CoolSculpting’s Risks and Side Effects: What You Need To Know

Since it received U.S. Food and Drug Administration (FDA) approval in 2010, CoolSculpting® — a nonsurgical body contouring procedure — has been a popular way to get rid of stubborn body fat that diet and exercise can’t vanquish.

But in 2022, the cover of People Magazine featured a headline that shook many people’s confidence. The headline read “My Cosmetic Procedure Nightmare.” It was written in bold yellow typeface, accompanied by a picture of supermodel Linda Evangelista. The “most photographed woman in the world” alleged that she was “brutally disfigured” by a condition called paradoxical adipose hyperplasia (PAH) after undergoing CoolSculpting.

While Linda Evangelista has since settled her lawsuit against CoolSculpting manufacturer Allergan Aesthetics, a growing number of doctors and patients are coming forward — both to the FDA and media outlets like The New York Times — alleging that PAH is far more common than we realize. But the FDA hasn’t changed its opinion that CoolSculpting is safe and effective, and it remains a very popular way to address stubborn body fat.

All this conflicting information may have you wondering whether CoolSculpting is miraculous or dangerous. As is usually the case, the answer lies somewhere in between those poles.

CoolSculpting is an effective and minimally invasive body contouring procedure that — like most cosmetic procedures — yields the best results when performed by an experienced specialist.

We asked dermatologist Shilpi Khetarpal, MD, about the news-making side effects of CoolSculpting. She walked us through the basics of the procedure, the type, severity and frequency of side effects, and tips for choosing a CoolSculpting practitioner.

What is CoolSculpting?

The medical term for what’s happening when you undergo CoolSculpting (also called cryolipolysis) is “cold panniculitis.”

“About 15 years ago,” Dr. Khetarpal says, “dermatologists at Harvard noticed that kids who sucked on popsicles would get these little indentations in their cheek. They called it ‘popsicle panniculitis.’ While the children’s cheeks went back to normal, the researchers realized that repeatedly exposing fat cells to cold would cause them to die. That’s how CoolSculpting came about.”

CoolSculpting uses a tool to expose skin and fat to very cold temperatures.

“The skin returns back to normal after the procedure,” Dr. Khetarpal explains. “Then, over the course of three to four months, the fat cells die permanently. They get processed in the body as normal fat cell turnover, which doesn’t raise cholesterol or lipids in the blood. Ultimately, you’re left with less fat in that area — a smoother contour. So, maybe your clothes will fit a little bit better and you’ll see fewer bulges in the area that was treated.”

There are nine areas of the body that CoolSculpting can treat:

1. Under your chin.
2. Under your jawline.
3. Your abdomen.
4. Your flanks (also known as “love handles”).
5. Your upper arms.
6. “Bra fat.”
7. Back fat
8. Fat below your buttocks (also known as the “banana roll”).
9. Your inner, outer and distal thighs.

Which tool the practitioner uses depends on the area (or areas) being targeted. “We have a small applicator for the chin. There are obviously larger ones for the abdomen and flat ones for the outer thigh,” Dr. Khetarpal notes.

Dr. Khetarpal also says it’s important to manage expectations when it comes to Coolsculpting. After all, it’s an outpatient, nonsurgical procedure. “CoolSculpting isn’t perfect and it isn’t going to replace liposuction or surgery,” she says. “It’s just meant to help contour.”

She continues, “I tell people they’re not going to lose pounds. They might lose inches, but it takes a series of treatments. And one applicator is about the size of your hand. So, we’re not talking about drastic makeovers. We just target small areas of fullness.”

Does Coolsculpting have short-term side effects?

CoolSculpting uses suction to pull skin and fat into the tool, so you can expect some discomfort during the procedure.

“There can be redness, swelling and potentially some bruising afterward,” Dr. Khetarpal explains. “You may actually look fuller immediately after treatment because you’re causing inflammation in the skin and the fat before it goes down.”

It’s important to keep in mind that the fat cells the procedure targets won’t die immediately: It could take up to four months to see the results. It’s also frequently the case that multiple sessions are required to get the desired effect. Maintaining the results also requires that you maintain your current weight. If you gain weight after the procedure, new fat cells will take the place of the ones CoolSculpting eliminated.

The short-term side effects of CoolSculpting are minimal. The main controversy around the procedure has to do with the potential for long-term complications — and how manufacturer Allergan Aesthetics handles them.

Long-term complications of CoolSculpting

Dr. Khetarpal says that contour irregularities can happen with CoolSculpting. “For example,” she says, “if someone has a very full abdomen and you only treat part of it, they can get an indentation where the area was treated — and then it could be full elsewhere.”

In most cases, contour irregularities can be resolved with additional CoolSculpting sessions. If that doesn’t do the trick, the next step is usually liposuction.

While contour irregularities can happen, the controversy around CoolSculpting is about a different long-term side effect: A rare condition we mentioned earlier, called paradoxical adipose hyperplasia (PAH).

People who get PAH from CoolSculpting develop painless, firm masses of fat in the areas where they were treated between three and nine months after the procedure. In the case of Linda Evangelista, she developed masses on her chin, thighs and bra area.

Dr. Khetarpal says that PAH usually happens because something is wrong with the equipment, or the practitioner is doing the procedure incorrectly. “Basically, the fat cells aren’t cooled enough to destroy them. Instead, the CoolSculpting actually stimulates them to grow more.”

