for that at present.
[00:15:08] Dr. Salvatore Pacella: Definitely. Now, Gabe, what one other question for you the device is is, is the device used in reconstructive surgery for breast cancer? Is it, is it approved
[00:15:17] Gabe Walters: for that indication?
[00:15:18] Dr. Salvatore Pacella: My understanding is so, so I, I'm a surgeon who does both cosmetic breast augmentation revision, but also breast cancer.
And the idea of the device in a, in a cancer patient is, It's very unique. Obviously, if we're kind of worried about any effect perhaps silicone has in the body or potential for rippling, this might be a really good option for them. So what, what is the, the FDA indication I, Is there any value to reconstructive surgery?
[00:15:47] Gabe Walters: Is it proof for that? Yeah, great question. And here's my disclaimer. So currently we are not approved for reconstruction. We have FDA approval for augmentation and revision augmentation only. However, because of the off-label use that Ideal implant was. Was being used at several hundred cases off-label by surgeons and patients who were just driving the use of it.
We were kind of forced to apply for that approval. So we've actually been approved for the trial. So we have we have our IDE approved already to go. Dr. Predis in Vanderbilt University is spear. That trial. And so we'll begin enrolling pa enrolling patients hopefully sometime this year.
So we will get that approval at some point. Great question. It is being used even more now for reconstruction with the introduction of what we're calling Generation two ideal implant. So we we're able to make some refine refinements in the manufacturing process, current manufacturing process.
And it yielded a product that looks and feels even more similar to silicone gel or, or natural breast tissue and wrinkles a lot. Less than even the original iteration of the product. So, with that and then the, the past experience in reconstruction, we're seeing more and more off-label use of ideal implant in reconstruction.
And some very large institutions across the country have actually adopted it for for recon. And I, I think that there again, that's the patient selection is that patient. Has obviously been through a tremendous amount health wise and is looking to do the healthiest thing possible with their reconstruction.
And not to say that silicone gel is unhealthy, but I think oftentimes these patients who have had breast cancer and had radiation, they're just trying to do whatever is most natural. And so I think that's driving the use of ideal implant. And then of course, with the added benefits of, of ideal implant.
The traditional saline. I think it's a, it's a good option for a lot and they're using it, you know, even in, in like prepec operations, so I think it speaks a lot to the reduction of that wrinkling that you get with the product.
[00:17:48] Dr. Sam Jejurikar: Yeah. You know, I, I think you can't really emphasize that enough. I mean, there's this emphasis now towards patient safety.
There's always been that. But you know, if you look at the, the popular media in the last two or three years, there's just been so much negative. Negative stories about breast implants, whether it's breast implant, associated lymphoma, breast implant, associated squamous cell carcinoma, breast implant illness, all of these things that we hear about.
I think for me, the thing that's really started to make the ideal implant a very appealing option for my patients. Is, you've mentioned it twice but you can't mention it enough, is how impressive the safety data is. Over a 10 year span, deflation rate, that's a third. Less of other implants, capsular contracture rates.
And so, you know, you can tell patients as a plastic surgeon if your implant ruptures, we're gonna know it. Unlike a silicone implant where it might rupture and you'll get a delayed inflammatory response you'll, there's no silent ruptures with the ideal implant, which patients seemingly actually love cuz they don't have to worry.
How will I know when my implant's ruptured? And then I think, you know, as a plastic surgeon, if you can tell your patients there's gonna be a less, a lower likelihood of them ha actually having an inflammatory process, which for our viewers, capsular contractor, is a hard. Pathologic shell that forms around the implant, which can not only cause severe pain, but increases the inflammation, it can deform the appearance.
So I, I think that, you know, as patient safety, particularly in regards to breast augmentation gets emphasized more and more. I can see the ideal implant having a, a larger role. Which kinda leads to this next question, which is, you know, in the, in. When you were sort of explaining to me how, how the ideal implant works for a case there's, there's not a lot of sort of choices in terms of the implants right now.
You know, there's sort of one profile that you have, like what are future directions with the implant in a cosmetic realm? Are there new profiles that you guys are looking into? Like, how, how is a, as an aesthetic surgeon who envisions using more and more of this you know, can, can we create a bigger.
[00:19:40] Gabe Walters: Yeah, that's an interesting question. In, you know, starting out the, the profiles and the sizes were created to try to cover the bell curve of the patient needs, right? So that, that middle range. And I would say that because the product is adjustable and I don't think we mentioned that yet, the outer lumen is adjustable from a minimum.
Fill to a maximum fill. And I, in, in terms of profile, if you look at the dimensions kind of cross comparison to you know, the other manufacturers, I think it lines up really well with the Allergan product catalog, the current Inspire line, and at the minimum fill, it's probably a moderate plus, you know, Profile fill, and then at max it's certainly more of a fuller, fuller volume.
