‘THAT’S NOT ME’

Company Undercounted Patient Deformities Caused By Its Fat-Zapping Device: NYT

The risk to patients posed by CoolSculpting may be much higher than previously reported by the company that owns the procedure.

The use of a medical device that promises to painlessly melt away fat cells poses a much higher risk of disfigurement than previously reported, according to The New York Times. Allergan Aesthetics, the company that now owns the device, CoolSculpting, reports that a side effect called paradoxical adipose hyperplasia is rare, affecting about 1 in 3,000 patients. But more than a dozen dermatologists and plastic surgeons who spoke to the newspaper said that those numbers don’t reflect the reality of CoolSculpting patients who’ve developed P.A.H., which causes fat to grow and harden in the body. The condition “is likely being underreported and misdiagnosed,” and often requires expensive surgery to correct, according to a 2020 study. “The hardest part is seeing photos of myself, so I barely take any now,” said a data analyst named Kathryn Black who was diagnosed with P.A.H. last year. “When I see one, I think, ‘That’s not me.’” Model Linda Evangelista famously alleged that CoolSculpting and P.A.H. left her permanently disfigured; she settled a lawsuit against the company in 2022. Allergan declined to respond to questions from the Times, instead noting in two statements that CoolSculpting has been “well studied” and used in more than 17 million treatments.