A beauty treatment promised to eliminate fat. For some, it has brought disfigurement.
CoolSculpting is one of the most popular fixes for unwanted bulges. But the risk of a serious side effect seems to be higher than previously thought.
More than a dozen years ago, a medical device hit the market with a tantalizing promise: it could freeze stubborn pockets of fat quickly, painlessly, and without surgery.
The device, called CoolSculpting, went into an already crowded beauty industry selling flatter bellies and tighter jawlines, but he had one advantage: a vaunted scientific pedigree. The research behind its development came from a lab at Harvard Medical School's main teaching hospital, a detail noted regularly in news reports and talk show segments.
Pitch worked. CoolSculpting machines are now common in dermatology and plastic surgery practices and medical spas, and the technology has generated over $2 billion in revenue.
Cryolipolysis, the technical term for the procedure, involves placing a device on a targeted part of the body to freeze fat cells. Patients usually undergo several treatments on the same area. In successful cases, the cells die and the body absorbs them.
But for some people, the procedure results in severe disfigurement. The fat can grow, harden and become lodged in the body, sometimes even taking the shape of the device's applicator. This side effect, called paradoxical adipose hyperplasia, usually requires surgery to correct. "It increased, not decreased, my fat cells and left me permanently deformed," supermodel Linda Evangelista wrote in 2021 of her experience with CoolSculpting.
Allergan Aesthetics, a unit of pharmaceutical giant AbbVie, which now owns CoolSculpting, says this is rare, occurring in 0.033% of treatments, or about 1 in 3,000 treatments.
But a New York Times review — drawing on internal documents, lawsuits, medical studies and interviews — indicates the risk to patients may be significantly higher.
The company behind CoolSculpting hired consultants who wrote about the low risks of P.A.H. in medical journals and online channels. It also blocked patients from talking about the issue through confidentiality agreements, and at one point stopped reporting the side effect to federal regulators after a Food and Drug Administration auditor determined that did not constitute a serious or life-threatening injury. .
More than a dozen doctors interviewed by The Times said the manufacturer's estimate of risk was significantly lower than what they had observed in their practices or their research, in part because the side effect can take several months to become visible, and patients don't always connect it to CoolSculpting. Sometimes the effect is subtle and patients believe they have just gained weight.
"PAH. is probably underreported and misdiagnosed," a revealed a 2020 study on paradoxical adipose hyperplasia.
In 2017, Dr. Jared Jagdeo, a dermatologist who was then a consultant for the maker of CoolSculpting, and two co -authors wrote in a journal article that the side effect should be...
CoolSculpting is one of the most popular fixes for unwanted bulges. But the risk of a serious side effect seems to be higher than previously thought.
More than a dozen years ago, a medical device hit the market with a tantalizing promise: it could freeze stubborn pockets of fat quickly, painlessly, and without surgery.
The device, called CoolSculpting, went into an already crowded beauty industry selling flatter bellies and tighter jawlines, but he had one advantage: a vaunted scientific pedigree. The research behind its development came from a lab at Harvard Medical School's main teaching hospital, a detail noted regularly in news reports and talk show segments.
Pitch worked. CoolSculpting machines are now common in dermatology and plastic surgery practices and medical spas, and the technology has generated over $2 billion in revenue.
Cryolipolysis, the technical term for the procedure, involves placing a device on a targeted part of the body to freeze fat cells. Patients usually undergo several treatments on the same area. In successful cases, the cells die and the body absorbs them.
But for some people, the procedure results in severe disfigurement. The fat can grow, harden and become lodged in the body, sometimes even taking the shape of the device's applicator. This side effect, called paradoxical adipose hyperplasia, usually requires surgery to correct. "It increased, not decreased, my fat cells and left me permanently deformed," supermodel Linda Evangelista wrote in 2021 of her experience with CoolSculpting.
Allergan Aesthetics, a unit of pharmaceutical giant AbbVie, which now owns CoolSculpting, says this is rare, occurring in 0.033% of treatments, or about 1 in 3,000 treatments.
But a New York Times review — drawing on internal documents, lawsuits, medical studies and interviews — indicates the risk to patients may be significantly higher.
The company behind CoolSculpting hired consultants who wrote about the low risks of P.A.H. in medical journals and online channels. It also blocked patients from talking about the issue through confidentiality agreements, and at one point stopped reporting the side effect to federal regulators after a Food and Drug Administration auditor determined that did not constitute a serious or life-threatening injury. .
More than a dozen doctors interviewed by The Times said the manufacturer's estimate of risk was significantly lower than what they had observed in their practices or their research, in part because the side effect can take several months to become visible, and patients don't always connect it to CoolSculpting. Sometimes the effect is subtle and patients believe they have just gained weight.
"PAH. is probably underreported and misdiagnosed," a revealed a 2020 study on paradoxical adipose hyperplasia.
In 2017, Dr. Jared Jagdeo, a dermatologist who was then a consultant for the maker of CoolSculpting, and two co -authors wrote in a journal article that the side effect should be...
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