Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.] · 2022
Adverse Events of Non-Invasive Body Contouring: Analysis of the Food and Drug Administration Manufacturer and User Facility Device Experience Database.
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Nguyen Christopher N, Nguyen Quoc-Bao D, Hebert Adelaide A, Gold Michael H
Аннотация
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.
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.