How a lucrative fantasy collided with the reality of the body
Why this story?
She had been one of the most visible, and most beautiful, women in the world. Throughout the 1980s and 90s, Linda Evangelista was one of the Big Five, with Claudia Schiffer, Naomi Campbell, Christy Turlington and Cindy Crawford – their beauty a lucrative super-brand. Evangelista once reportedly said she wouldn’t get out of bed for less than $10,000. But then, as time went on, and she approached her 50s, she disappeared. Until September, 2021. She posted on Instagram, explaining that a procedure called CoolSculpting, promising to freeze away unwanted fat, had damaged her almost beyond recognition; that it had caused trauma, scarring, and “masses”. She announced she was suing the company that had developed and sold her the procedure.
I started reporting on CoolSculpting when I saw Evangelista’s post. On forums across the internet, other people – predominantly women – were speaking of “masses” too. I discovered a story about a giant pharmaceutical company which trades in fantasies and remains vague about the risks and possible harm to its customers; and a cautionary tale, about a body that rejects the secret it is being asked to keep on our behalf. Basia Cummings, Editor
[Clip: phone ringing]
Basia Cummings: Hello, hello.
Consultant: Good morning.
Basia Cummings: Hi there…
Basia Cummings, narrating: I’m having a consultation about freezing the fat on my stomach.
[Clip of Basia talking on the phone in the background]
Basia Cummings: Sorry I didn’t get it.
Consultant: It’s okay, no problem.
Basia Cummings, narrating: I’ve sent a picture to a clinic who have looked at my abdomen and they’ve suggested that I’ll need two sessions of something called CoolSculpting, for £800, to eradicate the fat.
Consultant: So we did have a look at your photos, you are, you are suitable to have it done. Looking at areas concerned, we are looking at…
Basia Cummings, narrating: With just some numbness, maybe a little bit of soreness, nothing a painkiller can’t fix, I could have the stomach of my dreams.
Consultant: … applicators… and you will have like instant results in terms of fat freezing. We are going to get rid with CoolSculpting of all your fat cells, and fortunately our bodies are not able to produce them anymore, only if you put like a huge amount of weight on, and we’re talking like about like a future 10 or 15 kilos that you can put on… in order to reproduce again those fat cells…
Basia Cummings, narrating: Well, that’s the promise.
CoolSculpting: the magic bullet in cosmetic weight loss.
A cool, non-invasive, no-down-time fix to the fat you just can’t shift.
And it’s everywhere.
Across the internet, and in clinics…
[Clip of CoolSculpting Commercial: Well now, fear no mirror and eliminate those problem areas with CoolSculpting]
Basia Cummings, narrating: Approved by the FDA and other regulators for use on more and more of our bodies.
Corey (Nurse at LaserAway): And you got that in other areas too right?
Jenny (Client of LaserAway): I have, I got CoolSculpting on my pouch, pooch, this… this business here. And it was wonderful and I love it and so I jumped at the opportunity to get it on my inner thighs.
Jenny: I recommend it for everyone.
Corey: Thanks for donating your body to CoolSculpting.
Jenny: You’re welcome.You’re welcome.
Jenny: I’d donate it to all the CoolSculpting. That’s fine with me… and Ben also told me that now everyone is, CoolSculpting is FDA approved for this!
Corey: Yes, the bat wings. Flap flap flap.
Basia Cummings, narrating: “Flap flap flap”.
I’m Basia Cummings, and this week on the Slow Newscast: an investigation into how a lucrative fantasy collided with the reality of the human body. A horror story about beauty and the crippling pressure on all of us to look good.
Basia Cummings, narrating: Dr Rox Anderson is a dermatologist. He’s a professor at Harvard, and a director at the Massachusetts General Hospital.
He’s behind some of the most significant innovations in dermatology – and as a result, in the beauty industry. He’s the guy behind laser hair removal, for example.
But it’s another one of his inventions that I’m most interested in.
At the opposite end of the spectrum – not heat, not lasers – but freezing.
Dr Rox, that’s R O X, gave a TED talk, in 2011.
And he talked about what he called magic bullets.
