Linda Evangelista Settles CoolSculpting Suit Involving Pleasanton Firm

PLEASANTON, CA — Linda Evangelista, a supermodel featured in fashion magazines throughout the 1990s, has settled her lawsuit against a Pleasanton company after a procedure that she said left her "brutally disfigured."

Evangelista filed a $50 million lawsuit against Zeltiq Aesthetics in September, saying the company's CoolSculpting treatment left her "permanently deformed."

On Wednesday, Evangelista wrote in an Instagram post that she settled the lawsuit.

"I'm pleased to have settled the CoolSculpting case," Evangelista, 57, said. "I look forward to the next chapter of my life with friends and family, and am happy to put this matter behind me. I am truly grateful for the support I have received from those who have reached out."

In September, the model wrote a message to her followers that she was not working even as her peers' careers were thriving. The reason: "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," Evangelista said at the time. "I have been left, as the media has described, 'unrecognizable.'"

The model said she developed paradoxical adipose hyperplasia, and said she wasn't aware of the risk before undergoing the procedures.

"PAH has destroyed my livelihood, it has sent me into a cycle of deep depression, profound sadness, and the lowest depths of self-loathing," she said at the time. "In the process, I have become a recluse."

CoolSculpting is described as a non-invasive procedure from Zeltiq Aesthetics, which is a subsidiary of Allergan.

The FDA cleared the cryolipolytic device as a method to reduce "flank and abdominal fat." In 2014, the FDA also cleared this system to treat subcutaneous fat in the thighs.

Clinical studies have shown that people who underwent the procedure reported seeing up to a 25 percent reduction in subcutaneous fat. Improvements were seen in 86 percent of treated subjects.

"The principle behind cryolipolysis exploits the premise that adipocytes are more susceptible to cooling than other skin cells," according to a 2014 article published on the National Library of Medicine website. "The precise application of cold temperatures triggers apoptosis of the adipocytes, which invokes an inflammatory response and leads to slow digestion by surrounding macrophages. "

The authors said cryolipolysis has been proven to be a "very safe method for body contouring." However, they also said paradoxical adipose hyperplasia, the condition described by Evangelista, was a rare, previously unreported side effect of the fat-freezing procedure that happens in 0.0051 percent of cases.

"No single unifying risk factor has been identified. The phenomenon seems to be more common in male patients undergoing cryolipolysis," the NIH article said.

A safety information page for CoolSculpting lists paradoxical hyperplasia as a possible, but rare, side effect seen in both clinical studies and commercial use. The condition is described 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. The enlargement requires surgical intervention, such as liposuction, for correction," the page said.