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Cryolipolysis treatment is a noninvasive body sculpting procedure. It uses controlled cooling techniques, called Cryolipolysis, to freeze fat cells at a temperature tolerated by the skin, causing fat cells to die and re-digest into the body. Patients are typically treated by having a fatty area sucked into a Coolsculpting device via a vacuum applicator, then cooled. The procedure is cleared by the Food and Drug Administration, Health Canada and the European Union.
The CoolSculpting procedure is considered a safe, effective treatment that results in about 25 percent reduction in the patient's fat layer and has high rates of patient satisfaction.[1] Side effects include temporary bruising, pain, skin stiffness and a loss of sensitivity.[2]
It is most effective for reducing fat in the abdomen or flanks (sides).[2][a]
CoolSculpting systems are sold by ZELTIQ Aesthetics Inc. It earns revenue by selling systems and consumables and charging a fee for each treatment. The company raised $50 million in funding by 2005 and went public in 2011, raising $91 million.
It is based on Cryolipolysis, the process of cooling fat cells, causing apoptosis (shrinkage and eventual death).
Afterward the fat cells are consumed by macrophages in the body.[1]
Different shapes and types of applicator, as well as different programming in the CoolSculpting machine, are used for different areas of the body.[3] The patient experiences mild pain or discomfort for a few minutes until the area becomes numb.[4]
Typically an individual treatment lasts one hour[b] for each part of the body being treated and involves two treatments, eight weeks apart.[c] The number and duration of treatments vary depending on the treatment area and desired results.[7] Afterwards patients can resume normal activities, but may experience sores, itching, bruising, pain or numbness in the treated area for two weeks.[8][7]
and flushed out over the following several weeks or months.[4]
Efficacy
editIn 2008, doctors from the Wellman Center for Photomedicine experimented with what they called "selective cryolysis" on pigs using prototype CoolSculpting systems.[9] They found that a 30-60 minute cold exposure caused a 30-50 percent loss in a pig's fat layer over 90 days, without causing damage to skin tissue or nerves or causing changes in lipids.[10][11] Prior research had indicated that fat cells were more susceptible to cold than the surrounding tissue. For example, children that excessively suck on popsicles lose fat in their cheeks, a phenomenon known as "‘popsicle panniculitis’’.[9]
Human trials in 2009 using ultrasound measurements found that subjects lost fat cells over 2-3 months following cold exposure. A trial with eight patients resulted in a median reduction in the fat layer of 20.4 percent two months after treatment, whereas a larger trial with 32 subjects found a 22.4 percent reduction after four months.[2][11] In a 2009 study of ten subjects, patients experienced an average 25.5 percent reduction in the fat layer six months after treatment.[2] A 2013 evaluation of 518 patients found an average 23 percent reduction in the fat layer.[2]
The CoolSculpting procedure is ideal for localized discrete fat bulges,[12]
The 518-patient study reported that flanks (sides) and abdomen (stomach) treatments were effective 85.5 percent of the time, while thighs and buttocks treatments had marginal results.[2][d] At the time, these were the only treatment areas cleared by the FDA and any other area was considered off-label use.[7]
Adverse effects
editIn 2013, a study of 518 subjects found that patients experienced redness in the treated area 100 percent of the time, as well as temporary clay-like (52%) or stiff (48%) skin. Ninety-six percent of subjects reported some discomfort. In rare cases treatment caused fainting (2.1%), severe pain (4%) or bruising (9.8%). Most side-effects subsided in about 5 minutes.[2] No long-term side-effects were identified in any patients and adverse effects subsided without medical intervention.[2] A 2009 study found that one-third of ten subjects evaluated experienced a temporary loss in feeling in the treated area.[2] Two clinical trials in 2009 and 2012 found that the dying fat cells did not cause abnormal liver function or lipid levels in human or animal subjects.[12]
According to an article in Clinical, Cosmetic and Investigational Dermatology, out of non-invasive fat reduction techniques like radio, laser, and ultra-sound, cryolipolysis has been around the longest and is best studied through clinical trials.[8] Liposuction is the most common and effective means of removing fat from the body, but is an invasive procedure with significant risks and side effects, such as scarring, pain, infection, and long-term recovery periods.[13][14]
Reception
editA 2013 study of 518 CoolSculpting treatments found that 73 percent of patients were "satisfied" or "extremely satisfied" and 83 percent would recommend the procedure to a friend.[2] A study of 528 patients published in Aesthetic Surgery Journal said only about 1 percent of patients were dis-satisfied and all but one dis-satisfied client was satisfied after an additional CoolSculpting treatment was provided for free.[7] It also found that 76 percent of patients were women and 25 percent were men.[7] A 2011 study published in Laser Medical and Surgery Journal found that 80 percent of patients reported being satisfied six months after treatment.[12] The authors of the 528-patient study found that the majority of CoolSculpting patients had not previously had any cosmetic treatments and came in specifically for the CoolSculpting procedure. Forty percent of CoolSculpting patients returned to the same business for other procedures afterwards.[7]
Notes
edit- ^ The 2013 study found only marginal results for treatments in the thighs or buttocks. The following year, a CoolSculpting device was released that was specialized for thighs.
