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CoolSculpting® and CoolSculpting® Elite are FDA-cleared for the treatment of visible fat bulges in the submental (under the chin) and submandibular (under the jawline) areas, thigh, abdomen, and flank, along with bra fat, back fat, underneath the buttocks (also known as banana roll), and upper arm. It is also FDA-cleared to affect the appearance of lax tissue with submental area treatments. CoolSculpting® and CoolSculpting® Elite are not treatments for weight loss.
Indications and Important Safety Information for CoolSculpting® Elite
CoolSculpting® Elite is 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.
Important Safety Information
CoolSculpting® Elite is 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® Elite System User Manual. Treatment applications that deviate from the guidelines are not recommended.