[vc_row type=”in_container” full_screen_row_position=”middle” column_margin=”default” column_direction=”default” column_direction_tablet=”default” column_direction_phone=”default” scene_position=”center” text_color=”dark” text_align=”left” row_border_radius=”none” row_border_radius_applies=”bg” overlay_strength=”0.3″ gradient_direction=”left_to_right” shape_divider_position=”bottom” bg_image_animation=”none”][vc_column column_padding=”no-extra-padding” column_padding_tablet=”inherit” column_padding_phone=”inherit” column_padding_position=”all” column_element_spacing=”default” background_color_opacity=”1″ background_hover_color_opacity=”1″ column_shadow=”none” column_border_radius=”none” column_link_target=”_self” gradient_direction=”left_to_right” overlay_strength=”0.3″ width=”1/1″ tablet_width_inherit=”default” tablet_text_alignment=”default” phone_text_alignment=”default” bg_image_animation=”none” border_type=”simple” column_border_width=”none” column_border_style=”solid”][vc_column_text] Back in 2015 former supermodel Linda Evangelista was struggling to get rid of some annoying lumps and bumps. So she decided to opt for a popular non-invasive fat freezing procedure called CoolSculpting. Unfortunately, she had an adverse reaction which resulted in a condition called paradoxical adipose hyperplasia (PAH), leaving her permanently disfigured. In 2021 Evangelista filed a lawsuit and has been vocal in the media ever since.
What is fat freezing?
Fat freezing or cryolipolysis has become very popular in recent years. So much so that in 2019, the Aesthetic Society ranked non-surgical fat reduction as the fourth-most popular non-invasive cosmetic procedure in the United States. Around 129,686 procedures were performed. CoolSculpting is the market leader.
According to the website Medical News Today, “A plastic surgeon uses a device to freeze fat cells under the skin. Once the fat cells have been destroyed, they are gradually broken down and removed from the body by the liver.”
“While the number of independent clinical research studies backing the procedure is still relatively small, Zeltiq Aesthetics claims CoolSculpting lowers the number of fat cells in the treatment area by between 20 and 25 percent.”
Most people start to notice the effects a few days after the procedure, but it often takes 1 to 4 months for the full results to show.
Image from People Magazine via @lindaevangelista
One of the main benefits of this fat freezing technique is that it is non-invasive and people experience very little downtime.
It’s also worth noting that it was cleared by the FDA in 2012 “for the treatment of visible fat bulges in the submental (under the chin) and submandibular (under the jawline) areas, thigh, abdomen, and flank, along with bra fat, back fat, underneath the buttocks (also known as banana roll), and upper arm”.
What experts say
Why has fat freezing become so popular? Medical News Today compared it to liposuction, explaining that “CoolSculpting offers mild-to-moderate fat loss. The procedure is unlikely to make a significant difference to a person’s body composition. It is, therefore, most appropriate for people wishing to remove specific areas of fat. Because it is a non-invasive procedure, it means that it carries fewer risks.”
Some possible side effects include:
redness
mild bruising
tingling and numbness in the area
discomfort
These side effects should go away within a few days after the procedure. However, the website notes that the fat freezing procedure carries a risk of paradoxical adipose hyperplasia.
Paradoxical adipose hyperplasia
As Medical News Today explains.
“In very rare cases, CoolSculpting may lead to paradoxical adipose hyperplasia (PAH), which causes the fat in the treated area to grow larger. This effect seems to be more common in males. It is possible to treat PAH with liposuction.” Medical News Today
What went wrong with Evangelista’s fat freezing procedure?
In Evangelista’s case, instead of reducing fat in certain areas, she experienced the fat cells increasing. Unfortunately, the areas that should have shrunk with the treatment expanded in size and became large, hard bulges. This left her with prominent bulges on her chin, thighs, and chest, which resulted in her retreating completely from the public limelight.
Evangelista had the procedure in 2015. By June 2016, she said could no longer cope with the disfigurement and went to see her doctor.
He diagnosed her withparadoxical adipose hyperplasia(PAH). According to the 58-year-old former supermodel, she’s been living in seclusion for almost five years since then, unable to face her reflection in the mirror.
Image from People Magazine via @lindaevangelista
“I have been left, as the mediahas described, ‘unrecognizable.’” Linda Evangelista told her followers on Instagram
Evangelista was a successful supermodel in the 1990s. She was famously quoted as saying she didn’t wake up “for less than $10,000 a day.”