- ^ Treatment on the thighs lasts two hours.[5]
- ^ According to Zeltiq, the CoolSmooth thigh applicator can take up to four treatments.[6]
- ^ The following year after the study was published, a specialized device for thighs was released.
References
edit- ^ a b Sadick, Neil; Luebberding, Stefanie; Mai, Sophia V.; Krueger, Nils (2014). "Cryolipolysis for noninvasive body contouring: clinical efficacy and patient satisfaction". Clinical, Cosmetic and Investigational Dermatology: 201. doi:10.2147/CCID.S44371. ISSN 1178-7015.
{{cite journal}}: CS1 maint: unflagged free DOI (link) - ^ a b c d e f g h i j Dierickx, Christine C.; Mazer, Jean-Michel; Sand, Mila; Koenig, Sylvie; Arigon, Valerie (2013). "Safety, Tolerance, and Patient Satisfaction With Noninvasive Cryolipolysis". Dermatologic Surgery. 39 (8): 1209–1216. doi:10.1111/dsu.12238. ISSN 1076-0512.
- ^ Gordon, Jennifer (February 18, 2013). "Fat-freezing device may bring gradual results". St. Joseph News.
- ^ a b Fulmer, Melinda (August 16, 2013). "With cosmetic treatments, more men enlist in battle of the bulges". Los Angeles Times. Retrieved October 11, 2014.
- ^ "Does CoolSculpting Work?". ABC Channel 8 News. September 29, 2014. Retrieved October 30, 2014.
- ^ Cite error: The named reference
daufhiuhwas invoked but never defined (see the help page). - ^ a b c d e f Cite error: The named reference
StevensPietrzak2013was invoked but never defined (see the help page). - ^ a b Stevens, W. G.; Spring, M. A.; Macias, L. H. (2014). "Counterfeit Medical Devices: The Money You Save Up Front Will Cost You Big in the End". Aesthetic Surgery Journal. 34 (5): 786–788. doi:10.1177/1090820X14529960. ISSN 1090-820X.
- ^ a b Manstein D, Laubach H, Watanabe K, Farinelli W, Zurakowski D, Anderson RR. (2008). "Selective cryolysis: a novel method of non-invasive fat removal". Lasers Surg Med. 40 (9): 595–604. doi:10.1002/lsm.20719. PMID 18951424.
{{cite journal}}: CS1 maint: multiple names: authors list (link) - ^ Coleman, Sydney R.; Sachdeva, Kulveen; Egbert, Barbara M.; Preciado, Jessica; Allison, John (2009). "Clinical Efficacy of Noninvasive Cryolipolysis and Its Effects on Peripheral Nerves". Aesthetic Plastic Surgery. 33 (4): 482–488. doi:10.1007/s00266-008-9286-8. ISSN 0364-216X.
- ^ a b Klein, Kenneth B.; Zelickson, Brian; Riopelle, Jeffrey G.; Okamoto, Eric; Bachelor, Eric P.; Harry, Rosemary S.; Preciado, Jessica A. (2009). "Non-invasive cryolipolysis⢠for subcutaneous fat reduction does not affect serum lipid levels or liver function tests". Lasers in Surgery and Medicine. 41 (10): 785–790. doi:10.1002/lsm.20850. ISSN 0196-8092.
{{cite journal}}: C1 control character in|title=at position 28 (help) - ^ a b c Bernstein, Eric F (2013). "Longitudinal evaluation of cryolipolysis efficacy: two case studies". Journal of Cosmetic Dermatology. 12 (2): 149–152. doi:10.1111/jocd.12036. ISSN 1473-2130.
- ^ Sasaki, G. H.; Abelev, N.; Tevez-Ortiz, A. (2014). "Noninvasive Selective Cryolipolysis and Reperfusion Recovery for Localized Natural Fat Reduction and Contouring". Aesthetic Surgery Journal. 34 (3): 420–431. doi:10.1177/1090820X13520320. ISSN 1090-820X.
- ^ Garibyan, Lilit; Sipprell, William H.; Jalian, H. Ray; Sakamoto, Fernanda H.; Avram, Mathew; Anderson, R. Rox (2014). "Three-dimensional volumetric quantification of fat loss following cryolipolysis". Lasers in Surgery and Medicine. 46 (2): 75–80. doi:10.1002/lsm.22207. ISSN 0196-8092.