{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,23]],"date-time":"2026-06-23T04:06:03Z","timestamp":1782187563237,"version":"3.54.5"},"reference-count":15,"publisher":"MDPI AG","issue":"4","license":[{"start":{"date-parts":[[2024,1,8]],"date-time":"2024-01-08T00:00:00Z","timestamp":1704672000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Craniomaxillofacial Trauma &amp; Reconstruction"],"published-print":{"date-parts":[[2024,12]]},"abstract":"<jats:sec><jats:title>Study Design<\/jats:title><jats:p> The study was a retrospective cross-sectional database analysis. <\/jats:p><\/jats:sec><jats:sec><jats:title>Objective<\/jats:title><jats:p> 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. <\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p> The MAUDE database was queried for all reports related to adverse events involving deoxycholic acid using the search terms \u201cKYBELLA\u201d and \u201cdeoxycholic acid.\u201d Reports were individually reviewed by 2 reviewers and categorized with special attention to adverse events. <\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p> 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. <\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p> 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. <\/jats:p><\/jats:sec>","DOI":"10.1177\/19433875231226034","type":"journal-article","created":{"date-parts":[[2024,1,8]],"date-time":"2024-01-08T11:55:51Z","timestamp":1704714951000},"page":"NP1-NP4","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":1,"title":["Deoxycholic Acid for Submental Convexity: A MAUDE Database Analysis"],"prefix":"10.3390","volume":"17","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-8283-5823","authenticated-orcid":false,"given":"Anna Celeste","family":"Gibson","sequence":"first","affiliation":[{"name":"Department of Otolaryngology - Head and Neck Surgery, University of Arkansas for Medical Sciences, Little Rock, AR, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anvesh","family":"Kompelli","sequence":"additional","affiliation":[{"name":"Department of Otolaryngology - Head and Neck Surgery, University of Arkansas for Medical Sciences, Little Rock, AR, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carissa","family":"Saadi","sequence":"additional","affiliation":[{"name":"Department of Otolaryngology - Head and Neck Surgery, University of Arkansas for Medical Sciences, Little Rock, AR, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vijay A.","family":"Patel","sequence":"additional","affiliation":[{"name":"Department of Otolaryngology - Head and Neck Surgery, University of California San Diego, La Jolla, CA, USA"},{"name":"Division of Pediatric Otolaryngology, Rady Children\u2019s Hospital, San Diego, CA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert A.","family":"Saadi","sequence":"additional","affiliation":[{"name":"Department of Otolaryngology - Head and Neck Surgery, University of Arkansas for Medical Sciences, Little Rock, AR, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tom","family":"Shokri","sequence":"additional","affiliation":[{"name":"Department of Otolaryngology - Head and Neck Surgery, George Washington University Hospital, Washington, DC, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2024,1,8]]},"reference":[{"key":"bibr1-19433875231226034","doi-asserted-by":"publisher","DOI":"10.1097\/DSS.0000000000001648"},{"key":"bibr2-19433875231226034","volume-title":"ASDS Consumer Survey on Cosmetic Dermatologic Procedures","year":"2021"},{"key":"bibr3-19433875231226034","first-page":"409","volume-title":"Cummings Otolaryngology - Head and Neck Surgery","author":"Mangat DS","year":"2015","edition":"6"},{"key":"bibr4-19433875231226034","doi-asserted-by":"publisher","DOI":"10.1016\/j.fsc.2022.03.014"},{"key":"bibr5-19433875231226034","doi-asserted-by":"publisher","DOI":"10.1111\/jocd.12122"},{"key":"bibr6-19433875231226034","doi-asserted-by":"publisher","DOI":"10.1016\/j.bjps.2022.08.012"},{"key":"bibr7-19433875231226034","doi-asserted-by":"publisher","DOI":"10.1093\/asj\/sjy008"},{"key":"bibr8-19433875231226034","doi-asserted-by":"publisher","DOI":"10.1007\/s00266-014-0364-9"},{"key":"bibr9-19433875231226034","doi-asserted-by":"publisher","DOI":"10.1093\/asj\/sjab100"},{"key":"bibr10-19433875231226034","volume-title":"Have Questions about Kybella? 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