Unveiling the Truth Behind Cryolipolysis

Welcome to our first podcast bodySCULPT Wellness and Aesthetics.

I’m Lisa Metler, I’m Christopher Chia. I am a board-certified plastic surgeon and I’m a board certified Physician Assistant.

We both practice Wellness Plastic Surgery and Aesthetics in Manhattan, and we’re happy to have you on our first podcast. We want to talk a little bit about how this came about and how we met and how we practice together. Well first of all, I’ve been practicing in New York City for 21 years with my partner Spero Theodorou for the last 16. Both of us are plastic surgeons we mentioned. So Lisa, I met through one of the medical device companies in their clinical department many years ago and we’re based here in New York City and we just started a new project and Lisa Metler is currently to be the project manager to lead a wellness and aesthetic component of our aesthetic plastic surgery practice in association with a well-known boutique hotel here in midtown Manhattan.

Lisa Metler: We both were clinical educators for a company and we started doing a livestream educational series. We’re both very passionate about education for both providers and patients.

Dr. Chia: We’d like to share our experiences with the audience outside of the strict medical professional realm in a more broad context is I think when we approach it.

Lisa Metler:  And we’re excited to start the show. Today, we are exploring the topic that’s gathered a mix of fascination and concern across the globe, cryolipolysis or CoolSculpting, as it’s more widely known. CoolSculpting has garnered endorsements from stars and gathered more than 2 billion dollars in revenue today. However, a concerning trend has arisen. Paradoxyl adipose hyperplasia or PAH for short, is a rare but serious response to treatment.

Before we dive into your research strategy, Dr. Chia, let’s set the stage. Imagine going in for a procedure that promises a safe and noninvasive way to zap away fat cells only to end up with an unexpected increase in fat volume at the treatment site.

Dr Chia: This isn’t what the patient signs up for, but in a small percentage of them, it’s a reality.

What is PAH clinically? It’s when you expect the post-cryolipolysis to induce cell death in fat cells. Ironically or paradoxically, it causes a hyperplasia, which is a medical term which just means that you have an unexpected multiplication or add or enlargement of fat cells. What it looks like in a person is that exactly where the applicator is put, you have an unexpected increase in volume which is very distinct, has a well demarcated or has a very distinct outline and you can’t really miss it. If you’ve ever seen photographs or images of it, it’s quite obvious and my colleagues and I looked into it. The lead author is Michael Stein along with other plastic surgeons Darren Smith and Dr. Allen Batter Russel as coauthors.  We looked into 33 patients with 60 different isolated incidences of PAH.

Lisa Metler: When did you first start seeing this in practice?

Dr. Chia: Well, the FDA approved the device in 2010 and I think the science is very well based. This is a relatively rare phenomena and we look into the paper, which is published just recently in 2024 in The Aesthetic Surgery Journal or ASJ and what we found is that the instance is probably a lot higher than was previously known. Just in a multi-center trial, that’s just a fancy way of saying we had several offices among the 4 plastic surgeons mentioned as coauthors, and we have each seen multiple cases and the percentages are a little bit higher than what we thought.

Lisa Metler: So what does it look clinically when you evaluate a patient, what do you actually see?

Dr. Chia: So the way device works, for those who aren’t familiar with it, it’s a hand piece that’s attached to the affected body part and has a gentle vacuum that draws in the soft tissue, including the fat into the device, which cools the surrounding soft tissue to a very cold temperature by 30.2 degrees Fahrenheit which is below freezing water. And what that does is causes apoptosis, the medical term for pre-programmed cell death. So it’s a DNA mediated suicideof the cell, and after 2 or 3 months when the fat cell is destroyed and the fat is releasing to the circulatory system, mainly lymphatics, and is generally metabolized by the liver and out through the body. Clinically, the areas get smaller because there is less fat, fewer fat cells and less fat volume. But just like you said, PAH is a small but significant complication.

