More than a decade ago, a medical gadget was introduced to the market with the alluring promise of permanently eliminating localised fat deposits by freezing them.
The CoolSculpting gadget entered a crowded market offering slimmer tummies and more defined jawlines, but it stood out thanks to its illustrious scientific lineage. Regularly mentioned in news articles and on talk shows is the fact that the research that led to its creation was conducted in a lab at Harvard Medical School’s main teaching hospital.
Clearly, the sales presentation was successful. More than $2 billion in profit has been made because to the widespread availability of CoolSculpting devices in dermatology and cosmetic surgery practises and medical spas.
The process, called cryolipolysis, involves freezing fat cells by applying a device to a specific area of the body. The same part of a patient’s body often receives several treatments. When this works, the cells die and are absorbed by the body.
However, the surgery leaves some patients severely disfigured. Sometimes the fat might even take on the form of the applicator and develop, solidify, and lodge in the body. Paradoxical adipose hyperplasia is a common adverse effect that often necessitates surgical intervention. For example, in 2021, supermodel Linda Evangelista said that CoolSculpting had the opposite effect of what was intended: on her body, fat cells multiplied, not reduced, and she was left permanently disfigured.
According to Allergan Aesthetics, a division of the pharmaceutical behemoth AbbVie that now owns CoolSculpting, this only happens in 0.033 percent of procedures, or approximately once per three thousand.
Consultants hired by CoolSculpting’s parent business have dismissed concerns about the procedure’s link to P.A.H. in articles published in medical publications and shared on social media. A Food and Drug Administration auditor concluded that the side effect did not meet the criteria for a life-threatening or seriously injured condition, and the company has since used confidentiality agreements to prevent patients from discussing the issue.
Because the negative effects can take many months to become visible and patients don’t always connect it to CoolSculpting, more than a dozen physicians interviewed by The Times said the manufacturer’s figure for the risk was significantly lower than what they had observed in their practises or research. Patients may misinterpret a milder impact as simple weight gain.
In 2017, dermatologist and CoolSculpting consultant Dr. Jared Jagdeo and two co-authors argued in a journal paper that the side effect should be classed because of how it affects patients. They concluded that the growing number of cases satisfied WHO standards for a “common” or “frequent” adverse event rather than a “rare” one.
The reported incidence of P.A.H. has silently and gradually grown since CoolSculpting’s launch, even in company estimations, underscoring problems in the F.D.A.’s process of clearing medical products for use and monitoring them after they have entered the market.
According to the firm, this adverse effect is very uncommon and is discussed at length in the materials provided to physicians and patients. Additionally, Allergan said, “We comply with all safety reporting requirements.”
About nine months later, Ms. D’Addario claims she discovered a big tumour in her belly. She blamed her weight increase, but neither dieting nor exercise helped. She said that the growth became so enormous that it prevented her from working out since her leg kept hitting the lump. Before Ms. Evangelista went public, neither she nor any of the several physicians she examined suspected that the growth was related to CoolSculpting.
One of the most famous supermodels of the 1980s and 1990s, Ms. Evangelista claimed in 2021 that she had gone into protracted isolation after being diagnosed with P.A.H. Last July, she revealed that she had settled with Zeltiq after filing a lawsuit against the corporation. Ms. Evangelista did not want to give an interview for this piece.
There were more complaints of CoolSculpting-related side effects in the year she went public than in the preceding decade combined. The number exceeded 1,900 last year. The term “hyperplasia” appears in the vast majority of the papers.
Ms. D’Addario, who informed the F.D.A. of her illness, claimed that she used to exercise daily to get rid of the fat that had reappeared following CoolSculpting, but that she had recently started to have P.A.H. She claims that she now realises it was not her fault after all these years have passed.
She claimed she still struggles to this day with the “mental trauma” she suffered as a result of the months she spent in the dark about the various ways her body grew disfigured. Perhaps even worse.