Description of Event or Problem · 1
INITIAL INFORMATION RECEIVED FROM A CONSUMER ON (B)(4) 2012: A (B)(6) FEMALE CONSUMER INITIATED POLY-L-LACTIC ACID (SCULPTRA AESTHETIC) (LOT # AND EXPIRATION DATE UNKNOWN) FOR COSMETIC USE ON (B)(6) 2011 (FIRST SESSION), (B)(6) 2011 (SECOND SESSION), AND (B)(6) 2012 (LAST SESSION). THE FIRST TWO SESSIONS WERE GIVEN BY A REGISTERED NURSE (RN) WHO INJECTED HER IN THE TEMPLES, UNDER THE NOSE AND AROUND THE JAWLINE. THE LAST SESSION WAS DONE BY THE PHYSICIAN AND HE ONLY INJECTED HER IN THE TEMPLE REGION. THE CONSUMER STATED THAT SHE DID NOT HAVE ANY ISSUES WITH THE FIRST INJECTIONS. TWO WEEKS AFTER HER SECOND SESSION, SHE NOTICED A SLIGHT SWELLING AROUND HER LIPS THAT LASTED A COUPLE OF HOURS, AND WOULD COME AND GO EVERY FEW DAYS. SHE MAY HAVE NOTICED SOME THROAT SWELLING TOO, BUT NOT HAD ENOUGH WHERE SHE FELT THE NEED TO GO TO THE HOSPITAL; SO SHE JUST DISMISSED IT. THE OFF AND ON SWELLING HAS BEEN GOING ON SINCE THEN, BUT NEVER VERY BAD. SHE ALSO HAD DERMAL FILLER (PERLANE) INJECTED AROUND HER LIPS IN (B)(6) 2011 OR (B)(6) 2012 SO SHE THOUGHT MAYBE IT WAS RELATED TO THAT TOO. THE PT HAD HER THIRD SESSION OF POLY-L-LACTIC ACID ON (B)(6) 2012. ABOUT A WEEK AFTER THE INJECTIONS, SHE NOTICED A COUPLE OF LUMPS IN HER TEMPLES. SHE VIGOROUSLY MASSAGED THEM TO GET THEM TO SMOOTH OUT. LATER, THAT EVENING, HER LIPS BEGAN TO SWELL. THEN HER THROAT BEGAN TO SWELL. IT GOT SO BAD SHE HAD TO GO TO THE EMERGENCY ROOM AND PRESUMED TO HAVE AN ALLERGIC REACTION WHICH THE PT SUSPECTED WAS POLY-L-LACTIC ACID. THE PT WAS TREATED WITH A STEROID SHOT IN THE EMERGENCY ROOM AND PLACED ON ORAL STEROIDS. SHE WAS ALSO PRESCRIBED DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL). AT THE TIME OF THE REPORT, THE SWELLING IMPROVED BUT WAS STILL PRESENT. THE STEROID INJECTION DID HELP THE LUMPS GO AWAY THOUGH. MEDICAL HISTORY AND CONCOMITANT MEDICATION WAS NOT PROVIDED. NO FURTHER RELEVANT INFORMATION PROVIDED.