Popular CoolSculpting treatment that rakes $2bn each year shown to cause severe disfigurement

A common cryotherapy procedure that freezes away love handles is causing severe disfigurement and even fat gain. 

The procedure known as CoolSculpting, now a common offering at dermatologists’ offices and med spas, is not a weight loss procedure, but one meant for body contouring. It uses a device that suctions a roll of fat between cold panels to freeze the underlying fat cells to -10ºC, which are disintegrated and leave the body as waste. 

But experts who study and administer the procedure say a distressing side effect is becoming more and more common by the year. A growing number of patients are presenting with a condition that causes fat cells to accumulate in the treated area and harden, leaving an unsightly bulge and regaining of fat. 

A CoolSculpting procedure lasts about an hour during which time a vacuum-like devices uses suction and ultra cold plates to wrap around a roll of fat and freeze the underlying fat cells. The body breaks those cells down, reabsorbs them, and passes them as waste

A 78-year-old woman underwent a single CoolSculpting session in 2014 on her abdomen to freeze stubborn fat there, but two months later, began to notice swelling in the area that grew bigger over time

The condition referred to as paradoxical adipose hyperplasia (PAH) has been known to produce what professionals call the ‘stick of butter effect’ characterized by a bulge that gets bigger and firmer than surrounding tissues, sometimes having a ‘stick of butter’ appearance that resembles the shape of the device’s applicator.

Studies suggest the company that licenses CoolSculpting, which generates more than $2 billion in revenue, has underestimated the risk of PAH. While the manufacturer puts the risk at about one in 3,000, some doctors say it’s more line one in 100. 

A trained technician performs the procedure using special applicators to cool the skin to just above freezing point for 30 minutes to two hours. 

It kills off fat cells without damaging the surrounding nerves, muscles, or skin cells.

How it works remains somewhat murky but scientists believe that freezing the fat cells kills them off a few days after treatment. 

The procedure is typically effective not for weight loss but for shaping the body, but studies pointing to 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 CoolSculpting to be effective, with 77 percent of patients showing visible fat reduction. However, the study was funded by companies with a stake in the CoolSculpting market.

Over the next several months, a portion of the immune system’s clean-up crew known as microphages digest the dead fat cells, leaving a more contoured shape.

Its widespread appeal stems from the fact that it’s a relatively quick, non-surgical procedure with little to no recovery time that is largely effective. 

But various case studies over the years have suggested that severe adverse effects are more common than once thought.

While not dangerous, the effect of PAH is unflattering and has left many people discouraged and depressed. 

PAH causes masses of fat cells to become enlarged and harden under the surface of the skin and typically requires surgery to remedy. 

The pharmaceutical company that licenses CoolSculping, Zeltiq, estimates the rate of this side effect occurring in around one in every 4,000 treatments. 

Allergan, the company that acquired Zeltiq in 2017 for over $2 billion, now puts that incidence at about one in every 3,000 treatments.

But doctors across the US suspect this is a massive undercount, in part because the company and consultants calculate the risk using the number of treatments, not patients.

In 2017, half a dozen plastic surgeons and dermatologists reported using their own patient data that the true burden was slightly more than one percent, or about one in every 100 patients. 

CoolSculpting was initially approved in 2010 to diminish stubborn fat and was subsequently cleared to be used for fat in the abdomen, thighs, back fat, underside of the buttocks, and chin.

It has been a huge moneymaker, 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 rate of PAH in patients who undergo CoolSculpting treatments varies depending on who is measuring them.

The numbers are confused and contradictory. While AbbVie estimates the rate to be about 0.03 percent of treatments, or one in 3,000, a team of French doctors said in 2014 that it’s more like 0.005 percent of treatments or one in every 20,000.

The manufacturer measured incidences using the number of treatments while doctors would usually use the number of patients affected, resulting in very different data. 

So if two patients each underwent 10 CoolSculpting sessions (the company recommends at least two for desired results) and one of them developed PAH, its calculations would yield an incidence rate of one in 20 treatments.

A 68-year-old man got CoolScultping on his abdomen and around to his back. After 12 months and four treatments, he had a significantly large, hard mass of fat tissue in those parts of his abdomen

Calculating the frequency by patient, though, would return 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 common procedure increased 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 man who underwent CoolSculpting on his abdomen. 

Five months later, he developed a mass of tissue under the skin on his abdomen about the same shape and size of the rectangular applicator.

An MRI confirmed a build up of fat tissue there. While the patient did not opt to take corrective action in the form of liposuction, many people afflicted by the delayed build up of fat tissue opt for surgery, finding that diligent exercising and dieting does not help.

The case study did not explicitly state that the treatment was licensed CoolSculpting, but the authors of it served on the Medical Advisory Board for Zeltiq.

That same year, a 78-year-old woman underwent a single CoolSculpting session on her abdomen to freeze stubborn fat there. She experienced positive results after the 60 minute session, but two months later, began to notice swelling in the area that grew bigger over time.

Her body mass index (BMI), commonly used to measure body fatness, also increased slightly after the procedure.  

And a 68-year-old man got CoolScultping on his abdomen and around to his back in an area where so-called ‘love handles’ form. After 12 months and four treatments, he had a significantly large, hard mass of fat tissue 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 abdomen in 2017.

About nine months later, she noticed a large mass where the procedure had been done and thought it was just weight gain, never occurring to her that it could be tied to CoolSculpting. She said the bulge grew so large that her leg would bump into it when she tried to work out.

Since being diagnosed with PAH in 2022, Ms D’Addario has undergone 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 I would never have gotten it done.’

More than 17 million CoolSculpting treatments have been sold. Allergan told the New York Times that its product is overwhelmingly safe, having been ‘well studied with more than 100 scientific publications.’