Fat removal procedures(Redirected from Cryolipolysis)
Fat removal procedures are used mostly in cosmetic surgery to remove unwanted adipose tissue. The procedure may be invasive, as with liposuction, or noninvasive, using laser energy, radiofrequency, ultrasound or cold (cryoablation) to reduce fat, sometimes in combination with injections.
These techniques are distinct from bariatric surgery, which aims to treat obesity by preventing people from eating too much or by interfering with the absorption of food during digestion, and are also distinct from injection lipolysis, in that these procedures are device-based, while injection lipolysis relies solely on injections that are marketed as causing lipolysis.
Liposuction is a type of cosmetic surgery that removes fat from the human body in an attempt to change its shape. Evidence does not support an effect on weight beyond a couple of months and it does not appear to affect obesity related problems. In the United States it is the most commonly done cosmetic surgery.
The procedure may be performed under general, regional, or local anesthesia. It then involves using a cannula and negative pressure to suck out fat. It is believed to work best on people with a normal weight and good skin elasticity.
Focused thermal ultrasound techniques work by raising the tissue temperature above 56 °C, resulting in coagulative necrosis of adipocytes, with sparing of vessels and nerves. Passive heating of the skin may also induce collagen remodeling.
Hydrolipoclasy is a technique that is being studied as an alternative to liposuction. It involves injecting a hypotonic solution into an area of fat and than subjecting it to ultrasound waves.
Low level laser lightEdit
Radiofrequency devices work by producing an alternating flow, which creates an electric field over the skin. The electric field shifts polarity millions of times per second, that causes a change in orientation of charged particles.
The method involves controlled application of cooling within the temperature range of +5 to -11 °C for the non-invasive, localized reduction of fat deposits, intending to reshape the contours of the body. The degree of exposure to cooling causes cell death of subcutaneous fat tissue, without apparent damage to the overlying skin. It appears primarily applicable to limited discrete fat bulges.  Adverse effects include transient local redness, bruising and numbness of the skin are common side effects of the treatment and are expected to subside. Typically sensory deficits will subside within a month. The effect on peripheral nerves was investigated and failed to show permanent detrimental results.
Based on the premise that fat cells are more easily damaged by cooling than skin cells. for example in popsicle panniculitis, cryolipolysis was developed to apply low temperatures to tissue via thermal conduction. In order to avoid frostbite, a specific temperature level and exposure are determined, such as 60 minutes at −5 °C (23 °F). While the process is not fully understood, it appears that fatty tissue that is cooled below body temperature, but above freezing, undergoes localized cell death followed by a local inflammatory response that gradually over the course of several months results in a reduction of the fatty tissue layer.
Typical cost per treatment area varies depending on location. Price in the US ranges from $750 to $1500, with UK prices about £750 per area to be treated. Treatment time for general use/application is 35–60 minutes per site, depending on the applicator used.
In September 2000, Zeltiq received EU CE Mark approval for their cryolipolysis device. In the U.S., the CoolSculpting procedure is FDA-cleared for the treatment of visible fat bulges in the submental area, 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.
In 2005, Meridian Co., a Korean company, and its North American licensee, Meridian Medical, a British Columbia company, received FDA marketing clearance for a laser device for fat reduction, the Lapex 2000; it was cleared by the FDA as an infrared lamp. and in 2008, a variant, the Lapex BCS, was cleared. Meridian Medical had been founded in 2004 by a Korean company called Meridian and had received an exclusive North American license for intellectual property of the parent company, which had originally developed the devices.
In 2010, Zerona, another low-level laster treatment, was cleared for marketing by the FDA as an infrared lamp and Zeltiq obtained FDA marketing clearance for cryolipolysis of the flanks, and in 2012 received marketingclearance for cryolipolysis of the abdomen.
Starting in 2010, the Korean company Meridian assigned US patents related to their fat reduction devices to a British Columbia company called "YOLO Medical". During this transition, the Lapex line was rebranded as the Yolo Curve. Strawberry, another infrared lamp device, was cleared by the FDA in 2013 SculpSure, another infrared lamp device, was cleared in 2015. Also in 2015, Yolo received marketing clearance for its Lipofina system.
