Microwave energy devices for hyperhidrosis are associated with infections, neurological symptoms, and burns in a retrospective analysis of the Manufacturer and User Facility Device Experience database 2013-2022.

To the editor: Hyperhidrosis affects 2.8% of the population of the United States (US) and may negatively impact the quality of life of these patients. 1 Strutton D.R. Kowalski J.W. Glaser D.A. Stang P.E. US prevalence of hyperhidrosis and impact on individuals with axillary hyperhidrosis: results from a national survey. J Am Acad Dermatol. 2004; 51: 241-248https://doi.org/10.1016/j.jaad.2003.12.040 Abstract Full Text Full Text PDF PubMed Scopus (503) Google Scholar Microwave energy devices (MEDs) are used for hyperhidrosis treatment; however, the largest MED clinical trial included only 101 patients. 2 Glaser D.A. Coleman III, W.P. Fan L.K. et al. A randomized, blinded clinical evaluation of a novel microwave device for treating axillary hyperhidrosis: the dermatologic reduction in underarm perspiration study. Dermatol Surg. 2012; 38: 185-191https://doi.org/10.1111/j.1524-4725.2011.02250.x Crossref PubMed Scopus (84) Google Scholar US Food and Drug Administration (FDA) medical device approvals are typically less stringent, less costly, and shorter compared with drug approvals (3-7 vs 12 years). 3 Van Norman G.A. Drugs, devices, and the FDA: Part 1: an Overview of Approval Processes for Drugs. JACC Basic Transl Sci. 2016; 1: 170-179https://doi.org/10.1016/j.jacbts.2016.03.002 Crossref PubMed Scopus (220) Google Scholar Because MED adverse event (AE) data are limited, we analyzed safety reports using the FDA Manufacturer and User Facility Device Experience (MAUDE) database.