Is CoolSculpting Safe? Risks, Benefits & FDA Approval

Transformation Talk / Blog

Is coolSculpting a safe procedure for fat reduction?

CoolSculpting, a non-invasive fat removal procedure, has gained significant popularity as a safe and effective treatment and a nonsurgical alternative to liposuction. It uses controlled cooling, also known as cryolipolysis treatment, to target and eliminate stubborn pockets of fat, helping individuals refine their body contour and achieve their desired shape. In this article, we’ll examine the medical procedure’s safety profile, its FDA approval, potential side effects, and key considerations to ensure a safe and successful treatment experience.

Fit couple holding hands and walking on the beach, showcasing toned bodies and confidence after body sculpting.

CoolSculpting FDA Approval & Clinical Studies

CoolSculpting, developed by Zeltiq Aesthetics, received FDA clearance in 2010 as a non-invasive procedure for fat reduction in specific body regions. This clearance confirms that the cryolipolysis procedure underwent extensive clinical evaluation and demonstrated both safety and effectiveness.

More than 100 clinical studies have examined the procedure, reporting positive outcomes with only minor side effects, which reinforces its strong safety profile.

Since its initial clearance, ongoing clinical research and technology enhancements have advanced CoolSculpting as a medical device, improving both technique and results while continuing to meet the highest standards for cosmetic procedures.

Now performed globally, with over 13 million fat reduction procedures completed since 2010, CoolSculpting maintains a reputation for consistent and safe outcomes.

Safety of CoolSculpting Treatment

  • Non-Invasive Nature: One of the main advantages of CoolSculpting is that it’s a nonsurgical procedure. Unlike invasive procedures such as tummy tucks or liposuction procedures, CoolSculpting requires no incisions, anesthesia, or downtime, which greatly reduces the risk of complications and allows patients to resume normal activities quickly.

  • Controlled Cooling: The treatment uses intense cold through a process called cryolipolysis to freeze and eliminate fat cells while preserving surrounding tissue. The technology targets fatty tissue selectively, ensuring the fat removal procedure doesn’t damage skin, nerves, or other structures.

  • Common Side Effects: While generally safe, CoolSculpting can cause typical side effects such as temporary redness, bruising, numbness, swelling, and mild discomfort in the treated areas. These minor side effects usually resolve on their own within a few days after treatment or weeks after surgery, depending on the individual response.

  • Rare Complications: Severe side effects are uncommon. However, a rare condition known as paradoxical adipose hyperplasia may occur, where fat bulges increase instead of decrease. This adverse effect results in an unexpected enlargement of localized pockets of fat and may require follow-up procedures for correction.

This rare issue has been largely addressed through advancements in CoolSculpting technology. In 2020, Allergan now the parent company released CoolSculpting ELITE, which significantly lowered the incidence of adipose hyperplasia. By 2022, they also withdrew older applicator devices from circulation due to their higher risk profile, making today’s treatments even safer.

Other potential side effects are discussed during the consultation. To minimize potential risks, it’s essential to meet with an experienced provider who will review your medical condition, assess your body type, and develop an individualized treatment plan. Following all preparation and aftercare instructions ensures optimal safety and results.

So is CoolSculpting really safe?

CoolSculpting has earned its reputation as a safe and effective non-invasive fat reduction procedure, supported by FDA approval and numerous clinical studies. Using controlled cooling through cryolipolysis, it targets fat deposits while avoiding the surgical risks and extended recovery time typical of invasive procedures. Though minor side effects like temporary numbness or redness may occur, they are usually short-term side effects that resolve on their own. More serious adverse side effects, such as paradoxical adipose hyperplasia, remain extremely rare.

To ensure safety and optimal results, it’s crucial to choose a qualified medical provider or CoolSculpting-certified medspa with an experienced provider who can evaluate your body type, review any medical conditions, and create an individualized treatment plan. With proper screening, expert guidance, and post-procedure care, CoolSculpting can help you refine your body contour with minimal pain, low risk, and high satisfaction.

Which CoolSculpting Provider Should you choose?

CoolSculpting is offered at many locations, including dermatology clinics, plastic surgeons’ offices, and luxury MedSpas. Selecting the right provider is key to achieving the best results, as experience plays a major role in effective fat removal procedures. At Sculpted Contours, we’ve performed over 12,000 CoolSculpting treatments since 2014, making us a trusted name in nonsurgical body contouring. 

