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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