Lisa Metler: So the cryolipolysis process began around 2010. When did you start seeing this in practice?

Dr. Chia: As you mentioned, 2010 is when it was FDA approved and was released to market, and it enjoyed quite good success as a noninvasive way of dealing with fat. Noninvasive means zero incisions, but minimally invasive means tiny incisions that foot instruments go there and of course, its’ traditional cut and sewing. So this is a noninvasive device for fat reduction. It’s rare, I mean the published percentages as my colleagues had pointed out in the paper in the Aesthetic Surgery Journal in 2024, the reported previously around 0.0225% is pretty low, you know, but in our series of 33 patients at 60 sites, it is anywhere from 0.05 to 0.39% which is over 10 times the incidence  in our study. So the first time I saw this was in 2012-2013. We keep a log of interesting cases, so it goes back over 12 years in our practice. You have your own practice, right, Lisa. Have you seen this in your aesthetic practice?

Lisa Metler: Well actually, we recently saw it in a male who is actually pretty fit and it was as you described – a clearly demarcated area that had significant hyperplasia. He didn’t actually know exactly what it was.  He thought it was a normal reaction. For his professional work, he needs to have a fit physique and this was a big concern for him.

Dr. Chia: As a matter of fact, as my coauthors pointed out in the paper, it is probably vastly under-reported, not just because if something that is outside of the medical realm, but patients themselves probably just think, oh if I gained a few pounds, but why is it shaped like this, the classic butter stick on the abdomen, for instance.  If you’ve seen images online about these things, it’s quite obvious. So when they walk into your office, as a provider, plastic surgeon or other, it’s not difficult to diagnose.

Lisa Metler:  So what do you do for treatment?

Dr. Chia: You have to stratify the severity and that may vary from the age of the patient, how many applicators they were put under, how many treatments they were under and those kind of variables which you can take an account, but at the end of the day, it’s a clinical diagnosis, right? You see this lump that is very demarcated, as you mentioned. It looks exactly like the tissue that’s been put into the device. Just to recap, the device has a gentle vacuum that bring draws in the soft tissue including the skin and the fat and it cools it down to about 30.2 deg Fahrenheit, which is below the freezing point of water. What we found out through the literature that was provided for the device before its indication for approval is that the apoptosis, which is something we talked about where, due to the cell’s lack of oxygen, it commits suicide and it lyses or bursts over time and the liver and body get rid of that block. So we’ve been seeing this pretty much since this has come out.

Lisa Metler: So is there a certain period of time where you would wait to treat a patient and how would you treat it? What would you do with that tissue?

Dr Chia: That’s a good question because initially we thought over time, it would get better. The first patient I treated was in 2012 and he was a very healthy young man but he had a very obvious site of this PAH and we watched it for a while and if anything, it didn’t start to get better, and it actually (looked like it was becoming little more demarcated, maybe just marginally. But at the end of the day, if you diagnose it clinically now, you just go ahead and recommend intervention if that’s what the patient agrees to.

Lisa Metler: Intervention immediately?

Dr. Chia: There’s literally no need to wait, in my opinion, because it doesn’t tend to get better with time.

Lisa Metler: And if this is to occur, when does it typically occur – 3 months later, 6 months later, a year later?

Dr. Chia: that varies but it is usually within a few weeks to months.

Lisa Metler: Oh okay.

Dr. Chia: At least, that’s my experience.

Lisa Metler: So what kind of patients are you seeing PAH? Men, women, thin?

Dr. Chia: So the benefit of having a multicenter trial, which is a fancy term that says there are multiple offices, we can pull our data, right. There are 4 plastic surgeons with significant body contouring practice and we do a lot of these things. So we were able to kind of compare notes and it kind of runs a whole gamut, full of females and males, and their breakdown in the paper is seen here, but they are generally younger patients and have good skin, otherwise they wouldn’t be good candidates for such a procedure. And they all benefited from an intervention, namely, liposuction, with and without energy such as ultrasound or radiofrequency and a patient even required a tummy tuck or abdominoplasty for the resolution of the problem.

