A popular body contouring procedure that’s supposed to freeze away stubborn bulges for good did the opposite for a Barton County woman. Now she’s suing a Wichita plastic surgery clinic, claiming it failed to warn her of a rare, plumping side effect of “Cool Sculpting.”
In addition to seeing fat increase in her body, the woman developed a benign tumor in her liver after she underwent nonsurgical fat-cell freezing, according to a negligence suit filed this spring in Sedgwick County District Court. She received three of the treatments over a 16-day period about 2 1/2 years ago.
Afterward, she noticed that the parts of her body she had treated “were growing, with more fat cells in those areas,” the lawsuit says.
The lawsuit accuses doctor Bruce Ferris and his clinic, Plastic Surgery Center, as well as Cool Sculpting makers Zeltiq Aesthetics and Allergan PLC, of not telling staff who perform the procedure about all of its known hazards and risks so they could warn customers.
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It also alleges the companies violated the Kansas Consumer Protection Act, which bars deceptive and unconscionable business practices.
The woman is seeking more than $75,000 in damages and demanding a jury trial.
Wichita attorney Mark Maloney, who represents Ferris and the Plastic Surgery Center, said in an emailed statement that the woman’s lawsuit “contains both legal and factual errors” and that the clinic “intends to vigorously defend the case.”
Plastic Surgery Center, 1861 N. Webb Road, is one of at least six spas and medical offices in Wichita that offer Cool Sculpting, according to www.coolsculpting.com.
Zeltiq and Allergan’s attorneys did not respond to a request for comment from The Eagle. The companies are denying the woman’s allegations, according to responses filed in the lawsuit.
Cool Sculpting as weight-loss method
Cool Sculpting is a noninvasive form of cryolipolysis, or fat freezing, in which unwanted cells are chilled for up to an hour using cooling pads so they break down and die. Once damaged, the body is supposed to flush the cells out, eliminating them permanently.
Traditional weight loss methods, like diet and exercise, only shrink fat cells.
Cool Sculpting was first cleared for limited use in the U.S. in 2010 by the federal Food and Drug Administration. It’s now OK’d to treat visible fat under the chin and buttocks, thighs, back, upper arm, abdomen and sides. It is not for use in people who are considered obese.
It’s advertised as reducing visible fat by up to 25 percent with few or no side effects, no downtime for patients and as a safe, effective, nonsurgical alternative to liposuction.
People typically spend $2,000 to $4,000 to get visible results, which can take months and multiple treatments.
In some cases, however, people experience serious problems.
The fat-increasing condition the woman who filed the suit developed is called paradoxical adipose hyperplasia — a visible enlargement of tissue under the skin that won’t go away on its own. A 2014 study published on the National Center for Biotechnology Information’s website estimates it occurs in about one in 20,000 people who have had a fat-freezing procedure done.
But some, including the woman who filed the lawsuit, worry the rate may actually be higher since fat-freezing is still relatively new and people might not realize fat growth can be an adverse side effect.
The woman, Tammy Hammond, spoke with an Eagle reporter about her experiences with Cool Sculpting, but she was hesitant to be interviewed for this article for privacy reasons.
She said she continues to experience health issues that she believes are linked to the procedures. She also worries that more problems may develop over time.
Her attorney, Steven Smith, declined to comment.
In a written response to the lawsuit filed June 18, Ferris and his clinic said the woman’s health issues developed “despite appropriate medical care and without negligence on the part of any healthcare provider.”
Ferris and his staff “used ordinary care and diligence” as well as “learning and skill ordinarily possessed and practiced by members of their profession” during her treatments, the response says.
Zeltiq and Allergan denied the woman’s allegations in written response to the suit filed June 25. They said in the response that her “damages, if any, are not of the nature and extent alleged.”
On July 2 they asked the woman to provide an itemized, written statement of the monetary damages she’s seeking within 14 days, according to court records.
