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Patient Safety and Quality Improvement

(135) Deoxycholic Acid for Submental Convexity: A MAUDE Database Analysis

Monday, October 2, 2023
2:45 PM – 3:45 PM East Coast USA Time

    Presenting Author(s)

  • AK

    Anvesh Reddy Kompelli, MD

    Resident Physician
    University of Arkansas for Medical Sciences
    Little Rock, Arkansas, United States

  • CM

    Charles D. Mullins, B.S.

    Medical Student
    University of Arkansas for Medical Sciences
    Little Rock, AR, United States

    • Co-Author(s)

  • Vijay A. Patel, MD

    Associate Physician
    University of California San Diego
    San Diego, CA, United States

  • RS

    Robert A. Saadi, MD

    Resident Physician
    University of Arkansas for Medical Sciences
    Little Rock, Arkansas, United States

    • Senior Author(s)

  • TS

    Tom Shroki, MD

    GWU, USA

    • Co-Author(s)

  • AG

    Anna Celeste Gibson, MD

    Resident Physician
    University of Arkansas for Medical Sciences
    Little Rock, Arkansas, United States

Disclosure(s):
Anvesh Reddy Kompelli, MD: No relevant relationships to disclose.
Vijay A. Patel, MD: No relevant relationships to disclose.
Robert A. Saadi, MD: No relevant relationships to disclose.
Anna Celeste Gibson, MD: No relevant relationships to disclose.


Introduction: Deoxycholic acid is 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: Study

Design: Retrospective Cross Sectional Database Analysis
Setting: Food and Drug Administration’s MAUDE database (2012-2022)
Subject and

Methods: The MAUDE database was reviewed for all reports related to adverse events involving Deoxcholic acid using simple search terms “Kybella” and “deoxycholic acid”. Reports were individually reviewed and categorized with special attention to adverse events.

Results: A total of 31 medical device reports were identified from the database query, which included 12 cases after excluding duplicate and unrelated adverse events. Reported adverse events include skin necrosis (n=3, 25%), swelling (n=2, 17%), numbness (n=3, 25%), marginal mandibular nerve weakness (n=2,17%), unsatisfactory aesthetic outcome (n=3), and device malfunction (n=1,8%). Two patients required hospitalization for skin necrosis management; both had underlying connective tissue disorders.

Conclusions:

Conclusion: Adverse events following Deoxycholic acid injection included infection, numbness, and nerve injury. Both hospitalizations in this cohort were found to have underlying connective tissue disorders. Patient counseling regarding these adverse events should be discussed when offering deoxycholic acid for submental convexity.