Various lipolysis techniques including injection lipolysis, RF, laser, ultrasound, and cryolipolysis were forbidden in France by a decree of the French Public Health Authority in 2011. The decree was revised in 2012, distinguishing invasive techniques, which remain forbidden, from permitted non-invasive techniques; laser, RF, ultrasound and cryolipolysis that did not penetrate the skin became legal, and injection lipolysis and mesotherapy remained illegal. Laser devices that involve inserting the probe through the skin transcutaneously but do not suck out the liquefied material are also prohibited. Surgeons are permitted to perform surgical liposuction techniques using laser-assisted lipolysis so long as suction is performed.
- Shridharani, SM; Broyles, JM; Matarasso, A (2014). "Liposuction devices: technology update". Medical devices (Auckland, N.Z.). 7: 241–51. doi:10.2147/MDER.S47322. PMC 4114741. PMID 25093000.
- Mulholland, RS; Paul, MD; Chalfoun, C (July 2011). "Noninvasive body contouring with radiofrequency, ultrasound, cryolipolysis, and low-level laser therapy". Clinics in plastic surgery. 38 (3): 503–20, vii–iii. doi:10.1016/j.cps.2011.05.002. PMID 21824546.
- Ortiz, AE; Avram, MM (September 2015). "Noninvasive body contouring: cryolipolysis and ultrasound". Seminars in cutaneous medicine and surgery. 34 (3): 129–33. doi:10.12788/j.sder.2015.0171. PMID 26566568.
- De Souza, MM; Jewell, AD; Grief, SN; Vail, BA (December 2018). "Plastic Surgery for Women". Primary care. 45 (4): 705–717. doi:10.1016/j.pop.2018.07.008. PMID 30401351.
- Dixit, VV; Wagh, MS (May 2013). "Unfavourable outcomes of liposuction and their management". Indian Journal of Plastic Surgery. 46 (2): 377–92. doi:10.4103/0970-0358.118617. PMC 3901919. PMID 24501474.
- Seretis, Konstantinos; Goulis, Dimitrios G; Koliakos, Georgios; Demiri, Efterpi (2015). "Short- and Long-Term Effects of Abdominal Lipectomy on Weight and Fat Mass in Females: A Systematic Review". Obesity Surgery. 25 (10): 1950–8. doi:10.1007/s11695-015-1797-1. PMID 26210190.
- Seretis, K; Goulis, DG; Koliakos, G; Demiri, E (December 2015). "The effects of abdominal lipectomy in metabolic syndrome components and insulin sensitivity in females: A systematic review and meta-analysis". Metabolism: clinical and experimental. 64 (12): 1640–9. doi:10.1016/j.metabol.2015.09.015. PMID 26475176.
- Norton, Jeffrey A. (2012). Surgery Basic Science and Clinical Evidence. Berlin, Heidelberg: Springer Berlin Heidelberg. p. 2014. ISBN 9783642572821.
- Khan, MH (November 2012). "Update on liposuction: clinical pearls". Cutis. 90 (5): 259–65. PMID 23270199.
- Tierney, Emily P.; Kouba, David J.; Hanke, C. William (December 2011). "Safety of tumescent and laser-assisted liposuction: review of the literature". Journal of Drugs in Dermatology. 10 (12): 1363–9. PMID 22134559.
- Draelos, Zoe (2011). Cosmetic Dermatology: Products and Procedures. John Wiley & Sons. p. Chapter 56. ISBN 9781444359510.
- Fabi, Sabrina Guillen (2015). "Noninvasive skin tightening: focus on new ultrasound techniques". Clinical, Cosmetic and Investigational Dermatology. 8: 47–52. doi:10.2147/CCID.S69118. ISSN 1178-7015. PMC 4327394. PMID 25709486.
- Jewell, Mark L.; Solish, Nowell J.; Desilets, Charles S. (October 2011). "Noninvasive body sculpting technologies with an emphasis on high-intensity focused ultrasound". Aesthetic Plastic Surgery. 35 (5): 901–912. doi:10.1007/s00266-011-9700-5. ISSN 1432-5241. PMID 21461627.
- "Use of transcutaneous ultrasound for lipolysis and skin tightening: a review". Aesthetic Plast Surg. 38: 429–41. Apr 2014. doi:10.1007/s00266-014-0286-6. PMID 24567045.
- Fonseca, BelchiolinaB; Godoy, FúlvioB; Levenhagen, MarceloA; Melo, RobertaT; Franco, MarianeA; Beletti, MarceloE (2011). "Structural changes of fat tissue after nonaspirative ultrasonic hydrolipoclasy". Journal of Cutaneous and Aesthetic Surgery. 4 (2): 105. doi:10.4103/0974-2077.85025.
