CoolSculpting® and CoolSculpting® Elite Indications
CoolSculpting® and CoolSculpting® Elite are FDA-cleared for the treatment of visible fat bulges in the thigh, abdomen, and flank, along with bra fat, back fat, underneath the buttocks (also known as banana roll), and upper arm in patients with a Body Mass Index (BMI) of ≤ 30 and in submental and submandibular areas in patients with a BMI of ≤ 46.2. It is also FDA-cleared to affect the appearance of lax tissue with submental area treatments.
CoolSculpting® and CoolSculpting® Elite Important Safety Information
CoolSculpting® and CoolSculpting® Elite are contraindicated in patients with cryoglobulinemia, cold agglutinin disease, or paroxysmal cold hemoglobinuria.
Ask your patient about any medical conditions including recent surgery, pre-existing hernia, and any known sensitivities or allergies.
During the procedure patients may experience sensations of pulling, tugging, mild pinching, intense cold, tingling, stinging, aching, and cramping at the treatment site. These sensations subside as the area becomes numb. Following the procedure, typical side effects include temporary redness, swelling, blanching, bruising, firmness, tingling, stinging, tenderness, cramping, aching, itching, or skin sensitivity, and sensation of fullness in the back of the throat after submental or submandibular area treatment.
Rare side effects may also occur. Paradoxical hyperplasia (visibly enlarged tissue volume in the treated area) may develop 2 to 5 months after treatment and requires surgical intervention for correction.
As with any medical procedure, a consultation should be done by a licensed healthcare professional to determine if the patient is a candidate for treatment. For a complete list of Contraindications, Warnings, Precautions, and Potential Side Effects, consult the CoolSculpting® System User Manual and the CoolSculpting® Elite System User Manual. Treatment applications that deviate from the guidelines are not recommended.
References: 1. Avram MM, Harry RS. Cryolipolysis for subcutaneous fat layer reduction. Lasers Surg Med. 2009;41(10):703-708. 2. Data on file, Allergan. Zeltiq Study Report TR-415.1. 3. Klein K, Zelickson B, Riopelle JG, et al. Non-invasive cryolipolysis for subcutaneous fat reduction does not affect serum lipid levels or liver function tests. Lasers Surg Med. 2009;41:785-790. 4. Data on file, Allergan, June 15, 2020; International CoolSculpting® Prospective Multi-Country Study to Evaluate Subject Satisfaction for Non-Invasive Fat Reduction in Abdomen and/or Flanks (iCOOL) Clinical Study Report.