Lisa Metler: How do you grade the severity of the PAH?

Dr. Chia: In order to recommend a good intervention, you need to diagnose it correctly, cause it’s a spectrum, not every case is the same. And the considerations that we give to the patient are whether there is skin excess or lack thereof. Hopefully, there isn’t, because if there’s excess you have to do something more drastic or how severe the volume of the excess adipose tissue is. In other variables such as fibrosity or how fibrous or thickrd, because if you look at the cells under a microscope, after being prepared for visualization or microscope, they actually look different than a typical fat cell and it certainly behaves that way clinically. The differences in the way it looks is that they’re larger, the cell structure seems to be different and there’s a lot more associated fibrous tissue that you can clinically feel very rubbery and firm.

Lisa Metler: How do you think this actually occurs?

Dr. Chia: I don’t think it’s entirely known. It certainly has something to do with the manipulation, in my opinion, of how cells divide and respond to stressors such as freezing. In a vast majority, I want to emphasize, do undergo cryolipolysis or apoptosis that is, cell death, but it’s interesting to note that this is a very different kind of outcome than expected.

Lisa Metler: So patients are experiencing this. Who should they see or should they report it or what’s their first step for recourse?

Dr. Chia: Well, I think the first thing to do is go back to your original provider. He or she should be well versed in the pros and cons of any procedure they have to go recommend for a patient and certainly this is a recognized complication that has been around since the of the device on a broad clinical scale. That being said, oftentimes these are provided by professionals who may not have advanced degrees, but they may have limited clinical experience, and they may not recognize that.  Further, we also put it out in the article that patients themselves may under-report the of it. And you know, we all have fluctuations in our weight, may have gained a few pounds. They don’t this to a specific medical indication, but you say, oh I just gained you know an “X” number of pounds, 15 to 20 pounds, after I did cryolipolysis and this is what happened, although most patients will notice that it’s an unusual shape of the fat, it is very specific, and if they’re aware, it’s exactly where the device was put on their body.

Lisa Metler: With my history being in the pharmaceutical industry, I think both providers and practitioners don’t actually know how to report these. What they don’t know is that they can actually call the company and that there is a resource for them. So I think, letting people know, patients and providers know that you can call the company, you can submit a claim, and submit a complaint and there’s an investigation that is completed with that.

Dr. Chia: I think to the company’s credit, that there’s a protocol just as you exactly described, where there’s recognized incidence of PAH in a certain number of cases and a qualified professional should be able to evaluate the patient and see if they’re a candidate for intervention and then they have their own protocols for dealing with such cases.

Lisa Metler: So what exactly do you do as treatments and as an intervention? Is it a one treatment or is it multiple treatments?

Dr. Chia: So most plastic surgeons who do a lot of body contouring will see a certain number of these patients walk up to the door for consultations. My partner and I don’t offer cryolipolysis as a service but we do a lot of contracting, so we do see referrals. So once you make a proper diagnosis, the patient can elect to go through the protocol with the company and if they do agree with intervention with the provider, myself and my colleagues throughout the country and the world, then they can be informed about their options, namely, liposuction with or without energy. What I mean by that is that liposuction, but you can use ultrasound which helps to kind of break up the fibrous tissue, make it mechanically easier to remove, or radiofrequency), which also helps tighten the soft tissue because invariably if you have a full balloon and you try to relax the volume by removing some of the fat out or air in this analogy, you don’t want to have too much laxity that the soft tissue. Andfinally, in severe cases, an abdominoplasty or tummy tuck, you have to actually remove the excess skin that results from it. And also in terms of and also the fibrous capsule, which is also sometimes associated with PAH. Then, what is the fibrous capsule? That is just part and parcel of the PAH, where we talked about what kind of microscope thickened, it’s just more difficult, more mechanical energy required to get it to look right, because there’s some sort of memory to it right? If it’s something firm, even if you take care of the volume of the fat, for instance, we still have so many retains of the shape.