Dr Rox Anderson: Well recently, in my lab, we asked the question, what about the opposite? I’ve been talking about light causing heat as the magic bullet, what would happen if we take energy away from the body and is it possible that cold can ever act as the magic bullet? Well if you take care of kids like I do, then you run into strange things, and there’s a rare, fortunately rare occurrence. Newborns and young children, when given a frozen treat, if they suck on it long enough, their fat little cheeks get very cold and they develop inflammation in their cheek, and what’s interesting is only the fat gets inflamed, and then, dies. And it’s harmlessly…
Basia Cummings, narrating: He is referring to a study from 1970, published in the New England Journal of Medicine, that looked at what happened to children’s cheeks when they sucked on popsicles, or ice lollies to you and I.
[Clip: TED talk audience laughing]
Dr Rox Anderson: It’s true! So we asked what’s going on here, and could this possibly be used in medicine? Well what’s going on is shown here. Here’s a microscopic picture of living fat cells, brought down to the temperature of your refrigerator, and inside those cells, the molecules of lipid, fat molecules, crystalised, and they formed lipid ice which is very stressful to the cell. It goes ahead and dies, and then is naturally absorbed by the body. That’s what goes on in the kids cheeks. It’s also what goes on with a stick of butter. You put butter in the refrigerator and it goes hard, put it out at room temperature and it’s soft and you can spread it around.
Basia Cummings, narrating: And this study inspired Dr Rox, and one of his colleagues, Dr Dieter Manstein.
In 2008, the two doctors began tests on black yucatan pigs – a Mexican breed, small for pigs, but quite average sized by human standards, about 70 to 90 kg.
They divided the pigs up, put them under general anaesthetic, and exposed fatty parts of their bodies to varying temperatures.
One set was treated to -1 degrees, another to -3, another to -5 and then to -7 degrees. Each for ten minutes – and then they were monitored over the next 28 days.
The doctors wanted to know if the cold would act on the pig fat, in the same way that it acted on the chubby cheeks of babies, sucking popsicles.
And the results were startling.
Fat layers on the pigs disappeared without damaging the surrounding skin or tissue.
And so, they tested it on humans.
Dr Rox Anderson: Well we thought that we could do something interesting with it. So we made a device that rolls up, picks up a roll of fat from your belly, and starts cooling it from both sides, and you leave that on there for about an hour at refrigerator type temperatures or maybe a little lower and you get the stick of butter phenomenon.
[Clip: TED talk audience laughing]
Dr Rox Anderson: Alright. And this was recently approved by the fDA, it’s available for those of you who ate a little too much for lunch, and it’s interesting, it’s very interesting that we can use something as simple as cold as a magic bullet…
Basia Cummings, narrating: What the audience, sitting in a banked, university lecture hall at this TED talk are laughing at, is a photograph of a stomach.
And you can see that the fat, the flesh, really, has been sucked into a boxy device and the device is no longer there, but the flesh remains stuck in this tall, brick-shape, jutting out.
If these two doctors could use cooling to destroy fat cells on the human body, it would be a medical and a scientific breakthrough.
But not just that of course.
Commercially, it could be – a stratospheric.
The body fat reduction market, as it’s called, is worth more than £8 billion, and it’s growing. It’ll be double that, at nearly £16 billion by 2026, as the global population gets older, and fatter, and more sedentary.
But of course back in 2008, when Dr Rox was developing this procedure, fat had been cast as the enemy of beauty for a long, long time.
Kate Thornton (Loose Women): In today’s papers is supermodel Kate Moss. Now she’s been accused of glorifying size zero by revealing that one of her mottos is the phrase,”nothing tastes as good as skinny feels,” a slogan that has been associated originally with weight watchers and has since been adopted by some pro-anorexia websites but does it resonate with us? Is there something in the saying that “nothing tastes as good as skinny feels”?
Lesley Garrett (Loose Women): Well I have to say I think there is to be honest, I think if that hadn’t been taken out of context and if it wasn’t associated with the anorexia…
Basia Cummings, narrating: And so any invention that could promise to melt it all away, without surgery, or exercise, or indeed, any effort, well, you can hear it in Dr Rox’s voice, a knowing laugh, that this, this might really be something.
Dr Rox Anderson: We’ll see where this goes next.
[Clip: TED talk audience laughing]
Basia Cummings, narrating: The optimal temperature for freezing away our fat turned out to be -11 degrees celsius, just a bit warmer than the temperature of a household freezer.
And the process was called cryolipolysis.
Cryo meaning cold, lipo meaning fat, and lysis, meaning destruction.
