According to CoolSculpting, its procedure has been cleared by the Food and Drug Administration for the treatment of visible fat bulges.
In response to questions, the F.D.A. said in an email that it could not comment on litigation, but that it was “committed to ensuring medical devices are safe and effective and that patients can be fully informed when making personal health decisions.” It said that it monitors reports from consumers of adverse events after a device reaches the market and would “take action where appropriate.”
Cryolipolysis, the name of the nonsurgical fat-freezing procedure, uses cold temperature to break down fat cells, according to the American Society of Plastic Surgeons.
It is mostly used by patients who want to reduce a specific fat bulge that they have been unable to diminish through other means. Generally, the area of concern is “vacuumed” into the hollow of an applicator, where it is subjected to cold temperature.
The surgeons’ society said the complication rate was low, with less than 1 percent of patients who may develop paradoxical fat hyperplasia, which is an unexpected increase in the number of fat cells. The side effect is more common in men than in women, the society said.
Ms. Evangelista also said that the public scrutiny of her appearance had harmed her emotionally. “I have been left, as the media has described, ‘unrecognizable,’” she said.
Jonah E. Bromwich contributed reporting.
Article source: https://www.nytimes.com/2021/09/23/us/linda-evangelista-lawsuit-paradoxical-adipose-hyperplasia.html