CoolSculpting Results and Booming Lawsuits: What to Expect?

by | Jan 19, 2023 | Product Liability, Medical Devices

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“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”.

When the celebrity shared the news and proceeded with a CoolSculpting lawsuit, fans were shocked seeing the results of the botched CoolSculpting she had undergone.

The journey of CoolSculpting, the trending and revolutionary fat removal treatment took a turbulent turn when Canadian supermodel Linda Evangelista took to Instagram to share a her own terrifying experience with the procedure.

With recent developments in non-invasive fat removal methods like CoolSculpting, people believed it was possible to say good-bye to the stubborn fat deposition in different areas of the body like thighs, arms, jaw etc,.

Will CoolSculpting results come to the rescue, providing a SAFE answer to your love handles and belly fat?

Evangelista’s testimony and the CoolSculpting lawsuits make us think before saying yes to ourselves, urging us to delve deeper and ask such critical questions.

Does CoolSculpting results offer a magical solution to unwanted fat, or does it carry with it a risk more than the results?


Apart from the glowing testimonials, there are also the stories of procedures gone twisted. That makes the pillar stone for this blog on CoolSculpting lawsuits.

Let’s traverse the complex scene of CoolSculpting cosmetic enhancements and sail through the CoolSculpting lawsuits mushrooming in the United States. Before that, let us give you a short insight on CoolSculpting.

What is CoolSculpting?

As the name indicates, CoolSculpting in layman terms refer to the carving or toning of human body by removing unwanted fat accumulation using cold temperature.

coolsculpting-results-and-booming-lawsuits

Zeltiq Aesthetics, which was launched in 2005, developed CoolSculpting®. In 2011, it secured $75 million in fundraising before going public. In 2017, Zeltiq was bought as a subsidiary of the pharmaceutical corporation Allergan (owned by AbbVie), based in Pleasanton, California.

Let’s now understand the process more technically.

CoolSculpting or fatfreezing uses a technique called cryolipolysis to freeze and destroy fat cells. Cryolipolysis, is a fancy term for using cold to break down fat cells. CoolSculpting is basically freezing the fat away without any surgical intervention.

CoolSculpting: How it works?

CoolSculpting process extracts energy from fat layers, causing fat cells to die gradually while leaving surrounding neurons, muscle, and other tissues intact. During the months following treatment, the digested fat cells are filtered out as waste by the lymphatic system.

During the process, it lowers the percentage of fat cells in the treated area, however it does not completely remove them. The body typically processes the fat and gets rid of these dead cells over the following weeks of CoolSculpting. This in turn deliver the patients a more sculpted figure. To guarantee the integrity of the newly carved body contours over the long term, it is crucial to maintain a healthy lifestyle.

Working of CoolSculpting Machines

CoolSculpting device is the backbone of the CoolSculpting procedure. Let’s investigate its working in detail now:

The CoolSculpting device works by pulling fatty regions of the body into an applicator where they are exposed to freezing temperatures. This technique aims to destroy fat cells without injuring the tissues surrounding.

By effectively freezing the fat cells, which causes them to crystallize and die, this occurs through regulated cooling. The body naturally processes and expels dying cells, which reduces the thickness of the fat layer in the targeted area.

Does CoolSculpting hurt? Not severely, patients may occasionally experience pulling, tugging, slight pinching, extreme cold, tingling, stinging, discomforting and cramping at the treatment site as the machine works. As the area numbs, these sensations diminish. The length of the treatment session depends on the particular area being treated and might range from 35 to 60 minutes.

After the procedure, the machine is taken away, and the treated region is massaged for a short period of time to break up the treated fat cells and promote fat loss.

Does CoolSculpting really reduce fat?

Ideally yes, studies indicate that CoolSculpting reduces 20-25% of the fat in the targeted area. It would take 4-6 months for the fat to be removed from the body.

The FDA has approved the use of CoolSculpting and other cryolipolysis procedures in 2010. Several reports depict cryolipolysis is a dependable and risk-free alternative to liposuction.