Our team is led by a former CoolSculpting trainer who delivers continuous clinical training to our licensed medical professionals. She also performs detailed assessments and creates an individualized treatment plan for each patient, ensuring natural-looking body contour results that match your unique shape.

HOW MUCH DOES COOLSCULPTING COST?

CoolSculpting ELITE pricing varies based on the number of areas treated and sessions required. At Sculpted Contours, our exclusive 150-Day Unlimited Program makes it more affordable than ever. You can treat two areas like your upper and lower abdomen or inner and outer thighs for just $1,760.

Additional areas can be added for only $560 each, and repeat treatments in the same area can go as low as $320 per session. Pricing varies by applicator size and your individualized treatment plan.

With over 13,000 procedures performed, our experienced team designs advanced protocols for natural, sculpted results. Don’t settle for less experience matters when it comes to achieving the best body contouring outcomes.

Schedule Your CoolSculpting Consultation with us

During your consultation, we’ll review your medical history to ensure that CoolSculpting is a safe option for you. Certain medical conditions, including adverse health conditions or autoimmune conditions, may exclude you from being a candidate but don’t worry, we offer other nonsurgical alternatives if needed.

Next, you’ll show us the body regions you’d like to slim down. We’ll measure each area and determine which applicator device combinations best target your stubborn pockets of fat, designing a customized treatment plan that delivers natural-looking body contouring results tailored to your body type.

Soon after, you’ll be relaxing in our luxury CoolSculpting suite while those unwanted fat cells are frozen through our advanced cryolipolysis procedure. Within a few weeks after treatment, you’ll start noticing a slimmer silhouette, with full results appearing around 3 months later. In some cases, a second session helps fine-tune your final, contoured look.

Call us at 404-872-8578

You can call our luxury Alpharetta MedSpa and schedule your consultation appointment or complete the online consultation request form at the bottom of this page and we’ll get your appointment set.  

You are one step closer to a slimmer you with CoolSculpting at Sculpted Contours Luxury Medical Aesthetics and we can’t wait to see your final results!  

TRUST YOUR RESULTS TO THE EXPERTS!

CALL TO SCHEDULE YOUR CONSULTATION TODAY 404.872.8578

Frequently Asked Questions

CoolSculpting uses cryolipolysis, a non-invasive technique that exposes fat cells to intense cold, causing cell death without harming surrounding tissue. These dead cells are then naturally eliminated by the body over several weeks. The procedure targets localized pockets of fat resistant to diet and exercise, helping refine your body contour without surgery or downtime.

During treatment, you may feel a pulling sensation as the applicator device suctions the area, followed by intense cold. Some patients report tingling, stinging, or numbness, but these feelings typically fade as the area becomes numb. The experience is well-tolerated and requires no anesthesia or incisions.

CoolSculpting is generally well-tolerated and involves minimal pain. You might experience mild discomfort at the start due to the cold temperature and suction. After the procedure, temporary tenderness or skin sensitivity may occur, but these effects are typically short-term side effects that resolve on their own.

Yes, minor side effects like redness, swelling, bruising, numbness, and skin sensitivity can occur in the treated area. These typical side effects are temporary and usually fade within a few days after treatment. Your provider will discuss all potential side effects during your consultation.

While CoolSculpting is safe for most people, rare adverse effects can occur. The most serious is paradoxical adipose hyperplasia, where fat bulges grow instead of shrink. Though uncommon, this adverse side effect may require further treatment. Additionally, results may vary based on body type, and some individuals may need multiple sessions for optimal outcomes.

CoolSculpting is not suitable for individuals with certain medical conditions, including cold urticaria, cryoglobulinemia, cold hemoglobinuria, or those with severe chronic pain conditions or autoimmune disorders. Pregnant individuals and those seeking a treatment for obesity or weight loss (not body contouring) should consider alternative options.

Yes, CoolSculpting is a nonsurgical procedure with minimal downtime. Most people resume normal activities immediately after their session. You may feel some mild discomfort or numbness, but these don’t typically interfere with your exercise routine or daily tasks. It’s an outpatient procedure designed for convenience and recovery ease.

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