Deoxycholic Acid for Submental Convexity: A MAUDE Database Analysis

Anna Celeste Gibson; Anvesh Kompelli; Carissa Saadi; Vijay A Patel; Robert A Saadi; Tom Shokri

doi:10.1177/19433875231226034

Deoxycholic Acid for Submental Convexity: A MAUDE Database Analysis

Craniomaxillofac Trauma Reconstr. 2024 Jan 8:19433875231226034. doi: 10.1177/19433875231226034. Online ahead of print.

Authors

Anna Celeste Gibson¹, Anvesh Kompelli¹, Carissa Saadi¹, Vijay A Patel^{2

3}, Robert A Saadi¹, Tom Shokri⁴

Affiliations

¹ Department of Otolaryngology - Head and Neck Surgery, University of Arkansas for Medical Sciences, Little Rock, AR, USA.
² Department of Otolaryngology - Head and Neck Surgery, University of California San Diego, La Jolla, CA, USA.
³ Division of Pediatric Otolaryngology, Rady Children's Hospital, San Diego, CA, USA.
⁴ Department of Otolaryngology - Head and Neck Surgery, George Washington University Hospital, Washington, DC, USA.

Abstract

Study design: The study was a retrospective cross-sectional database analysis.

Objective: Deoxycholic acid (DOC) injections are a novel, in-office procedural alternative to submental liposuction or submentoplasty to address excess submental fat. Post-market safety data regarding this treatment is currently limited. The objective of this study is to analyze adverse events reported in the Manufacturer and User Facility Device Experience (MAUDE) database.

Methods: The MAUDE database was queried for all reports related to adverse events involving deoxycholic acid using the search terms "KYBELLA" and "deoxycholic acid." Reports were individually reviewed by 2 reviewers and categorized with special attention to adverse events.

Results: A total of 34 medical device reports were identified from the database query. Thirteen of these reports (21 total events) were included in the analysis after excluding duplicates, unrelated adverse events, or events associated with the off-label use of DOC. Reported adverse events include excessive swelling (n = 5, 24%), marginal mandibular nerve weakness (n = 4, 19%), unsatisfactory aesthetic outcome (n = 4, 19%), numbness (n = 3, 14%), dysphagia (n = 1, 5%), infection (n = 1, 5%), and skin necrosis (n = 3, 14%). Two patients required hospitalization for skin necrosis management; both had underlying systemic diseases.

Conclusions: Adverse events following DOC injections included excessive swelling, dysphagia, numbness, infection, unsatisfactory aesthetic outcome, facial nerve weakness, and skin necrosis requiring hospitalization and/or surgery. Patient counseling regarding these adverse events should be discussed when offering DOC injections for submental convexity.

Keywords: MAUDE database; adverse event; deoxycholic acid; submental convexity.