Dr. Sam Jejurikar: For our viewers today, we’re going to discuss a new breast implant that some of you may not have heard of. We want to make it clear that we have no financial relationship whatsoever with this company or any other new technologies we may be presenting. We also are not promoting this product; instead of other products that might be available. Still, as listeners of this podcast, we recognize that you are interested in newer technologies, and this is our way to get that message out to you.
What makes good silicone & saline breast implants?
Dr. Sam Rhee: As plastic surgeons, we all have debated. What do we do in terms of showing off new technologies or having people interested in other plastic surgery products and showcasing them on our podcast? Does that seem like a big commercial for these products? We decided that if we don’t have a financial interest, we will let you know. We want you to 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 believe that’s worthy enough for us to include in our podcast. As Sal and Sam have said to me and as we’ve discussed, 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 care about in our podcast is to show you an unbiased, if possible, and informative look at what might interest you. We’ll just start the podcast, and I hope you found it informative and enjoyable. Thanks.
Dr. Sam Jejurikar: Good morning, everyone, and welcome to our latest edition of 3 Plastic Surgeons and a Microphone. I’m Sam Jejurikar. And as always, I’m joined by my compatriots, Doctor Salvatore Pacella from La Jolla, California, who’s at San Diego Plastic Surgeon, and also Doctor Sam Rhee from Paramos, New Jersey. Whose Instagram handle is @BergenCosmetic. Good morning, gentlemen. Today, we are very fortunate to be joined by some 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 will be talking about silicone and saline breast implants.
Gabe is currently the vice president and in charge of US sales for the Ideal Implant, which is a special implant that our listeners will get to hear more about. But before this position, he also worked with a major silicone implant manufacturer, Sientra well. So, he’s going to be able to highlight some of the things about this. So, before we get on to this exciting topic, I’m going to let one of my compatriots talk about the nitty-gritty legal details that we have to say before every podcast.
Dr. Sal Pacella: Alright, that’s me up. This show is not a substitute for professional medical advice, diagnosis, or treatment. The show is for informational purposes only. Treatment and results may vary based on the circumstances, situation, and medical judgment after appropriate discussion. Always seek the advice of your or another qualified health provider with any questions you may have regarding medical care. Never disregard professional medical advice or delay seeking advice because of something in this show.
Dr. Sam Jejurikar: Alright, and with that, Gabe, welcome to the podcast. So, as I mentioned, I had known you first when you were with Allergan, then when you were with Sientra, and now with the Ideal Implant, and I know you to know a lot about breast implants. I’ve come to you with a lot of information about data about various implants in the past. So, maybe you could start off by just telling our listeners what the Ideal Implant is.
What makes the Ideal Implant?
Gabe Walters: Yeah, for sure, and thank you for that. 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 novel idea, and it is the confluence of some really good engineering and some good luck, honestly. So, Doctor Robert Hamas was a plastic surgeon in Dallas for about 37 years. I practiced contemporaries with like John Tebbitts and some of those guys. So, right there, 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 90s, we had the moratorium on silicone gel implants. That was right in the meat of Doctor Hamas’s practice, and he had used both salines filled as well as silicone gel implants. So, when the FDA pulled gel, it was undetermined how long that period would be until they came back if they ever came back, and so Doctor Hamas had no formal training in engineering but certainly viewed himself as kind of an architect and an engineer and has a mindful thought process and art and just it looks at things differently.
So, he has several patents in other medical areas, orthopedics, and had one of the original textured devices of implants back with Dow Corning, actually. So, he’s always had that process of coming up with new ideas and ingenuity. So, he was generally on a plane to Aspen with his wife for a ski trip, and this was right after the moratorium had started on gel implants. They were flying over the mountain, and he had a scotch on the rocks, and his wife had a cup of water. And as you often do, going over the mountains in the smaller planes hit turbulence, and his wife’s cup of water slashed and spilled, and his scotch did not. He started thinking, well, why did my scotch not spill? It was because of the ice inside the glass.
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 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 going to be stuck with saline for im-perpetuity. So, as his wife says, they landed, and they went straight to a store, and he started buying water balloons, marbles, and other materials and proceeded to ruin the entire Ski trip. Because he spent the whole time designing what eventually became the Ideal Implant. So, the Ideal Implant trademark name is structured as Saline Implant. 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 that single lumen vax saline. Because it’s multi-layered, it’s got two lumens. So, you’ve got an internal lumen surrounded by an alternative, excuse me, external. And then, in between are multiple layers depending on the implant size of what we call Baffle Shells.