To treat PAH, Dr. Khetarpal says you “basically don’t do more CoolSculpting. You can either do liposuction or there’s an injectable called deoxycholic acid. We treat PAH by removing the fat.” The problem, according to The New York Times article about the controversy, is that those treatments aren’t always successful post-CoolSculpting.

Of course, complications happen with all sorts of medical procedures. The question that outlets like The New York Times are asking about is frequency.

CoolSculpting was first approved by the FDA in 2010. In 2014 an article in the Journal of the American Medical Association reported that PAH was occurring in 1 out of every 20,000 treatments. Meanwhile, a 2016 letter to the editor and a 2017 study by healthcare providers who regularly performed the procedure placed the incidence markedly higher, at nearly 1 in every 100 treatments. Allergan Aesthetics has maintained confidence in its own PAH estimate (! in every 3,000 treatments) since 2017.

Since Linda Evangelista came forward about her experience with PAH, the number of reports to the FDA has skyrocketed. According to The New York Times investigation, “The year [Evangelista] went public, the FDA received over 1,100 reports of adverse events from CoolSculpting treatments — more than in the entire previous decade.”

Some patients have said they assumed the bulges were their fault, that they’d simply gained weight, undoing the effect of the procedure. Others have come forward (in People Magazine, The New York Times article and elsewhere) alleging that — after they’d been diagnosed with PAH — Allergan Aesthetics offered to pay for their corrective surgeries on the condition that they sign a nondisclosure agreement (NDA).

We can’t be sure how often PAH occurs, based on the data that’s currently available. There’s some evidence to suggest that the age of the equipment could play a role, as could patient characteristics. For example, one study found that the majority of PAH cases were in men of European descent who were treated in the abdominal region.

Dr. Khetarpal estimates she’s performed CoolSculpting on at least 500 people. She has never seen a case of PAH, but she isn’t surprised by the possibility that it occurs more often than previously assumed. That’s because the FDA reporting process is often lengthy and cumbersome.

“Can PAH happen? Yes,” concedes Dr. Khetarpal. “It’s in our consent form. And I do discuss it with patients. Just like any other procedure, there are risks and benefits.”

She continues “It’s important that, as a provider, you’re picking the right people and administering the procedure correctly. PAH is unlikely, but if you read the bottle of Tylenol®, it says there’s a risk of liver failure. So, I try and put the risk in that real-life context.”

Choosing your provider

Bad publicity aside, CoolSculpting remains an immensely popular nonsurgical body contouring option. And there’s no reason to think that will change any time soon.

If you’re interested in CoolSculpting, the single best thing you can do to protect yourself from side effects like PAH is to find the right technician. Not all of the people who are certified to perform CoolSculpting have a medical background, so it’s important to keep each prospective provider’s qualifications in mind.

You can find facilities that offer CoolSculpting in your area through the company web page. From there, it’s time to do some comparison shopping.

“I think it’s important to talk with the provider and feel comfortable with them,” Dr. Khetarpal advises. She also suggests looking at the provider’s before and after photos — not the photos provided by the company. Those before and after photos should also state how many sessions the patient had to undergo to achieve the “after” result. “It’s really important to see that because the success of the procedure is very much operator-dependent,” Dr. Khetarpal stresses.

According to Dr. Khetarpal, a poor practitioner can not only raise your risk of complications, but also make the procedure unnecessarily expensive. “We have focused applicators. And it’s really important that the operator is experienced with them because it’s all about the planning. You have to think through where we put the applicators and where the most fullness is. That helps you get the best bang for your buck.”

Your CoolSculpting provider should also be:

1. Estimating the number of treatments you’ll need to get to achieve the effect you’re looking for.
2. Counseling you ahead of time about all the possible side effects and complications of the procedure.
3. Asking you to sign a consent form.
4. Making a follow-up appointment to check that the procedure was effective.

If those things don’t happen, it’s time to look for somebody else.

Who should NOT try CoolSculpting?

Part of what makes CoolSculpting so popular is the fact that it’s a nonsurgical, outpatient procedure that requires very little downtime. We’d all rather have a quick and easy procedure than something more involved. But different bodies require different body-contouring approaches. CoolSculpting isn’t the best choice for you if:

• You have a body mass index (BMI) over 25 or under 18.5.
• You’re pregnant or expect to be pregnant in the near future.
• You have issues with cold-induced skin conditions like Raynaud’s syndrome or cold urticaria.
• You have a hernia that hasn’t been repaired.
• You have extensive scarring in the treatment area that the CoolSculpting applicator can’t go around.
• You have an active infection.
• You have loose, hanging skin.

If you fit into any of these categories and a CoolSculpting practitioner is still encouraging you to get the procedure, that’s a red flag. There are other options available to get rid of unwanted fat. A good provider will let you know about those options and explain why they might be safer and more effective for you, even though they’re more invasive.

CoolSculpting alternatives

If you’re not a good candidate for CoolSculpting, don’t despair. There are other options available to help you.

“If you have a hernia, a lot of scarring or significant skin laxity, a plastic surgeon can help,” Dr. Khetarpal says. “They can do things like a hernia repair, liposuction, abdominoplasty (tummy tuck) or a combination of procedures to help you get the results you’re looking for.”

Other options include Kybella®, SculpSure® and Vanquish®.

The takeaway

We can’t know for sure how common PAH is. What we do know is that CoolSculpting remains very popular and generally safe. We also know the procedure isn’t a good fit for all people.

And choosing a qualified and experienced provider — and being educated about the process — can make all the difference in your experience.