What Is Coolsculpting?
It's a noninvasive treatment that carries a risk of a rare, but serious, side effect
The fat-freezing procedure known as CoolSculpting has been gaining popularity for years now. While there are other procedures, such as SculpSure and Emsculpt Neo, that may achieve similar results using different technologies, CoolSculpting was the most popular body-sculpting treatment as of 2019, the most recent year for which data is available, according to a survey of its members by the American Society for Dermatologic Surgery. A CoolSculpting Facebook post from September 2020 said that more than 8 million treatments had been administered worldwide. For people with stubborn fat pockets that just won't go away despite diet and exercise, the noninvasive treatment sounds like a dream—but is it?
CoolSculpting is a Food and Drug Administration-cleared device used to perform cryolipolysis, a noninvasive, medical cosmetic procedure that destroys cold-sensitive fat cells by freezing them. The fat-freezing procedure is intended to treat "stubborn" fat areas under the chin and on the abdomen, buttocks, and thighs, according to the CoolSculpting website. The company notes it is not a weight-loss treatment.
"According to clinical studies which have correlated with our clinical experience, patients can expect up to 20 percent reduction in fat in the treatment area," says Paul Friedman, MD, director at the Dermatology & Laser Surgery Center in Houston, which performs CoolSculpting. "After the treatment, the targeted cells are eliminated for good."
However, according to the CoolSculpting website, if a patient gains weight after the procedure, they will likely see that weight gain happen evenly throughout the body and not just the treatment area.
Safety information available on the CoolSculpting website lists several possible side effects—including mild bruising, skin sensitivity, tingling, numbness, and skin redness—that should subside in days or weeks. But, as with any cosmetic procedure, there's a risk of more serious side effects, too. One of those risks is paradoxical adipose hyperplasia (PAH).
The patient safety information provided by CoolSculpting recognizes PAH as a side effect and describes it as "the gradual development of a visibly enlarged tissue volume, of varying size and shape, in the treatment area two to five months after the treatment. This is distinguished from temporary swelling and will not resolve on its own."
In other words, it enlarges the area the patient had wanted to diminish. Patients who experience this side effect report a hardened fat mass accumulating in the treatment area.
In 2014, five researchers—three of whom had financial ties to CoolSculpting manufacturer Zeltiq—found an incidence rate of PAH in 1 in 20,000 patients. But as the procedure became more popular and continued to be studied, small case studies at individual practices suggested that the incidence rate was actually much higher than that. One larger study from 2015 found an incidence rate of 2 out of 1,445 patients.
CoolSculpting has introduced a newer version of its equipment, CoolSculpting Elite. After that introduction, a study this year, which was co-authored by a consultant for Allergan Aesthetics, the parent company of Zeltiq, maker of CoolSculpting, estimated the incidence to be about 1 in 2,000 cycles. Most patients require two to three cycles of CoolSculpting to achieve their desired results.
Former supermodel Linda Evangelista, a fixture on runways and in fashion magazines throughout the 1990s and 2000s, alleged on Instagram in September that she has been left "disfigured" and "unrecognizable" due to PAH.
A post shared by Linda Evangelista (@lindaevangelista)
"I have developed Paradoxical adipose hyperplasia, or PAH," Evangelista claimed on her Instagram post, "a risk of which I was not made aware before I had the procedures." Evangelista is now suing the makers of CoolSculpting, Zeltiq Aesthetics, for damages.
We contracted Allergan Aesthetics to ask about the lawsuit, as well as how consumers can identify whether their practitioner is using a newer machine, but Allergan declined to comment.
Studies report that PAH can be treated in most cases via liposuction. But in order to perform liposuction, patients have to wait a few months for the hardened fat to soften. This means these patients have to undergo an invasive procedure (liposuction) to correct a noninvasive one (cryolipolysis).
According to the CoolSculpting website, when the applicator is placed on the treatment area, there will be a slight sucking sensation as it adheres to the patient's body, followed by a cooling effect. It goes on to say, "During the procedure you may experience sensations of pulling, tugging, mild pinching, intense cold, tingling, stinging, aching, and cramping at the treatment site. These sensations subside as the area becomes numb. Following the procedure, typical side effects include temporary redness, swelling, blanching, bruising, firmness, tingling, stinging, tenderness, cramping, aching, itching, or skin sensitivity, and sensation of fullness in the back of the throat after submental or submandibular area treatment."
The cost of CoolSculpting depends on the treatment area and how many sessions it takes to achieve desired results. According to the CoolSculpting website, CoolSculpting typically costs anywhere from $2,000 to $4,000, which may include up to two to three sessions. Because CoolSculpting is a voluntary cosmetic medical procedure, it is typically not covered by insurance.
With any cosmetic procedure, it's important to first understand the risks and find an experienced practitioner.
"Do your homework to know the facts to determine which provider and procedure is best for you," says Friedman at the Dermatology & Laser Surgery Center in Houston. "Evaluating risks of a procedure is a personal decision. If you know exactly which procedure you want, seek a provider with expertise in that particular area with experience treating your skin type. A provider will be good at procedures they perform frequently."
Friedman recommends people ask the practitioner how many times they’ve performed the procedure, request before and after pictures of their work, and ask about possible complications and what percentage of their patients have experienced them.
"The right answer is not necessarily ’none.’ Any provider who does a lot of procedures will encounter complications," he says.
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