Not many people know what a baffle is unless you were perhaps in the navy and if you’re on a boat and the whole of the boat are partitions or layers of walls. So, the whole ship doesn’t sink immediately if you were to take on water. It slows the flow of the fluid. Fuel tanker trucks utilize similar technology. So, if you see a gas truck going down the highway. There’re partitions inside, so if they are too fast. The water or the fuel doesn’t mean 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 a slower movement of the saline because they got to move through the multiple layers of baffle shells.
And what resulted is a saline-filled device certainly doesn’t act like traditional saline. So, it looks better, feels better, wrinkling is mitigated, certain, and I said part of this was luck as well. The data has bared out just tremendously, so we’ve got ten-year data in which the other three manufacturers were all subjected to the same ten-year PMA, and the deflation rates are extremely low. So, about a third of the current implants are on the market, and contraction rates are about half. So, that’s the luck factor. So, he designed an implant because he wanted to create a better outcome with the current product and got good data as well, which he would have known until it was all said and done.
So, we’ve been very pleased so far with the results. We’ve got about 1,200 Ford-certified plastic surgeons in the United States that have experienced the product and used it, and are currently using it. We sell in Canada and Puerto Rico, and we just started selling outside the US. So, the product is done well. We are certainly still kind of at the beginning phases of getting it launched. Even though we’ve been out since 2016, breaking into this market could be tough, but we’re pleased with the progress so far.
Ideal Implant vs Silicone Implant?
Dr. Sam Jejurikar: So, yeah, I have not put in many, but I have finally put in one, a pair of Ideal Implants, and it is definitely very different, like you say, from traditional saline implants. It looks and feels way better than traditional saline implants. But the question I would ask you is someone with extensive experience with silicone implants. It still feels different than a silicone implant. So, in your mind, who is the ideal candidate for an Ideal Implant versus someone who might be wanting a silicone implant? How should patients how would you advise a friend that’s asking you which implant they should get in which situation?
Dr. Sam Jejurikar: Yeah, that’s a great question, and yes, because I did silicone gel implants for about four years. I launched the Sientra Dallas market in 2012. Now, 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 new generation of more cohesive gel implants, provide a very good outcome for patients. I think it’s about having the opportunity for different selections and different products available to the patients so they can choose to tailor to their needs. It’s a bit of a setup question when you ask me who is the ideal patients. I am selling the product. My answer is that everyone is the Ideal Implant patient because I think the implants all do 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 product benefits. So, in simple terms, silicone gel looks and feels, I guess we would say, natural. This whole feel thing is a 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 ultimately decide what feels right to them inside their body, and I think that we tend to, or at least I feel like, in consultations, patients tend to get the table test, so they fill the implant outside the body. Perhaps they put it in a bra and fill it under a shirt. But it never mimics the true effect you get inside the body, so I think you’re right. I think they filled slightly differently, 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, you could make distinguishing differences between all of those as well. I think it really comes down to what the patient wants and what they think feels best for them.
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 1,200 plastic surgeons that have experienced it 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 contraction rates, and 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 that most patients, everything being somewhat similar or equal, would always choose saline over silicone gel. I think most plastic surgeons, at least the ones that I have pulled, if I ask if you were going to put an implant in your wife or your daughter, what would you prefer to do? And if the answer is almost always, that’s why I prefer to do saline.
Now there are other reasons why silicone gel gets chosen, and it’s because of a feeling that the patient wants or maybe its profile or base diameter or projection. So, there are 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 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 have to replace it, but you know about it and don’t have to monitor it, obviously MRI for an ultrasound.
Ideal Implant vs traditional Becker Implant
Dr. Sal Pacella: Gabe, question a couple of questions for you. So, how is the implant different from, say, the traditional Becker implant for our viewers out there or listeners that the Becker device is similar but dissimilar? It was a silicone implant surrounded by a saline shell. Throughout the years, there have been numerous permeations of this. They are kind of swapping saline, a silicone shell with a saline internal section. So, maybe from the outside it, can you describe exactly how the device is designed?
Gabe Walters: Yeah, it’s a great question. So, the Becker Doctor Pacella was slightly before my time, but if I recall, the problem was that it had a pretty high deflation rate. Is that correct?
Dr. Sal Pacella: The finders. Yeah.
