Dr. Hakky on malleables

[LastHope]

Dr. Hakky's new video on malleables, December 20, 2024.

https://youtu.be/TexwGPSqR5Q?si=TUtow_5MMnv6ys4h

Title:
A Complete Review of Semi-Rigid Penile Implant Review Coloplast vs Boston Sci vs Rigicon by Dr Hakky

Transcript:
(Transcript can have errors)

Hi, this is Dr. Hacky with Atlanta Cosmetic Urology. We're doing a malleable implant review today, so I'm going to review the malleables that I've got. I don't have them all, but I've got all of the companies that are available in the United States. We're going to start with Coloplast, move on to Boston Scientific, and then go to the Rigicon malleables.

First up, the Genesis. The Genesis malleable has been out the longest. Okay, this malleable implant's got a copper coil and then it's got the silicone backing. You can see that the way it was designed, they have these little caps, so let's say you make a mistake in the sizing; you could just change the cap sizing. It comes with a zero called STD or standard, and a one and a half, so you can change the sizing if you're like, "Oh, that doesn't look right," you can adjust it, which is kind of nice, right? It goes out from 9.5 to 11 to 13, and you can see here with the markings going from 16 all the way to 24, and the 13 going all the way from 18 to 26. So, you can see there's a longer implant for the other device. It's got a copper coil; it's the only malleable that's coated with Bioflex, so you could coat this with antibiotic material, right? You could coat this with antifungal, you could coat this with, you know, Betadine or whatever you want. So, this could kill in an infection situation.

I would tell you that I do not like these tips. The erectile body tip does not look like airplane noses, right? This is not correct sizing based on anatomy tests that I have actually performed, and the arc radius or the circle of the corpora up here wouldn't look like a natural corpora, something I'm just not happy with, right? So, pros: it's got the antibiotic coating; you do have the ability as the surgeon to kind of customize what's happening here. The sizing that we can see here, 13.5, is a little bit wider than 13. I am checking them, you know, we are checking what they're saying when they say, "Hey, is it this size?" This is actually coming in, clocking in at 10.0 from a 9.5, so this is actually clocking in at 10.2 right now, so this is slightly over what they're saying, "Hey, it's 9.5 millimeters in diameter." It's not, okay? So, I always like to double-check. It's easy to bend down, has some memory which is what you kind of want here, but you don't want too much memory, and you can bend it up, so concealability is definitely important. We'll do a side-by-side at the end with all the biggest malleables, okay?

So, that's the Coloplast Genesis implant. Now, onto Boston Scientific's Tactra. The Tactra is one of their newer models, right? You can see it has a more dull tip, which is more accurate for tip analysis on the arc radius of the corpora; the way the distal end of the erectile body looks, looks more like this, right? You can see they've done very much like Coloplast; you know, they have a 9.5, an 11, and a 13, and this goes from 14 all the way down at the bottom here to 22, right, and then their 13 goes all the way from 18 to 26, kind of like the Coloplast Genesis. The Tactra also got the customization so you can change the back ends if there's like a mistake, and you say, "Oh, let me go up a size," or "Let me resize this," or "Oh, I cut too much," and you can adjust this by a cap; you can change the cap on the end and change the size. That's really important. Now, this does not have any coating, so it's a downside; it's a non-coated implant, so it's just going to be just the silicone layer itself, and it is what it is. Infection rates are lower with malleables, that's the argument you can make back, however, and if you are in an infected situation, this isn't going to help you, right? It's not going to elute anything after the surgical procedure, which would be a pro for the Coloplast implant. This has significantly more memory than the other one because it's made of Nitinol in the core tip, and you can see it takes a lot more to get it down. You see, so you really have to kind of work at this one. I would anticipate, you know, you can see that's not bending nearly as easy as the smaller 9.5. Let's line this up right, 13 to 13, and see. So, if we had two 13s put in and we bent you down, right, you can see it does come back, but it's much, much harder. The Tactra, I have to push really, really hard just to kind of get it there, and you can see it's kind of a little uneven there. The copper coil bends much easier; if I just use one finger bending it downwards, it's much easier. If I just use one finger to bend it downwards, it doesn't bend as easy. You can see, kind of one finger bending it downwards, it really has more memory. You can see that line by line there, so the Tactra is a little harder; you have to use more torque to really get it down. You can see there again on the wider model, it's much more stiff than the Genesis. Here we're comparing apples to apples, 9.5 to 9.5, and you're bending it again, and you can see that the Genesis just has more bendability than the Boston Scientific. So, there's more memory; you're going to have to do a little bit more work getting it down. You can see that here, right? I can see that I can use one finger and bend this down; I can use one finger and bend it down. It doesn't even sit at the same scale.

Let's measure them to see, hey, are they lying or are they telling us the truth when they say their sizes? So, the 9.5 comes in at actually smaller, 8.9, so this is measuring for me at 8.9 mm, so it's slightly under what they're telling you, okay. This is the 13, let's see what it's measuring: 12.9, so this is about a 13, so that's pretty accurate, okay? So, these are very accurate, right? So, again, pros: it has a better arc radius tip here at the end, and it's got extendable rear tips that you can change out, right? And then you've also got the changes in size based on length, which is good if you're a longer penis, you're getting a longer malleable, right? And then you have the bendability factor, which is the downside I think of this, and then it doesn't elute anything, so it has a little bit more muscle memory, may take a little bit more, that's that.

