Is Fat-Freezing and Non-Surgical Body Sculpting Safe? The Cold Truth about Cryolipolysis and Paradoxical Adipose Hyperplasia (PAH)

Former supermodel, Linda Evangelista recently revealed that she was the victim of a rare side effect after undergoing seven rounds of cryolipolysis. According to the lawsuit filed against CoolSculpting manufacturer, Zeltiq Aesthetics (at the time of treatment, now Allergan Aesthetics, an Abbvie Company), Evangelista was diagnosed with paradoxical adipose hyperplasia, or PAH–a rare complication in which fat cells grow instead of shrink. This leaves the affected area hardened and visibly enlarged, bearing the shape of the applicator used during the treatment.

What is cryolipolysis? 

Fat cells are more affected by temperature changes than the endothelial cells of your skin. By freezing the fat, cryolipolysis effectively eliminates fat from your body. This quick and relatively painless procedure is becoming increasingly popular worldwide. 

Controlled cooling targets localized fat in hard-to-reach areas of weight loss such as the lower and back, chin, stomach, inner thighs, and back of the arms. The procedure itself is completed within hours and has low down time, usually allowing patients to return to work within the same day. Other benefits include:

• Avoids scarring and stitches by using your body’s natural processes to remove the fat
• Achieves natural-looking results that are visible after 1 session
• Improves quality of life by removing unhealthy fat and increasing self-confidence

What are the top body contouring devices that use cryolipolysis? 

There are a variety of reputable machines on the market that offer excellent results. The the top two devices in the United States are:

1. CoolSculpting® and CoolSculpting® Elite by Allergan Aesthetics, an AbbVie Company
2. Sub-Z designed by Zimmer exclusively for Cartessa Aesthetics

With the proper device, technique, and fat freezing aftercare, side effects are reduced. However, as with any medical procedure, providers must be privy to and prepare for potential adverse events such at PAH.

As a provider, how do I prevent PAH?

 

According to a 2014 study in JAMA Dermatology, PAH is estimated to occur in 0.0051% of the 1.5 million individuals who have had CoolSculpting. This means, about 1 in 20,000 patients treated will develop PAH. While no risk factor has yet to be determined, the study notes that this phenomenon seems to be more prevalent in male patients. 

“While there is little information about its treatment, this rare, but serious, adverse event can be remedied…:”

While there is little information about its treatment, this rare, but serious, adverse event can be remedied with liposuction. In fact, Allergan reimburses patients who have experienced cryolipolysis-induced PAH from their CoolSculpting device.  A 2018 study published by the Journal of American Society of Plastic Surgery, recommends delaying surgical treatment for 6 to 9 months after a fat freezing procedure, allowing the affected adipose tissue to soften. In some cases, abdominoplasty is performed in conjunction with power-assisted liposuction.

What are the top body contouring devices that do not use cryolipolysis?

There are a variety of body contouring and body sculpting devices that deliver effective results without surgery and cryolipolysis. Several of these machines utilize alternate pathways such as heat, radio frequency, ultrasound, and even vacuum technology to reduce body fat, increase muscle tone, and improve skin texture. Check out the most popular body contouring devices below:

1. VelaShape III by Candela Medical – combines vacuum technology with infrared light and bi-polar radio frequency (RF) to gently heat fat cells and surrounding tissues, reducing the number of treatment sessions by up to 75% 
2. UltraShape® Power by Candela Medical – gently destroys fat by delivering focused, pulsed, and selective non-thermal ultrasound energy waves
3. CoolTone® by Allergan Aesthetics, and AbbVie Company – uses AMP™ technology (Active Magnetic Pulse™) to strengthen, tone, and firm muscle from the outside in while also providing active recovery 
4. PHYSIQ by Cartessa Aesthetics – the first multi-modality body device that utilizes STEP technology (Sequential Thermal & Electrical Pulse) for the body by incorporating both electrical muscle stimulation (EMS) and a super luminescent diode matrix (SDM) to target both muscle and tissue in one single session
5. Emsculpt® and Emscult Neo® by BTL  – simultaneously emits both radio frequency (RF) and high intensity electromagnetic (HIFEM+) energies to reduce fat and build muscle in patients up to BMI 35
6. Emtone® by BTL – simultaneously emits both radiofrequency and targeted pressure energy to reduce cellulite, build elastin and collagen, and improve overall of skin appearance
7. Smartlipo® Triplex®, Cellulaze®, SculpSure®, and TempSure® Platform by Cynosure – A minimally invasive treatments body contouring, laser lipolysis, and cellulite reduction

How do I choose the right body contouring and body sculpting device for my practice?

“Having a good knowledge of the treatment and potential risks and side effects will equip you to make an informed decision about the right machine for your patients.”

Whether you already own a body contouring device or are interested in adding one to your practice, it is important to conduct your own background research into each device.

First, understand each device. Request a demo, call and speak with reps, read journal articles, and visit each manufacturer and distributor site. Having a good knowledge of the treatment and potential risks and side effects will equip you to make an informed decision about the right machine for your patients.

Second, take advantage of training programs to develop the skills necessary to use the equipment properly. This will enable you to have a detailed knowledge of the benefits your patients can expect to gain from each treatment when performed properly and how to manage any adverse reactions in the event they occur. Many distributors and manufactures offer virtual and live training programs throughout the year.

Last, invest in professional, high quality, and medical grade aftercare so you can empower your patients to maintain the best treatment outcome. Brands like Recovery Care Products specialize in laser and non-invasive aftercare kits that are ideal for most any procedure.

What should I know about patient paperwork?

Regardless of which device you choose to use, it is paramount to have the necessary paperwork and after-treatment protocols in place in the event you must deal with patient satisfaction issues.  A thorough intake questionnaire helps to identify appropriate patients for treatment but also helps the Provider to uncover red flags or contraindications for treatment. Additionally, a good intake process gives the practice a Glimpse into the psyche of the patient and can help shine a light on issues like BDD that may have long term consequences outside of the procedure. 

Also, ensure you have the appropriate consents available upfront so that Patients can make an informed decision about undergoing treatment. Additionally, the proper consent will also explain that, as a Practice, you can in no way guarantee results or predict the likelihood of an adverse event or reaction. In the event something goes awry, be sure you have things like your refund policy or patient satisfaction measures already defined so you can deal with the situation quickly and with empathy despite the escalation. 

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