Description of Event or Problem · 1
INITIAL INFORMATION WAS REC'D FROM A PHYSICIAN ON (B)(6) 2010: A (B)(6) FEMALE PT WITH NO HISTORY OF IMMUNOLOGICAL OR COLLAGEN-VASCULAR DISEASE REC'D HER FIRST INJECTION WITH POLY-L-LACTIC ACID (SCULPTRA AESTHETIC) (LOT # UNK, EXPIRATION DATE UNK) ON (B)(6) 2008 FOR FILLING IN HER CHEEK. ONE VIAL WAS INJECTED ALL OVER HER FACIAL AREA. SHE HAD HER SECOND TREATMENT WITH 6 ML OF POLY-L-LACTIC ACID ON (B)(6) 2008, HER THIRD TREATMENT WITH 3 ML OF POLY-L-LACTIC ACID ON (B)(6) 2008, HER FOURTH TREATMENT WITH 4 CC OF POLY-L-LACTIC ACID ON (B)(6) 2009, AND HER LAST TREATMENT WITH 4 ML OF POLY-L-LACTIC ACID ON (B)(6) 2009. THE PT NOTED A LITTLE LUMP ABOUT ONE YEAR AGO (2009) AND IT HAD PROGRESSIVELY ENLARGED. THE PHYSICIAN SAW HER ON (B)(6) 2010 WHERE SHE REPORTED THE LUMP UNDER THE SKIN ON HER LEFT UPPER MEDIAL CHEEK BENEATH THE ORBITAL RIM. WHEN THE PHYSICIAN SAW THE PT, IT LOOKED MORE LIKE A CORD THAN A NODULE IN THE SUPERIOR MEDIAL TO INFERIOR LATERAL AREA BENEATH THE ORBITAL RIM. IT WAS ABOUT 12X3 MM, CORDLIKE, NOT FIXED TO EITHER SKIN OR BONE, AND VISIBLE. THERE WAS NO SIGN OF INFLAMMATION. THERE WAS NO EVIDENCE OF SYSTEMIC PROCESS. HE REMOVED IT ON (B)(6) 2010 BY A SMALL 1 CM INCISION AND IT RESOLVED. IT WAS A GREY RUBBER-LIKE ELONGATED BODY WHICH WAS SENT FOR PATHOLOGY. THE BIOPSY REPORT DESCRIBED IT AS MULTIPLE DERMAL FOREIGN BODY GRANULOMA WITH POLARIZABLE FOREIGN MATERIAL. THE PHYSICIAN EXPECTED THAT THE EVENT WOULD NOT BE IRREVERSIBLE. THE ONLY OTHER INJECTION THE PT HAD PREVIOUSLY WAS HYALURONIC ACID (JUVEDERM) IN THE NASOLABIAL FOLDS AND THE PHYSICIAN DID NOT EXPECT THE HYALURONIC ACID (JUVEDERM) TO AFFECT THIS AREA. THE PHYSICIAN STATED THAT THE PHOTOMICROGRAPH MAY HELP TO SEE IF THE EVENT WAS RELATED TO HYALURONIC ACID (JUVEDERM) OR POLY-L-LACTIC ACID. NO FURTHER RELEVANT INFORMATION REPORTED.