Lisa Metler: What does it look like recovery-wise for patients and if they’re having liposuction, general versus local anesthesia, tummy tuck, explain what recovery would be like.

Dr. Chia: I’m glad you asked that because, in our practices, although the treatments are all very similar, they are dictated by the clinical presentation to help, just like we talked about, we have to diagnose it correctly and then see how severe it is, then make a recommendation.

We all do things slightly differently right? In our practice, if you’re familiar with, we do a lot of local anesthesia, which means patients don’t have to go to sleep. They give you something orally by mouth to help you to relax. The bottom line is that you’re awake and you’re aware what’s going on and we take great pains to make sure that they’re completely comfortable with the tumescent anesthesia technique which is just saline or salt water and everything. And then you can undergo the procedure in a relatively comfortable manner and patients do very well. It‘s extraordinarily safe because of the general anesthesia aspect, which is fine for healthy patients, and it’s one fewer things to worry about and recovery is much, much quicker.

Lisa Metler: So they walk into the office on their own and they walk out on they’re own.

Dr. Chia: Yeah, and generally within a few hours, exactly. Most contouring surgeons will always use some sort of compression garment to help reshape and reduce the edema or swelling, but I think it’s particularly important for the PAH patient as you can buy senior practice that need a little longer time and extra compression I believe and the use of drains. Why do I use drains? Because I think it takes a lot or mechanical energy or elbow grease to get the patients looking right and it does elicit a little more stimulation there and what happens is, just like any stress, you’re gonna have some fluid accumulate and if it overcomes the ability for the body to get rid of it, the drain may assist in its removal and make it a it a lot more resolution or betterment of the swelling more quickly.

Lisa Metler: So generally, if they’re having local anesthesia with a compression garment, they will walk in, walk out. Are there restrictions for activity?

Dr. Chia: Good question. I think 90% or the great majority of their daily activity are not limited I should say, except for things like obvious heavy exercise, lifting a certain amount of weight and walking excessively. We do encourage low impact exercises such as walking. We want this thing to go down and if you’re doing heavy exercise, you can have increased blood pressure and the resolution of the swelling is delayed and also you can have a very rare bleeding complication or some sort of fluid collection that can result also.

Lisa Metler: So given the discussion regarding local anesthesia, it seems very safe, very low risk, why would individuals opt for cryolipolysis?

Dr. Chia: That’s a good broad question because it’s 2 apples or oranges. Noninvasive is not surgery and zero incisions and on the other opposite of the spectrum are traditional cutting. So operations like tummy tucks, facelifts, breast lifts and reductions, we’re actually removing skin and in between there’s the minimally invasive techniques like liposuction. So that just entails a small incision just to get the instrument under the skin or to where you need it, in this case, the fat space, and even that is a surgical procedure and it has to do with the potential patient’s personal preference, right? I don’t want any surgeries that they opt for another which is totally respectable and we respect their wishes. But they also need to be informed of the limitations to each category of intervention.

Generally, the more intervention there is, the more you can change. So that is the appeal, that you  can have the cryolipolysis done on your lunch hour and there’s truly additionally no downtime, but you have to be informed that there’s a limitation to how much can be done and there are certain risks and benefits associated with that, which vary from procedure to procedure.

Lisa Metler: Which I think sometimes economics is part of the decision maker but not necessarily the results you’re looking for.

Dr. Chia: Certainly, the traditional operations are financially more intensive, right, and non-invasive is certainly more attractive. However cryolipolysis which is specifically a noninvasive treatment in general require multiple visits, right? You have a very busy practice doing both noninvasive and invasive. You have to pick and choose, you have to read the rules, right?  So, when a patient consults with you for body contouring, what you tell him or her in terms of what can be achieved and what can’t be achieved, local, as to small procedure versus completely noninvasive. 

