Paradoxical adipose hyperplasia (PAH) is a known rare, moderate to severe side effect associated with cryolipolysis or CoolSculpting. PAH has been described as “a delayed increase in adipose tissue at the treatment site” and “a gradual enlargement of the treated area … a well-defined subcutaneous mass, which is slightly painful on palpation”.
Studies showed incidence rates between 0.05% and 0.39%. So that is a probability of less than 1 incident per 2000 cycles. Incidence rates at all sites were dramatically reduced by over 75% with the implementation of newer models of CoolSculpting devices.
Of the patients who developed paradoxical adipose hyperplasia, 55% were male and 77.8% were of European ethnic origin. The majority of cases (76.9%) were associated with older models of the CoolSculpting devices.
Although no scientific research is yet available, we at CoolSculpting Kliniek see that the latest generation machine (CoolSculpting Elite) has yet to show a PAH case with us after more than 8,000 treatments. The improved head and other cold distribution could be reasons for less stress in the treated parts, but this needs to be better investigated
CoolSculpting Kliniek has a unique insurance policy/guarantee. In fact, should our treatment result in hyperplasia (PAH), we will ensure that this affected tissue is removed via liposuction at no cost.
CoolSculpting Kliniek has a standard procedure for when we suspect that the treatment has developed hyperplasia. First, we have a doctor determine if it is hyperplasia. Second, the regulation comes into effect with insurance. We will arrange the liposuction for you and our insurance will reimburse the full liposuction to remove the area affected by hyperplasia.
Nikolis, A., & Enright, K. M. (2020). A Multicenter Evaluation of Paradoxical Adipose Hyperplasia Following Cryolipolysis for Fat Reduction and Body Contouring: A Review of 8658 Cycles in 2114 Patients. Aesthetic Surgery Journal. https://doi.org/10.1093/asj/sjaa310