Gabe Walters: The 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 utilize the same silicone dispersion to make the shells. And funny, all four manufacturers actually source that silicone from the exact same place a company in California called NuSil. So, it’s the same core product that’s being used for baking the shells. However, with saline-filled implants, the shells have to be cured differently. They’re cured through a process called RTV, which is Room Temperature Vulcanization, and silicone gel implants use a process called High-Temperature Vulcanization. The reason is that high-tech vulcanized shells filled with saline abrade on themselves. So, they will rub and eventually get a crease and fail. And so that was the problem with the Becca implant that you had an HTV-filled shell, so the silicone core was surrounded by saline. And so that shell eventually failed, and then the outer shell was actually made HTV as well.
So, that’s one main difference between the way current saline products and the Ideal Implant alike are made. It’s through the vulcanization process called other differences that obviously we are saline 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.
Dr. Sal Pacella: And it is a smooth device, correct?
Gabe Walters: Yes, 100% smooth.
Dr. Sal Pacella: There’s no texturing, not even an option for texture.
Gabe Walters: No, there’s not, and so when the product was first designed and then brought to market, Smooth Round was king. Smooth Round was the majority of what was being used in the US, and of course, we could add an option, a textured option, at some point, but as fate would have it, texturing has certainly taken a dip in its usage.
Dr. Sam Jejurikar: Yes.
Gabe Walters: And I don’t really see that there there’s value in us suspending the resources to come out with the texture device, at least currently.
Dr. Sam Jejurikar: There’s no market demand for that
Gabe Walters: Definitely.
Is the Ideal Implant FDA Approved?
Dr. Sal Pacella: Now, Gabe, what one other question for you? Is the device used in reconstructive surgery for breast cancer? Is it approved for that indication? My understanding is that I’m a surgeon who does both cosmetic breast augmentation revision but also breast cancer. And the idea of the device in cancer patients is unique; obviously, if we’re kind of worried about any effect perhaps silicone has on the body or potential for rippling, this might be a really good option for them. So, what is the FDA indication? Is there any value to reconstructive surgery approved for that?
Gabe Walters: 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, Ideal Implant was being used in 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 our IDE approved and are all ready to go. Doctors at Vanderbilt University have a spirit that trial, and so we’ll begin enrolling patients hopefully this year. So, will we 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 the generation two Ideal Implant.
So, we’re able to make some refinements in the manufacturing process and current manufacturing process, and it yielded a product that looks and feels even more similar to silicone gel or for natural breast tissue and wrinkles a lot less than even the original iteration of the product. So, with that and then the past experience in reconstruction, we see more and more off-label use of Ideal Implant and reconstruction, and some very large institutions across the country have actually adopted it for recon. I think that there again that’s the patient selection is that patient who has obviously been through a tremendous amount health-wise and is looking to do the healthiest thing possible with their reconstruction. Not to say that silicone gel is unhealthy, but I think oftentimes these patients have had breast cancer and had radiation. They’re just trying to do whatever is natural, and so I think that’s driving the use of Ideal Implant. And then, of course, with the added benefits of Ideal Implant over the traditional saline. I think it’s a good option for a lot, and they’re using it even in, like, pre-pec operations, so I think it speaks a lot to the reduction of that wrinkling that you get with the product.
Ideal Implant’s Safety Data
Dr. Sam Jejurikar: Yeah, I think you can’t really emphasize that enough. I mean, there’s this emphasis now toward patient safety. There’s always been that, but if you look at the popular media in the last two or three years. There have just been so many negative stories about breast implants, whether it’s breast implant-associated lymphoma, breast implant-associated squamosal carcinoma or 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 enough how impressive the safety data is over a 10-year span. Deflation rate, that’s a third less of other implant capsular contractor rates.
So, you can tell patients as a plastic surgeon, if your implant ruptures, we’re going to know it, unlike a silicone implant where it might rupture and you’ll get a delayed inflammatory response. There’re no silent ruptures with the Ideal Implant, which patients seemingly actually love because they don’t have to worry about how they will know when their implants have ruptured. Then, I think, as a plastic surgeon, if you can tell your patients, there’s going to be a less, a lower likelihood of them actually having an inflammatory process which, for our viewers, capsule 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 think that patient Safety, particularly in regard to breast augmentation, gets emphasized more and more. I can see the Ideal Implant having a larger role which kind of leads to this next question which is when you were sort of explaining to me how the Ideal Implant works for a case. There are not a lot of sorts of choices in terms of implants right now. You have sort of one profile that you have. What are the future directions of the implant in the cosmetic realm? Are there new profiles that you guys are listening to? Like how, as an aesthetic surgeon envisions using more and more of this, can we create a bigger role?