Lisa Metler: First of all, I do a detailed consult, right? First, I check their medical history. I want to make sure whatever I recommend is safe for that individual. Then I ask them their goals – are their goals to see a slight improvement, quite a large improvement or maximum improvement, right.  So that’s how I decide the spectrum of minimally invasive versus maximum invasive. Obviously, for the minimally invasive, I can recommend treatments, for maximum invasive or more invasive, I can recommend a consult with you.

Dr. Chia: Would you agree that the noninvasive treatments almost always require multiple visits

Lisa Metler:  Yes.

Dr. Chia: It takes both going cumulatively more time and probably a comparable amount of financial resources than one smaller, minimum basic procedure. Is that something that you see in your practice?

Lisa Metler:  Generally, yes, it really depends on the issue.

Dr. Chia: So like 3 cryolipolysis treatments, which the overwhelming majority are effective, I counsel patients for the following, you see, there’s certain risk and everything and granted there’s slightly more risk with an invasive procedure certainly because you actually break the skin, but it’s not terribly much higher but I’ll say there’s a limit to the efficacy of an noninvasive procedure.

Lisa Metler: That’s correct.

Dr. Chia: Even in the best outcomes.

Lisa Metler: I would rather opt for a procedure I know I can deliver results on.

Dr. Chia: So this is the way I look at it, I’m probably an impatient surgeon when I say this, but I like to see the results pretty quickly. It’s very satisfying to providers. You and I know to see the fat coming out of the device into a receptacle or bucket and the patient can actually see it for themselves.

Lisa Metler: Yes

Dr. Chia: You’ve been carrying that around pretty much since puberty and it’s pretty much a single procedure and the results are seen more quickly, and also, to percentage of production, in my opinion, is a multiple of which can be done. It’s like going to see the Grand Canyon or seeing a Google image of it and that’s of course, I’m biased but you can just do more with more intervention.  But there are certain risks associated with it. Today’s topic of PAH is a good topic in terms of the introduction of what’s face of good science. Cryolipolysis is proven but there are certain things the patient should be aware of.

Lisa Metler: So does the noninvasive treatment versus a minimal invasive treatment automatically mean that it’s a safer procedure?

Dr. Chia: In general, there are fewer associated complications with noninvasive procedures as a blanket category where you don’t have to make an incision of any kind and your risk for something such as infection or bleeding are of course much less. But the minimally invasive row as well as traditional ones, the percentages are certainly higher but they are not so high that they preclude recuperation. For instance, in our series, my partner and I have done peer review studies and one of them was 15 cases of minimally invasive body contouring. We had 1 out of 2000 incidents of minor infection as our major morbidity.

Lisa Metler: So what are the associated complications of liposuction?

Dr. Chia: the ones that are associated with the surgical portion are infection that’s eventually very rare. You can have bleeding such as blood collection or hematoma, also very rare, maybe 1 out of 200 in our series and then one something called a seroma which is a non-bloody fluid collection extracted by draining with a needle or something of that sort, and then things that are associated with the actual contouring procedure which are complicated per se, but poor outcomes in these things like lumpiness where we miss it. That’s really up to experience of the provider I think.

Lisa Metler: That was a great discussion that was great discussion about PAH. I think the way to wrap it up is to talk about where the patients and providers go from here, what resources we can guide them to.

Dr. Chia: We can direct them to the manufacturer’s website and the major provider. Of course, go back to the regional provider from which they received the treatment or treatments, and they should have the protocol like I mentioned earlier, on how to manage this. And they can always get a second authoritative opinion and acknowledge the power, especially with our access to the internet in general. It really empowers the patient.

Lisa Metler: And that’ll wrap up our first podcast.

Dr. Chia: Thank you for taking the time to listen to this.

We like to present interesting, up-to-date science-based topics. So if you have a specific topic in mind, please email us at info@bodysculpt.com. We’re happy to answer any questions you may have as well. Thanks for joining us!