REVANESSE LIPS+ 1.2 ML

Description of Event or Problem

ON (B)(6) 2023 A 45YO PATIENT WAS TREATED WITH 0.4 CC OF REVANESSE LIPS+, MOST OF WHICH WAS INJECTED INTO THE UPPER LIP. IMMEDIATELY PRIOR TO THE TREATMENT HIGH DOSE COMPOUNDED BLT (BENZOCAINE, LIDOCAINE & TETRACAINE) TOPICAL ANESTHETIC WAS APPLIED TO HER LIPS AND THE IMMEDIATELY SURROUNDING SKIN. THE UPPER LIP WAS INJECTED FIRST WITH 0.3-0.4 CC OF REVANESSE LIPS+. AS THE INJECTOR STARTED TO INJECT THE LOWER LIP SHE NOTICED BOTH UPPER AND LOWER LIPS WERE SWOLLEN. THE SURROUNDING SKIN IN ALL 4 QUADRANTS WAS ALSO ERYTHEMATOUS AND SWOLLEN. THIS IS CLEARLY SEEN ON THE 2 AFTER PHOTOS PROVIDED. THE INJECTION WAS STOPPED AND "EPI PEN + STEROIDS" WERE USED. IT SEEMS AT SOME POINT 0.9 CC OF HYLENEX WAS ALSO INJECTED. THE PATIENTS SWELLING RESOLVED COMPLETELY. IT IS IMPORTANT TO NOTE THAT BOTH UPPER AND LOWER LIPS SWELLED COMPLETELY, AS WELL AS THE SURROUNDING SKIN. HA WAS ONLY INJECTED INTO THE UPPER LIP. THE HIGH DOSE BLT WAS APPLIED TO ALL AREAS THAT WERE SWOLLEN, AS SEEN IN THE AFTER PHOTOS. BASED ON THE PHOTOS AND HISTORY PROVIDED MY CLINICAL OPINION IS THAT THIS REPRESENTS A NOT UNCOMMON ALLERGIC REACTION TO BLT TOPICAL ANESTHETIC. COMPOUNDED BLT HAS NEVER HAD CLINICAL TRIALS AND IS THEREFORE USED COMPLETELY OFF LABEL. IT WAS NEVER MEANT TO BE USED ON THE THIN EPITHELIUM OF THE LIPS. TETRACAINE, AN ESTER, IS THE MOST ALLERGIC OF THE TOPICAL ANESTHETICS. INTERNAL COMPLAINT NUMBER: (B)(4).