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Deoxycholic Acid for Submental Convexity: A MAUDE Database Analysis.

Anna Celeste Gibson1, Anvesh Kompelli1, Carissa Saadi1

  • 1Department of Otolaryngology - Head and Neck Surgery, University of Arkansas for Medical Sciences, Little Rock, AR, USA.

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|November 18, 2024
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Summary

Deoxycholic acid injections for submental fat can cause adverse events like swelling, nerve weakness, and skin necrosis. Patient counseling is crucial before this cosmetic procedure.

Keywords:
MAUDE databaseadverse eventdeoxycholic acidsubmental convexity

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Area of Science:

  • Aesthetic Medicine
  • Dermatology
  • Plastic Surgery

Background:

  • Deoxycholic acid (DOC) injections offer a non-surgical option for submental fat reduction.
  • Limited post-market safety data exists for DOC injections.
  • Analyzing real-world adverse events is essential for patient safety.

Purpose of the Study:

  • To investigate adverse events associated with deoxycholic acid injections.
  • To analyze data from the Manufacturer and User Facility Device Experience (MAUDE) database.

Main Methods:

  • Retrospective cross-sectional database analysis.
  • MAUDE database queried for deoxycholic acid (KYBELLA) adverse events.
  • Reports reviewed and categorized for specific adverse events.

Main Results:

  • 13 reports (21 events) analyzed from 34 initial reports.
  • Common adverse events: excessive swelling (24%), nerve weakness (19%), poor aesthetic outcome (19%).
  • Other events included numbness, dysphagia, infection, and skin necrosis (14%), with 2 cases requiring hospitalization.

Conclusions:

  • Deoxycholic acid injections can lead to various adverse events, including swelling, nerve issues, and skin necrosis.
  • Some cases necessitate hospitalization or surgical intervention.
  • Informed patient consent discussing potential risks is vital for deoxycholic acid treatments.