Description of Event or Problem · 1
INITIAL AND ADDITIONAL INFORMATION WAS RECEIVED FROM A CONSUMER ON 08/22/2011 AND 08/23/2011: A (B)(6) FEMALE RECEIVED HER FIRST AND ONLY TREATMENT WITH POLY-L-LACTIC ACID (SCULPTRA AESTHETIC) (LOT # UNKNOWN, EXPIRATION DATE UNKNOWN) ON (B)(6) 2011 FOR A COSMETIC INDICATION. SHE HAD IT INJECTED INTO THE UPPER CHEEK, NASOLABIAL FOLD, AND CHIN ON BOTH SIDES OF HER FACE. SHE THOUGHT SHE RECEIVED ABOUT FOUR TO FIVE INJECTIONS ON EACH SIDE OF THE FACE. THE AREA ON THE UPPER CHEEK BEGAN TO BRUISE AS THE PHYSICIAN WAS INJECTING THE POLY-L-LACTIC ACID. THE BRUISING OCCURRED IN THE UPPER CHEEK AREA INJECTIONS SITES ONLY AND LASTED ABOUT A WEEK. SHE HAD TO TAKE OFF WORK FOR ONE WEEK AND HER CHEEKS LOOKED LIKE EGGPLANTS. THE AREAS WERE DESCRIBED AS HAVING DISCOMFORT, BUT WERE NOT INFLAMED. THERE WAS SOME SWELLING AT ALL INJECTION SITES. THERE WAS NO EVIDENCE OF A SYSTEMIC PROCESS WHICH DEVELOPED AFTER INJECTION. SHE MASSAGED THE AREAS AS INSTRUCTED AND THIS HELPED. SHE ALTERNATED ICE WITH A HEATING PAD. SHE FELT THE HEATING PAD MADE THE BRUISED AREA SPREAD. THE PATIENT ALSO APPLIED A HERBAL GEL TOPICALLY TO THE BRUISED AREA. SHE WAS NOT ON ACETYLSALICYLIC ACID (ASPIRIN) PRODUCTS OR ALCOHOL, BUT SHE BELIEVED THE FISH OIL SUPPLEMENTS WERE POSSIBLY TO BLAME FOR THE EXTREME BRUISING. THE PATIENT HAD NO HISTORY OF IMMUNOLOGICAL OR COLLAGEN-VASCULAR DISEASE. NO FURTHER RELEVANT INFORMATION REPORTED.