A growing number of doctors and angry consumers are warning that the CoolSculpting fat-freezing cosmetic procedure can cause the growth of disfiguring fat bulges, rather than shrinking fat.
Problems with the CoolSculpting treatment went mainstream last year, when the popular 80s supermodel Linda Evangelista agreed to a settlement after filing a $50 million lawsuit against Allergan and Zeltiq.
She claimed that she was left “permanently deformed” and “brutally disfigured” when fatty areas that she wanted to shrink with CoolSculpting instead started to grow and harden all over her body.
The condition, called Paradoxical Adipose Hyperplasia (PAH), can occur a few months after a person undergoes CoolSculpting, when fat areas suddenly grow into what some people call “a stick of butter.”
No amount of dieting or exercising can eliminate PAH, according to doctors. Often the only treatment is liposuction, but it is expensive and even liposuction may not fully correct the disfiguring appearance.
Earlier this month, The New York Times published a report warning that “the risk of a serious side effect appears to be higher than previously known.”
At least a dozen doctors who were interviewed by the Times said the manufacturer’s estimate of the risk of PAH was significantly lower than what they had observed.
The original manufacturer, Zeltiq, told the FDA that the risk of PAH was only about 1 in 20,000 patients before it was approved in 2010. However, since 2010, doctors have published several studies showing that the actual risk of PAH from CoolSculpting may be much higher.
For example, a study by Dr. Jose Rodrigues-Feliz found that 1 out of 128 patients developed PAH after undergoing CoolSculpting.
Another problem is that the manufacturer has stopped reporting PAH cases the the FDA. Zeltiq determined in 2013 that they did not have to report the side effect because it was not life-threatening or serious.
Allergan purchased Zeltiq for $2.48 billion in 2017 and is the current owner of CoolSculpting. The company told the Times that it adheres to FDA reporting requirements for medical devices.