Uses:
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.

Important safety information:

During the procedure patients may experience sensations of pulling, tugging, mild pinching, intense cold, tingling, stinging, aching and cramping at the treatment site.13 These sensations subside as the area becomes numb.13

Following the procedure, typical side effects include redness, swelling, blanching, bruising, firmness, tingling, stinging, tenderness, cramping, aching, itching, skin sensitivity and numbness. Numbness can persist for up to several weeks. A sensation of fullness in the back of the throat may occur after submental treatment. The following rare and very rare side effects have the following incidence rates (approximate occurrences per number of treatments): paradoxical hyperplasia (1/3000 [0.033%]); late-onset pain (1/6000 [0.017%]); severe pain (1/6000 [0.017%]); hyperpigmentation (1/11000 [0.009%]); freeze burn (1/15000 [0.006%]); treatment area demarcation (1/20000 [0.005%]); vasovagal symptoms (1/30000 [0.003%]); subcutaneous induration (1/30000 [0.003%]); cold panniculitis (1/60000 [0.002%]) and hernia (1/185000 [0.001%]).13,15 The CoolSculpting® procedure is not for everyone. Patients should not have the CoolSculpting® procedure if they suffer from cryoglobulinaemia, cold agglutinin disease or paroxysmal cold haemoglobinuria.13 The CoolSculpting® procedure is not a treatment for obesity.14 CoolSculpting® is not a weight loss procedure and should not replace a healthy diet and active lifestyle.

Please see CoolSculpting®  and CoolSculpting Elite®  Important Safety Information for additional information.

Effect of treatment varies with individuals

References:

  1. Medical Insight Inc. The Global Aesthetic Market Study: Version XVII. 2019
  2. All time International Cycles Summary_040621. Data sourced from Connect Cube database [provided by International Business Excellence]. May 2021.
  3. Manstein D et al. Lasers Surg Med 2008; 40: 595-604
  4. Zelickson B, et al. Derm Surg 2009; 35:1462-70
  5. Allergan Inc. Unpublished Data. CoolSculpting® Publications. INT-CSC-2050471. December 2020.
  6. Sasaki GH, et al. Aesthet Surg J 2014; 34:420–31
  7. Allergan. Unpublished data. INT-CSC-2050028. CoolSculpting® clinical “Fit and Function” study to test the V003 wells. February 2020.
  8. Allergan. Unpublished data. INT-CSC-2050288. Applicator cooling and distribution dye test. August 2020.EN-A.
  9. Allergan. CoolSculpting® system (CoolSculpting® ELITE) user manual. CS-UM-CM3-04-EN-A. 2020.
  10. Manstein D et al. Lasers Surg Med 2008; 40: 595-604
  11. Avram MM and Harry RS. Lasers Surg Med 2009; 41:703-8
  12. Krueger N, et al. Clin Cosmet Investig Derm 2014; 7:201-25
  13. Allergan, CoolSculpting® System User Manual. BRZ-101-TUM-EN6-K
  14. FDA 510(K) Summary Document. Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf19/K193566.pdf [Accessed November 2021].
  15. Allergan Inc. US CoolSculpting® Important Safety Information. November 2021. Available at: https://www.coolsculpting.com/pdfs/CSC125713-v3-CoolSculpting-Important- Safety-Information.pdf [Accessed November 2021]