Deoxycholic Acid Injection for the Reduction of Submental Fat in Adults

Submental fat remains a major problem in our cosmetic maxillofacial surgery patients. Until the middle of 2015, the treatment modality for these patients was submental liposuction. In April 2015, Kybella (Deoxycholic acid) was approved by the FDA for the reduction of moderate-to-severe supraplatysmal submental fat¹. Deoxycholic acid is a naturally occurring bile acid produced in our body that aids in several processes such as cholesterol metabolism and the emulsification of fat-soluble vitamins for absorption. With cytotoxic properties, it is able to destroy cells via plasma membrane disruption and cell lysis. This lytic process is exploited when injected into fat cells leading to their destruction. This treatment provides a minimally invasive alternative to a submental liposuction. However, as with any procedure, there are risks of adverse events. The most common adverse events associated with Kybella include pain, numbness, erythema, edema, bruising and induration at the treated areas. More serious side effects include marginal mandibular nerve injury and dysphagia. The purpose of this study is to assess the use of Kybella by an oral and maxillofacial surgeon in an outpatient setting for the reduction of supraplatysmal submental fat. A retrospective assessment of clinical outcomes and adverse events of the administration of Kybella in 10 patients between the ages of 44 and 57 with ASA classifications I and II in an outpatient setting was performed. The treatment usually takes about 10-15 minutes. Kybella is supplied in 2 ml vials (10 mg/ml) and does not require reconstitution. The average initial treatment used by the surgeon is one to three vials (2 to 6 ml). Depending on the amount of submental fat, subsequent follow-up treatments may be required using lower volumes than the initial treatment with injections usually repeated in 4- to 6-week intervals. Subjects included in this study received no more than 4 treatments. However, a patient can receive up to 6 treatments. The results to date are promising as our patients had a 1-point or 2-point improvement in the Clinician-Reported Submental Fat Rating Scale (CRSMFRS). Adverse events were similar to the ones experienced in the North American as well as the European trials, and included pain, swelling, bruising, numbness, erythema, and induration². None of our patients experienced marginal mandibular nerve injury.

References:

1. FDA News Release: FDA approves treatment for fat below the chin. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm444978.htm. Accessed January 21, 2016.
2. McDiarmid J, Ruiz JB, Lee D, Lippert S, Hartisch C, Havlickova B: Results from a pooled analysis of two European, randomized, placebo-controlled, phase 3 studies of ATX-101 for the pharmacologic reduction of excess submental fat. Aesthetic Plast Surg. 38(5):849-860, 2014.