- Nestor, Mark S.; Newburger, Jessica; Zarraga, Matthew B. (March 2013). "Body contouring using 635-nm low level laser therapy". Seminars in Cutaneous Medicine and Surgery. 32 (1): 35–40. ISSN 1085-5629. PMID 24049928.
- Orringer, Jeffrey; S Dover, Jeffrey; Alam, Murad. "Body Shaping, Skin, Fat, Cellulite": 21. ISBN 978-0-323-32197-6.
- Ingargiola, M. J; Motakef, S; Chung, M. T; Vasconez, H. C; Sasaki, G. H (2015). "Cryolipolysis for Fat Reduction and Body Contouring: Safety and Efficacy of Current Treatment Paradigms". Plastic and Reconstructive Surgery. 135 (6): 1581–1590. doi:10.1097/PRS.0000000000001236. PMC 4444424.
- Derrick, C. D; Shridharani, S. M; Broyles, J. M (2015). "The Safety and Efficacy of Cryolipolysis: A Systematic Review of Available Literature". Aesthetic Surgery Journal. 35 (7): 830–6. doi:10.1093/asj/sjv039. PMID 26038367.
- Krueger, N; Mai, S. V; Luebberding, S; Sadick, N. S (2014). "Cryolipolysis for noninvasive body contouring: Clinical efficacy and patient satisfaction". Clinical, Cosmetic and Investigational Dermatology. 7: 201–205. doi:10.2147/CCID.S44371. PMC 4079633.
- Coleman, SR; Sachdeva, K; Egbert, BM; Preciado, J; et al. (2009). "Clinical efficacy of noninvasive cryolipolysis and its effects on peripheral nerves" (PDF). Aesthetic Plastic Surgery. 33 (4): 482–8. doi:10.1007/s00266-008-9286-8. PMID 19296153.
- Nelson, AA; Wasserman, D; Avram, MM (2009). "Cryolipolysis for reduction of excess adipose tissue". Seminars in Cutaneous Medicine and Surgery. 28 (4): 244–9. doi:10.1016/j.sder.2009.11.004. PMID 20123423.
- Avram, MM; Harry, RS (2009). "Cryolipolysis for subcutaneous fat layer reduction". Lasers in Surgery and Medicine. 41 (10): 703–8. doi:10.1002/lsm.20864. PMID 20014262.
- Meyer, Patricia Froes et al. (2016). "Effects of Cryolipolysis on Abdominal Adiposity". Case Reports in Dermatological Medicine. 2016: 1. doi:10.1155/2016/6052194.
- "Can you freeze your fat away?". 24 December 2015. Retrieved 25 August 2016.
- "CoolSculpting is only cold-based treatment cleared by US FDA for fat loss". 21 March 2016. Retrieved 25 August 2016.
- Hilton, Lisette. "The Skinny on fat reduction, cellulite devices". dermatologytimes.modernmedicine.com/. Dermatology Times. Retrieved 3 January 2018.
- K034009, FDA (2005), "510(k) Premarket Notification", www.accessdata.fda.gov
- K081962, FDA (2008), "510(k) Premarket Notification", www.accessdata.fda.gov
- "Meridian Co., Ltd.: Form 20-F for 2010". Meridian via SEC Edgar. 19 August 2011. Index Page
- "Meridian history". Archived from the original on 29 December 2009.
- "Meridian Co Ltd". FDA Establishment Registration & Device Listing. Retrieved 17 July 2018.
- Louis, Catherine Saint (February 3, 2010). "Zap or Chill? Targeting Fat Without Surgery". New York Times.
- "510(k) filing for Zelitq CoolSculpting" (PDF). FDA.gov. 2012.
- "Patents assigned to Yolo". USPTO. Retrieved 17 July 2018.
- "Press release: YOLO Medical Now Manufacturing In Canada", www.yolomedical.com/, 2013
- "510(k) filing for Laser Lipo Ltd Strawberry" (PDF). FDA.gov. 2013.
- "510(k) Premarket filing for SculpSure". FDA.gov. 2015.
- K143741, FDA (2015), "510(k) Premarket Notification", www.accessdata.fda.gov
- "Décret n° 2011-382 du 11 avril 2011 relatif à l'interdiction de la pratique d'actes de lyse adipocytaire à visée esthétique", legifrance.gouv.fr, 2011, retrieved 2015-01-08
- Touraine, Marisol (2012), "Questions / answers on the prohibition order of lipolyses", www.sante.gouv.fr