PRS AAPS Oral Proofs 2016
Elizabeth Kiwanuka, MD, PhD, Patrick K. Sullivan, MD
From the Brown University, Providence, R.I.
PURPOSE: In 2015, the Food and Drug Administration approved deoxycholic acid as a treatment of submental convexity. However, clinical trials have reported that what we feel is an unacceptable complication rate. This study sets out to analyze the complications reported. Also, we review the anatomy and present injection techniques to avoid complications associated with administrating deoxycholic acid.
METHODS: Results from clinical trials were evaluated, and the reported adverse reactions were assessed. A review of the anatomy was conducted, and technical considerations to minimize complications were outlined.
RESULTS: A total of 1019 patients were enrolled in 2 double-blind placebo-controlled clinical trial. Adverse reactions lasting more than 30 days occurred in 10% of enrolled subjects. Major complications included injuries to the marginal mandibular nerve and were seen in 4% of patients. This could be compared with less than 1% of patients treated with placebo. Paresthesia was present for up to 298 days (median of 44 days). Two percent of patients complained of dysphagia lasting for 1 to 81 days. Minor complications, such as edema, swelling, or hematoma formation, were seen in 87% and 72% of patients.
CONCLUSIONS: Deoxycholic acid introduces an additional therapeutic option for patients with excess submental fat. However, the rates of major and minor complications, such as marginal mandibular nerve injury and dysphagia, are unacceptably high. Screening patients for other potential cases of submental fullness, as well as reviewing the anatomic landmarks, can improve the efficacy and safety of treatment of submental convexity with deoxycholic acid.