Linda Evangelista, a model who rose to prominence in the 1990s, says she is the latest victim of complications of a popular fat-freezing procedure.
On Wednesday, Evangelista said on her Instagram page the popular CoolSculpting procedure by Zeltiq Aesthetics had left her “permanently deformed.” She has since sued Zeltiq, the California-based company that manufactures the devices used to perform the treatment.
CoolSculpting, known officially as cryolipolysis, is a nonsurgical cosmetic procedure that attempts to use skin-cooling to reduce fat. The process was invented by Boston-based dermatologist R. Rox Anderson and was approved by the FDA in 2010.
The treatment is done by applying a device to the targeted area and freezing and killing the fat cells in that area. According to the CoolSculpting website, an average of 25% of the fat in the treated area is reduced. The treatment is typically done twice or three times on the same area for optimal results.
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CoolSculpting can be done in a variety of places in the body, including under the chin, under the jawline, on the thighs, abdomen and sides of the body, on bra and back fat, on the upper arms and underneath the buttocks.
Dr. David Rapaport, a New York-based plastic surgeon, estimated he has completed about 20,000 CoolSculpting treatments on several thousand people since 2010. He said CoolSculpting is the leading procedure worldwide for noninvasive body contouring.
“It’s the secret sauce of the right temperature, with the right protection for the right amount of time,” Rapaport said.
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In recent years, more studies have been done on the complications of CoolSculpting. The most common, the one Evangelista is claiming, is paradoxical adipose hyperplasia, or PAH. PAH is a rare side effect that creates visibly enlarged tissue volume in the treated area, according to the CoolSculpting website.
Dr. Rapaport said he has successfully treated more than a dozen cases of PAH in patients who have received CoolSculpting, either from him or another surgeon. In his experience, PAH presents as a firm growth that typically matches the size and shape of the applicator that was used.
PAH can be treated with liposuction, which is the surgical equivalent of cryolipolysis that sucks out fat cells rather than freezing them.
Evangelista said she underwent “two painful, unsuccessful, corrective surgeries,” which Rapaport said is likely liposuction. She also said she was uninformed of PAH prior to the procedure. Rapaport said patients are supposed to sign consent forms acknowledging potential complications before treatment.
“Paradoxical hyperplasia is what it says it is — meaning, it’s paradoxical, it’s not well understood at all biologically why this happens to rare individuals,” Rapaport said. “Basically, instead of a certain fraction of fat cells being killed, instead, the fatty tissue grows more.”
In cases of PAH, Rapaport said he has to submit a report to Zeltiq, who will then agree with his diagnosis. In exchange for a release, Zeltiq will pay the patient for the full surgical price.
Zeltiq, a subsidiary of the Allergan pharmaceutical company, did not return requests for comment at the time of publication.
The occurrence rate of PAH is unknown. A 2014 study in the medical journal JAMA Dermatology said PAH is rare, whereas a 2018 report from the Journal of the American Society of Plastic Surgeons said it may not be a rare complication after all.
Correction (Sept. 27, 1:07 p.m.): An earlier version of the story misspelled Dr. David Rapaport’s name.