Coolsculpting has been in the news a lot lately. In this article published in April 2023 from the New York Times, reporters describe disfigurement and the possible cover-up by Allergan, the company that makes the machines. As part of the investigation, they also published an article later that month specifically trying to determine just how often the worst side effects happen.
Ever since Linda Evangelista filed her lawsuit against Coolsculpting in 2021 (settled for an undisclosed amount the following year) people have been much more discerning about body sculpting in general. Read on for a summary of the ins and out of Coolsculpting.
Yes. It is possible to freeze fat, resulting in the death of fat cells and the reduction of fat in this area. The way it works is by using an applicator cup. The fat is sucked into the cup and frozen. The fat cells that die release their lipids into the body and over the next few months, they are drained away by the lymph system, and eventually excreted.
There are several problems with the technology. First, you can only kill fat that is able to be sucked into the cup. Any adjacent fat that is not sucked into the cup is left untreated. This can yield some very uneven results and what is often called “shelfing” when you can feel the edge of the treatment area.
Second, the skin overlying the area of fat loss ends up being loose, because it is no longer stretched over the fat. You have to have the perfect arrangement of fat to get an even result. Many people end up with lumpy areas covered by loosey-goosey skin.
There are also risks besides uneven results. There can be nerve damage from the freeze, but this is pretty rare. The other big complication is that the fat can react in an opposite way than was intended– it can grow instead of shrink. That is called Paradoxical Adipose Hyperplasia or PAH.
PAH when it happens is rock-hard, and does not respond to the normal fat removal treatments like liposuction. In most cases, the only way to get rid of PAH is surgery to remove it.
This question is the focus of the second article in the New York Times mentioned above. When I was first evaluating body sculpting devices in 2015, I was quoted a rate of PAH of less than 1% by the sales rep. The company has maintained that this is the case for years.
The true rate turns out to be much higher than that, but it is impossible to know the exact number. According to the article, the true rate could be as high as 50% of patients may experience some degree of PAH.
The massive difference in numbers has in part to do with how they define the rate. Allergan wants to use “per applicator” as the denominator, whereas in medicine we use the term “per patient.” Each patient experiences 4-8 applicators per treatment, and Allergan recommends at least 2 treatments per patient, so the total number of applicators each person receives is anywhere from 8 to 16.
Sometimes more if they do more treatments or more body parts. So the rate may be 8 to 16 times what the company reports, just by that alone. As a patient, wouldn’t you want to know how likely it would be to get PAH?
The second part of why the number might be wrong is underreporting. Patients may not report this at all if it is minor. But also, when people have experienced PAH and sought restitution from the company, this was contingent on signing a confidentiality agreement. So Allergan would pay for corrective surgery only if you didn’t talk about it. What is the true number? One person I spoke with who used to work for Allergan said it was closer to 20%.
If that were true, I would think there would be a lot more very unhappy people out there given how many treatments have been done since the device was FDA approved way back in 2010. But we may never know.
One of our essential tenets of aesthetic medicine at Glow Medispa: nothing in Aesthetics is worth any permanent harm. Whether the risk of PAH from Coosclupting is 2% or 20%, the risk of permanent harm is too high. For lots of procedures we do, there could be potential temporary issue– like a burn or hyperpigmentation. We do our absolute best to prevent adverse outcomes, but it will occasionally happen to any provider, no matter how experienced. However, permanent harm is (and should be) exceedingly rare. If you pick and choose safe effective treatments, you will minimize any risks.
This is why at Glow we use non-ablative lasers for resurfacing (rather than ablative lasers which carry higher risks) and why we have Emsculpt Neo instead of Coolsculpting.
We have been using the RF and HIFEM technologies of Emsculpt Neo since 2018 with no adverse events.