However, CoolSculpting effectiveness could be minimal in people with high levels of fat deposition in the body and those suffering from obesity. To answer the query in deep, more research is needed to acquire a better understanding of the results and side effects of CoolSculpting.

CoolSculpting Process

Unwanted fat can be removed painlessly with CoolSculpting without the use of anesthetic, needles, or cuts. How to do CoolSculpting? Here is an in-depth breakdown of the phases.

Consultation

The first stage is a consultation with a licensed healthcare professional to evaluate the particulars of your situation, discuss about what you want to achieve, and plot out the CoolSculpting treatment areas.

Preparation

The target area is chosen before the procedure begins, and your skin is protected by a protective gel pad.

Application

The target area is covered with a specialized applicator, which vacuums the skin into the applicator cup. The area is then chilled using the gadget to a temperature that targets fat cells precisely.

Treatment

The patient might feel pressure and extreme cold during the cooling action for 35–60 minute duration. However, as the area numbs, these sensations typically go away within some time.

Aftercare

To loosen up any frozen deep tissue, the treated area is massaged after the session. As the fat cells are normally eliminated through the lymphatic system, this aids the body in beginning to absorb the destroyed fat cells during the CoolSculpting recovery stages.

Trending CoolSculpting Procedures

Below-mentioned are the most popular CoolSculpting procedure in the United States.

  • CoolSculpting Arms
  • CoolSculpting Chin
  • CoolSculpting Neck
  • CoolSculpting Stomach
  • CoolSculpting Belly Fat
  • CoolSculpting Love Handles
  • CoolSculpting Face
  • CoolSculpting Neck Fat
  • CoolSculpting Buttocks

CoolSculpting Pros and Cons

Let’s now understand the benefits and disadvantages of CoolSculpting in detail.

CoolSculpting Benefits

  • CoolSculpting is non-invasive without involving anesthesia, needles, or painful recovery time.
  • The treatment has a high safety profile when performed by a trained healthcare professional following ethical guidelines.
  • CoolSculpting offers customized fat reduction on specific body parts like the abdomen, thighs, or under the chin.
  • Overall weight loss with CoolSculpting could be achieved by targeting each body parts and not as a whole.
  • Due to minimal CoolSculpting downtime, individuals can return to their regular life activities immediately following the procedure.
  • Results after a CoolSculpting procedure develops gradually over a period of two to four months, offering a more natural transformation to the individual.

CoolSculpting Disadvantages

  • CoolSculpting is on the expensive side where the cost ranges from $2,000 to $4,000 depending on the area treated.
  • During the process, the individual might experience sensations like pulling, tugging, or pinching which can cause a temporary discomfort.
  • The procedure is not a complete weight-loss solution. It is only suitable for reducing localized fat deposits.
  • CoolSculpting results are not uniform. Some individuals may require multiple CoolSculpting sessions for optimal outcomes.

CoolSculpting Side Effects and Risks

Despite the fact that body CoolSculpting is often seen as a safe and non-invasive process, it’s crucial to remember that every medical procedure involves some level of risk or adverse reactions. We’ll go into detail about the variety of side affects people experience, following CoolSculpting sessions.

Common Side Effects

Like any other medical procedure, individuals undergoing body CoolSculpting may experience certain side effects. They are:

Redness and Swelling

The individual may notice redness and swelling in the treated area right away after the treatment. Usually, this is only a transitory problem that goes away in a few hours to a few days.

Bruising

Some people develop bruises as a result of the applicator’s suction. This usually goes away after a week.

Feeling Tingly and Numb

Temporary numbness or tingling feelings may result from the cooling process, but they will eventually go away when the area gets back to its usual temperature.

Mild Pain and Discomfort

Some people claim to experience a slight soreness, pain, or cramping in the treated area. The majority of the time, over-the-counter painkillers are adequate to treat these symptoms.

Less Common Side Effects

There are few less common side effects of CoolSculpting reported by some individuals. Let’s check out them.