Gabe Walters: Yeah, that’s an interesting question, and starting out, the profiles and the sizes were created to try to cover the bell curve of the patient needs, right, so that middle range. I would say that because the product is adjustable, and I don’t think we have mentioned that yet. The outer lumen is adjustable from a minimum fill to a maximum fill. And in terms of profile, if you look at the dimensions, kind of cross-comparison to the other manufacturers, I think it lines up really well with the Allergan product catalog of the current Spire line. And at the minimum fill, it’s probably a moderate plus profile fill, and then it’s max. It’s certainly more of a fuller volume. So, I think that the need certainly has been dictated by the plastic surgery community 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 we’re at that lower end of the profile. I know that’s a smaller percentage of patients, but it certainly seems like there is that niche market that wants a lower profile fill.
Dr. Sam Rhee: I don’t have any experience with these implants, but 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 this implant is at those, say, larger volumes for patients or thin patients.
Gabe Walters: Yeah, I think it generally performs very well. I’ve heard very little feedback in terms of visible or palpable at all, even in the thinner patients. And I’ve been 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. I think that Doctor Jejurikar, you mentioned that they feel slightly different. So, I think that if a patient may be had silicone implants prior and then they get the Ideal Implant, they may notice something slightly different way they feel, maybe on the edges. I think that might be it, but in terms of visible wrinkling, I’m completely confident. They do just fine, even at larger volumes and certainly within our patients.
So, there again, I think this is a selection that the patient makes, and there’s certainly a level of subjectivity to it in terms of how they feel. I think data also supports the fact that feeling often with patients is second or even tertiary in the process of what they’re looking for right behind look and safety profile. So, I think what gets overlooked oftentimes is that the way the implant feels is not as necessarily important as the way it makes the patient feel. I think that’s what we’re trying to do at Ideal Implant to give a product that provides long-term satisfaction rates to the patient and not just that 6-month window where everything is all hunky dory. But how do they feel 5 or 10 years down the road when 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.
Dr. Sal Pacella: I think it’s important to understand too that in general, not just with one specific implant but silicone implants in general, all implants, for example. The differences that they have had in the last 20 to 30 years are dramatic compared to, say, 1980. So, the safety profile of implants, in general, has been phenomenal for all implants, ideal and silicone implants. So, it’s not for our viewers out there; it’s not that we haven’t necessarily demonstrated in massive detail that one is safer than another. So, I think it’s just important to understand that.
Gabe Walters: Right.
Dr. Sam Rhee: 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.
Gabe Walters: I completely agree, and I think that implants have gotten just such a bad rep over the years, and even now, 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 not to say ALCL is not a bad thing. It certainly is, but it’s such a small sampling of people, and then this new STC thing that has come out is an even smaller sampling of patients. There’s always this focus on implants, and I think they generally do get a bad rep because I think you’re right, Doctor Pacella. I think that they all have exhibited a very high safety profile over.
So, this is not about Safety when we talk about choosing an Ideal Implant over silicone gel. It’s about the patient choosing a product that provides them with the mental benefits that they want. I’ve heard patients over the years just say, I don’t have a problem with silicone gel. I would prefer to have saline. I would just prefer to have saline. I think that, yes, you’re right that the predominant use of an implant is still silicone worldwide, but when you look at the data from ASPS ASAPs, the percentage of saline has not gone down. It stayed pretty steady. I think that we might even be having a little bit of a resurgence of the usage of saline just for some of the reasons you guys mentioned; BII and ALCL, and all those aren’t exclusive to silicone gel implants. I just think the more noise around it, the more patients will be seeking out something that they in their minds view as a safer option.
Dr. Sam Jejurikar: Great. Well, I think we’re nearing the end of our time. We should just tell our viewers that neither Doctor Pacella, Doctor Rhee, nor myself of any financial relationship with the Ideal Implant company. We think it’s an exciting option. It’s still in its early stages, but if you are one of those patients who, for whatever reason, may feel uncomfortable, the silicon implant is certainly something to consider. So, thanks again for your time this morning, Gabe. We appreciate it as always, and thank you, gentlemen.
Dr. Sal Pacella: Thank you.
Gabe Walters: It was a pleasure. Thanks, guys.
Dr. Sam Jejurikar: Take care.