Popsicle panniculitis reported
A report in the New England Journal of Medicine described popsicle panniculitis, fat inflammation from cold. Cold-induced panniculitis is the observation cited behind cryolipolysis.[1][2]
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History
From a 1970 report of cold injury to fat to FDA clearance of fat-freezing in 2010: the steps that made the treatment.
Timeline
A report in the New England Journal of Medicine described popsicle panniculitis, fat inflammation from cold. Cold-induced panniculitis is the observation cited behind cryolipolysis.[1][2]
Lab and pig-tissue tests showed that sodium deoxycholate, the detergent in phosphatidylcholine fat injections, caused most of the cell lysis.[1]
Cooling pig skin to -1 to -7 C for 10 minutes caused a loss of several mm of fat over 3.5 months without skin injury or a rise in blood lipids.[1]
In 10 subjects treated with a prototype cooling device, the fat layer fell 20.4% at 2 months and 25.5% at 6 months. Reduced sensation in 6 of 9 returned by a mean of 3.6 weeks.[1][2]
FDA granted De Novo classification to the Zeltiq Dermal Cooling Device on August 24, 2010, creating Class II contact cooling systems for aesthetic use. The first cleared area was the flank.[1][2]
CoolSculpting was cleared for the abdomen on May 2, 2012. truSculpt was cleared on November 2, 2012 for tissue heating and temporary cellulite reduction.[1][2]
A man in his 40s developed a growing fat mass in the treated area 3 months after one cryolipolysis cycle. The authors put the incidence at 0.0051%. CoolSculpting was cleared for the thighs in April 2014.[1][2]
40 subjects had 4 weekly 30-minute sessions of selective radiofrequency. Abdominal circumference fell an average 4.93 cm.[1]
FDA approved deoxycholic acid injection for fullness under the chin on April 29, 2015, after an application filed May 13, 2014.[1][2]
SculpSure was cleared for the flanks on May 15, 2015. CoolSculpting was cleared for the submental area later in 2015, after a 60-subject study.[1][2][3]
The two phase 3 Kybella trials were published with 506 and 516 subjects. CoolSculpting was cleared for bra fat, back fat and the banana roll on March 23, 2016.[1][2][3]
An MRI study of 22 Emsculpt patients reported fat and muscle changes. FDA added abdominal lipolysis to truSculpt on June 6, 2018.[1][2]
A 72-patient sham-controlled trial tested radiofrequency with HIFEM. MAUDE analyses counted 1,325 reports for 2011 to 2021 and 165 for 2014 to 2020.[1][2][3]
A meta-analysis of 28 studies and 13,078 patients put paradoxical adipose hyperplasia at 0.22%, about 1 in 455.[1]
People
Their studies led to the devices and drug in use today.
Massachusetts General Hospital dermatologist who first described selective cryolysis of fat in pigs.[1][2]
Co-author of the first selective cryolysis study and of the first report of paradoxical adipose hyperplasia.[1][2]
Massachusetts General Hospital dermatologist; co-wrote early cryolipolysis reviews and FDA MAUDE analyses of body-contouring devices.[1][2][3]
Led the pig cryolipolysis study and co-wrote the submental cryolipolysis study that led to FDA clearance.[1][2]
First author of the first human cryolipolysis series, with nerve testing.[1]
Showed deoxycholate is the active fat-lysing agent in phosphatidylcholine injections, the basis of Kybella.[1]
First author of REFINE-1, a phase 3 trial of deoxycholic acid for submental fat.[1]
First author of REFINE-2 and of the 3-year follow-up of the REFINE trials.[1][2]
First author of the first report of paradoxical adipose hyperplasia after cryolipolysis.[1]
First author of the MRI study of HIFEM abdominal treatment.[1]
Wrote a systematic review of electromagnetic body-contouring treatments that rated the efficacy evidence tenuous.[1]