Description of Event or Problem · 1
INITIAL INFORMATION RECEIVED FROM A CONSUMER ON (B)(6) 2010: A (B)(6) FEMALE INITIATED TREATMENT WITH INJECTABLE POLY-L-LACTIC ACID (SCULPTRA) (LOT # AND EXP DATE UNK) ON (B)(6) 2010 (FIRST AND ONLY SESSION) FOR COSMETIC PURPOSES. SHE RECEIVED A TOTAL VOLUME OF 1 VIAL THAT HAD COVERED BOTH SIDES OF HER FACE WHICH INCLUDED THE NASOLABIAL FOLDS AND CHEEK AREA. NONE OF THE INJECTABLE POLY-L-LACTIC ACID WAS INJECTED NEAR HER LIP AREA OR UNDER HER EYES. SHE MASSAGED THE AREA AS INSTRUCTED FOLLOWING THE INJECTION SESSION. ONE WEEK AFTER THE INJECTION, SHE DEVELOPED PROBLEMS ON ONLY THE RIGHT SIDE OF HER FACE WHICH WAS DESCRIBED AS SWELLING UNDER HER EYE THAT INCREASES WITH TIME. SHE ALSO REPORTED "STUFFINESS" NEAR THE NASOLABIAL FOLD, SINUS CONGESTION, "PUFFY" IN THE CORNER OF THE RIGHT LIP WHICH GETS MORE NOTICEABLE IF PRESSING ON THE AREA, "HOLLOWNESS" UNDER THE CHEEK BONE, A "TINGLING PRESSURE" THAT COMES AND GOES FROM THE CHEEK BONE UP TO THE TEMPLE, PUFFINESS UNDER THE EYE ALONGSIDE THE NOSE WHICH CREATES A "RIDGE" ON THE CORNER OF THE EYE, AND PRESSURE AT THE CORNER OF THE EYE WHICH SHE NOTICED ON (B)(6) 2010. SHE NOTED THAT SHE DID NOT FEEL ANYTHING HARD BENEATH THE AREAS OF CONCERN AND CONFIRMED THAT IT WAS NOT A GRANULOMA OR INFECTION. SHE ADVISED THAT THESE SYMPTOMS HAVE PERSISTED FOR ALMOST 2 MONTHS AND ARE NOT IMPROVING. SHE SAW THE PHYSICIAN WHO INJECTED THE POLY-L-LACTIC ACID AND SAW ANOTHER PHYSICIAN FOR THE EVENTS BUT SHE SAID THAT NO ONE KNOWS WHAT TO DO. SHE THEN WENT ON TO SAY THAT SHE THOUGHT THE PHYSICIAN HAD INJECTED THE POLY-L-LACTIC ACID INCORRECTLY EVEN THOUGH HE WAS CERTIFIED BY SANOFI-AVENTIS AND WAS A TRAINER. THE PROBLEMS WERE PERSISTING AT THE TIME OF THIS REPORT. NO FURTHER RELEVANT INFO REPORTED. PHARMACOVIGILANCE COMMENT: SANOFI-AVENTIS COMPANY COMMENT DATED (B)(6) 2010: THIS CASE INVOLVING A (B)(6) FEMALE PT WHO REPORTEDLY DEVELOPED MULTIPLE ADVERSE EVENTS 1 WEEK AFTER POLY-L-LACTIC ACID (SCULPTRA AESTHETIC) ADMINISTRATION LACKS SUFFICIENT INFO FOR A COMPLETE MEDICAL ASSESSMENT. ADD'L INFO IS NEEDED INCLUDING MEDICAL CONFIRMATION OF THE EVENTS, A MORE DETAILED DESCRIPTION OF THE ADVERSE EVENTS, THE PT'S MEDICAL HISTORY, DETAILS OF CONCOMITANT MEDICATIONS, TREATMENT DETAILS INCLUDING RECONSTITUTION TECHNIQUE AND DOSAGE RECEIVED, DETAILS OF CORRECTIVE TREATMENT PROVIDED, FINAL OUTCOME, AND A HEALTH PROFESSIONAL'S CAUSALITY ASSESSMENT.