Itching or Skin Sensitivity

Some people could itch more or have more sensitive skin. Topical treatments can help you manage these symptoms because they are typically transient.

Body Cramping

Muscle cramps could occasionally happen before, during, or after the procedure. Typically, this is short-lived and goes away on its own.

Serious Side Effects

Though rare, there can be side effects like paradoxical adipose hyperplasia, where the treated fat cells grow larger instead of being eliminated.

Paradoxical Adipose Hyperplasia (PAH)

PAH is the severe side effect of CoolSculpting, where the treated fat cells enlarge instead of shrinking. Want to know more on PAH? Continue your reading.

Freeze Burns

Patients have described freeze burns or first-degree frostbite in extremely unusual circumstances. Typically, malfunctioning devices or incorrectly delivered treatment causes free burns and resulting complications.

Scarring, Skin Discoloration and Hyperpigmentation

Although extremely rare, some individuals may experience scarring, changes in skin color or skin pigmentation in the treated area.

Allergic Reaction

Though CoolSculpting doesn’t involve any injectable, the gel pad or applicator may trigger an allergic skin reaction in some individuals.

How to address the side effects of CoolSculpting?

To lessen swelling and discomfort following the treatment, the professional treating you could suggest giving the treated region a little massage. Ibuprofen and other over-the-counter painkillers can assist with mild discomfort or cramps. Topical creams or cold compresses can provide relief for symptoms of the skin, such as minor irritation or itching.

Consult your healthcare professional for an in-depth evaluation and the best course of treatment for any symptoms that are severe or becoming worse.

CoolSculpting- The Top Ten FAQs

Let’s try to answer the common FAQs of people who think of undergoing CoolSculpting for fat reduction.

Before that what you have to understand that, we are trying to give you the best possible answers, based on the latest study reports. Your safety is our priority and this blog is not a medical opinion for any one who wish to proceed with CoolSculpting or had already undergone a session.

  1. Can CoolSculpting cause cancer?

There are no research studies indicating that CoolSculpting can trigger or cause cancer. However, it’s not advisable for cancer patients to consider this procedure for body toning.

  1. Can CoolSculpting tighten loose skin?

Fat-freezing is not primarily employed to increase the firmness of the skin as it is a procedure for lowering subcutaneous fat. Tighter skin emerges from the irritation that CoolSculpting produces. It is advisable for patients to opt different cosmetic procedures that combine with fat-freezing procedures for firmer skin.

  1. Is CoolSculpting safe and effective?

As discussed above, like any other medical procedure, CoolSculpting is not 100 percent safe and effective. Side effects or results may vary from one person to the other depending upon the factors like

  • Age
  • Gender
  • General health condition
  • Level of fat deposition
  • Area to be treated
  • Expertise of the healthcare professional
  1. Is CoolSculpting permanent or temporary?

As the fat cells are frozen, technically, CoolSculpting is permanent. However, it is quite feasible for existing fat cells to grow and for weight to be gained again if a patient does not maintain a consistent weight and a healthy lifestyle. The effects of CoolSculpting will endure a long time if you can maintain healthy food habits and weight.

  1. How many CoolSculpting treatments are needed?

The quantity of extra fat in the targeted areas has the biggest impact on how many CoolSculpting body contouring treatments you will require. You might require four to six treatment sessions if there is a particularly fat-prone area of your body. The number of locations and the size of the areas you want to treat are additional factors that will influence the number of sessions you need.

  1. Why is CoolSculpting so expensive?

Depending on the targeted body part and other factors, CoolSculpting rates for a single session can cost from $600 to more than $1,000. CoolSculpting prices are high because of the cost of the machinery involved and the professionals are exclusively trained to carry out this procedure.

The cost will be less when the treatment area requires fewer applicators and sessions. The total cost of CoolSculpting will rise if more body parts are treated. The cost also varies depending on the applicator used which is variable for different body parts.

  1. Can CoolSculpting cause blood clots?

Yes, rarely in some patients CoolSculpting leads to minor or even severe blood clots. Patients with any blood-related conditions should discuss the possibility of blood clot before undergoing the procedure.