In September 2010, just two years after their experiments on the Yucatan pigs, the US Food and Drug Administration, the FDA, approved Dr Anderson and Dr Manstein’s procedure for use on the body.
At first, it was only approved for use on the lower back, described as our ‘flank’ or love handles, though I’m not sure which description is worse.
A startup, called Juniper Medical, had licensed the patent for cryolipolysis from the Massachusetts General Hospital and so the attractive-sounding CoolSculpting was born, and went to market.
[Montage of news clips]
CNBC: Chicago’s freezing winters are famous for the cold but it turns out those temperatures may actually be a dieters dream.
Today: This is sort of the next generation of terchnocloyyu that’s probably going to supersede liposuction.
E!: For those who don’t want to have an operation, there’s a new, non-invasive option.
Dr. Oz Show: It sounds like science fiction but it’s now a reality. A revolutionary non-invasive procedure that’s giving liposuction a run for its money by literally freezing away your fat.
Global Toronto: The newly approved procedure is called CoolSculpting, and it promises to get rid of about 20 per cent of fat…
Basia Cummings, narrating: Compared to liposuction, where surgeons vacuum the fat out of your body, which is one of the most popular plastic surgeries in America, CoolSculpting was a breeze.
Even experts, professionals, were lapping it up.
CBS: As for the cost, one abdominal treatment is about $1,300 and each love handle is about $800.
Charlie Rose (CBS): So, tell Dr Rose you’re ready for this.
Gayle King (CBS): Dr Rose, I am ready for this, I’m going to put some popsicles on my butt. I’m going to so so do that, I’m not kidding. I’m not trying to be funny, I would do that. You don’t have to have surgery, I’m in, I’m in.
Charlie Rose (CBS): Tonight, tomorrow night, the next night.
Gayle King (CBS): I’m going to be busy this weekend Charlie.
Basia Cummings, narrating: In the first 15 months after it went on the market, more than 150,000 people signed up to undergo CoolSculpting in America.
Juniper Medical renamed as Zeltiq Aesthetics. By 2017, just 7 years after cryolipolysis was approved by the FDA, the company Zeltiq was acquired, for $2.48 billion, by Allergan, a pharmaceutical which owns Botox and Kybella, an injection to burn away fat under your chin, using synthetic bile acid, that’s bile, as in, your stomach, bile.
Zeltiq’s entry into the world of big pharma allowed it to keep growing.
Soon, there was a CoolSculpting University and a CoolSculpting Masters Course, to train up an army of sculpters.
By March last year, more than 8 million people had been CoolSculpted, worldwide.
But as it grew in popularity, so too did the talk of “masses”.
This is Kaye Whitley…
Kaye Whitley: When I went into the CoolSculpting place, they were just thrilled that I was there and said that you were the perfect candidate for this and that you would be amazed you know, blah blah blah.
Basia Cummings, narrating: She’s in her 70s living in Atlanta, Georgia.
Kaye Whitley: I live in the Atlanta area in Georgia. I’m retired… and one of the things I always wanted to do in my retirement is to dance competitively.
Basia Cummings, narrating: She has a PhD in Counseling and Human Development, and for more than a decade she worked at the Department of Defense – in Communications, and then as Director of Sexual Assualt Prevention.
Kaye Whitley: And so since I retired like five years ago, I’ve been doing ballroom and country competitions.
Basia Cummings: Wow… and how, how sort of serious and competitive dancing are we talking here?
Kaye Whitley: Yeah, it’s a large group of people and from all over the country and then usually the first week in January, we have a world’s competition where people come from all over the world to compete. So it’s quite a big event and it has its own little subculture, but it has some of them, the, one of the things I love about it is I’m retired and I’m single, and it just gives me a social group of people and everyone cares about everybody and takes care of everybody and it’s just a nice group to be a part of.
And what happened… you have to do two competitions, West Coast Swing would be my favourite but I do seven different dances.
Basia Cummings, narrating: The world dance championships happen every January, and Kaye had her sights set on the 2020 competition.
She wanted to look perfect.
Kaye Whitley: But it was part of my, part of my motivation was, the costumes I wear to dance, I wanted to be able to wear different costumes that were, you know, made of lycra, kind of tight and show off your body and just look really good on the floor but I always had to have a little something extra to hide my tummy.
