Risks of PAH & CoolSculpting Disfigurement
CoolSculpting, a procedure that attempts to reduce fat in specific areas of the body by freezing fat cells (cryolipolysis), has caused some patients to suffer permanent injuries like paradoxical adipose hyperplasia (PAH).
Instead of reducing fat, PAH may cause fat cells to expand and harden afterwards, leading to firm bulges where CoolSculpting treatments took place. These bulges may resemble a stick of butter — which is the same size and shape as the CoolSculpting device used to freeze the fat cells.
Linda Evangelista, a Canadian model, went public about her PAH diagnosis in 2021. She filed a lawsuit after being disfigured by CoolSculpting procedures.
While Allergan Aesthetics — an AbbVie company and the owner of CoolSculpting — claims that only .033% of patients develop PAH, the actual number may be much higher.
The U.S. Food and Drug Administration (FDA) received over 1,900 reports of adverse events from CoolSculpting treatments in 2022 alone, according to the New York Times. The majority of these reports were about patients who developed PAH.
Lawsuits against Allergan claim the company knew about the risk of PAH since 2011, but Allergan allegedly failed to inform CoolSculpting providers about this risk.
As a result, patients underwent the procedure without fully knowing the complications it could cause.
CoolCurve™ ZELTIQ & CoolSculpting Elite Recall
The FDA has announced multiple Class 2 CoolSculpting recalls due to an increase in cases of PAH and other injuries following CoolSculpting procedures.
A Class 2 FDA recall is when a product has the potential to cause temporary health problems, or when there is a risk of more severe health issues. Products need to be fixed or removed from the market to protect people's health.
Products impacted by the CoolSculpting FDA recall include:
- Devices using the CoolCurve™ ZELTIQ Vacuum Applicator
- The CoolSculpting Elite System
While these specific products have been recalled, the CoolSculpting procedure remains otherwise approved by the FDA as of December 2023.
Side Effects of CoolSculpting
While CoolSculpting is a non-invasive method of reducing fat cells, there are still a variety of side effects that have been linked to this procedure.
CoolSculpting side effects may include:
- Bruising or swelling
- Burns
- Frostbite
- Hernias
- Muscle cramping
- Numbness
- Pain or stinging
- Paradoxical adipose hyperplasia (PAH)
- Scarring
Many side effects of CoolSculpting can be mild and disappear within a few weeks of the procedure. However, others — including PAH — may be considered more serious complications.
Symptoms of Paradoxical Adipose Hyperplasia
Paradoxical adipose hyperplasia (PAH) can develop 2-5 months after a CoolSculpting procedure. However, cases of PAH may go unreported or be misdiagnosed, in part because some victims may believe they simply gained weight after the procedure.
Symptoms of PAH can include:
- Disfigurement
- Firm bulges or lumps where treatment took place
- Sudden and inexplicable increase in fatty tissue
- Swelling and pain
Unfortunately, the hardened bulges from PAH may be permanent unless treated with surgery.
If you’ve suffered PAH or other side effects, our CoolSculpting lawyers may be able to fight for compensation that can help pay for corrective surgery, medical bills, lost wages, pain and suffering, and more.
Who Can File a CoolSculpting PAH Lawsuit?
You may be able to file a CoolSculpting lawsuit if you or a loved one:
- Underwent a CoolSculpting procedure
- Developed paradoxical adipose hyperplasia or other serious injuries as a result
State laws, known as statutes of limitations, restrict how long you have to file a legal claim after an injury. Because of this, it’s important to reach out to an experienced CoolSculpting attorney as soon as possible.
Get Help Filing an Allergan CoolSculpting Lawsuit
At Sokolove Law, we strive to make filing a lawsuit as stress-free as possible. Our CoolSculpting lawyers can handle every step of the legal process for you, so you can focus on your health and well-being.
We can help CoolSculpting victims in all 50 states take legal action — and there are no upfront or hourly costs to work with our team.
Our lawyers have recovered over $1.6 Billion for clients across the country who were injured by medical devices and dangerous drugs. We have the experience and resources to fight for the compensation you deserve.
Model CoolSculpting Lawsuits FAQs
Who owns CoolSculpting?
Zeltiq Aesthetics was the original owner of CoolSculpting, but Zeltiq has since been purchased by Allergan Aesthetics, an AbbVie company.
Are there long-term side effects of CoolSculpting?
Yes, potentially. Thousands of patients have reported adverse side effects following their CoolSculpture procedures.
Some long-term side effects of CoolSculpting include:
- Burns
- Numbness
- Paradoxical adipose hyperplasia (fat cells that have expanded and hardened)
- Scarring
Is there a recall on CoolSculpting?
Yes. The FDA announced a CoolSculpting recall in July 2022 for devices that use the CoolCurve ZELTIQ Vacuum Applicator. This was due to an increase in reports of paradoxical adipose hyperplasia in patients.
In 2021, there was also a CoolSculpting Elite recall announced by the FDA, after the CoolSculpting Elite System provided incorrect error messages that could lead to second and third degree freeze burns.
What is PAH from CoolSculpting?
Paradoxical adipose hyperplasia (PAH) is a condition that causes fat cells to expand and harden following a CoolSculpting treatment. PAH can cause raised masses to appear on the body, which are permanent unless removed through surgery.
Compensation may be available from a CoolSculpting PAH lawsuit if you suffered side effects after the procedure.
Who filed the CoolSculpting model lawsuit?
Linda Evangelista, a Canadian fashion model, filed a $50 million lawsuit against CoolSculpting after she developed paradoxical adipose hyperplasia.
Evangelista claimed she was left disfigured and unable to work after her CoolSculpting procedure. The lawsuit settled for an undisclosed amount in 2022.
Is there a CoolSculpting class action lawsuit?
Although a class action lawsuit against CoolSculpting was proposed in 2021, current lawsuits are being filed on an individual basis.
How much does a PAH CoolSculpting lawyer cost?
At Sokolove Law, there are no upfront or hourly fees to work with our CoolSculpting attorneys.
We work on a contingency-fee basis, which means we only get paid if we successfully secure compensation for you.
How much is the CoolSculpting settlement?
CoolSculpting settlements will vary based on the unique details of each case, like the severity of your injury and the medical bills you incurred as a result.