  1. Can CoolSculpting be done at home?

No, simply applying ice packs on your skin will not provide any fat freezing as it cannot maintain consistent freezing temperature and also suction. Moreover, it can result in freeze burns and other complications.

  1. Can CoolSculpting be covered by insurance?

No, insurance seldom pays for CoolSculpting, like it does for many cosmetic procedures. If you go for numerous sessions, you might be eligible for a payment package plan or discounts.

  1. Who should avoid CoolSculpting?

You should avoid CoolSculpting procedure if you are someone with

  • Loose and poor skin tone
  • Nerve problems
  • Rashes or lesions
  • Cryoglobulinemia, where abnormal proteins in your blood thicken in cold temperatures
  • Cold urticarial, a skin condition that causes skin hives at extreme cold temperatures
  • Paroxysmal cold hemoglobinuria, a type of anemia that destroys red blood cells in response to cold temperatures
  • Raynaud’s phenomenon, where the blood flow to the fingers gets affected due to cold.
  • Varicose veins

Pregnant women and individuals who are obese should also avoid considering a CoolSculpting session.

What is Paradoxical adipose hyperplasia (PAH)?

PAH or “stick of butter” effect is a condition only known to occur following a cryolipolysis such as CoolSculpting body sculpting therapy. Of the 1.5 million CoolSculpting procedures performed globally, the incidence of paradoxical adipose hyperplasia is estimated to be 0.0051%.

What are the signs of PAH after CoolSculpting?

PAH causes the treated area to progressively enlarge. It occurs when a reactionary mechanism in the fatty tissue is triggered by the freezing stimulus. It causes the fat cells to thicken and expand rather than disintegrate and enable the body to metabolize and eliminate them.

A sizable, firm, and often painless lump beneath the skin in the treatment area can result from the problem. Additionally, a change in body weight could be apparent.

Hardened fat deposits can negatively impact one’s quality of life and general mental health.

For early signs of paradoxical adipose hyperplasia to appear, it might take nearly six months, or for some people, within a few days after treatment, to develop.

  • Agonizing puffiness
  • Widespread enlargement
  • Solid bumps on the treated area
  • bulkiness in the treated area

CoolScuplting Injuries and Side Effects

After Linda Evangelista made her lawsuit against CoolScuplting public in 2021, the FDA received 1,100 reports of unfavorable outcomes from the procedure. In 2022, the number increased to 1,900. Majority of the reports were focusing PAH.

Are you injured after CoolSculpting? Check out the steps to be followed.

  1. Consult your physician immediately.
  2. Report to the relevant authority like the FDA MedWatch.
  3. Document your injuries or symptoms.
  4. Consult a CoolSculpting injury lawyer for a case evaluation.

CoolSculpting Lawsuit

Victims suffering from the side effects and injuries of CoolSculpting process can file a lawsuit against the manufacturer of the device and also the heath care professional for any negligence.  There are many legal grounds such as defective design, failure to warn, negligence etc. for such lawsuits. The statute of limitations to file a CoolSculpting lawsuit is 1-2 years, depending on the state.

Damages Covered in CoolSculpting Lawsuits for PAH Victims
  • Medical expenses, including corrective surgeries for PAH.
  • Lost wages, especially for victims such as models whose physical appearance influences their job
  • Pain and suffering.
Is there a Cool-Sculpting class action lawsuit?

As of now, there aren’t any class action lawsuits filed against Zeltiq CoolSculpting. However, there is a pending class action lawsuit filed in the northern district of California, hoping to get compensation for the people who are affected by PAH after undergoing the CoolSculpting. Every individual who has suffered due to coolsculpting failures FVhas the right to file a personal injury lawsuit with the support of an expert attorney.

Zeltiq CoolSculpting Lawsuits

Let’s get to knwo the complete story of Linda Evangelista’s CoolSculpting story. The celebrity underwent seven sessions of CoolSculpting in a dermatologist’s office from August 2015 to February 2016. Within three months after the treatment, she started noticing bulges at her chin, thighs and bra area. She reported that the treatment areas started suddenly growing and hardening which then, turned numb.

