Description of Event or Problem · 1
INITIAL INFORMATION RECEIVED FROM A CONSUMER ON JUL-19-2010: A (B)(6) FEMALE RECEIVED TREATMENT WITH INJECTABLE POLY-L-LACTIC ACID (SCULPTRA) [LOT # AND EXPIRATION DATE UNKNOWN] ONCE ON JUL-06-2010 FOR THE INDICATION OF COSMETIC FILLING. SHE RECEIVED INJECTIONS ON BOTH SIDES ABOVE HER LIPS. LATER THAT EVENING, SHE BEGAN TO EXPERIENCE NUMBNESS AND LOSS OF MUSCLE CONTROL ON THE LEFT SIDE OF HER LIPS. WHEN SHE TRIED TO PUCKER OR MOVE HER LIPS, SHE HAD NO CONTROL ON THE LEFT SIDE. HER HUSBAND FELT THAT A NERVE MAY HAVE BEEN HIT. THE CONSUMER ADVISED THAT SHE REFUSED TO GO BACK TO THE PHYSICIAN FOR ANY FURTHER TREATMENT. THE EVENTS REMAINED ONGOING AT THE TIME OF THIS REPORT. NO FURTHER RELEVANT INFORMATION REPORTED. PHARMACOVIGILANCE COMMENT: SANOFI-AVENTIS COMPANY COMMENT DATED JUL-19-2010: CAUSAL ROLE OF POLY-L-LACTIC ACID INJECTION IN THE REPORTED REACTION CANNOT BE EXCLUDED, BUT THE EVENT IS MORE LIKELY DUE TO THE PROCEDURE (NOT DUE TO THE PRODUCT PER SE). MOST LIKELY EXPLANATION INCLUDES ACCIDENTAL INJECTION OF THE FACIAL FILLER INTO THE SMALL BRANCH OF THE FACIAL NERVE OR IN CLOSE PROXIMITY TO IT. HOWEVER, THIS CASE IS LACKING SUFFICIENT INFORMATION SUCH AS PATIENT MEDICAL HISTORY, COMPLETE LIST OF CONCOMITANT MEDICATIONS, NEUROLOGICAL EVALUATION AND MEDICAL CONFIRMATION BY THE PHYSICIAN TO MAKE A FINAL MEDICAL CONCLUSION.