“He ruled that based on his opinion the warnings about PAH by Zeltiq were adequate to warn doctors of the condition. “Unfortunately, the judge did not allow the case to go to a jury trial,” she tells Rolling Stone. Tarassova and her client have appealed the ruling. In 2021, a judge ruled in favor of Zeltiq, saying the company’s warnings were legally “adequate,” that the man had signed a waiver acknowledging risk of injury. He claimed he had not been sufficiently warned about the side effect or the difficulty of reversing it. In 2019, a man from the Bahamas, represented by Tarassova, sued the company saying that a few months after getting CoolSculpting treatments in 2018, he developed a hard mass “the shape and size of a bowling ball” above his navel. Others have claimed in federal court that they experienced adverse side effects from the same procedure.

They described in a vague, two-line way that would mislead practitioners.”Įvangelista is not the only person who has brought legal action against Zeltiq. “The way they handled it was so beyond any normal decent behavior, any morality. “It’s such a severe, permanent, adverse effect,” she says, noting that she’s spoken to some people who underwent surgery for the condition only to see it return. At the same time, she condemns Zeltiq’s handling of the discovery of PAH, which, as the “paradoxical” in its name suggests, creates the complete opposite effect of what CoolSculpting is supposed to do. “The more popular the product is, the more they’re going to be exposed to various claims and lawsuits,” she says. Companies like Zeltiq - and its parent pharmaceutical companies Allergan and AbbVie - have to anticipate legal action and plan for it. Personal injury lawyer Louiza Tarassova, who specializes in cosmetic procedure cases and has represented multiple clients about CoolSculpting, says in one sense, lawsuits like Evangelista’s are to be expected. The warning says the condition occurs in about one in 3,000 treatments, and describes it as “the gradual development of a visibly enlarged tissue volume, of varying size and shape, in the treatment area.” The condition won’t go away on its own, it reads, adding, “Surgical intervention may be required.” Rare reported side effects can include paradoxical hyperplasia, severe pain or late-onset pain, and continue to be well-documented in the CoolSculpting information for patients and health care providers and sample consent form given to health care providers to use with patients.” The spokesperson added that a warning about rare side effects, including paradoxical hyperplasia, is included in the complete safety information, a link to which can be found on the website for the procedure. In the lawsuit, Evangelista claims that after receiving seven CoolSculpting treatments between 20, she developed a condition known as paradoxical adipose hyperplasia, or PAH, which court documents describe as “a serious adverse effect where the targeted fat cells increase in number and size (and actually grow larger) after treatment and form hard, bulging masses under the skin.” In a recent People article, Evangelista said that because of hard protrusions at the top of her inner thighs, which she claims were caused by the treatment, she couldn’t wear dresses without a girdle underneath or her bare thighs would chafe to the point of “almost bleeding.”Ī spokesperson for CoolSculpting provided a statement from the company, saying, “CoolSculpting has been well studied with more than 100 scientific publications and more than 11 million treatments performed worldwide. Its advertising says it “literally freezes and kills fat cells” and that it’s “FDA-cleared” to treat fat under the chin and jaw, as well as on thighs, the stomach, and back, among other places. Evangelista is suing Zeltiq, the company that markets CoolSculpting, claiming the so-called fat-freezing treatment left her “permanently disfigured.”ĬoolSculpting is a cosmetic procedure designed to reduce the appearance of fat bulges without surgery. Since September, Nineties supermodel Linda Evangelista has been embroiled in a lawsuit over a cosmetic procedure that she said did the opposite of what it advertised, and ruined her famous physique.

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