She started intensive dieting and exercising without understanding that CoolSculpting problems had started haunting her life. In June 2016, she was diagnosed with Paradoxical adipose hyperplasia (PAH). The shocking truth she had to accept was that there was no exercise or diet to fix her condition.

In September 2021, the supermodel filed a $50 million lawsuit against Zeltiq Aesthetics, the parent company of CoolSculpting, alleging that the procedure had “brutally disfigured” her. Evangelista claimed that prior to having CoolSculpting, she was not informed about the possible risk.

The lawsuit claimed that the company was aware of the potential risks linked to PAH, a serious side effect of CoolSculpting, as early as 2013. They even mentioned this in a report to their investors, indicating they knew the procedure might not be safe for everyone. The big question was, did they make sure to tell Evangelista and other patients about this risk clearly enough?

Standing firm, Zeltiq argued that they did indeed warn Evangelista through the paperwork she signed before the procedure, where the possibility of experiencing PAH was mentioned along with other potential side effects. They defended that they have stood by the law, sticking to all legal timelines and correctly using terms like “safe and effective” to describe their procedure.

A spokesperson for CoolSculpting provided a statement from the company as follows.

“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.”

The spokesperson added that a warning about rare side effects, including paradoxical hyperplasia, is included in the complete safety information, a link to which can be found on the website for 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.” The condition won’t go away on its own, it reads, adding, “Surgical intervention may be required.”

In 2022, the celebrity settled the CoolSculpting PAH lawsuit for an undisclosed settlement amount. “I’m pleased to have settled the CoolSculpting case,” “I look forward to the next chapter of my life with friends and family, and am happy to put this matter behind me.” She posted in her Instagram.

Apart from Evangelista, Zeltiq has been the target of legal action from many CoolSculpting victims. In federal court, many individuals have asserted that they also encountered unfavorable side effects from the same procedure.

On August 27, 2021, the FDA issued a CoolScuplting Elite System recall. Class II was assigned to the recall, indicating that using or being exposed to the system could result in health consequences.

Recently, the Eleventh Circuit court ruled in favor of Zeltiq Aesthetics, Inc., stating that the healthcare provider’s misunderstanding of a side effect didn’t make the product’s warning insufficient. This decision upheld Zeltiq’s earlier win in the court, defending itself against claims of inadequate warning and design flaws in their CoolSculpting device.

To conclude,

In recent years, cosmetic procedures, especially, painless techniques had gained high popularity in the United States. However, like with many cosmetic procedures, CoolSculpting is also prone to side effects and complications, leading to a growing number of CoolSculpting lawsuits.

It casts a shadow of doubt and concern over the CoolSculpting industry. CoolSculpting disfigurement and the emerging CoolSculpting lawsuits also bring to light the importance of stringent regulations and standards to which clinics must adhere to ensure the safety and wellbeing of their clients.

However, it is up to the clients to be fully aware of the potential risks associated with CoolSculpting before deciding to undergo the treatment. People should conduct diligent research, consulting with certified and experienced practitioners who prioritize client safety over profits.

It is not just about choosing a facility that offers CoolSculpting but individuals should understand about the potential risks associated with such cosmetic procedures.

CoolSculpting lawsuits are sounding an alarm, encouraging people to be more careful when choosing such procedures. It also warns the companies to transparently disclose to the public about any risks or side effects involved.

Before one choose to walk the path of CoolSculpting, it is critical to weigh the pros and cons, to make an informed decision rooted in awareness. This could potentially save people from becoming victims and getting added in the growing list CoolSculpting lawsuits.

Is the pursuit of aesthetic perfection worth the potential risks, including the alarming rise in CoolSculpting lawsuits? Stay tuned with us for timely updates on Coolsculpting lawsuits 2024.

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MedLegal360 is a specialized author in medical-legal matters, providing clear, authoritative insights on healthcare legislation and personal injury litigation for professionals and the curious.

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