- CoolSculpting has been sold as a quick and easy route to a slimmer silhouette.
- Supermodel Linda Evangelista filed a lawsuit in September saying CoolSculpting left her disfigured due to an adverse reaction known as PAH.
- Sometimes called the "stick of butter effect," PAH may be more common than people think. Insider talked to women who experienced it.
For the last decade, CoolSculpting has been marketed as a noninvasive way to reduce love handles or a double chin that's quick and easy enough to schedule over your lunch break.
More than 11 million treatments have been administered worldwide by dermatologists, plastic surgeons, and medical spas. In the last 12 months, CoolSculpting was the 5th most-searched procedure globally, according to plastic surgery reviews site, RealSelf.com.
Khloe Kardashian and Kris Jenner are CoolSculpting fans. The actress and model Molly Sims became a spokeswoman after she credited CoolSculpting with helping her slim down following her pregnancy.
Since CoolSculpting was cleared by the FDA in 2010, non-invasive body contouring has grown into a $992 million business. There are other similar devices, like EmSculpt Neo (which uses electromagnetic energy) or Sculpsure (which employs lasers). But CoolSculpting is the most popular and widely used procedure for getting rid of stubborn fat.
So when supermodel Linda Evangelista, one of the most photographed women of the 1990s, announced via Instagram that the treatment left her "brutally disfigured," it came as a shock.
Evangelista said she had developed an adverse reaction that's known as PAH, or paradoxical adipose hyperplasia. "To my followers who have wondered why I have not been working while my peers' careers have been thriving, the reason is that I was brutally disfigured by Zeltiq's CoolSculpting procedure which did the opposite of what it promised," Evangelista wrote.
A post shared by Linda Evangelista (@lindaevangelista)
By many accounts, CoolSculpting has helped a lot of people get the body they want. The procedure has a 73% "worth it" rating (based on 4,377 reviews) on RealSelf.com.
But like every medical procedure, cosmetic or not, there's a risk of adverse effects. CoolSculpting's marketing and safety materials say that PAH is a risk, but that it's rare and correctable with "surgical intervention, such as liposuction."
PAH is often described as the "stick of butter effect" – an unnatural bulge that takes the rectangular shape of the CoolSculpting applicator. Others experience irregular shapes of lumpy deposits of tissue in the treated area or other side effects that they might mistake for gaining weight.
Insider has interviewed five women who said that they developed PAH after CoolSculpting. Like Evangelista, four of the women had to have multiple corrective procedures, and none felt that the issue was fully fixed. The fifth patient plans to seek additional treatment, but had to delay it due to the pandemic.
"It felt like an apron of gelatin," said one woman, who Insider is calling Angela." It was very firm and thick and there was a difference in viscosity."
A spokesperson from Allergan Aesthetics, which purchased Zeltiq in 2017, declined to respond to a detailed list of questions from Insider. AbbVie, the parent company of Allergan Aesthetics, also did not reply to a request for comment.
The concept of CoolSculpting is that it uses cryolipolysis, or fat freezing, to kill fat cells underneath the skin for a slimmer, more sculpted body in a matter of one to three months. A technician pulls the flesh of the target area between two paddles to cool the tissue to below freezing temperatures. While multiple sessions might be required, the patient can be in and out within an hour.
According to Paul M. Friedman, MD, a dermatologist and laser surgeon based in Houston and New York whose practice offers CoolSculpting and who has authored papers and case studies on PAH, said PAH "remains a rare adverse event," given the number of treatments overall.
"Cryolipolysis has a well established safety profile and is an effective noninvasive treatment option for patients who are the right candidate for this treatment," Dr. Friedman said.
But some patients who've experienced PAH question whether patients are being adequately warned about the seriousness of the risks.
There have been at least two class-action lawsuits filed in recent years against the companies behind CoolSculpting, and several hundred user accounts regularly share information about the procedure's side effects on Facebook.
"The biggest problem with the whole situation is the manufacturer is in charge of the reporting," said Louiza Tarrasova, a Florida-based personal injury attorney who has been litigating CoolSculpting claims since 2018. (Tarrasova is on the legal team behind the two class action suits. Two support groups for CoolSculpting patients have formed on Facebook with a total of around 600 members, and Tarrasova serves as the administrator of both.)
When things go wrong patients simply reach out to their provider, who then reaches out to the manufacturer, Tarrasova said. The manufacturer then might reach a private agreement with the patient that the company will pay for a corrective procedure, like liposuction, and be released from liability, Tarrasova said.
A welcome fix for stubborn fat
In Evangelista's case, her dermatologist performed seven cycles of CoolSculpting on her abdomen, flanks, back and bra area, inner thighs, and chin between 2015 and 2016, according to her lawsuit, which was filed in federal court in New York and is unrelated to the class action cases.
Within a few months of the treatments, her suit alleges, she had developed hard, painful masses underneath her skin in spots where the CoolSculpting applicators were applied, and she was eventually diagnosed with PAH.
Evangelista says that Zeltiq agreed to pay for corrective liposuction, only to back out of the agreement 24 hours before the scheduled procedure when Evanglista refused to sign a waiver releasing the company from liability. She had the surgery anyway, but said the PAH masses were back within months.
The same thing happened after her second liposuction procedure, which, she said, also left her with permanent scarring.
Five patients interviewed by Insider said that Evangelista's story is unfortunately all too familiar. Two were able to provide thorough documentation related to getting the treatment and then corrective procedures for PAH, while three others offered evidence for key pieces of their stories.
Angela, who asked that Insider conceal her real name but provided surgical notes from her corrective procedures, didn't think much about the small patch of flab on her lower abdomen. It was during a visit to a medical spa for laser hair removal in February 2017 that she said the technician recommended CoolSculpting.
