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Linda Evangelista, best known as one of the original supermodels of the '90s, recently filed a $50 million lawsuit against Zeltiq Aesthetics, the parent company of CoolSculpt. On Sept. 22, the runway star shared via Instagram that she suffered horrific side effects from a popular fat-reducing procedure called CoolSculpting, which left her "brutally disfigured."
Instead of producing a slimmed down effect, Evangelista says the procedure triggered a condition called paradoxical adipose hyperplasia (PAH), which caused hardened protruding fat masses across her body. But how can a non-invasive treatment that promises to permanently eliminate up to 25% of fat cells ending up granting the opposite result?
"With any non-surgical treatment, whether it's some sort of skin-tightening thing, some sort of energy-based treatment, CoolSculpting, really anything, you don't know exactly what it's going to do," says San Francisco-based plastic surgeon Dr. David Sieber. "You can predict the outcome with surgical procedures. Say you're going to have liposuction. I can remove that tissue and the tissue is gone 100%, but with these non-surgical things, like CoolSculpting, you can't precisely predict what's going to happen."
And while CoolSculpting claims that instances of PAH are extraordinarily rare — developing in less than .1% of patients — some doctors believe that these statistics are underreported, at best.
"It has not been recognized by the general public because of a lack of awareness, until now, but it is a well-known side effect in the medical community, and by physicians that perform this procedure," says Miami-based dermatologist Dr. Janelle Vega.
To find out more, we asked four renowned plastic surgeons and dermatologists to explain exactly what happened to Evangelista, as well as their take on the now-controversial procedure.
What Is CoolSculpting?
CoolSculpting is an FDA-approved, in-office treatment. A doctor or licensed aesthetician uses a device that literally freezes the fat cells in a specific area — most commonly the stomach, thighs, and buttocks — effectively killing the unwanted tissue to leave you with fewer fat cells. Over the next few months, the dead fat cells are naturally flushed from the body, unveiling a thinner appearance by up to 20 to 25% in the treated area. The results are said to be permanent.
Like liposuction, CoolSculpting targets stubborn pockets of fat in areas of the body that have been resistant to diet and exercise, but people often choose CoolSculping over a surgical procedure, like liposuction, as it is widely viewed as safer with less risk. To achieve the desired effect, patients typically need two to four treatments of CoolSculpting, with results appearing about four months post-procedure.
What Is PAH?
"PAH is paradoxical adipose hyperplasia," says Dr. Bruce Katz of JUVA Skin and Laser Center in New York City. "It activates the stem cells to grow new fat in the area treated, which is more dense and tighter, making it harder to get rid of."
According to Dr. Vega, PAH appears gradually, about one to two months after treatment, and shockingly, the new fat is typically in the shape of the CoolSculpting device applicator. New York City-based dermatologist Dr. Macrene Alexiades adds that the swelling "may continue to enlarge out to one year" while BMI remains stable "in order to determine that the increase in fat is not due to weight gain, but rather a direct result" of the procedure.
"Once we see bumpy, bulging skin, and the patient reports they've had a fat-freezing procedure, we can diagnose PAH quickly," says Dr. Katz. "It's unsightly and it can be painful, especially if you have symptoms on the thighs or buttocks, where you'd sit on these harder fat deposits."
What Exactly Happened to Linda Evangelista?
According to the lawsuit, Evangelista underwent multiple CoolSculpting procedures between 2015 and 2016, targeting her thighs, abdomen, back, flanks, and chin, causing her body to develop PAH and grow new fat cells, inciting substantial weight gain.
"PAH is most common in the treatment areas," explains Dr. Katz. "If [Evangelista] had CoolSculpting on her abdomen, back, bra area, inner thighs, and chin, it would certainly seem like she has PAH all over her body."
VIDEO: Linda Evangelista Reveals That She's Been "Brutally Disfigured" by CoolSculpting
What Causes PAH?
Ah, the billion dollar question. Truth is: no one knows. And without knowing why it develops in some patients and not others, "there's no way to mitigate risk," says Dr. Katz. This means that every person getting CoolSculpting, or other forms of cryolipolysis, is rolling the dice.
Additionally, there are several contributing factors that can amplify the risk of developing PAH, says Dr. Alexiades, including the use of negative pressure suction, a large handpiece and the duration of a session. "The negative suction hypothesis is supported by the decrease in reported incidence of PAH with the newer handpieces that lack suction," she explains.
Can You Fix PAH?
Once you've developed PAH, the very last thing you should do ever is get another CoolSculpting treatment, as it will provoke additional fat cells to grow. Liposuction or, depending on the area, an excision, is the only way to remove PAH, says Dr. Vega, and even then, it's not a done deal. "There are reports of PAH returning in these areas even after removal," she says. "Additionally, liposuction of this type of fat can be much more difficult and unpredictable."
Is PAH as Rare as We Think?
The three doctors InStyle spoke to for this story believe that numerous PAH cases have gone underreported, especially Dr. Katz. "I have treated quite a few of these PAH cases throughout the years successfully, and think these types of cases have gone unreported," he says, adding that his PAH case counts have been "consistent" throughout the years and that "the side effect of CoolSculpting has always been there."
Dr. Alexiades, an active laser and device researcher who sits on the board of the American Society for Laser Medicine & Surgery (ASLMS) and serves as the assistant editor for Lasers in Surgery and Medicine, was familiar with the development of the CoolSculpting device and the possible side effect of patients' developing PAH, which is called a "potentially adverse event" within the medical field. She explains that early on, the rate of PAH was very low — one in 20,000 — which was calculated by the inventors based on the number of cases in the first report, published in 2014, versus the number of treatments administered.
"As more and more reports accumulated, the incidence has increased substantially, with estimates currently reported by the manufacturer of .025%, or one per 4,000 cycles." Although she notes that another analysis puts the rate of incidence closer to .15%, or one per 666 cycles.
Are Some Communities More Vulnerable to PAH Than Others?
Yes, according to Dr. Vega. The most at-risk groups are "men, patients with fubrous fat, and Hispanic patients," she says. "We believe that it's more common in the Latino community, as there is a tendency for more fibrous fat, which is a higher risk for PAH."
The Bottom Line...
"What happened to Linda Evangelista is a terrible reminder that there can always be side effects or adverse events when you undergo a medical procedure," says Dr. Vega. "Seeing a physician who can properly guide you through the possible risks and benefits is critical in terms of having a complete informed consent."