More than a dozen years ago, a medical device hit the market with a tantalising promise: it could freeze away stubborn pockets of fat quickly, painlessly and without surgery.
The device, called CoolSculpting, was entering an already-crowded beauty industry selling flatter stomachs and tauter jawlines, but it had an advantage: a vaunted scientific pedigree. The research behind its development came from a lab at Harvard Medical School’s primary teaching hospital, a detail noted routinely in news features and talk show segments.
The pitch worked. CoolSculpting machines are now common in dermatology and plastic surgery offices and medical spas, and the technology has generated more than US$2 billion (NZ$3.2b) in revenue.
Cryolipolysis, the technical term for the procedure, involves placing a device onto a targeted part of the body to freeze fat cells. Patients typically undergo multiple treatments on the same area. In successful cases, the cells die and the body absorbs them.
But for some people, the procedure results in severe disfigurement. The fat can grow, harden and lodge in the body, sometimes even taking on the shape of the device’s applicator. This side effect, called paradoxical adipose hyperplasia (PAH), usually requires surgery to correct.
“It increased, not decreased, my fat cells and left me permanently deformed,” supermodel Linda Evangelista wrote in 2021 of her experience with CoolSculpting.
Allergan Aesthetics, a unit of the pharmaceutical giant AbbVie that now owns CoolSculpting, says this is rare, occurring in 0.033 per cent of treatments, or about 1 in 3000.
But a New York Times examination indicates that the risk to patients may be considerably higher.
The company behind CoolSculpting has retained consultants who have written about low risks of PAH in medical journals and online channels. It has also restricted patients from talking about the problem through confidentiality agreements and, at one point, stopped reporting the side effect to federal regulators after an auditor from the Food and Drug Administration determined that it did not qualify as a life-threatening or serious injury.
More than a dozen doctors interviewed by the Times said the manufacturer’s estimate of the risk was sharply lower than what they had observed in their practices or research — in part because the side effect can take many months to become visible, and patients don’t always connect it to CoolSculpting. Sometimes the effect is subtle, and patients believe they have just gained weight back.
“PAH is likely being underreported and misdiagnosed,” a 2020 study on PAH found.
Gina D’Addario, 40, who used to sell cable TV and internet services door-to-door in Syracuse, New York, tried CoolSculpting on her stomach in 2017.
D’Addario said she noticed a large mass in her abdomen about nine months later. She thought it was weight gain, but dieting and exercise did not help. The bulge grew so large, she said, that her leg would bump into it when she tried to work out. It didn’t occur to her, or the many doctors she saw, that the mass could be connected to CoolSculpting, until Evangelista went public years later.
Since being diagnosed with PAH in 2022, D’Addario has had multiple surgeries and may need more. She said Allergan offered her US$10,000 to help cover the costs, contingent on her signing a confidentiality agreement. She declined.
“I wish I loved my body back then,” she said, referring to a time before she had CoolSculpting. “To go back to that day, I wish I could, because I would never have gotten it done.”
Procedure’s popularity rapidly grew
The FDA initially cleared CoolSculpting in 2010 for use on love handles after Zeltiq, a small company that developed the device, submitted a study of 60 subjects. That study’s modest size is typical for medical devices, while drug approvals often require much larger clinical trials. Subsequent studies led to clearances for use on other body parts.
As CoolSculpting’s popularity rapidly grew, problems were quietly developing for some patients. In 2011, soon after the initial FDA clearance, Zeltiq learned of a person whose treated fat had solidified into a noticeable mass, according to an internal company document obtained by the Times.
The next year, two physicians on the company’s medical advisory board — Dr R. Rox Anderson, an inventor of CoolSculpting, and Dr Mathew Avram, director of the Massachusetts General Hospital Dermatology Laser and Cosmetic Center — wrote an internal review of 11 patients experiencing the side effect.
Zeltiq notified the FDA. But it was not until 2014, more than two years after the company had learned of the side effect, that PAH entered the medical literature, through an article in The Journal of the American Medical Association. Avram and Anderson were among its authors.
A war of numbers
When Avram and Anderson published information on the side effect in 2014, they estimated that its prevalence was 0.005 per cent, or about 1 in every 20,000 treatments.
The previous year, however, a doctor advising Zeltiq had estimated the risk to be more than double that number — 0.011 per cent, or about 1 in every 10,000 treatments — according to a document sent to company executives, a copy of which was obtained by the Times.
More discrepancies in data would follow, in part because the company and its consultants used the number of treatments to calculate the risk of PAH, while physicians observing the side effect usually used the number of patients.
For example, if two patients each underwent 10 sessions of CoolSculpting and one developed PAH, the company’s method would yield an incidence of 1 in 20 treatments, or 5 per cent. Calculating the frequency by patient, however, would produce an incidence of 1 in 2 patients, or 50 per cent.
Dr Jose Rodríguez-Feliz, a plastic surgeon in Miami, said he and his colleagues grew sceptical that the side effect was as rare as Zeltiq claimed.
In 20 months, four patients out of 510 who underwent CoolSculpting at their practice were diagnosed with PAH, according to a 2016 letter to the editor of a medical journal from Rodríguez-Feliz and two co-authors.
“We felt that the difference was so big that we needed to put it out there,” Rodríguez-Feliz said in an interview.
This became a pattern.
‘That’s not me’
Kathryn Black, 32, a data analyst in Colorado, underwent CoolSculpting in December 2021 and then again last year for her double chin. Months later, she noticed a mass in the shape of the applicator forming in the same area. In August, she was diagnosed with PAH.
“The hardest part is seeing photos of myself, so I barely take any now,” she said. “When I see one, I think, ‘That’s not me.’”
Surgery to fix the growths can cost tens of thousands of dollars and leave scars.
Allergan has helped cover the cost of surgery for some patients with PAH, but that can be preceded by difficult negotiations. The payment is usually part of a settlement agreement that includes a confidentiality requirement, patients and doctors said.
The agreement is likely to discourage some patients from reporting their condition to the FDA, said Madris Kinard, a former public health analyst for the agency and the founder of Device Events, which analyses medical device adverse-event reports.
A supermodel sued
In 2021, Evangelista, one of the most recognisable supermodels of the 1980s and ‘90s, sued Zeltiq and announced last summer that she had settled with the company.
D’Addario, who reported her condition to the FDA, said that before she knew what PAH was, she would work out constantly, trying to lose the fat that had emerged after CoolSculpting. Now, years later, she said, she understands that it was not her fault.
But the “mental trauma” from the mysterious ways her body became deformed, and the months of not knowing what was happening, remains with her, she said. “I’m struggling now to this day. Probably worse.”
This article originally appeared in The New York Times.
Written by: Anna Kodé
Photographs by: Amrita Stuetzle and Beth Hall
©2023 THE NEW YORK TIMES