So the motivation was for dancing, I think, because you know, when you perform, you want to look the best you can and that was, that was what made me do it and honestly, I thought it was like a shortcut and an easy way to get what I wanted done.
Basia Cummings, narrating: Kaye had come across adverts for CoolSculpting.
She researched it – she knew anything that looked too good to be true, usually was.
But across the internet, there was little that she could find about any serious side effects.
CoolSculpting: CoolSculpting safely freezes and removes fat cells with little or no down time, and no surgery! Results and patient experience may vary. Some rare side effects include temporary numbness, discomfort and swelling.
Basia Cummings, narrating: In this 2018 TV advert – published on CoolSculpting’s own YouTube Channel just over a year before Kaye went to her local clinic – the ‘rare’ side effects were described as temporary numbness, discomfort and swelling.
That’s exactly what I was warned about, when I called a clinic to ask for a consultation.
Basia Cummings: Yeah I was just wondering what to expect after the treatment, if anything?
Consultant: You can have bruising, swelling, itchiness in the area, you can also have, there will be numbness… it’s normally a round three weeks that it takes to go away, but it can last up to eight weeks, I’ve experienced up to eight weeks myself when I’ve done CoolSculpting.
Basia Cummings, narrating: And when Kaye arrived at the clinic, it didn’t feel like a medical setting, it felt leisurely, pretty luxe.
Kaye Whitley: It took almost all day and the atmosphere was very spa-like and they take you in and you put on a bikini and they take pictures at every angle… and then you put on shorts and a tank top…
Basia Cummings, narrating: She had lunch, snacks, wifi. It was actually more like a really nice spa, she said. She got into a pair of shorts and a tank top, and into a hospital bed.
And the whole thing just felt really easy. An extension of the name itself.
But of course, that was the point.
Rhonda Garelick: The idea that something that seems so benign it’s even cool, it has cool in the name. It sounds so gentle.
Basia Cummings, narrating: This is Rhonda Garelick. An author, a culture critic, and Dean of the school of art and design history and theory at Parsons School of Design in New York city.
Rhonda Garelick: …and it was marketed as something that would be an easy fix, not so much for weight loss, but as your other interview subjects suggested, a kind of sculpting.
Basia Cummings, narrating: Rhonda has written an article for the New York Times about CoolSculpting, and the ways that it enables us to enact a fantasy on our own bodies.
Rhonda Garelick: There is a kind of… burden of shame on women, even as they are trying to live up to societal conventions of beauty, which are, you know, as we know unrealistic, but also chronologically impossible.
So to impose on women this narrative that they’re always to look backward towards a better time and spend insane amounts of money, energy, and anguish to approximate their girlhood cells… that’s an insane amount of work but we are expected not only to do it but to pretend we are not doing it and so to me, that’s the real burden.
Basia Cummings, narrating: It’s a performance that is inescapable.
Like, have thick, dark eyelashes but don’t let the mascara clump, or smudge, to reveal itself.
Or, have perfect, unblemished skin, but buy a foundation that doesn’t dry out, or move, to reveal itself as the mask.
Or, harder to manage like don’t wrinkle, don’t age. Have Botox, but don’t look frozen. Don’t sag but don’t look like you’ve had a facelift.
The message, subtle but undeniable, is: don’t show your workings, as you try and solve this impossible problem of staying young, and staying beautiful.
And Kaye, well she was pretty matter-of-fact about this.
She’s said that she’d had a face-lift and a neck-lift, both since she retired but she said she’d never had body dysmorphia, that she was pretty happy with herself and her body and that extra bit of fat she saw, well if that could just disappear, it would be a bonus. A boost before her dance competition.
And so that’s how she found herself in a clinic in Georgia.
Kaye Whitley: They started with one flat paddle right under my breast to get that, to get that that was bulging out. And then they did two panels right under that, that curved around and then two panels on my very lower ab. So it was my entire abdomen and it took all day.
And it was… the treatment itself did not bother me that much. It wasn’t… I mean when you say CoolSculpting, I don’t know, I thought it was going to be like them putting something, ice cold… but I really didn’t have that feeling. I don’t remember it hurting at all, having it done, but then after the freezing of the area, they come back in with their hands and they knead that area to break up the ice crystals she said, that was kind of painful but that’s the, that’s kind of the process.
Basia Cummings, narrating: At first, her stomach area reduced in size. It looked like it had been a success. Slightly more painful than Kaye was anticipating, but true to the promise, the fat had sort of disappeared.