On to the newest one in the market, this is Rigicon's device. And you can see that they come in 9, 10, 11, 12, and 13; it's kind of excessive, I would think from the manufacturing standpoint. They can say, "Oh, we have more options," but it doesn't make sense in my mind. I mean, the difference between a 9 and a 10 is so minimal, I don't think it really matters. Now, when you get up in the 12-13 range, the bendability factor does change, and this is the easiest one to bend of all of them, right? So, let's start again at the tip; the arc radius here is more accurate. You can see it's closer to the American Medical Systems, the Boston Scientific tip. They're very close; it's less pointy than the Coloplast tip. Remember, this is pushing out on the erectile bodies, so you don't kind of want a focal point; you want more dull ends to have a larger surface area, right? It's less uncomfortable for the patient just anatomically speaking, but very, very easy to bend; I mean, I can use one finger. This is very nice; it's very, very easy to bend, which is much easier for patients with arthritis, you know, things like that, right? You can see it's very, very easy to bend, nice arc radius. Now, it doesn't elute anything that I'm aware of; it starts here at 17 and goes down to 25, right, and then this starts again at 14 and goes down to 23, so again, it's graduated like all of them, but there's no caps so if you have to make a mistake, you're kind of stuck, and you have to open up another device. Let's say that you cut this off here to shorten it; you're really kind of stuck at that size, and when you slice this off, the end is dull, right? So, this is more of a rounded end, and I think that's more of a natural corpora look. It's also easier to thread in something that doesn't have shoulders, right? So, this has got a little bit of a shoulder on it, right? And I think that the Boston Scientific ones and the Coloplast ones do not have those shoulders, right? Where this one has a shoulder when you're inserting it in the back end, you can say it's definitely a downside that if I cut this off, there's no cap to put on there to smooth out the edge; it just be a sharp edge from where the blade cut this, and that may be more difficult to seed in proximately, may make me think twice about going up to a 13, go down or dilate more tissue to try to get this out there. Now, let's measure this first one; this is a 9, and it's measuring at 9.1, so this is measuring just or 9.0. Now, I got it; it's 9.0 measuring, so it's a 9.0 measuring 9.0, and then this is the 11 measuring at 10.9, so they're pretty accurate. I don't have any other larger sizes, so I'm going to try to bend these together so you can kind of just see, you know, how they are all together when you kind of line them up, and you can see just from a standpoint of the three of them. You bend them down, right? You bend them up; I'm using the same pressure across my hand, and you can just see that it's pretty much they're going to get you done, but there's more memory with that the other device. Look, I'm just going to bend this down, bend this down, just one finger at a time. You can see the Coloplast one really comes down there a little bit further than the other two. Let's just get all the nines together, right? Put all the tips the same; this is more apples to apples in that one because the Rigicon one's a little smaller, so it's not exactly the same thing, right? So, then again, we're going to take this and bend it down, right? You can see again that the Genesis Coloplast implant is the most bendable of all of them, with the Rigicon coming in second place, and Boston Scientific last. If you just give it more power, you can kind of even them out, but it takes a lot more power, and you can still see it retains some memory compared to that, you know? So, there are definitely pros and cons here for them. You can see that this one is much easier; I feel like it has some rigidity to it, and you can feel the copper coil definitely giving me some pressure and feedback. The same thing here with the Nitinol; I can feel it; there's some memory in this. This one is just the softest. Let's just do a one-finger bend, one-finger bend, one-finger bend, and you can see there again that the Genesis is just easier, you know, but this is the softest one as far as implants go. I don't feel the rigidity of this one; there's like a rope in here; you can feel that right there.

So, that's my review here. I think each one has its pros and cons when it comes to malleable implants. Those are the major players in the U.S. market. Again, talk with your local urologist to see if this works for you. Malleable implants have fewer moving parts than inflatables, right? So, if you have fewer moving parts, it's less likely to fail, less likely to require revision surgery. The downside is that you have an erection all the time, right? So, this is a little bit harder to conceal in patients who might have spinal cord injuries or less sensation, or worse diabetics; they may not actually feel the pressure here and may have an increased risk of erosion because this is constantly pushing on the end of the corpora cavernosa. Malleables have their downsides, right? They're hard to conceal, and there's a risk of erosion in certain people, which is even higher because they can't feel well down there, you know? But these are less maintenance, have lower infection rates, and generally lower complication rates because there are just fewer moving parts.

This is Dr. Hacky. Please like us and leave comments in the box if you like this video. We'll try to make some more. Thank you.

[fucked0ne]

This is interesting because I just spoke to him a week ago about the Rigi10, and after our call he sent me a video giving a similar demonstration of the three malleables. Of course, correlation doesn't equal causation--but hey.

[1day2Bbionic]

Why cant the genesis have a smoother arc/radius at the front tip? That is the only downside to it. And why can't the rigicon have a smoother end or nose cap on the back side for smoother transition? Both of those seem obvious you would think

[LastHope]

Why cant the genesis have a smoother arc/radius at the front tip? That is the only downside to it. And why can't the rigicon have a smoother end or nose cap on the back side for smoother transition? Both of those seem obvious you would think

Reasoning by Coloplast.

[1day2Bbionic]

But yet Hakky doesnt necessarily agree

[LastHope]

Maybe it's between...

Better fit+support+aesthetics (anchoring)
Vs
Comfort (round tips)

Hakky is taking the side of comfort?

[LastHope]

Well, Rigicon Rigi10 has extenders!

[1day2Bbionic]

huh, hakky said they didn't. That makes me lean towards the rigicon.

[LastHope]

The Nitinol alloy core in Boston Scientific's Tactra is also worth mentioning for its superior fatigue and fracture resistance (most durable in theory). I wish they would add an antibiotic eluting coating! Maybe BS doesn't want to increase the manufacturing cost.

[fucked0ne]

huh, hakky said they didn't. That makes me lean towards the rigicon.

In our phone convo, Hakky said he felt the Rigi10 was best.