FDA APPROVAL COOLSCULPTING
The most important thing about a treatment is that it is safe and provides results. The cryolipolysis method performed with the CoolSculpting device has an FDA (the American Food & Drug Administration) approval. That is, independent clinical research shows that a treatment does what it promises. FDA approval is a guarantee that a treatment works and produces results and is safe: the definitive removal of fat cells without surgery, without injections, without anesthesia and without a long recovery period. On average, 20% of the fat cells disappear after just one cryolipolysis treatment. The scientific studies into cryolipolysis have been carried out with this CoolSculpting device. On this basis, CoolSculpting by Allergan is the only one to receive FDA approval for cryolipolysis: the removal of fat cells by means of cooling.
SCIENTIFIC STUDIES
An overview of all independent and commercial studies on cryolipolysis performed with the CoolSculpting device from Allergan on the PubMed website:
http://www.ncbi.nlm.nih.gov/pubmed/23858510
Learn more about the safety and effectiveness of CoolSculpting on Allergan’s website:
http://www.coolsculpting.com/for-physicians/faqs/
REFERENCES
- Manstein D, Laubach H, Watanabe K, Farinelli W, Zurakowski D, Anderson R. Selective cryolipolysis: a novel method of non-invasive fat removal. Laser Surg Med. 2008,40:595-604.
http://www.ncbi.nlm.nih.gov/pubmed/18951424 - Zelickson B, Egbert BM, Preciado J, Allison J, Springer K, Manstein D. Cryolipolysis for noninvasive fat cell destruction: initial results from a pig model. Poster presented at 2008 Annual Meeting of the American Society for Dermatologic Surgery; Nov 6-9 2008; Orlando, Fla.
http://www.ncbi.nlm.nih.gov/pubmed/19614940 - Coleman SR, Sachdeva K, Egbert BM, Preciado J, Allison J. Clinical Efficacy of Noninvasive Cryolipolysis and Its Effects on Peripheral Nerves. Aesthetic Plastic Surg 2009; 33(4):482-8
http://www.ncbi.nlm.nih.gov/pubmed/19296153 - Dover J, Burns J, Coleman S, Fitzpatrick R, Garden J, Goldberg D, Geronemus R, Kilmer S, Mayoral F, Tanzi E, Weiss R, Zelickson B. A Prospective Clinical Study of Noninvasive Cryolipolysis for Subcutaneous Fat Layer Reduction – Interim Report of Available Subject Data. Lasers in Surgery and Medicine 2009; 41:S21:43.
- Klein K, Zelickson B, Riopelle JG, Okamoto E, Bachelor EP, Harry RS, Preciado JA. Non-Invasive Cryolipolysis for Subcutaneous Fat Reduction Does Not Affect Serum Lipid Levels or Liver Function Tests. Lasers in Surgery and Medicine 2009; 41:785-790.
