The fat-freezing procedure left supermodel Linda Evangelista “disfigured.” Here’s what experts say it is supposed to do and what the most common side effects are.
On Wednesday, Linda Evangelista, the ’90s-era supermodel, shared on Instagram that she had been disfigured by a fat-reducing procedure called CoolSculpting that did the opposite of what it promised: Instead of reducing the amount of fat she had, CoolSculpting increased it, she said.
After treatment, Evangelista said, she developed a condition known as paradoxical adipose hyperplasia, or PAH, in which the tissue in the treated area grows larger and hardens and stays that way. PAH is sometimes referred to as the “stick of butter effect,” because it can look like a stick of butter hidden under the skin; the enlarged tissue matches the long, thin shape of the CoolSculpting applicator.
“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,” Evangelista wrote. She filed a lawsuit on Tuesday against Zeltiq Aesthetics Inc., the subsidiary of Allergan that markets and licenses CoolSculpting devices, claiming that the company had “intentionally concealed” the risks and had “failed to adequately warn” consumers, including Evangelista, about them.
What is CoolSculpting?
CoolSculpting is an outpatient treatment, approved by the Food and Drug Administration, that is designed to kill fat cells near the surface of the skin by cooling them in a process known as cryolipolysis. Scientists first proposed the idea behind the technique in 2008, based in part on the existence of a rare phenomenon that afflicts kids, called Popsicle panniculitis. When some young children suck on Popsicles, their cheeks develop permanent divots because the cold damages nearby fat cells. Similarly, doctors had noticed in 1980 that when women go horseback riding in the cold, they sometimes lose fat around their thighs.
CoolSculpting isn’t intended to help people lose significant amounts of weight, though. “This is not a weight-loss treatment,” said Dr. Paul M. Friedman, a dermatologist in Houston and the director of the Dermatology & Laser Surgery Center there. It “is meant for stubborn pockets of fat that are nonresponsive to diet and exercise in patients who are at their ideal body weight,” he said.
Licensed by Zeltiq Aesthetics, CoolSculpting can be administered by doctors — usually dermatologists or plastic surgeons. After applying gel to the skin to protect it from damage, the doctor will use special applicators to cool the skin to just above the freezing point in fatty areas such as the chin, the abdomen, the thighs, the arms, the back or underneath the buttocks. The cold, which is administered to the skin for 30 minutes to two hours, “kills off fat cells, without damaging surrounding nerves, muscles, or skin cells,” said Dr. Whitney Bowe, a New York City-based dermatologist.
Over the next one to six months, the fat cells die, Dr. Bowe said, and patients usually see a reduction in fat in the treated areas of about 20 percent; patients will often have two or more treatments to the same area to reduce fat by 40 to 50 percent, eliminating small bulges and giving the area a more toned look. The procedure is not covered by health insurance, and treatment regimens usually range in price from $600 to $3,000, Dr. Bowe said.
How popular is CoolSculpting?
More than eight million CoolSculpting treatments had been administered in the U.S. as of 2019, according to the CoolSculpting website. The American Society for Aesthetic Plastic Surgery reports that board-certified U.S. plastic surgeons performed 129,686 nonsurgical fat-reducing treatments in 2019, a category that includes CoolSculpting as well as treatments that use ultrasound to kill fat cells. But those numbers do not reflect CoolSculpting treatments done by dermatologists, so the real number is probably much higher.
Compared with surgical techniques such as liposuction, CoolSculpting does not require a long recovery time, so patients who don’t want interruptions to their lifestyles might prefer it. “You can go into the CoolSculpting procedure, and then you can hit the gym later that day,” Dr. Bowe said.
What are the risks associated with CoolSculpting?
During the procedure, patients may feel a pulling sensation on the skin — most machines use vacuums to hold the skin in place — and the cold can feel uncomfortable until the skin grows numb during treatment. Afterward, Dr. Bowe said, patients sometimes feel a tingling, pins-and-needles sensation as feeling returns to the treatment area.
In the days and weeks after treatment, according to the manufacturer, patients may also experience a litany of temporary side effects including redness, swelling, bruising, firmness, tingling, stinging, tenderness, cramping, aching, itching or skin sensitivity. When patients are treated below the chin, they may also experience a feeling of fullness at the back of the throat. Rare side effects also include frostbite, hernia, dizziness or pain that can last for weeks.
PAH, the condition Linda Evangelista now has, is cited by the manufacturer as another rare side effect of CoolSculpting — but recent estimates suggest the risk may be higher than the company says. Zeltiq, the company that licenses CoolSculpting, estimates that PAH develops after one out of every 4,000 CoolSculpting treatments. But in a study published this year, physicians in Canada followed 2,114 patients who had received a total of 8,658 CoolSculpting treatments from 2015 to 2019, finding that PAH occurred after one out of every 666 treatments. And once patients develop the condition, it typically has to be treated with surgical liposuction, but surgery may not eliminate the problem or may introduce new issues. According to her lawsuit, Ms. Evangelista underwent several corrective surgeries, which left her with “immense keloid scarring.”
Newer CoolSculpting models seem safer, however. In the Canadian study, the researchers reported that the risk of PAH was significantly lower — occurring after approximately one out of every 2000 treatments — among patients treated with newer machines, probably because they require shorter treatment times and lower vacuum settings so less force is exerted on the tissue, Dr. Friedman said.
What causes PAH?
Doctors don’t yet know what causes PAH to develop in some CoolSculpting patients. The statistics suggest that men are at increased risk compared with women, because 55 percent of the patients who developed PAH in the Canadian study were men, even though men typically comprise only about 15 percent of CoolSculpting patients.
As for what happens to the tissue when PAH develops, that’s also unclear. It’s possible that as the body tries to repair the damage from CoolSculpting, it recruits other cells or turns on repair mechanisms that result in tissue growth, Dr. Bowe said. “But we don’t really fully understand why it happens.”
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