But then Kaye noticed herself getting heavier.
Right in the place where the paddles had been applied.
Kaye Whitley: Well you know honestly, I was so confused and I mean, I try to be a fit person and so I was, I had been doing everything, I was starving myself. I was walking like five miles a day and nothing was happening. And then I just felt, I started looking very strange cause I was getting thinner, but I still had this big belly and it just, it was just so depressing.
Basia Cummings, narrating: Kaye was convinced that something had gone wrong. So she went back to the clinic.
Kaye Whitley: But when I went back and said, I think I have PAH, she convinced me, I didn’t, she said, you’ve gained weight. She said, you’ve gained seven pounds. And I said, well, you said, if I gain weight, it won’t be in the area where I had CoolSculpting, it would be other places, and I said, this is the only place that I’m bigger. And she said, well, I’m just the let’s just wait and see what happens.
Well, I got bigger and like a month later I go back and she said, yeah, we need to have you checked out and I’ll get you… and this was April, and she said, I can get you an appointment with our doctor in October. And I walked out of there and said, I can’t, you know, to myself, I can’t wait until October and I immediately called one of my friends who was an aesthetician and I went to see her and she said, oh my God, this is, I don’t know what is wrong with you? And I told her, so she got me in that day, it was almost the same day, with a plastic surgeon that kind of supervises their med spa, and then I went to, I got a second opinion… you have PAH.
Basia Cummings, narrating: Kaye Whitley had developed something called Paradoxical Adipose Hyperplasia, or PAH.
CoolSculpting, it turned out, can have one significant side-effect.
Not just numbness or swelling, but the inverse of what’s supposed to happen.
Paradoxical – meaning surprising, or the opposite of what you’d expect
Adipose – a medical term for fat, and hyperplasia – meaning, overgrowth.
In some cases, the fat not only returns, but it hardens and grows back even bigger.
Often, the mass is in the shape of the machine used to treat it – a boxy, brick-like mass, under the skin.
In Kaye’s case, that meant 3.2 kilograms worth of growth. She showed me a picture. In the first, pre-CoolSculpting, she looks slim, she looks like she’s got a perfect body.
In the second, after this fatty paradox has made itself known, she has a belly. A round mass under her t-shirt.
It was as you can imagine, pretty distressing for Kaye.
She returned to the clinic, but she was told to wait months for another consultation.
Kaye ignored them. She wanted it off, out of her – so she went and got liposuction.
Kaye Whitley: So basically I spent $5,000 for the CoolSculpting and then $10,000 to correct it. So that’s a lot of money for something that does you harm.
But I just had a really hard time. It just took forever. And also my fluid would build up, I had to go back in several times to have my stomach drained. So it was a pretty miserable procedure. And they say three months, but I don’t know. Maybe I’m older. I think it was closer to four before I felt like I could dance or do anything.
Basia Cummings, narrating: In the end, this non-invasive CoolSculpting had cost tens of thousands of pounds, and had required the vacuuming of her tissue.
And of course, Kaye isn’t alone.
In time, as CoolSculpting has become one of the leading cosmetic fat reduction treatments on the market, many other people began to post online, about masses, and growths, and bulges returning.
And I suppose you might ask at this point: why does it matter?
It’s an elective procedure, people choose to have it done. It works, to varying degrees, for the majority of customers.
CoolSculpting and Zeltiq acknowledge PAH – and they offer an incidence rate, meaning – how often they think it occurs.
They say, “Rare side effects may happen in 1 to 10 out of 10,000 CoolSculpting® and CoolSculpting® Elite treatments.”
“One such rare side effect,” they say, “is a visible enlargement in the treated area, which may develop 2 to 5 months after treatment and requires surgical intervention for correction.”
But there’s more to this story.
It’s about something more insidious. Something Rhonda said to me.
About a snake, swallowing a mouse.
Rhonda Garelick: The body seemed to me to refuse the secret… and that was the literary, if you will, sort of epiphany for me.
The body looks as though it has swallowed the wand that the machine has, like a snake might look after swallowing a mouse, right? The aggressor as you say.
And to me it seemed like a rejection of the entire requirement of secrecy. It’s like the curtain backstage was pulled away and you’re going to look.
Basia Cummings, narrating: The body refuses the secret. It refuses the treatment. The fat refuses to go quietly.