Side effects of freezing fat cells
Plastic Surgery Center’s website lists the minor side effects of Cool Sculpting in its question-and-answer section about the procedure. Those include brief numbness, redness, swelling, bruising, firmness, tingling, stinging and pain in the treated areas. It does not specifically mention paradoxical adipose hyperplasia.
But it does say that in some cases “some rare side effects may occur.”
Zeltiq and Allergan mention paradoxical adipose hyperplasia as a rare side effect of Cool Sculpting on a patient information sheet on www.coolsculpting.com. It also acknowledges that the condition has shown up in clinical trials and commercial use.
Since the FDA cleared the Cool Sculpting device for use in 2010, it’s received at least three dozen reports of adverse side effects from patients and physicians. FDA clearance is not the same as FDA approval, which is required for devices like mechanical heart valves that have a high patient risk.
To receive clearance, a manufacturer has to convince the FDA that the technology in a product is substantially equivalent to a medical device that is already FDA cleared rather than submitting it for clinical trials.
Complaints the FDA has received about Cool Sculpting include severe pain that persists for days, insignificant or no noticeable fat loss, decreased sensitivity in treated areas, inflammatory responses, blistering, skin discoloration similar to frostbite, blood clots and hernias.
At least a third of reports were about patients who saw increased body fat in treated areas rather than shrinkage. Some said the fat felt hard to the touch or that it was permanent unless they underwent liposuction to remove it.
One report the FDA received in October was from a physician who stated concerns that the side effect may be under-reported.
“The manufacturer claims the incidence is 1 in 150,000 treatments. I have treated only 54 patients or 84 treatments,” the physician’s report said.
“My concern is that the incidence of this problem is under reported. It seems quite unlikely that I would or should have ever seen it if the incidence is correct.”
Nearly 181,000 of the 3.2 million nonsurgical plastic surgery procedures performed in the U.S. last year were for fat-reduction treatments including Cool Sculpting, according to a report from the American Society for Aesthetic Plastic Surgery. That’s 217.3 percent more than were performed in 2012. It was the third most-common nonsurgical procedure performed in 2017.
Nearly 44 percent of patients were 35 to 50 years old. About 27 percent were 51 to 64.
Americans spent $8.5 billion on all plastic surgery procedures in 2017, including almost $301 million on nonsurgical fat reduction, the society’s report says.
More than 6 million Cool Sculpting procedures have been performed worldwide, according to www.coolsculpting.com.
‘Condition has disfigured her body‘
According to the lawsuit, Hammond had the fat-freezing procedure done at Ferris’ clinic on Jan. 13, 19 and 28, 2016, after a sales representative there told her the procedure “was extremely safe” with “guaranteed significant reduction of stubborn fatty areas” and had “no down time” afterward.
“All literature regarding ‘Cool Sculpting’ supported that it was completely safe,” the suit says. Hammond agreed to undergo the treatments under Ferris’ supervision.
“At no time was Plaintiff advised of any risk or known adverse results from undergoing ‘Cool Sculpting,’” the lawsuit says.
After receiving the treatments, the lawsuit says, she “suffered significant pain, swelling and redness at the treated areas for several weeks.” Eventually the pain subsided.
But later, she “noticed the areas (treated) were growing, with more fat cells in those areas.”
During a follow-up appointment at the Wichita clinic, the doctor, Ferris, “admitted he had not previously heard of risks” associated with cool sculpting and “after doing some research” diagnosed her with paradoxical adipose hyperplasia, according to the lawsuit.
To try to counteract the fatty tissue growth, Hammond had two liposuction treatments — in June 2016 and May 2017 — that were “extremely painful and unsuccessful,” the suit says.
Eight months after receiving Cool Sculpting, she sought treatment for severe pain under her rib cage and was diagnosed with a benign tumor in her liver.
The tumor “is believed to be another side effect” of cool sculpting, according to the lawsuit.
The fat-freezing procedures left the woman “with a condition that has disfigured her body and shattered her self-confidence,” the suit says.