"I thought it would eliminate the 'extra' in that area," Angela says.
Five months later, the tissue in the area had expanded, she said in an interview. Curiously, it had also become rubbery and tough, what she described as an "apron of gelatin."
"I couldn't get on a single dress I owned. I was horrified," she said.
That October, Angela found out it was PAH, and was told she needed surgery to correct it.
When she reached out to the provider who performed her CoolSculpting, she was referred to the manufacturer, Zeltiq. In an interview, Angela said that she spoke to a representative from Zeltiq to say that she believed she had PAH and was offered reimbursement for corrective liposuction surgery.
She also discussed her case with Tarrasova, the lawyer, but has not joined in any of the lawsuits.
What concerns Angela more than the lingering physical effects, is the amount of mystery still surrounding PAH. It's unclear why some people develop it, and others don't. It's also not clear what exactly causes it.
"They make it seem like it's not a big deal, and it's not true," she said. "If it goes wrong, the results are so devastating."
'A rare adverse event'
When CoolSculpting was first cleared by the FDA in 2010, PAH wasn't on the FDA's radar. That's because among adults, it's a phenomenon that almost exclusively develops as a result of noninvasive body sculpting procedures like cryolipolysis, explains Misbah Khan, MD, a dermatologic surgeon based in New York.
The first time PAH related to CoolSculpting was reported in the medical literature more broadly was 2014.
Much of the existing research on the incidence of PAH is conflicting. In 2018, the manufacturer estimated one PAH case per 4,000 treatment cycles (it's standard for patients to receive more than one cycle of treatment).
Zeltiq and its parent companies have received at least 7,798 reports of PAH since 2009, court documents say, though it's unclear if a single report represents one patient or just one treatment area and the manufacturer did not respond to questions about this. The company deemed 5,920 of those reports as confirmed and 1,878 as unconfirmed.
"It's very hard to get the right number because people are very embarrassed to talk about it. For some patients it may go unnoticed at first. The problems are undiagnosed," said Dr. Khan, who authored a 2019 paper on treating PAH. "What's likely closer to reality is the higher number."
Louiza Tarrasova, the lawyer, first started digging into CoolSculpting in 2018 after a man approached her about seeking damages related to a PAH diagnosis. Their case was not ultimately not successful – the judge ruled that the CoolSculpting provider had been adequately warned of the risks by the company. They have since filed an appeal. The experience convinced Tarrasova that there could be more to investigate about adverse effects related to CoolSculpting.
Patients who have been through PAH talk about wanting their bodies to return to normal, but it's not clear whether that's a realistic outcome. The inflammatory response that they experienced after CoolSculpting can result in fibrous scar tissue that is difficult to remove.
Moreover, the inflammatory response can be long-lasting, and when you add corrective surgical procedures to the mix, you're adding more trauma and damage to tissues that are already struggling to heal, Dr. Khan said. The tissue may never return to "normal."
"You're also dealing with an altered metabolism overall," Dr. Khan said, noting that some patients with PAH will experience unexplained weight gain throughout the body as a response to the damaged areas of fat. "Fat is an organ. It stores excess calories. When you have damaged fat, other places in the body will begin to store that excess," Dr. Khan said. "You're dealing with a global response."
Even when PAH is diagnosed appropriately it is hard to get it treated because it's a relatively new phenomenon. Many doctors and surgeons aren't sure how to treat it effectively. "They're shooting in the dark," Dr. Khan said. This adds another layer of frustration to an extremely painful process of serious surgeries, which themselves can give rise to complications.
Damaged fat
In her Instagram post, Evangelista wrote about the shame of living with what she considered a "disfigured" body and said she had become a recluse. "PAH has not only destroyed my livelihood, it has sent me into a cycle of deep depression, profound sadness, and the lowest depths of self-loathing," she wrote.
Diana, who also asked Insider to conceal her identity, is an MD dermatologist herself. She got CoolSculpting done four times between 2014 and 2015 on her flanks and abdomen. Her first treatment was done by one of the dermatologist's responsible for bringing CoolSculpting technology to market, she said. Another of her treatments was done at her workplace during training after her boss had bought a CoolSculpting machine.
She says she has gone through the CoolSculpting training herself, seen the photos of PAH in a lecture from the technology's lead investigator during her residency training, and spoken to company reps directly. It still took nearly two years for her to be diagnosed with PAH, and only after she got more sessions of CoolSculpting done—which was recommended by her provider after it appeared at first not to work.
"It doesn't always present the way they say it does in the training," Diana said. "In the photos, it looks like a shelf. Mine looked like a bulge."
She's since had two liposuction procedures as well as an abdominoplasty that led to her losing sensation in her abdomen. The masses in her abdomen feel like they are growing back again, but at this point she can't fathom having another procedure.
Diana believes many of her colleagues simply misdiagnose PAH as weight gain following the procedure. She said she's on a group chat with a number of dermatologists, who reacted to news of Linda Evangelista's lawsuit by ridiculing her with comments like "maybe she just started to eat lots of ice cream."
Danielle, a nurse practitioner in South Carolina who is part of the class action suit in California but requested that she not be identified by her real name for fear of attracting harassment, describes her experience with PAH and the surgeries to correct it as "pure hell."
After developing PAH in 2019, she had an abdominoplasty and a liposuction procedure in 2020. For both, the recoveries were painful. She got infections in her wounds. The stress of the experience caused a Shingles flare-up. She couldn't care for her family or work for months.
"Since then it feels like it's coming back," she said. "I don't know what to do anymore. Every day I have spasms in my abdomen. I can't stand up straight half the time."
"Here I went in for a two hour procedure sold to me as noninvasive, and now I'm scarred from my flank area on one side to the flank area on the other side," she said. "I just want to warn people."
Read the original article on Business Insider
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