And not only that.
It might be a woman refusing the secret that really changes how we think about CoolSculpting in particular, and medical aesthetics more generally.
And that woman is one of the world’s most beautiful.
The supermodel, Linda Evangelista.
Basia Cummings, narrating: In September 2021, Linda Evangelista wrote a post on Instagram to her more than one million followers.
Her feed is usually populated with pictures of her in her heyday – back in the 1980s and 1990s, as one of the ‘big five’, the original supermodels – a term coined for Naomi Campbell, Christy Turlington, Cindy Crawford and Claudia Schiffer, the most famous, the most attractive, women in the world.
Linda Evangelista has, you might remember, this impossible, haughty beauty – cat-like eyes, and piercing features.
Linda Evangelista: Everyday I work… for today, Chanel, and then I just have to do… a fitting. On Wednesdays… his first show, and what I’ve decided to do this season for free, each season I choose a young new designer to support…
Basia Cummings, narrating: But in September, she posted #thetruth #mystory.
Now aged 56, she wrote: “Today I took a big step towards righting a wrong that I have suffered and have kept to myself for over five years.
She said that she had been “brutally disfigured by Zeltiq’s CoolSculpting procedure which did the opposite of what it promised.
“It increased, not decreased, my fat cells and left me permanently deformed even after undergoing two painful, unsuccessful, corrective surgeries. I have been left, as the media has described, ‘unrecognizable.’”
After seven treatments using the ZELTIQ CoolSculpting System on her abdomen, flanks, back and bra area, inner thighs, and chin, she was left in a “cycle of deep depression, she wrote, profound sadness, and the lowest depths of self-loathing”
She announced that she was suing Zeltiq.
Soon after, her attorney issued a statement, which made some extraordinary claims.
That Zeltiq had disclosed the risk of PAH to its investors in SEC filings, years before it had disclosed the risk in its consumer marketing.
They alleged that Zeltiq’s own marketing materials – and on the CoolSculpting website – failed to mention the risk of PAH until after Linda Evangelista had had the procedure, in 2016 and that Zeltiq had only updated the homepage of its website to mention PAH in 2019.
It was a remarkable story, Greek in its layers of tragedy.
The world’s most beautiful woman, in trying to preserve a particular kind of beauty, a particular kind of body, had succumbed to the promise of CoolSculpting, only for her body to grow, not shrink, in response.
Her post made headlines, but it revealed something else too.
Other lawsuits, and other extraordinary claims.
Louiza Tarassova: So I am a personal injury attorney and I focus my practice on cosmetic procedure injury. And I had a client that came to me about two years ago in the beginning of 2019 and he said, I got this CoolSculpting procedure done.
Basia Cummings, narrating: This is Louiza Tarassova. She specialises in cosmetic injury claims. She’s based in Florida, and she’s been fighting Zeltiq.
Louiza Tarassova: When these initial cases of PAH came out, at the time, there was no such thing as PAH,right? It was just people reporting that I have the opposite effect, I have what appears to be masses growing in the treatment sites.
Basia Cummings, narrating: The first reports of PAH appeared in 2014, with two studies.
One of the studies is written by the developers of CoolSculpting and in it, they say: We estimate that the incidence of PAH is about 0.0051 per cent, or about 1 in 20,000 treated patients. That’s the rate they now publicise.
So, if around 8 million people have had CoolSculpting, that would mean around 400 people developing PAH. A small number.
And that’s all the information Louiza had, when she first heard from a patient.
Louiza Tarassova: And I started doing my own research and realised there are so many people online when you put in the right key phrases, you find people in chat rooms and, and, you know, comments on blogs saying, I have this, I have this too. And when I looked at what the manufacturer disclosed about the condition or how they described it, it was so vague.
Basia Cummings, narrating: It’s 2019, and she began to investigate.
The information, she said, was really patchy.
Zeltiq said PAH was very, very rare.
And yet, it seemed that more and more people were claiming to have it, in chatrooms and forums and Facebook groups.
Other research papers have since claimed that it’s more common – but to quite different degrees.
The most recent, from the Aesthetic Medicine Journal, published in July 2021, puts PAH at around 0.05 per cent. If 8m people have been had CoolSculpting, that would mean around 4,000 people with PAH in the world.
That would fit better with reports that suggest thousands of people suffer from it.
