CoolSculpting® and CoolSculpting® Elite Important Information
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.
Important Safety Information
CoolSculpting® and CoolSculpting® Elite are contraindicated in patients with cryoglobulinemia, cold agglutinin disease, or paraoxysmal cold hemoglobinuria.
Ask you patient about any medical conditions including pregnancy, recent surgery, pre-existing hernia, and any known sensitivities or allergies. Avoid treatments near/over implants, such as pacemakers, defibrillators, breast or buttock implants.
During the procedure patients may experience sensations of pulling, tugging, mild pinching, intense cold, tingling, stinging, aching, cramping, and discomfort at the treatment site. These sensations subside as the area becomes numb. Following the procedure, typical side effects include temporary redness, swelling, blanching, brusing, firmness, stinging, tenderness, cramping, skin inflammation, and aching. Sensory alteration (itching, skin sensitivity, tingling, and numbness) can persist up to several weeks after treatment. Patients may also experience throat discomfort/soreness and sensation of fullness in the back of the throat after submental or submadibular 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, will not resolve on its own, and may require 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.