And so I, I think that the need certainly has, has been dictated from the plastic surgery community is that there's a need for a lower profile fill. And that is something that we've actually started already working on with manufacturing. So no timeline on launch for that. But I think if we were to add.
Another profile line that it certainly would be that more that lower end of the profile. And I know that's a smaller percentage of patients, but it certainly seems like that there is that niche market that wants a a lower profile fill. I
[00:20:46] Dr. Sam Rhee: don't have any experience with these ex implants, but and maybe you, Sam can answer that, I'm not sure.
But I think when the volume is extremely large, patients tend to gravitate or they have very thin tissue coverage. They tend to gravitate to silicone just because of the rippling, because of what they can feel and see. And how different is this implant at those say larger volumes for patients or, or thin patients?
[00:21:14] Gabe Walters: Yeah I, I think it performs generally very well. I, I've heard very little negative feedback in terms of visible or palpable wrinkling at all. And even in the thinner patients, and, you know, myself, I've been in, in several cases where the patient was extremely thin and early on with the product.
I probably tended to worry a little bit about what the outcome was going to be like, but over time I've grown much more confident in the product. You know, I, I think that Dr. Jejurikar, you mentioned that they feel slightly different. So I think that if a patient maybe had silicone implants prior and then they get the ideal implant, they may notice something slightly different in the way they feel maybe on the edge.
I think that might be it. But in terms of visible wrinkling, I, I'm completely confident that they do just fine, even at the larger volumes and certainly within our patients. So, you know, there again, I think this is a. A selection that the patient makes. And there's certainly a level of subjectivity to it in terms of how they feel.
And I think data also supports the fact that feel often with patients is second or even tertiary in the, in the process of what they're looking for right behind look and safety profile. So I think that gets overlooked oftentimes. Is that the, the way the implant. Feels is not as necessarily important as the way it makes the patient feel.
And I think that's what we're trying to do at Ideal Implant is to give a product that provides long-term satisfaction rates to the patient and not just, you know, that six month window where everything is all hunky dory, but you know, how do they feel five, 10 years down the road when you know they can be confident in the product?
Because they know that if it was to break, they would know it instantly. And they don't worry about it. So, You know, I think,
[00:22:57] Dr. Salvatore Pacella: I think it's important to understand too that, you know, in, in general, not, not just with one specific implant, but silicone implants in general all implants for example, you know, the differences that they have had in the last 20, 30 years are dramatic compared to, say the 1980s.
So the safety profile of implants in general has been phenomen.
[00:23:21] Dr. Sam Jejurikar: For, for all
[00:23:22] Dr. Salvatore Pacella: implants ideal and silicone implants. So it's, it's not for our viewers out there, it's not that. You know, we, we haven't necessarily demonstrated in massive detail that one is safer over another. So I think it's just important to understand that.
[00:23:37] Dr. Sam Rhee: Right. And the overwhelming choice of patients is still silicone implants. I mean, that is the number one choice worldwide. And. I think in the United States still. So
[00:23:46] Gabe Walters: I, I, I completely agree and I, I think that implants have gotten just such a bad rap over the years and, you know, even now they could, you know, there's so much scrutiny around the product and we're looking at data points that are just so small and insignificant when you look at the overall effect that it has.
You know, not to say a L C L is not a bad thing. It certainly is. But it's such a small sampling of people. And then, you know, this new STC thing that has come out is even a smaller sampling of patients and there's always this focus on implants and you know, I think they, they generally do get a bad rep.
Cuz I think you're right, Dr. Pacella. I think that they all have exhibited a very high safety profile over decades. And so this, this is not about safety. When we talk about choosing ideal implant over silicone gel it's. The patient choosing a product that provides them with the, the mental benefits that, that they want.
And you know, I've heard patients over the years just say, you know, I, I don't have a problem with silicone gel. I just, I would prefer to have saline. I would just prefer to have saline. And I think that, you know, yes, you're right that the predominant use of implant is still silicone worldwide, but, You know, when you look at the data from P and asaps, the the percentage of saline has not gone down.
It stayed pretty steady. And I think that we might even be having a little bit of a resurgence of, of the usage of saline. Just for some of the reasons you guys mentioned, you know, Bii and a LCL and all those, those aren't exclusive to silicon gel implants. I just think the more noise around it, patients will be seeking out something that they, in their minds view as as a safer.
Great.
[00:25:22] Dr. Sam Jejurikar: Well, I, I think we're nearing the end of our time. We should just tell for our viewers that neither Dr. Pacella, Dr. Reed, nor myself have any financial relationship with the Ideal Implant company. We think it's an exciting option. It's still, you know, in, it's in its early stages, but if you are one of those patients who.
For whatever reason may feel uncomfortable. The silicone implant is certainly something to consider. So thanks again for your time this morning, Gabe. We, we appreciate it as always and thank you gentlemen. Thank you.
[00:25:50] Gabe Walters: It was a pleasure. Thanks guys. Take care.
