What Is Cosmetic Gynecology Surgery?

[Dr. Cheryl Iglesia]

Yes, and honestly, that term "vaginal rejuvenation", "designer laser vaginoplasties", that's not in these official terms. Because that is a marketing term, and you and I also know that the FDA recently, as of 2018, came down pretty hard on some companies, who were marketing for specific indications ahead of really having any robust data. However, I want to be clear that the definition of cosmetic gynecology has two different aspects of it.


It's the elective intervention to alter the aesthetic appearance of the external genitalia, or modify the genital organs, and for elective functional procedures in the absence of any pathology. I'm talking like you're not having incontinence. You're not having an episiotomy that didn't heal well, overt stage three prolapse. Anyway, it's elective with the goal of improving a person's quality of life, and that could be sexual function or whatnot, but it's a pretty broad definition that isn't specific to certain diagnosis.


People have the option of not liking the way their eyelids look, their nose looks, and I think people have the option of not liking the way their labia minora look. I think that in general, OBGYNs look at the full spectrum of normality. I think we may be less likely to do elective interventions than cosmetic surgeons, plastic surgeons who are trained, who don't really look at pathology.


At the same time, they're not following women longitudinally like we do, cradle-to-grave, and know what happens over time, as women age after you have children, after menopause hits, and so on. There's two different hats, in terms of aesthetics, functionality, and then the whole reconstructive realm. There's a flow chart in this document, which maybe we can add.


[Dr. Mark Hoffman]

We can put it in the show notes for sure.


[Dr. Cheryl Iglesia]

That'll be great, so that people can click onto it. I do like this flow chart. The first question is, is this, whatever procedure you're planning on doing, medically indicated, or does it address a pathology? If you have stress incontinence, that's not considered cosmetic surgery. If you have overt cystocele uterine prolapse surgery that's not considered. If you have abnormal labia, and it's getting in the way or discomfort with exercise.


[Dr. Mark Hoffman]

Which is a common one a lot of us hear, getting stuck in clothes, and things like that, or even pain during intercourse, or discomfort and things like that.


[Dr. Cheryl Iglesia]

That's right. Huge asymmetry. That's not necessarily considered cosmetic gynecology. If they answer, "No", to that, being medically indicated, or addressing a pathology, the next question on this flow diagram is: “ is the intent to cause injury or psychological harm?”
What we're getting at there, and I know the World Health Organization really comes out strongly on this, is the aspect of female genital mutilation or FGM for clitorectomies, infibulation, the gishiri cuts that are done in certain cultures. Again, that would not be considered cosmetic gynecology. There are cultural mores, and there are laws about doing some of these procedures in our own country, particularly, for adolescents under the age of 18.


Then, if the answer to that, in terms of causing psychological harm or causing injury is, "No", then the question is, is the patient making a well-informed autonomous decision in the absence of any external pressure or coercion? I think this is where this has exploded, because of what people are seeing, images that people are seeing on the internet, pornography.

[Dr. Mark Hoffman]

Yes, so we've talked a little bit about labiaplasty, and I think many of us are familiar with that.


[Dr. Cheryl Iglesia]

Yes. You can do a labia minoraplasty, or you can do things with labia majora with fat grafting and augmentation.


[Dr. Mark Hoffman]

I was reading about that, like liposuction of the labia majora.


[Dr. Cheryl Iglesia]

Yes.


[Dr. Mark Hoffman]

You mentioned lasers and RF ablation, what's being done, what's out there? What does the data show about those technologies, and how should we be counseling our patients?


[Dr. Cheryl Iglesia]

Yes, so for the laser, which most of these are fractioned, we're all OBGYNs who are really familiar with lasers. We use it for CO2, for HPV, and we use it for like zapping endometriosis intraperitoneally, which is cool, particularly, if you're near a vessel, or the ureters, but these are fractionated lasers, and when you do that, the lasers are divided into much smaller laser beams with normal tissue between, and the temperatures, the power and fluency is a lot lower, so that you're not burning tissue, you're supposedly, stimulating the tissue growth factors, and to make new collagen and new blood vessels, and that's how it works.


There have been a lot of histological studies that are published for the vagina, and for the vulva. So lasers are being used for resurfacing, it's known very well in Fraxel for the face that different kinds of lasers have different depths of penetration. Most of the ones that are used in cosmetic gynecology are in that far infrared spectrum with a very low depth of penetration, not the Argon beam or Pico lasers which go a lot deeper.


Argon beam, we use for cancers, and around the liver, and Pico is used for tattoo ink. But this stuff is like, doesn't even get down past the dermis to the lamina propria, so it's very superficial. The good news is, the types of burns are pretty low. The bad news is that, I think that, again, it needs that water, and so if it's super, super dry, particularly, in people who are with their aromatase inhibitors, just don't think we're going to have that tissue effect.


[Dr. Mark Hoffman]

What tissue effect are you looking for? What are the indications for these procedures, what are the outcomes we would have?


[Dr. Cheryl Iglesia]:

Again, none of these have been cleared because the FDA has defined processes, has only cleared it for incision, ablation, coagulation of tissue, including gynecological, vulvar skin, and vaginal skin. It's not been cleared for indication, but what it's been used for is GSM, which is Genitourinary Syndrome of Menopause and lichen sclerosus. That's for the CO2, and the Erbium lasers.


