Description of Event or Problem · 1
INITIAL INFO RECEIVED FROM A PHYSICIAN ON (B)(6) 2010: IT WAS REPORTED THAT A MALE PT WITH (B)(6), WHO HAD SEVERAL SESSION WITH POLY-L-LACTIC ACID (SCULPTRA, LOT# AND EXP DATE UNK), BEGAN TO COMPLAIN ABOUT INCREASING PAIN/PARESTHESIAS, RADIATING IN AN AREA INVOLVING THE CHIN (RIGHT SIDE) AND LOWER LIP (RIGHT SIDE). THE PAIN WOKE HIM AT NIGHT. AT FIRST, THE PT THOUGHT THIS WAS RELATED TO HIS VIGOROUS MASSAGE AND SUBSEQUENT SELF-INDUCED TRAUMA IN THE REGION OF THE MENTAL NERVE. HE SAW A NEUROLOGIST, FACIAL SURGEON, ENDODONTIST, AND AN ENT. THE PHYSICIAN REPORTED, HE HAD NOT INJECTED THE AREA OF PAIN/PARESTHESIA, ALTHOUGH, THE PT ADMITTED TO MASSAGING THAT AREA ANYWAY. EVENTUALLY, A DEEP NODULE APPEARED IN THE REGION OF THE RIGHT, MID LATERAL CHIN. A BIOPSY WAS TAKEN AND SHOWED A NON-HODGKINS LYMPHOMA THAT WAS TRACKING ALONG THE MENTAL NERVE. HE UNDERWENT CHEMOTHERAPY AND AFTER, RESUMED HIS POLY-L-LACTIC SESSIONS. THE PT REMAINS IN THE REPORTING PHYSICIAN'S CARE AND HAS PERIODIC POLY-L-LACTIC INJECTIONS. NO CONCOMITANT MEDICATIONS OR ADDITIONAL MEDICAL HISTORY REPORTED. NO FURTHER INFO REPORTED. PHARMACOVIGILANCE COMMENT: SANOFI-AVENTIS COMPANY COMMENT DATED (B)(6) 2010: NON-HODGKIN'S LYMPHOMA (NHL) WAS THE 6TH MOST COMMON CANCER IN THE (B)(6) IN 2009 AND OCCURS IN ABOUT (B)(6) NEW PTS EACH YEAR. TEN (B)(4). NERVE COMPRESSION SECONDARY TO THE NHL MODULE CAUSED THIS PT'S PAIN/PARESTHESIA AND WAS LIKELY NOT RELATED TO THE ADMINISTRATION OF POLY-L-LACTIC ACID.