Lawsuit: Kansas woman not warned of ‘CoolSculpting’ effects
WICHITA, Kan. (AP) — A woman is accusing a Wichita plastic surgery clinic of failing to warn her of a rare, plumping side effect of a popular body-contouring procedure.
Tammy Hammond filed the lawsuit earlier this year against Dr. Bruce Ferris and his clinic, the Plastic Surgery Center, the Wichita Eagle reported .
Hammond received three treatments of “CoolSculpting” over a 16-day period more than two years ago. CoolSculpting is a noninvasive form of fat-freezing, in which cooling pads chill fat cells for up to an hour so they break down and die. The federal Food and Drug Administration first cleared the procedure for limited use in 2010. It’s not for use in people considered obese.
The woman developed a benign tumor in her liver and experienced fatty tissue growth post-procedure, according to the lawsuit. The fat-increasing condition is called paradoxical adipose hyperplasia, which occurs in about 1 in 20,000 people who had a fat-freezing procedure done, according to a 2014 study published with the National Center for Biotechnology Information.
Plastic Surgery Center’s website lists the minor side effects of CoolSculpting. It includes brief numbness, redness, swelling and tingling among others, but does not specifically mention paradoxical adipose hyperplasia. The makers of CoolSculpting mention paradoxical adipose hyperplasia as a rare side effect on a patient information sheet and acknowledge the condition has shown up in clinical trials.
The lawsuit accuses the clinic of not telling staff who perform the procedure about its known hazards so they could warn customers.
The procedure left the woman “with a condition that has disfigured her body and shattered her self-confidence,” the lawsuit said.
An attorney for Ferris and clinic said the lawsuit “contains both legal and factual errors.” The woman’s health issues developed “despite appropriate medical care and without negligence on the part of any health care provider,” according to a recent written response to the lawsuit.
Information from: The Wichita (Kan.) Eagle, http://www.kansas.com