PMID- 36054047
OWN - NLM
STAT- MEDLINE
DCOM- 20220908
LR  - 20230815
IS  - 1524-4725 (Electronic)
IS  - 1076-0512 (Linking)
VI  - 48
IP  - 9
DP  - 2022 Sep 1
TI  - Adverse Events of Non-Invasive Body Contouring: Analysis of the Food and Drug 
      Administration Manufacturer and User Facility Device Experience Database.
PG  - 943-948
LID - 10.1097/DSS.0000000000003525 [doi]
AB  - BACKGROUND: Multiple non-invasive modalities have become popular alternatives to 
      surgical procedures for body contouring. OBJECTIVE: To analyze adverse events 
      (AEs) associated with non-invasive body contouring devices reported through the 
      Manufacturer and User Facility Device Experience (MAUDE) database. METHODS AND 
      MATERIALS: The MAUDE database were queried for AEs associated with non-invasive 
      body contouring devices between January 2011 and June 2021. An extensive list of 
      keywords and brand and manufacturer names was used. RESULTS: A total of 1,325 
      reports with 1,590 AEs were identified among 6 modalities. More than 70% were 
      reported in the past 5 years. Cryolipolysis made up 38.3% reports, which mostly 
      pertained to paradoxical hyperplasia and hernias. Radiofrequency had the most 
      reports (41.9%). Like laser devices, most of their reports described burns. 
      Focused ultrasound was commonly associated with unintentional fat loss and 
      surface irregularities. Focused electromagnetic field resulted in only 7 reports. 
      CONCLUSION: The analysis of present study supports previous studies concerning 
      common local symptoms caused by these devices, but it also reveals complications 
      not reported in previous device studies. This study highlights the importance of 
      proper technique and adherence to device guidelines. Practitioners should be 
      knowledgeable of potential complications from each device to both prevent and 
      manage them accordingly.
CI  - Copyright (c) 2022 by the American Society for Dermatologic Surgery, Inc. Published 
      by Wolters Kluwer Health, Inc. All rights reserved.
FAU - Nguyen, Christopher N
AU  - Nguyen CN
AD  - School of Medicine, Baylor College of Medicine, Houston, Texas.
FAU - Nguyen, Quoc-Bao D
AU  - Nguyen QD
AD  - Department of Dermatology, The University of Texas, MD Anderson Cancer Center, 
      Houston, Texas.
AD  - Department of Dermatology, UTHealth Houston, McGovern Medical School, Houston, 
      Texas.
FAU - Hebert, Adelaide A
AU  - Hebert AA
AD  - Department of Dermatology, UTHealth Houston, McGovern Medical School, Houston, 
      Texas.
FAU - Gold, Michael H
AU  - Gold MH
AD  - Gold Skin Care Center, Nashville, Tennessee.
AD  - Tennessee Clinical Research Center, Nashville, Tennessee.
LA  - eng
PT  - Comment
PT  - Journal Article
DEP - 20220705
PL  - United States
TA  - Dermatol Surg
JT  - Dermatologic surgery : official publication for American Society for Dermatologic 
      Surgery [et al.]
JID - 9504371
SB  - IM
CON - Lasers Surg Med. 2015 Feb;47(2):133-40. PMID: 25655709
MH  - *Body Contouring/adverse effects
MH  - Databases, Factual
MH  - Humans
MH  - United States
MH  - United States Food and Drug Administration
EDAT- 2022/09/03 06:00
MHDA- 2022/09/09 06:00
CRDT- 2022/09/02 13:24
PHST- 2022/02/25 00:00 [received]
PHST- 2022/06/02 00:00 [accepted]
PHST- 2022/09/02 13:24 [entrez]
PHST- 2022/09/03 06:00 [pubmed]
PHST- 2022/09/09 06:00 [medline]
AID - 00042728-202209000-00009 [pii]
AID - 10.1097/DSS.0000000000003525 [doi]
PST - ppublish
SO  - Dermatol Surg. 2022 Sep 1;48(9):943-948. doi: 10.1097/DSS.0000000000003525. Epub 
      2022 Jul 5.