Canadian supermodel Linda Evangelista announced publicly for the first time that she suffered rare side effects of CoolSculpting that left her “brutally disfigured” after undergoing the procedure in 2015 and 2016.
Her September 22, 2021 statement, posted on Instagram, reads:
- “Today I took a big step towards righting a wrong that I have suffered and have kept to myself for over five years. To my followers who have wondered why I have not been working while my peers’ careers have been thriving, the reason is that I was brutally disfigured by Zeltiq’s CoolSculpting procedure which did the opposite of what it promised. It increased, not decreased, my fat cells and left me permanently deformed even after undergoing two painful, unsuccessful, corrective surgeries. I have been left, as the media has described, ‘unrecognizable.’
(A September 2017 Daily Mail article headline reads, “Linda Evangelista is unrecognizable as she jets out of New York… as the rest of the original supers return to the catwalk.”)
- “I have developed Paradoxical Adipose Hyperplasia or PAH, a risk of which I was not made aware before I had the procedures. PAH has not only destroyed my livelihood, it has sent me into a cycle of deep depression, profound sadness, and the lowest depths of self-loathing. In the process, I have become a recluse. With this lawsuit, I am moving forward to rid myself of my shame, and going public with my story. I’m so tired of living this way. I would like to walk out my door with my head held high, despite not looking like myself any longer.”
According to the lawsuit, Evangelista underwent multiple CoolSculpting sessions in 2015 and 2016, the last year she was paid to model.
Paradoxical Adipose Hyperplasia
CoolSculpting safety information from Allergan Aesthetics says paradoxical hyperplasia is among the “rare side effects that have been seen both in clinical studies and commercial use” and describes PAH 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,” Allergan goes on to say.
“The enlargement requires surgical intervention, such as liposuction, for correction.“
A March 2014 study was the first to name the rare condition after a 41-year-old male and a 56-year-old female underwent cryolipolysis treatment with a device from Zeltiq Aesthetics, Inc., and later experienced a gradual enlargement of the treated area.
“Paradoxical adipose hyperplasia is a rare, previously unreported side effect of cryolipolysis with an incidence of 0.0051%,” the study says. Thirty-three confirmed cases of PAH had been reported at the time of the study and the authors estimated that the incidence of PAH was “about 1 in 20,000 treated patients.”
Three of the study’s five authors declared financial disclosures relevant to the device’s manufacturer.
Recent studies suggest the incidence of PAH after CoolSculpting may be significantly higher.
Lawsuit Seeks $50 Million in Damages
A day before her public declaration, on September 21, Evangelista filed a lawsuit in New York federal court seeking $50 million in damages.
She later posted her attorney’s statement to Instagram: “This is my attorney’s statement about my case. The truth of my horrific ordeal will be told through the legal system and I offer my sympathy to anyone suffering, as I do, from PAH’s painful, hardened masses which protrude from the skin wherever CoolSculpting was performed.”
Her attorney’s statement, as posted to Instagram, reads:
- “On September 21, 2021, Linda Evangelista through her counsel Wrobel Markham LLP filed a products liability lawsuit in the Southern District of New York against ZELTIQ Aesthetics, Inc. (“ZELTIQ”) for grievous injuries Ms. Evangelista suffered as a result of ZELTIQ’s CoolSculpting System. By doing so, Ms. Evangelista is standing up not only for herself but for others who have been similarly injured and ignored by ZELTIQ.
- “It is telling that ZELTIQ disclosed the risk of paradoxical adipose hyperplasia (‘PAH’) to its investors in its SEC filings years before disclosing that risk in any of its aggressive direct-to-consumer marketing material. Zeltiq’s 2012 10-K warned its investors of possible ‘additional liability from claims related to known rare side effects such as late-onset pain, subcutaneous induration, hernia, and paradoxical hyperplasia’ and that its product liability insurance ‘may not be adequate to cover [ZLETIQ] against potential liability.’ Remarkably, ZELTIQ’s marketing material and the CoolSculpting website failed to mention the risk or PAH until after Ms. Evangelista underwent the procedures. ZELTIQ failed to even include any general warning on CoolSculpting’s main homepage until February 2019.”