But then another claim, from 2018, published in the Journal of Plastic and Reconstructive Surgery, presented the experiences of a single clinic. From a smaller sample size, it suggested an incidence rate of 0.72 per cent, or about 1 out of every 138 cryolipolysis treatments. That would suggest 57,000 sufferers.
After Linda Evangelisa’s statement, the anecdotal evidence started to stack up.
Talking to the New York Post, one New York plastic surgeon Dr. Ryan Neinstein, said that 20 per cent of his clientele undergoes liposuction to correct the side effects from CoolSculpting.
“Many of them have significant deformities that trigger severe emotional distress,” Neinstein told the Post.
“They feel an overwhelming sense of embarrassment because they think they did something stupid.”
But beyond the actual numbers, it’s also unclear what, exactly, is growing.
Are these masses always an overgrowth of fat? Or could it be something different?
The more Louiza worked on her case, the more convinced she became that this was not easily curable by a round of liposuction.
This, she said, is often something more persistent… something much harder to vacuum out of the body.
“They’ve known since 2011, 2012, that these masses are fibroplasia – it’s scar tissue that grows in your body as the result, or in reaction to the trauma of the CoolSculpting device. Because the way it works is it sucks up with a vacuum, your tissue that it wants to freeze, freezes it, right? And that trauma in a lot of people creates this wound healing response where you start growing scar tissue instead of reducing the fat cells.
Well, what I realized is they are misrepresenting the condition as regular, an increase of fats, which leads doctors that are doing these procedures to believe that, ‘oh, well, it’s just, you know, an increase of fat in some people can be easily sucked out with liposuction’, but based on what they knew based on the pathology of this, they knew it’s not an increased effect because if it was just like multiplication of fat cells, then you would be able to lose these masses with diet and exercise.”
Another attorney I spoke to, Court Kennedy, working in Kansas City on behalf of a PAH sufferer, said the same thing.
Court told me of a case in which PAH sufferers had been offered liposuction for free by Zeltiq, in exchange for a release form which would bar them from suing the company.
It’s what Linda Evangelista’s lawsuit says, too – that after she told Zeltiq about her weight gain, they referred her to a “preferred doctor” to undergo corrective lipo, which Zeltiq would pay for.
But she claims that on the eve of the surgery, Zeltiq added a condition: that they’d only pay for the treatment if she agreed to a Confidentiality Agreement and Release, meaning she wouldn’t be able to launch legal action, or talk about what had happened to her.
If this is routine, it would mean no one really knows just how many people have had to undergo liposuction, to correct CoolSculpting.
Working with their clients, both Louiza and Court have filed lawsuits against Zeltiq, which remains owned by Allergan.
But Allergan itself is now owned by AbbVie, one of the world’s biggest pharmaceutical companies.
It bought Allergan, now called Allergan Aesthetics, in 2019 – for 63bn.
Louiza: So ultimately under the law in America, the manufacturer of a medical device owes a duty to warn the doctor, right? Not the patient, even though they directly advertise this procedure to the consumer, the legal duty is to make sure that the doctor knows about the risks, right?
And so when we look at what the manufacturer is presenting to the doctors, it’s a two-line description in the user manual. And I can pull it up, I mean, and we can look at it together because it’s ridiculous how big it is.
And that is their official statement on what this is, right? And because there was no such thing as PAH prior to the CoolSculpting device going on the market, PAH is solely related to the school sculpting device doctors who are buying these CoolSculpting devices and performing the procedure. Have no idea what this is.
So they are under the impression that it is not a serious side effect and it’s not a big deal. Right. And therefore they’re not warning their patients about this very serious thing.
Louiza wanted to show me the user manual for the CoolSculpting device…
Louiza: Oh, will you you’ll have to allow me to share the screen?
This is what the CoolSculpting manufacturer allegedly sends out to the clinicians who use it.
Louiza: So this is the user manual for the product, and this is the extent of the description here, under rare adverse effects: paradoxical hyperplasia, visibly enlarged tissue volume within the treatment area, which may develop two to five months after treatment. Surgical intervention may be required. And that’s it. That’s it. That’s it.
Basia: So it’s not just a case that it’s not a case that … You couldn’t argue that the people who are undertaking this in America – obviously in the UK, I’ll have to check about what are the rules around notifying patients – but in America, they only have to let the doctor know it’s up to the doctor to pass on that information to the client. And even then it’s only two lines in the manual that the doctors get.
