A common cryotherapy procedure that freezes love handles away causes severe disfigurement and even fat gain.
The procedure known as CoolSculpting, now a common offering in dermatologists’ offices and medical spas, is not a weight loss procedure, but for body contouring. It uses a device that sucks a roll of fat between cold panels to freeze the underlying fat cells down to -10ºC, which break down and leave the body as waste.
But experts who study and perform the procedure say a troubling side effect is becoming more common by the year. A growing number of patients present with a condition that causes fat cells to build up in the treated area and harden, causing an unsightly bulge and the fat to come back.
A CoolSculpting procedure takes about an hour, during which time a vacuum-like device uses suction and ultra-cold plates to wrap a roll of fat and freeze the underlying fat cells. The body breaks down those cells, reabsorbs them and passes them off as waste
A 78-year-old woman underwent a single CoolSculpting session on her abdomen in 2014 to freeze stubborn fat there, but two months later began noticing swelling in the area that got bigger over time
The condition referred to as paradoxical fat hyperplasia (PAH) is known to cause what professionals call the “butter stick effect,” characterized by a bulge that grows larger and firmer than surrounding tissues, sometimes with a “butter stick” appearance that resembles the shape of the device’s applicator.
Studies suggest that the company that licenses CoolSculpting, which generates more than $2 billion in revenue, underestimated the risk of PAH. While the manufacturer estimates the risk to be about one in 3,000, some doctors say it’s more likely to be one in 100.
A trained technician performs the procedure using special applicators to cool the skin to just above freezing for 30 minutes to two hours.
It kills fat cells without damaging surrounding nerves, muscles or skin cells.
How it works remains somewhat murky, but scientists believe that freezing the fat cells kills them a few days after treatment.
The procedure is typically not effective for weight loss, but for shaping the body, but studies suggesting its efficacy have largely been funded by companies that make products used for CoolSculpting.
A 2016 study published in the journal Lasers in Surgery and Medicine found that CoolSculpting is effective, with 77 percent of patients with visible fat reduction. However, the research was funded by companies with a stake in the CoolSculpting market.
Over the next few months, part of the immune system’s cleanup crew, known as microphages, digests the dead fat cells, leaving behind a more rounded shape.
Its widespread appeal stems from the fact that it is a relatively quick, non-surgical procedure with little to no recovery time that is largely effective.
But several case studies over the years have suggested that serious side effects are more common than once thought.
Although not dangerous, the effect of PAH is not very flattering and has left many people discouraged and depressed.
PAH causes masses of fat cells to enlarge and harden beneath the surface of the skin and usually requires surgery to correct it.
The pharmaceutical company that licenses CoolSculping, Zeltiq, estimates the rate of this side effect to be approx one in 4,000 treatments.
Allergan, the company that acquired Zeltiq in 2017 for more than $2 billion, now estimates that percentage to be about one in 3,000 treatments.
But doctors across the US suspect this is a huge undercount, in part because the company and consultants calculate risk based on the number of treatments, not patients.
In 2017, half a dozen plastic surgeons and dermatologists reported, based on their own patient data, that the true burden was just over one percent, or about one in 100 patients.
CoolSculpting was initially approved in 2010 to reduce stubborn fat and was subsequently approved to be used for fat in the abdomen, thighs, back fat, bottom of the buttocks and chin.
It has been a huge money maker, raking in more than $2.2 billion between 2011 and 2019. Allergan, which was acquired by pharmaceutical giant AbbVie in 2020, has not disclosed more current figures.
The incidence of PAH in patients undergoing CoolSculpting treatments varies depending on who measures them.
The numbers are confusing and contradictory. While AbbVie puts the rate at about 0.03 percent of treatments, or one in 3,000, in 2014 a team of French doctors said it’s more like 0.005 percent of treatments or one in 20,000.
The manufacturer measured the incidence by the number of treatments, while doctors usually used the number of patients affected, resulting in very different data.
So if two patients underwent 10 CoolSculpting sessions each (the company recommends at least two for desired results) and one of them developed PAH, the calculations would yield an incidence of one in 20 treatments.
A 68-year-old man received CoolScultping on his stomach and around his back. After 12 months and four treatments, he had a significantly large, hard fat mass in those parts of his abdomen
However, calculating the frequency per patient would yield a rate of one in two patients, or 50 percent.
Supermodel Linda Evangelista, one of the most notable fashion icons of the 1980s, said two years ago that instead of freezing away stubborn fat, the usual procedure increases it.
In 2014, doctors from Boston and Los Angeles, including two who served on Zeltiq’s advisory board, wrote about a case of a 41-year-old male who underwent CoolSculpting on his stomach.
Five months later, he developed a mass of tissue under the skin on his abdomen, about the same shape and size as the rectangular applicator.
An MRI confirmed a buildup of fatty tissue there. Although the patient did not choose to take corrective measures in the form of liposuction, many people who suffer from delayed fat tissue build-up opt for surgery because they feel that diligent exercise and dieting do not help.
The case study did not explicitly state that the treatment was licensed under CoolSculpting, but its authors served on the medical advisory board for Zeltiq.
That same year a 78-year-old woman underwent a single CoolSculpting session on her stomach to freeze stubborn fat there. She experienced positive results after the 60-minute session, but two months later, she started noticing swelling in the area that got bigger over time.
Her body mass index (BMI), which is often used to measure body fat, also increased slightly after the procedure.
And a 68-year-old male received CoolScultping on his stomach and around his back in an area where so-called ‘love handles’ develop. After 12 months and four treatments, he had a significantly large, hard fat mass in those parts of his abdomen.
The mass stopped growing after five or six months. While she was offered liposuction to treat her PAH, she refused.
a New York Times analysis of patient and clinic records included Syracuse native Gina D’Addario’s experience with the procedure. A former cable TV and Internet services salesperson, D’Addario, 40, opted for CoolSculpting on her stomach in 2017.
About nine months later, she noticed a large mass where the procedure was done and thought it was just weight gain, but it never occurred to her that it could be related to CoolSculpting. She said the bump got so big that her leg bumped into it when she tried to exercise.
Since being diagnosed with PAH in 2022, Ms. D’Addario has had multiple surgeries, including liposuction and a tummy tuck, and may need more.
She told the Times, “To go back to that day, I wish I could, because then I never would have done it.”
Over 17 million CoolSculpting treatments have been sold. Allergan told the New York Times that its product is overwhelmingly safe because it is “well-studied with more than 100 scientific publications.”