CoolSculpting Lawsuit Filed Over Risk of PAH Side Effects Following Treatment

The manufacturers of the CoolSculpting system face a lawsuit filed by a California woman, which claims the cosmetic surgery left her with disfiguring tissue masses, instead of freezing away fat as advertised.

The complaint (PDF) was filed by Salma and Kefah Dwabe in Los Angeles Superior Court on October 2, naming various companies involved in the development and sale of the CoolSculpting system as defendants, indicating that consumers and physicians were not adequately warned about the risk of paradoxical adipose hyperplasia (PAH), which is a permanent condition that has been identified as a potential side effect of CoolSculpting treatments.

CoolSculpting has been marketed as a safe and effective treatment for the removal of fat from areas of the body, without having to undergo surgery. The procedure involves a device that uses cryolipolysis to target and freeze off fat cells.

The system was approved by the FDA in 2010, and has since spread in popularity nationwide. However, a number of doctors have raised warning flags in recent years about potential CoolSculpting PAH side effects, indicating the procedure has been linked to a high rate of severe disfigurement, where the fat grows, instead of shrinks, leaving patients deformed and often requiring them to undergo numerous surgeries to correct the problems.

CoolSculpting PAH Side Effects

PAH is a disfiguring condition that Dwabe indicates is only developed as a result of undergoing cryolipolysis via CoolSculpting, where the procedure causes permanent change to the microstructure of the tissue in the treatment area. This can result in enlarged and sometimes hardened tissue masses, which often must be surgically removed from surrounding healthy tissue.

Dwabe indicates that the manufacturers publicly claim that PAH is a rare side effect from CoolSculpting, only impacting about one in 3,000 treatments. However, the CoolSculpting lawsuit indicates that the true incidence rate is substantially higher, alleging that the manufacturers manipulated statistics to underreport the complication and provide patients a false sense of security.

According to the recently filed complaint, Salma Dwabe began undergoing a series of CoolSculpting treatments in May 2023. However, the results were not what she was told to expect, as the treated areas swelled instead of shrunk.

Dwabe was diagnosed with PAH from CoolSculpting in November 2023, which caused her abdomen to expand so rapidly it split into two distinct, disfiguring bulges. This has led to not only an unsightly and misshapen appearance, but also created folds and creases that have resulted in chronic skin irritation, fungal infections, and the need for ongoing medical treatments.

“Following the final round of CoolSculpting treatments, Mrs. Dwabe noticed that the areas treated with the CoolSculpting System were getting larger not smaller,” the lawsuit states. “Mrs. Dwabe was unaware that PAH was an adverse effect associated with use of the CoolSculpting system that will give the complete opposite effect of what she desired to achieve, that PAH was alarmingly common amongst CoolSculpting patients, and that to treat the effect of PAH, surgical intervention is necessarily required – not may be required.”

Dwabe indicates that the manufacturers have known, since at least 2007, that potential PAH side effects from CoolSculpting were significant, yet failed to adequately investigate the risk or provide information to women considering the treatment.

If warnings had been properly disclosed, Dwabe indicates that she would not have chosen to undergo CoolSculpting treatments, which have now left her with permanent and disfiguring injuries.

The lawsuit presents claims of manufacture, design and warning defect, negligence, breach of warranty, failure to warn, negligent misrepresentation and concealment, fraudulent misrepresentation and concealment, and loss of consortium.