The Hidden Dangers of CoolSculpting®
When CoolSculpting hit the market in 2010, it sounded almost too good to be true: freeze away stubborn fat bulges without surgery or downtime and all you have to do is sit there for an hour?
CoolSculpting, or Cryolipolysis, is the non-invasive, selective destruction of adipose tissue by controlled cooling. The treatment device utilizes a cup shaped applicator that draws a roll of skin and subcutaneous adipose tissue between two cooling plates.
The majority of patients experience mild side effects such as redness, tingling, and numbness, which go away after a few days. However, one serious side effect of CoolSculpting appears to be more common than the manufacturer reported. It is a complication called Paradoxical Adipose Hyperplasia (PAH) or, in layman’s terms, the “stick of butter” effect.
PAH typically cannot be confirmed until about 6 months post-procedure, with patients complaining that they are getting bigger in the exact shape of the applicator.
If you or a loved one developed Paradoxical Adipose Hyperplasia (PAH) or other serious side effects after Cryolipolysis treatments, filing a lawsuit could help pay for medical bills, lost wages, and lost earning capacity. Take your first step towards holding the manufacturer responsible for their willingness to put profits over people, fill out the following form for a FREE case review and to receive the E-Book “The Hidden Dangers of CoolSculpting”.
Paradoxical Adipose Hyperplasia (PAH), also referred to as Paradoxical Hyperplasia (PH) is a condition in which the tissue treated by CoolSculpting is damaged, resulting in the opposite effect of what CoolSculpting seeks to achieve -an increase of the targeted fat bulges. A person suffering from PAH may find that the treated area has grown three to four times its pre-treatment size (for example if a man had his chest area treated and developed PAH, he would experience enlarged breasts). Or, an even more disturbing presentation of PAH is a large, hard mass that develops in various shapes, sometimes in the form of the machine’s applicator.
The manufacturer of CoolSculpting did not adequately warn medical providers about the severity, permanency, and frequency of this very serious adverse effect. Many medical providers operating the medical device do not have an adequate understanding of this very serious adverse effect of CoolSculpting and do not know the accurate incidence rate of Paradoxical Adipose Hyperplasia. Therefore, they are not properly informing CoolSculpting patients about their risk of developing deformities after CoolSculpting.
As with any medical device, doctors using the CoolSculpting device on patients must understand all aspects of the device, including any risks that the device poses for their patients. CooSculpting providers rely on the manufacturer to tell them crucial information about the serious adverse effects of the CoolSculpting device. Unfortunately, based on our investigation, it is our belief that the manufacturer did not disclose vital information about this permanently deforming condition to physicians operating the medical device. As a result, CoolSculpting providers did not properly warn patients about PAH.
Once a person develops Paradoxical Adipose Hyperplasia, it will not go away on its own. The only known way to remove it is through plastic surgery. This is especially frustrating to people undergoing CoolSculpting because their reason for doing the fat freezing procedure is to avoid invasive surgical procedures. Based on reports from people that developed PAH and plastic surgeons that have attempted to remove it, multiple surgeries may be required and include but are not limited to abdominoplasty, excision, power-assisted liposuction (multiple), and liposculpture. In some cases, PAH affected tissue cannot be completely removed.