CoolSculpting Lawsuit Filed Over Risk of PAH Side Effects Following Treatment

California woman indicates areas of her stomach treated by CoolSculpting System began showing large, misshapen bulges, requiring additional surgeries.

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.

Did You Know?

Change Healthcare Data Breach Impacts Millions of Customers

A massive Change Healthcare data breach exposed the names, social security numbers, medical and personal information of potentially 100 million Americans, which have now been released on the dark web. Lawsuits are being pursued to obtain financial compensation.

Learn More

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.

0 Comments

Share Your Comments

I authorize the above comments be posted on this page*

Want your comments reviewed by a lawyer?

To have an attorney review your comments and contact you about a potential case, provide your contact information below. This will not be published.

NOTE: Providing information for review by an attorney does not form an attorney-client relationship.

This field is for validation purposes and should be left unchanged.

More Top Stories

Hair Relaxer Lawsuits Moving Forward Simultaneously in Federal MDL and Various State Courts
Hair Relaxer Lawsuits Moving Forward Simultaneously in Federal MDL and Various State Courts (Posted today)

Lawyers will meet today with the federal judge presiding over all hair relaxer lawsuits, as women diagnosed with uterine, endometrial and ovarian cancer continue to file claims throughout the U.S. court system.

SteriCare Sodium Chloride Lawsuit Claims Recalled Saline Solution Caused Infection, Wrongful Death
SteriCare Sodium Chloride Lawsuit Claims Recalled Saline Solution Caused Infection, Wrongful Death (Posted today)

A California couple has filed a SteriCare recall lawsuit, indicating they were prescribed contaminated sodium chloride solution that they used on their son's legs, leading to his death.

Silicosis Lawsuit Filed Against Artificial Stone Manufacturers, Distributors
Silicosis Lawsuit Filed Against Artificial Stone Manufacturers, Distributors (Posted yesterday)

An artificial stone countertop fabricator and installer has filed a lawsuit after he developed a debilitating lung disease, known as silicosis, alleging that manufacturers failed to protect workers from inhaling dangerous amounts of silica dust.