There's been a little bit on incontinence, a stress urinary incontinence, none of which has panned out, but the radiofrequency, laser is light energy, and radiofrequency is more current. For radiofrequency, that's been used more so with, I even liken it to shrinky-dink. They used it on the outside to get rid of wrinkles until the labia shrink down. It's more labor-intensive, you're there wondering for a much longer time.


They used it at the introitus, at the level of the perineal body to help with vaginal laxity. There's a couple of studies that are out there looking at level one evidence, Sham versus active radiofrequency for that. It's also been used for stress incontinence, and there's even intraurethral, but many of us know that there were some former products that were used using radiofrequency devices that never really panned out, in terms of that.


The bottom line is, the data is low-level evidence. We don't have big randomized trials. In fact, I think that's what the FDA is trying to get at. We need for our GSM, both vaginal atrophy, dyspareunia, I think that's one of the big ones. We need level one evidence for looking at laser versus sham. We did a small pilot study looking at laser. It's called the velvet trial with us, Haven Clinic. There were seven sites looking at laser versus estrogen for GSM and dyspareunia, and they were pretty much equivalent. The study was very under power.


[Dr. Mark Hoffman]

That's a big deal, though.


[Dr. Cheryl Iglesia]

It was equivalent.


[Dr. Mark Hoffman]

That's not nothing.


[Dr. Cheryl Iglesia]

It's not nothing. We had the Vaginal Maturation Index, which was better with the estrogen, but pretty much all the other objective factors, Vaginal Health Index, and the female sexual function was pretty much equivalent. We need larger trials, we need multi-site trials. I think the FDA probably wants to look at more of these Sham-controlled studies, specifically, before you start marketing and having been paid thousands of dollars, because each of these treatments range from $500,000 a pop.


You need three or four of them to get the desired effect several weeks apart. That's a biophysics of that. That literally is more on the energy-based side. I guess laxity, GSM, lichen sclerosus, stress urinary incontinence. I think people are even looking at urgency, incontinence, dyspareunia. Those are some of the major diagnoses that people are looking at.


In terms of the other anatomical aesthetic stuff, it gives me pause a little bit, because there's been a lot of cosmetic surgery that's based on what they're doing to the clitoris. There's the clitoral, you can get a frenulum reduction, called a frenulectomy. You can do surgery to affect the prepuce.


[Dr. Mark Hoffman]

Is that with the intent of increasing sexual arousal?


[Dr. Cheryl Iglesia]

Some people feel there's exposing the glans for an enhancement of sexual function, orgasmic dysfunction, but there's a clitoral hood lift with the prepuce, they call it, hoodectomy. Some people will resect that, lichen sclerosus, if there's adhesions around it.


[Dr. Mark Hoffman]

Any data on any of that?


[Dr. Cheryl Iglesia]

Rachel Rubin just recently did a little study on clitoral adhesiolysis. She's got some stuff out there, not a lot. Then, there's a clitoral amplification with the platelet-rich, the PRP, platelet-rich factor, a plasma, and the injections, like the O-Shot and stuff. Again, not a lot. A lot of this is proprietary. I'm just letting you know what's out there.


[Dr. Mark Hoffman]

Well, no, because our patients are going to be interested in it. They're going to be searching for it, and we talked about the internet. They're going to find it, and the question is if they come to us, and we give them nothing, they're going to go somewhere else and find it. If we can all educate ourselves, and It's very concerning, because you do damage, and it's irreversible.


[Dr. Cheryl Iglesia]

That's right. I worry about the clitoris, right? Particularly, in a young woman, it's highly innervated. Thousands of nerve endings. The clitoris itself with arousal can engorge 50% to 300%. I don't like to mess with it. Anyway, that gives me pause a little bit, but obviously, people are doing it.


[Dr. Mark Hoffman]

If they're doing it, we should know about it a little more.


[Dr. Cheryl Iglesia]

We should know about it, and buyer beware, yes, really. Particularly for young people, I think, lichen sclerosus is a bit different. Then, there are other options that, in addition to the tightening, which is more on the radiofrequency energy-based side, that's that whole vaginal rejuvenation.


[Dr. Mark Hoffman]

Is that just basically, in a sense, heating up? When we talk about RF ablation in gynecology, we think more about endometrial ablation.


[Dr. Cheryl Iglesia]

The shrinky-dink effect.


[Dr. Mark Hoffman]

Shrinky-dink effect of the vagina. Tightening. Any data on that?


[Dr. Cheryl Iglesia]

Vaginoplasty. No, there's not. It's proprietary. Which we can just do. I can do an anterior and posterior repair. Now, is there a randomized trial? That would be very interesting to see. The question is, Mark, and this is where, again, the gray goes. Again, remember the first question is, is this addressing a significant pathology? What people who do this stuff as marketing, and again, it's very, very gray.


They're going to be marketing for the not significant pathology, just a little bit of, they call laxity. I just want it to be a little bit tighter without having to have an incision over what we do for overt prolapse. Again, I think we just need some more data on it because it is a problem. The International Incontinence Society or whatever, the IUGA does have a terminology called vaginal laxity. How do we define it? It's a sensation of looseness.