Although a fair amount of concern about risks, Coolscupting is very safe, very effective. But like other medical therapies, there are complications. There have been a couple of notorious incidents where Coolsculpting there has been an expansion instead of elimination of fat. There are a few risk factors, it is very rare, and the treatment would be liposcution. No cases of paradoxical adipose hyperplasia (PAH) from Emsculpt Neo have been reported in the published medical literature. This complication is specifically and almost exclusively associated with cryolipolysis (CoolSculpting), never has been reported with electromagnetic or radiofrequency-based devices. Reviewing all the studies on Emsculpt Neo, the technology that builds muscle and reduces fat clinical studies (15 studies total) found no complications reported across any of the included trials.
An analysis of the FDA MAUDE database (2011–2021) where such events are reported identified 1,325 adverse event reports across six noninvasive body contouring modalities. Paradoxical hyperplasia was reported almost exclusively (99%) with cryolipolysis. In contrast, focused electromagnetic field devices (the category that includes Emsculpt) resulted in only 7 total reports, none of which were described as paradoxical hyperplasia. A second MAUDE analysis (2015–2021) confirmed that PAH was overwhelmingly linked to cryolipolysis, with incidence estimates ranging from ~1 in 20,000 in some studies, others about 1/5000 which is what we have seen in our practice. No similar findings were attributed to electromagnetic or combined RF/HIFEM devices.[5]
PAH is thought to be a unique response to controlled cooling of adipocytes, po
Why this Would Occur With CoolSculping
No one knows for sure why this would ever occur, possibly related to cold-induced vessel damage and ischemic stress or other cooling-specific pathways with lack of oxygen to the tissue, or thickening of the septum distributed in the fat, or some sort of stem cell trigger. Emsculpt Neo uses a fundamentally different mechanism — synchronized radiofrequency heating (42–45°C) and high-intensity focused electromagnetic energy to induce muscle contractions and fat apoptosis via thermal and mechanical pathways. This mechanism does not share the cryogenic trigger implicated in PAH.
The treatment would be liposuction, which is very effective for the abnormal growth.