Linda Evangelista showing damage from CoolSculpting taken on December 3, 2021 in New York, NY via People
Suing for damages
According to Evangelista, together with her doctor, she approached the owners of CoolSculpting about her condition well before her lawsuit was filed. According to her, they said they wanted to “make it right” and offered to pay for liposuction.
However, the beauty alleges the liposuction had to be done by “ a surgeon of the company’s choosing” rather than her own. In addition she was informed “on the eve” of her surgery that Zeltiq (CoolSculpting’s parent company) would only be paying if she signed a confidentiality agreement. Evangelista says she declined to do so and paid for the treatment out of her own pocket.
Linda Evangelista photographed at a private residence in New York, NY on December 3, 2021. NO Photographer credit Hair: Garren/R+Co BLEU Makeup: James Kaliardos/The Wall Group Producer: Shake Productions Stylist: Anne Christensen/Art & Commerce Via People
But the liposuction (she had two) didn’t work, and Evangelista is still left with hard, deformed lumps on her body. She says that she is forced to wear a girdle when she wears a dress. If not, she “has chafing to the point of almost bleeding”.
She subsequently filed a $50 million lawsuit against the company in September 2021.
When fat-freezing goes wrong
In an article published by the Washington Post, specialists weighed in on Evangelista’s situation. Notably, Troy Pittman, a board-certified D.C.-based plastic surgeon said he’s “not surprised” about Evangelista’s experience with PAH. Referring to a July 2021 study published in the Aesthetic Surgery Journal, he said “the risk of PAH in those undergoing CoolSculpting is approximately 1 in 2,000 treatment cycles. The estimate in the first paper on PAH, published in 2014, reported that it affected 1 in 20,000 patients.”
“The disparity between incidence rates found within the literature indicates that PAH is likely to be underreported and misdiagnosed,” the researchers wrote.
The legal challenge
Evangelista’s disfiguration is making headlines all over the US and even in other parts of the world. Zeltiq is challenging her $50 million lawsuit. They contend that a warning about rare side effects, including PAH, has been included in all their material along with a link to the website detailing the procedure. The warning says the condition occurs in about one in 3,000 treatments, and describes it as “the gradual development of a visibly enlarged tissue volume, of varying size and shape, in the treatment area.
They say the CoolSculpting literature was also clear that PAH can be difficult to treat.”The condition won’t go away on its own, it reads, adding, “Surgical intervention may be required.”
Obligation to inform and warn with fat freezing procedure
Evangelista remains adamant the company did not adequately warn her or the dermatologist who performed the fat freezing procedure about the risk.
Her lawsuit claims Zeltiq, the company that invented and markets the procedure, knew about the risk of PAH since at least 2013. That their annual report to investors tabled a risk of liability for potential lawsuits.
Zeltiq’s lawyers believe the company fulfilled its obligation to warn Evangelista of the risk when she signed paperwork that included information about the possibility of PAH.
Beyond that, they argue her claims fail for other reasons. These include consumer law, statutes of limitations, and whether a proclamation like “safe and effective” can legally be considered a warranty.
Zeltiq has filed a motion to dismiss the case
CoolSculpting’s website lists numerous potential side effectswhen having this fat-freezing procedure. These include PAH, late-onset pain, frostbite, hyperpigmentation, and hernia.). Doctors and other specialists performing the procedure will also be provided with this information.
A spokesperson for CoolSculpting issued this statement.
“CoolSculpting has been well studied with more than 100 scientific publications and more than 11 million treatments performed worldwide.
Rare reported side effects can include paradoxical hyperplasia, severe pain or late-onset pain, and continue to be well-documented in the CoolSculpting information for patients and health care providers and sample consent form given to health care providers to use with patients.”
A court will decide
Evangelista is not the only person to have suffered from PAH after a fat-freezing procedure. However, to date, she’s arguably the most high profile. If you hop onto Facebook, you’ll find a page for PAH survivors among many other online references.
Ultimately, though, it won’t be the court of public opinion that resolves this. The court of law will have to decide.
We all know that our bodies change as we grow older. That can be difficult enough to deal with when you aren’t a celebrity. When you’re known for your face and body, it becomes more than just part of who you are. It’s tied to your character, and you are recognizable because of it. Evangelista has remarked that while she knew she would age, her fat-freezing procedure has led to a complete loss of identity for her.
And she wonders “Why do we feel the need to do these things [to our bodies]?”.
At the time of writing this post, a judge had yet to rule on this high-profile matter.
Research Study: A Multicenter Evaluation of Paradoxical Adipose Hyperplasia Following Cryolipolysis for Fat Reduction and Body Contouring: A Review of 8658 Cycles in 2114 Patients
