REVANESSE VERSA+ 1.2 ML

Additional Manufacturer Narrative

THE CLINICAL COMPLAINT HAS BEEN ADEQUATELY INVESTIGATED. THE LOT NUMBER HAS BEEN VERIFIED AND HAS BEEN CONFIRMED TO BE RELEASED BY THE COMPANY. IT HAS BEEN CONFIRMED THAT NO PREVIOUS CLINICAL COMPLAINTS HAVE BEEN FOUND FOR THE PARTICULAR LOT NUMBER IN QUESTION. THE BATCH RECORD, QC TEST REPORTS, AND TRAINING OF STAFF WERE ANALYSED AND IT HAS BEEN DETERMINED THAT PRODUCT IS WITHIN REQUIRED SPECIFICATIONS, AND MANUFACTURED ACCORDING TO APPROPRIATE PROCEDURES. THIS COMPLAINT IS CONSIDERED AS OFF LABEL USE AND THE CLINIC HAVE BEEN INFORMED BY PROLLENIUM MEDICAL TECHNOLOGIES THAT INJECTIONS INTO UNAPPROVED AREAS SUCH AS THE LIPS, LOWER EYELID, TEAR TROUGHS AND MEDIAL CHEEKS ARE TO BE AVOIDED AS STATED IN THE REVANESSE® VERSATM+ DIRECTIONS FOR USE (DFU) AVAILABLE AT WWW.HTTP://REVANESSEUSADFU.COM/. PROLLENIUM MEDICAL TECHNOLOGIES' MEDICAL DIRECTOR'S RESPONSE TO THIS ADVERSE EVENT WAS PROVIDED TO CLINIC. THE RESPONSE FROM MEDICAL DIRECTOR IS AS FOLLOWS: "THE FOLLOWING IS A MEDICAL OPINION BASED ON THE INFORMATION REPORTED IN THE FOLLOWING AE COMPLAINT; THE HISTORY AND PICTURES PROVIDED SHOW SWELLING OF THE LIP WHICH IS MOST LIKELY ALLERGIC IN NATURE. THE THREE VARIABLES TO CONSIDER IN ALLERGIC SWELLING IS THE PRODUCT INJECTED, COMPOUNDED TOPICAL ANESTHETIC APPLIED ( IN THIS CASE BLT ) AND ANY PRODUCTS THE PATIENT MAY HAVE APPLIED POST PROCEDURE. IN THIS CASE THE BRUISING CAUSED BY NEEDLE TRAUMA WILL EXACERBATE THE REACTION THRU RELEASE OF ADDITIONAL HISTAMINES AND BRADYKININ. THE PRIOR MRNA VACCINE CAN ALSO PLAY A ROLE IN AMPLIFYING THE ALLERGIC / IMMUNE RESPONSE. ALTHOUGH THERE IS NO PRE PHOTO FOR COMPARISON, IT APPEARS THAT PRODUCT WAS INJECTED INTO THE CENTRAL PORTION OF BOTH THE UPPER AND LOWER LIPS AS WELL AS THE UPPER VERMILLION BORDER. IT IS OF NOTE THAT THE VERMILLION BORDER IS NOT SWOLLEN OR DISTORTED WHICH ONE WOULD EXPECT IF THE ALLERGIC REACTION WAS FOCUSED ON THE HA PRODUCT. ALLERGIC REACTIONS TO HA, WHICH IS BIO IDENTICAL IN ALL SPECIES, CAN OCCUR BUT ARE CONSIDERED EXTREMELY RARE AND WOULD BE EXPECTED TO PRECIPITATE AN AUTO IMMUNE TYPE REACTION AGAINST THE 9+ GRAMS OF HA CURRENTLY IN OUR BODIES. ADDITIONALLY WE WOULD ASSUME THAT A REACTION TO INJECTED HA WOULD CONTINUE UNTIL THE HA WAS REMOVED FROM THE SYSTEM AS IS THE CASE WITH OTHER DRUG ALLERGIES. BLT COMPOUNDED TOPICAL ANESTHETIC IS A NON CLINICAL TRIAL STUDIES PRODUCT THAT IS DESIGNED TO ALLOW RAPID ABSORPTION OF 3 HIGHLY CONCENTRATED DRUGS INTO OUR BODY. IT IS THEREFORE USED OFF LABEL. THIS IS FURTHER COMPLICATED BY THE FACT THAT IT IS BEING APPLIED TO THE VERY THIN EPITHELIUM AND MUCOSA OF THE LIP. ESTER ANESTHETICS ARE THE MOST ALLERGENIC AND BLT CONTAINS 2 OF THESE ( BENZOCAINE AND TETRACAINE). BASED ON THE INFORMATION PRESENTED MY CLINICAL OPINION IS THAT THIS CASE REPRESENTS AN ALLERGIC REACTION TO BLT TOPICAL ANESTHETIC APPLIED TO THE THIN EPITHELIUM OF THE LIP. I TRUST THIS MEDICAL OPINION IS OF VALUE TO ALL PARTIES CONCERNED."

Description of Event or Problem

BASED ON THE INFORMATION PROVIDED, ON (B)(6) 2021, PATIENT - FEMALE, (B)(6), (B)(6) YEARS OLD. FIRST TIME LIP FILLER TREATMENT. PATIENT HAS BEEN INJECTED WITH 0.5 ML OF REVANESSE VERSA+ INTO LIPS. TOPICAL ANAESTHETICS USED - BENZOCAINE, TETRACAINE, LIDOCAINE TOPICAL CREAM. THE LIPS LOOKED GOOD AFTER THE PROCEDURES AND STARTED TO SWELL WHILE SHE WAS DRIVING HOME ABOUT 1.5 HOURS AWAY. AS REPORTED, SEVERE SWELLING THE DAY OF INJECTION AND THE DAY AFTER. SEVERE SWELLING COUPLE HOURS AFTER PROCEDURE, SINUS NUMBNESS, BRUISING, NUMBNESS. TREATMENT PLAN WAS 1 TAB BENADRYL, 1 TAB MOTRIN ON (B)(6) 2021. METROL DOSE PACK ON (B)(6) 2021. (B)(6) COVID-19 VACCINE RECEIVED ONE MONTH PRIOR THE PROCEDURE. PATIENT HAS HAD MOMMY MAKEOVER IN (B)(6) 2020. NO MEDICATIONS BEFORE TREATMENT. NO ALLERGIES.