FDA MAUDE database reported adverse events on noninvasive body contouring, cellulite treatment, and muscle stimulation from 2015 to 2021. Issue 1 (2nd August 2022)

• Record Type: Journal Article
• Authors: Lim, Young; Wulkan, Adam; Avram, Mathew
• Other Names: Rossi Anthony M. guestEditor.
• Is Part Of: Lasers in surgery and medicine. Volume 55:Issue 1(2023)
• Page Start: 146
• Page End: 151
• Publication Date: 2022-08-02
• Subjects: adverse‐events -- cellulite -- contouring -- coolsculpting -- MAUDE -- muscle -- noninvasive; Lasers in medicine -- Periodicals; Lasers in surgery -- Periodicals; 617
• DOI: 10.1002/lsm.23592
• Languages: English
• ISSNs: 0196-8092

Abstract

Abstract: Objective: Noninvasive cosmetic procedures have continued to gain popularity, owing to their short, in‐office treatments combined with little to no downtime. These procedures are also highly accessible, even offered at medical spas by nonphysician operators. The coronavirus disease 2019 (COVID‐19) pandemic also saw heightened interest in all cosmetic procedures, presumably as social distancing and stay‐at‐home orders allotted time and space for postop recovery. As the market for these procedures expand, a thorough understanding of potential adverse events is critical for providers to better counsel their patients on risks and expectations when obtaining informed consent. Materials and Methods: We employed the Food and Drug Administration (FDA's) Manufacturer and User Facility Device Experience (MAUDE) database (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm ), which compiles medical device reports (MDRs) for suspected injuries from device use or malfunction, submitted by manufactures and operators. We focused our query on three main categories: noninvasive body contouring, cellulite treatments, and muscle stimulation therapies that utilize electromagnetic energy. The query was performed in February 2022 using a comprehensive list of product names and manufacturers. Results: The initial search yielded 827 MDRs, which were individually reviewed for duplicate reports or insufficient data. Ultimately, 723 MDRs were analyzed (660 for noninvasive body contouring, 55 for cellulite treatment, and 8 for muscle stimulation). Paradoxical hyperplasia accounted for the majority of MDRs for noninvasive body contouring, while burns and scars were most common for muscle stimulation and cellulite treatments, respectively. Of the 7‐year span we surveyed, 2021 accounted for 515 of the 723 total assessed MDRs (71.2%), the majority of which were from cryolipolysis procedures. Conclusion: The MAUDE database remains an essential tool to monitor potential adverse events of medical devices, including those utilized for noninvasive, cosmetic procedures. Insight from the MAUDE database can be clinically translated when discussing treatment options with patients, helping to optimize patient safety and satisfaction.