A Beauty Treatment Promised to Zap Fat. For Some, It Brought Disfigurement.
April 17, 2023
(New York Times) – The company behind CoolSculpting has retained consultants who have written about low risks of P.A.H. in medical journals and online channels. It has also restricted patients from talking about the problem through confidentiality agreements and, at one point, stopped reporting the side effect to federal regulators after an auditor from the Food and Drug Administration determined that it did not qualify as a life-threatening or serious injury.
More than a dozen doctors interviewed by The Times said the manufacturer’s estimate of the risk was sharply lower than what they had observed in their practices or research — in part because the side effect can take many months to become visible, and patients don’t always connect it to CoolSculpting. (Read More)