Description of Event or Problem · 1
INITIAL REPORT: THIS NON-SERIOUS SPONTANEOUS CASE REPORT FROM (B)(6) WAS REPORTED BY A PHYSICIAN VIA SALES FORCE ON 16-NOV-2010 - (B)(4). THIS CASE INVOLVES A PT (AGE AND SEX NOT REPORTED) WHO EXPERIENCED AN ADVERSE EVENT (NOS) WITH POLY-L-LACTIC ACID (SCULPTRA), THAT WAS INFILTRATED 4-5 MONTHS AGO. RELEVANT MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. CAUSAL RELATIONSHIP: NOT SPECIFIED. FURTHER INFO WAS NOT REPORTED. (B)(4). ADDITIONAL INFO RECEIVED ON 29-NOV-2010, CORRESPONDING TO THE SCULPTRA FOLLOW-UP FORM FOR NODULAR EVENTS COMPLETED BY THE PHYSICIAN: BASED ON THIS ADDITIONAL INFO, THIS CASE INITIALLY ASSESSED A NON-SERIOUS, HAS BEEN UPGRADED TO SERIOUS BASED ON THE RECLASSIFICATION FOR THE EVENT (S) FOLLOWING ASSESSMENT UTILIZING THE COMPANY'S NEW DEVICE REPORTING TREE. THIS CASE INVOLVES A (B)(6) FEMALE, PT, WHO WAS INJECTED POLY-L-LACTIC ACID SCULPTRA ON (B)(6) 2010. THE PT EXPERIENCED LOCALIZED FIBROSIS WHICH APPEARED 5-6 MONTHS AFTER THE FACIAL TREATMENT WITH POLY-L-LACTIC ACID. THE PHYSICIAN DESCRIBED THE ADVERSE EVENT AS LOCATED IN THE MANDIBULAR, CHIN AND NASOGENAL AREAS, INCLUDING 4-5 VISIBLE HARD NODULES OF DIFFERENT SIZES. THE FIRST NODULE APPEARED ON (B)(6) 2010. DETAILED INDICATION WAS REPORTED AS FACIAL SAGGING. NO BIOPSY WAS TAKEN. THE PHYSICIAN REPORTED, ACCORDING TO THE PT, THE PT BEGAN TO NOTICE THE NODULES AFTER A SESSION OF MAINTENANCE RADIO FREQUENCY. ACCORDING TO THE PHYSICIAN, THE NODULES ARE GROWING IN SIZE AND HARDNESS AFTER SESSIONS OF RADIOFREQUENCY. TREATMENT DETAILS: (B)(6) 2010. DILUTION VOLUME: STERILE WATER (5ML) + LIDOCAINE NOS (1 ML). AMOUNT INJECTED: 6 ML NOS. BATCH NUMBER: (NR, EXP. DATE NR). REGION(S) INJECTED: LEFT AND RIGHT CHEEKS, LEFT AND RIGHT CHEEKBONES AND LEFT AND RIGHT MARIONETTE LINES. ON (B)(6) 2010. DILUTION VOLUME: STERILE WATER (5 ML) + LIDOCAINE NOS (1 ML). AMOUNT INJECTED: 6 ML NOS. BATCH NUMBER: (NR, EXP. DATE NR). REGION(S) INJECTED: LEFT AND RIGHT CHEEKS, LEFT AND RIGHT CHEEKBONES AND LEFT AND RIGHT MARIONETTE LINES. ON (B)(6) 2010. DILUTION VOLUME: STERILE WATER (5 ML) + LIDOCAINE NOS (1 ML). AMOUNT INJECTED: 6 ML NOS. BATCH NUMBER: (NR, EXP. DATE NR). REGION(S) INJECTED: LEFT AND RIGHT CHEEKS, LEFT AND RIGHT CHEEKBONES AND LEFT AND RIGHT MARIONETTE LINES. CORRECTIVE TREATMENT: INTRALESIONAL INJECTION OF CORTICOSTEROIDS: DILUTED TRIAMCINOLONE ACETONIDE (TRIGON DEPORT). ACCORDING TO THE PHYSICIAN THE ADVERSE EVENT DID NOT LEAD TO PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE. REGARDING NEED OF SURGICAL INTERVENTION, THE PHYSICIAN ANSWERED NO. OUTCOME: NOT RECOVERED. HISTORY: NO CONCOMITANT DISEASE/MEDICATION. NO PREVIOUS SIMILAR EVENTS EITHER AFTER POLY-L-LACTIC ACID OR WITH OTHER PRODUCTS. NO ACUTE/CHRONIC CUTANEOUS DISEASES. NO AUTOIMMUNE DISORDERS. NO GRANULOMATOUS DISEASE. NO TENDENCY TOWARDS PATHOLOGIC SCARRING. THERE WERE RECENT HORMONAL CHANGES (NOS). THE PT WAS SUBMITTED TO OTHER ESTHETIC TREATMENT (NOS). THE PT UNDERWENT SURGERY FOR BREAST CANCER IN 2004. CAUSAL RELATIONSHIP: NOT SPECIFIED. PHARMACOVIGILANCE COMMENT: SANOFI-AVENTIS COMPANY COMMENT DATED 1-DEC-2010: THE EVENT OF FIBROSIS IS UNLISTED FOR POLY-L-LACTIC ACID; HOWEVER, IN THIS CASE IT MAY BE REPRESENTATIVE OF SCARRING SECONDARY TO THE FORMATION OF NODULES. THE EVENT HAS BEEN UPGRADED TO SERIOUS BECAUSE OF THE USE OF INTRALESIONAL STEROIDS NOT CLEARLY DONE AT PT REQUEST. THE EFFECT OF RADIOFREQUENCY TREATMENTS ON THE NODULES AND FIBROSIS SHOULD BE CONSIDERED SINCE THE REPORTER NOTED THAT THE NODULES SEEMED TO INCREASE IN SIZE AND HARDNESS AFTER A TREATMENT.