Louiza: Exactly. And the rule is that they have to adequately warn the providers.
But what happened in my first case is we went through all this litigation, collected all this evidence and the judge looked at it and said, that’s sufficient.
Louiza’s first case was a struggle. A judge ruled that those two lines, that warning she had shown me, was sufficient to warn doctors and patients of the risks of PAH.
Louiza: Two years in litigation. They had 10 lawyers on the case. I was by myself. Um, which sometimes I think is an advantage because like it’s not split … all the information is like contained in me, so I can react faster.
Um, but ultimately it’s now under appeal. We’ve appealed to a higher court asking the higher court to make a ruling on whether the lower court made the correct decision as a matter of law. Because the judge had two options, he could have either said, “I believe as a matter of law, the warnings were adequate or this is a question of fact for the jury to decide”.
And so he said – based on his understanding of the condition, which is … No one understands the condition; doctors don’t understand the condition. Y’know, he thought that these two lines that we just looked at were sufficient, um, which it’s … it’s not … it’s not possible.
But Louiza wasn’t deterred. I thought, as I was speaking to her, that she has that brilliant, Erin Brokovitch, or Elle Woods, feel about her. Despite facing an army of litigators, she was determined to keep going.
In August last year, two years after her first litigation, and not long after that had failed, Louiza filed another suit. This time a class action.
A month later, Linda Evangelista published her Instagram post.
Louiza: I think it’s an incredible thing that has happened with her coming out so courageously.
And I think the biggest problem was that we were fighting in silence because when people went online and typed in CoolSculpting, they saw great information about it. CoolSculpting spent millions of dollars to pay bloggers and websites to put out a lot of positive information.
There was virtually no negative information there. And with her coming out and talking about what happened and being so direct about naming them by name. It’s saying that it disfigured her because it is a disfiguring condition. And with her notoriety, I think it shed light to a condition that thousands of people are dealing with silently, and I think for Zeltiq, which was taken over … now by AbbVie, which is a huge international pharmaceutical company, I think it finally hit them where it hurts. I think that now when you go and Google CoolSculpting, there is also the negative side of what can happen readily available.
Basia, narrating: The class action lawsuit is currently underway. There are multiple plaintiffs, and Louiza is hopeful more will come.
She’s set up a Facebook group to let sufferers discuss symptoms and side effects. There are more than 270 members in the group. Many of them have joined the class action.
Zeltiq, now in the world of big pharma, has defended its position aggressively.
One of their expert witnesses wrote in his testimony in Louiza’s case that: “It is my opinion that paradoxical hyperplasia, although rare, has become a well known side effect of CoolSculpting in large part because of the openness and due diligence of the Company.”
In a separate testimony, the company argued that the very fact that there were warnings visible in the relevant CoolSculpting clinic, meant that the plaintiff was aware of the risk they were undergoing.
I put all of the allegations and questions in this podcast to Zeltiq and to Allergan, but I didn’t get a response from them.
After she refused to sign a release form, Linda Evangelista underwent full body liposuction.
Her recovery took months. And it didn’t work.
The fatty hyperplasia returned.
And so she had another round of liposuction – and another painful, lengthy recovery.
The second “corrective” surgery was also unsuccessful, and resulted in immense keloid scarring – that’s thick, lumpy scars, raised up from the skin.
She’s now seeking 50m in damages from Zeltiq.
The story of Linda Evangelista, and of CoolSculpting, is a story, really, I think, about shame.
About an industry that helps to pathologise our bodies, and then sells us the fix, all the while using the language of self-empowerment.
And as Rhonda explained to me, the real paradox here is not that our bodies respond poorly to being frozen.
It’s that middle-aged women are expected to look 30 years younger than they are.
It’s that the bulges and wrinkles that arrive in time on all of our bodies are considered unsightly, un-aesthetic.
The real paradox is a multi-billion dollar industry to medically dispense beauty with lasers, and injections and surgeries – often, at great risk to our health
…But, always… as the small print reminds us… at our own expense, and at our own shame.
“Mirrors – they show us all our problem areas: those places that we can’t wish or squish away…
Well now, fear no mirror, and eliminate those problem areas with CoolSculpting. The patented cooling technology targets and kills fat cells with no surgery or downtime …”