Medicine:Non-surgical liposuction

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Non-surgical liposuction techniques use laser energy, radiofrequency, ultrasound or cold (cryolipolysis) to reduce fat.[1] Devices are applied directly to the skin of the treatment area and do not employ injections (as in injection lipolysis) or incisions (as in laser assisted liposuction).[2]

History and development

In 2005, Meridian Co., Ltd., 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.[3] and in 2008, a variant, the Lapex BCS, was cleared.[4] 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.[5][6][7]

In 2010, Zerona, another low-level laster treatment, was cleared for marketing by the FDA as an infrared lamp[8] and Zeltiq obtained FDA marketing clearance for cryolipolysis of the flanks, and in 2012 received marketingclearance for cryolipolysis of the abdomen.[9]

Starting in 2010, the Korean company Meridian assigned US patents related to their fat reduction devices to a British Columbia company called "YOLO Medical".[10] During this transition, the Lapex line was rebranded as the Yolo Curve.[11] Strawberry, another infrared lamp device, was cleared by the FDA in 2013[12] SculpSure, another infrared lamp device, was cleared in 2015.[13] Also in 2015, Yolo received marketing clearance for its Lipofina system.[14]

Techniques

Low level laser light

Low level laser light reduces the stability of adipocyte cell membranes, allowing cells to release their stores of fat without damaging the cell.[15]

Ultrasound

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.[16][17][18]

Radiofrequency

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.[19]

Cryolipolysis

Cryolipolysis is the term for using cryogenics to induce lipolysis. Adipose tissue is cooled above freezing causing localized cell death and inflammation.

Legal status

Various lipolysis techniques ("actes de lyse adipocytaire à visée esthétique") including injection lipolysis, RF, laser, ultrasound, and cryolipolysis were forbidden in France by a decree of the French Public Health Authority on 11 April 2011. The decree was revised on 17 February 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.[20] [21]

References

  1. ↑ Mulholland, R. Stephen; Malcolm D. Paul; Charbel Chalfoun (2011). "Noninvasive body contouring with radiofrequency, ultrasound, cryolipolysis, and low-level laser therapy". Clinics in Plastic Surgery 38 (3): 503–520, vii-iii. doi:10.1016/j.cps.2011.05.002. ISSN 1558-0504. PMID 21824546. 
  2. ↑ Goldman, Mitchel P.; Richard E. Fitzpatrick; E. Victor Ross; Suzanne L. Kilmer; Robert A. Weiss (2013). Lasers and Energy Devices for the Skin. CRC Press. ISBN 9781841849331. 
  3. ↑ K034009, FDA (2005), 510(k) Premarket Notification, http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K034009 
  4. ↑ K081962, FDA (2008), 510(k) Premarket Notification, http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K081962 
  5. ↑ "Meridian Co., Ltd.: Form 20-F for 2010". Meridian via SEC Edgar. 19 August 2011. https://www.sec.gov/Archives/edgar/data/1135174/000106299311003404/form20f.htm.  Index Page
  6. ↑ "Meridian history". Archived from the original on 29 December 2009. https://web.archive.org/web/20091229234322/http://www.meridianmedical.ca:80/history.php. 
  7. ↑ "Meridian Co Ltd". FDA Establishment Registration & Device Listing. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?rid=18594. Retrieved 17 July 2018. 
  8. ↑ Louis, Catherine Saint (February 3, 2010). "Zap or Chill? Targeting Fat Without Surgery" (in en). New York Times. https://www.nytimes.com/2010/02/04/fashion/04SKIN.html. 
  9. ↑ "510(k) filing for Zelitq CoolSculpting". 2012. http://www.accessdata.fda.gov/cdrh_docs/pdf12/K120023.pdf. 
  10. ↑ "Patents assigned to Yolo". USPTO. https://assignment.uspto.gov/patent/index.html#/patent/search/resultFilter?searchInput=YOLO%20MEDICAL%20INC.. Retrieved 17 July 2018. 
  11. ↑ Press release: YOLO Medical Now Manufacturing In Canada, 2013, http://www.yolomedical.com/newsroom_press.php?i=51 
  12. ↑ "510(k) filing for Laser Lipo Ltd Strawberry". 2013. http://www.accessdata.fda.gov/cdrh_docs/pdf13/K130341.pdf. 
  13. ↑ "510(k) Premarket filing for SculpSure". 2015. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K150230. 
  14. ↑ K143741, FDA (2015), 510(k) Premarket Notification, http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K143741 
  15. ↑ 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. 
  16. ↑ 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. PMID 25709486. 
  17. ↑ 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. 
  18. ↑ "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. 
  19. ↑ Orringer, Jeffrey; S Dover, Jeffrey; Alam, Murad. Body Shaping, Skin, Fat, Cellulite. pp. 21. ISBN 978-0-323-32197-6. 
  20. ↑ Décret n° 2011-382 du 11 avril 2011 relatif à l'interdiction de la pratique d'actes de lyse adipocytaire à visée esthétique, 2011, http://legifrance.gouv.fr/affichTexte.do?cidTexte=JORFTEXT000023845272#LEGIARTI000023846926, retrieved 2015-01-08 
  21. ↑ Touraine, Marisol (2012), Questions / answers on the prohibition order of lipolyses, http://www.sante.gouv.fr/questions-reponses-sur-le-decret-d-interdiction-des-lipolyses.html 




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