Eventually, she underwent corrective liposuction, which went well, though she had never wanted to undergo such a procedure.
Evangelista — an iconic ’90s supermodel who liked to say she wouldn’t wake up for less than $10,000 a day — posted a statement on Instagram, saying that Zeltiq’s CoolSculpting treatment, “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.”
On Tuesday, Evangelista filed a lawsuit against Zeltiq Aesthetics Inc. and is seeking compensatory damages of $50 million. The company did not respond to several requests for comment.
According to the lawsuit, Evangelista had seven treatments by a dermatologist to break down fat cells in her “abdomen, flanks, back and bra area, inner thighs, and chin.” After a few months, she developed paradoxical adipose hyperplasia, or PAH — which causes firm tissue masses in the area that’s been treated. As a result, Evangelista said on Instagram, she has not been working. Instead, she’s been left “permanently deformed” and become a recluse, engulfed in self-loathing and depression.
“I certainly feel terrible for her,” said Alan Matarasso, a clinical professor of surgery at Hofstra University Northwell School of Medicine and past president of the American Society of Plastic Surgeons. “It can be a pretty devastating emotional and physical outcome to something that should have had a positive, pleasing outcome.”
What is CoolSculpting?
CoolSculpting is a Food and Drug Administration-approved noninvasive procedure (which means it doesn’t involve surgery, cuts or anesthesia). It’s a branded version of cryolipolysis, a treatment that works by freezing the fat cells in areas like the chin and jaw, as well as on the thighs, abdomen and back. “The cells actually die and are ingested by the body,” says Daniel Maman, a board-certified plastic surgeon based in New York. He offered CoolSculpting in his office for about five years. “It definitively works,” he said.
During a CoolSculpting session, the practitioner places one or two applicators on the targeted area, and most people feel a sucking sensation and intense cold as the machine freezes their fat cells.
CoolSculpting is a lunchtime procedure, Maman said: A single session takes about an hour, and while patients might feel sore or experience bruising, they can typically return directly to their normal lives. Many need multiple sessions. Results kick in within several months, Maman said; the company claims that one treatment can reduce up to 20 to 25 percent of fat cells in the area it’s applied to. It costs about $650 to $800 for a single area. (A personalized treatment plan, which typically includes multiple areas, is $2,000 to $4,000, according to the company’s website. The website also lists numerous potential side-effects, including PAH, late-onset pain, frostbite, hyperpigmentation and hernia.)
The experts interviewed for this piece, including Matarasso and Maman, agreed that liposuction, a surgical fat removal procedure, is generally the gold-standard for people who want to get rid of stubborn fat. “I always say, with CoolSculpting you can accomplish somewhere between zero and 15 percent of what I could accomplish with a single session of traditional liposuction,” Maman said. The average cost for liposuction is $3,637, and it has a longer recovery time than CoolSculpting.
However, CoolSculpting can make sense for people who have a low volume of fat, or who are, say, on blood thinners or have a medical condition that precludes surgery, Matarasso said.
In 2019, the Aesthetic Society ranked nonsurgical fat reduction (such as CoolSculpting, the largest brand of cryolipolysis devices, and its competitors, Vaser Shape and Liposonix) as the fourth-most popular noninvasive cosmetic procedure in the United States, with 129,686 procedures performed.
When fat-freezing goes wrong
Troy Pittman, a board-certified D.C.-based plastic surgeon, said he’s “not surprised” about the news that Evangelista experienced PAH.
According to a July study published in the Aesthetic Surgery Journal, the risk of PAH in those undergoing CoolSculpting is approximately 1 in 2,000 treatment cycles, while the estimate in the first paper on PAH, published in 2014, was that it affected 1 in 20,000 patients. “The disparity between incidence rates found within the literature indicates that PAH is likely being underreported and misdiagnosed,” the researchers wrote.
“I can tell you that in my own practice, I’ve seen it several times,” Pittman said. “It’s unmistakable when you know what to look for.”
PAH tends to be more common in men, he said, and often affects the abdomen. “We don’t know exactly why it happens,” he said. “It’s totally benign from a health standpoint — there are no adverse health effects from this. It is purely cosmetically and psychologically disturbing.”
While CoolSculpting is meant to kill fat cells, PAH causes those cells to “just blow up,” Pittman said. If you see a photo of someone who’s experiencing it, they’ll look like “they got fatter rather than skinnier.”
PAH doesn’t go away: “You’re stuck with it,” Pittman said, though there are a few treatment options. Some patients are candidates for tummy tucks, while others can undergo liposuction in the affected area; meaning they’ll have to have surgical treatments they were trying to avoid in the first place.
Venuto said she spent months trying to get CoolSculpting to resolve the situation. Eventually, a claim she had submitted was approved, and CoolSculpting paid for her to have corrective liposuction, which was done by Maman. She remains angry at CoolSculpting and feels like she was robbed of a couple “prime” years of her life. Having the protrusion, she said, was mentally debilitating. “You’re constantly just looking at it, touching it and it just makes you extremely upset.”
She’s active in a Facebook group for PAH survivors and said she has been stunned at how many people have had the experience.
Maman and other experts noted that CoolSculpting is often offered by spa technicians and others who are not board-certified doctors, which they said may mean that the risks aren’t always properly communicated, and that PAH is not always recognized or reported. (CoolSculpting’s website says that it’s used “by or on the order of a physician.”) “It’s a very simple device,” Maman said. “It’s commonly done in spas by technicians — it requires very little training.” Depending on the laws in the state where it’s being done, he added, a physician may be required to be present in the building.
“I think there’s this sense that if you can get it done in an innocuous environment, like a salon, it’s just like getting a pedicure,” Pittman said. “But it’s a real medical treatment. And I want people to know, if you’re considering this, it’s important to see a board-certified practitioner,” such as a plastic surgeon or dermatologist.
“Just because it says ‘noninvasive’ doesn't mean it’s without risk,” he said. “I think sometimes if it seems too good to be true, it is.”
Before you undergo a cosmetic procedure
Mental health professionals such as Stephanie Van Schaick, a licensed counselor who specializes in the treatment of eating disorders and body-image issues, say you should consult another kind of expert as well: A therapist.
Cosmetic surgery “used to be for the wealthy and for celebrities,” she said. But while new and less-invasive procedures are luring people by offering what seems like a quick, easy fix, she believes they don’t always address the real issues that send people to surgeons in the first place. (For example: Some patients could have body dysmorphic disorder, which means they’re obsessed with imaginary defects in their appearance.)
One study, published in the journal Plastic and Reconstructive Surgery, found that those who have unrealistic expectations or a history of issues such as depression, anxiety or BDD were more likely to report poor outcomes post-cosmetic surgery. Among them: a tendency to request repeat procedures or to experience adjustment problems, isolation, anger toward the doctor or self-destructive behaviors.
“I don’t care what you do to your body. It’s not actually going to give you long-term happiness or improve your mental health,” Van Schaick said. She advises working with a professional to address the roots of these inadequacies before going under the knife — or the freezing applicator.
Angela Haupt is a freelance writer and editor. Follow her on Twitter @angelahaupt.