Management of Serious Adverse Events Following Deoxycholic Acid Injection for Submental and Jowl Fat Reduction: A Systematic Review and Management Recommendations

Abstract

Pivotal Phase 3 randomized control trials have demonstrated a favorable safety profile for ATX-101 in submental fat (SMF) reduction; however, in real-world settings, several serious adverse events (SAEs) have been reported, most of which are procedure related and avoidable. Current understanding of the management of uncommon AEs and SAEs is based on the aesthetic surgeon's discretion, and overzealous protocols for sclerosis agents are being applied for ATX-101-induced arterial injury. This review focuses on showcasing the management of SAEs reported previously and updating it with personal clinical experiences with ATX-101 for SMF and jowl fat reduction. Along with adherence to the standard procedures for ATX-101 administration, the authors recommend investigating other potential causes of SMF accumulation and jowling mechanism, appropriate demarcation of the surface area to determine the number of vials, and assessment of the fat pad thickness to determine the number of required treatment cycles for optimal therapeutic outcomes. Surgery is preferable for jowling caused by compartment displacement (ptosis), whereas fat-reducing treatments such as ATX-101 are contraindicated for jowling caused by subcutaneous tissue atrophy. Some proactive measures that can be employed to prevent AEs include avoiding intradermal injections to prevent skin ulceration/necrosis, injecting lidocaine to check for smile asymmetry as an indication of marginal mandibular nerve proximity, administering 1 to 2 mm deeper injections in males to prevent alopecia, employing good aseptic techniques to prevent abscess formation, injecting 1 product at a time using correctly labeled syringes, and confirming the diagnosis of pyoderma gangrenosum before treating it as an infection.

Figure 1.

Best practice to manage unavoidable AEs and prevent avoidable SAEs. AE, adverse event; MMN, marginal mandibular nerve; SAE, serious adverse event; SMF, submental fat.

Figure 2.

The management of avoidable SAE. SAE, serious adverse event.

Figure 3.

Management of delayed-onset SAEs. MMN, marginal mandibular nerve; SAE, serious adverse event.

Figure 4.

Treatment algorithm for intraarterial injection, modified from Lindgren and Welsh.