BEUDAMED
    FDA Adverse Event Summary report: N

    SCULPTRA

    MDR report key: 1736838 · Received December 21, 2009

    Report

    Report Number
    3002807108-2009-00168
    Date Received
    December 21, 2009
    Report Date
    December 19, 2007
    Manufacturer
    GLOBAL PHARMACOVIGILANCE AND EPIDEMIOLOGY/SANOFI-AVENTIS
    Product Code
    LMH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    DISCUSSION: OUR EXPERIENCE, AS WITH OTHERS, IS THAT NODULE FORMATION AFTER INJECTION OF PLA DOES OCCUR AND CAN PRESENT AS A LATE COMPLICATION. AS IN THE PRESENT CASE, THESE NODULES MAY APPEAR REFRACTORY TO TREATMENT WITH INJECTION OF LOW CONCENTRATIONS OF INTRALESIONAL CORTICOSTEROID DESPITE THE ONSET OF CORTICOSTEROID-INDUCED FACIAL SKIN ATROPHY. WE HAVE FOUND IT HELPFUL TO CLASSIFY NODULES ASSOCIATED WITH PLA IMPLANT INTO TWO GROUPS: EARLY-ONSET AND LATE-ONSET NODULES. TYPICALLY, LATE-ONSET NODULES (APPEARING 3-36 MONTHS AFTER INJECTION), HAVE ABRUPT ONSET, MAY BE ASSOCIATED WITH EDEMA AND DISCOLORATION, TEND TO GROW WITH PERIODS OF FLARE-UP AND TEMPORARY REGRESSION, AND RESPOND WELL TO INTRALESIONAL CORTICOSTEROID INJECTIONS. IN CONTRAST, EARLY-ONSET NODULES OFTEN TERMED NON-INFLAMMATORY (ONSET 1-3 MONTHS AFTER INJECTION), ARE SMALLER (1-2 MM), AND APPEAR GRADUALLY WITHOUT EDEMA; REMAIN STABLE IN SIZE, AND RESPOND POORLY TO CORTICOSTEROIDS, OFTEN AWAITING ABSORPTION OR EXCISION. HISTOLOGICALLY, LATE-ONSET NODULES TYPICALLY SHOW A FOREIGN BODY GRANULOMATOUS FORMATION WITH SCATTERED MATERIAL IN A STRONG CELLULAR REACTION, WHEREAS EARLY-ONSET NODULES SHOW PACKED MATERIAL IN A SCARCE CELLULAR REACTION. SUMMARY: NODULE FORMATION FROM INJECTION OF PLA CAN BE EXPECTED TO OCCUR. IN OUR EXPERIENCE, HIGHER DILUTIONS OF PLA APPEAR TO YIELD A LOWER INCIDENCE OF LATE-ONSET, INFLAMMATORY NODULES. THE TREATMENT OF LATE ONSET NODULES ALSO APPEARS TO REQUIRE INITIAL HIGH DOSES OF INTRALESIONAL CORTICOSTEROIDS AS AN EFFECTIVE APPROACH TO THIS TYPE OF COMPLICATION.

    Description of Event or Problem · 1

    AVENTIS CASE ID: (B)(4). INITIAL REPORT DATED (B)(6) 2007: THE FOLLOWING INFO WAS IDENTIFIED IN THE LITERATURE. SPECIFICALLY: HAMILTON DG, GAUTHIER N, ROBERTSON BF, LATE-ONSET RECURRENT FACIAL NODULES ASSOCIATED WITH INJECTION OF POLY-L-LACTIC ACID. DERMATOLOGY SURGERY 2008; 34(1): 123-126. A (B)(6) FEMALE PT INITIATED THERAPY IN (B)(6) 2002 WITH INJECTABLE POLY-L-LACTIC ACID (SCULPTRA) FOR FACIAL CONTOURING FOR VOLUME LOSS OF THE MID AND LOWER FACE. MEDICAL HISTORY INCLUDES PREVIOUS TREATMENT WITH HYALURONANS AND COLLAGEN, SITES NOT SPECIFIED. CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE PT RECEIVED A TOTAL VOLUME OF 9 CM3 OF THE POLY-L-LACTIC ACID (PLA) DURING TWO SESSIONS AT THE PARIS OFFICE. EACH VIAL OF PLA POWDER WAS RECONSTITUTED WITH 3 CM3 OF STERILE WATER AT A 3:1 DILUTION. IN THE FIRST SESSION, 6 CM3 WAS INJECTED SUBDERMALLY INTO THE NASOLABIAL FOLDS, ORAL COMMISSURES, AND DEPRESSIONS ON EACH SIDE OF THE CHIN. A QUANTITY OF 1 CM3 WAS ALSO INJECTED INTO THE CUTANEOUS BORDER OF THE VERMILION, THE WHITE ROLL OF THE LIP. THREE DAYS LATER, 1 CM3 WAS INJECTED DEEP AT EACH JUGOMALAR DEPRESSION ADJACENT TO THE INFRAORBITAL PERIOSTEUM. DURING THE SECOND SESSION, NO AREAS TREATED IN THE FIRST SESSION WERE RE-INJECTED OR AUGMENTED. THE PT RETURNED TO THE UNITED STATES AND DID WELL FOR ONE YEAR, WHEN SHE ABRUPTLY DEVELOPED TENDER NODULES AT HER PREVIOUS INJECTION SITES. ONSET OF THESE NODULES WAS COINCIDENT WITH A CHANGE IN HER ESTROGEN HORMONE REPLACEMENT THERAPY, NOS. SHE INITIALLY SAW ANOTHER PHYSICIAN WHO BEGAN TREATMENT WITH INTRA-LESIONAL TRIAMCINOLONE INJECTIONS, 1 TO 5 MG, TWICE MONTHLY. AFTER SEVERAL MONTHS, THESE INJECTIONS SEEMED TO BRING ONLY SLIGHT IMPROVEMENT AND SHE WAS REFERRED TO A PHYSICIAN IN OUR GROUP IN (B)(6) 2003. HER EXAMINATION WAS REMARKABLE FOR SEVERAL RED, NON-TENDER, DEEP NODULES VARYING IN SIZE FROM 0.3 TO 1.0 CM INVOLVING THE PREVIOUS PLA INJECTION SITES, INCLUDING THE PERIORBITAL AREA. SHE ALSO EVIDENCED FACIAL SKIN ATROPHY AND TELANGIECTASIAS COMPATIBLE WITH PREVIOUS CORTICOSTEROID INJECTIONS. SHE REFUSED A SKIN BIOPSY. HORMONE REPLACEMENT THERAPY WAS DISCONTINUED, AND INTRALESIONAL TRIAMCINOLONE WAS TITRATED TO A CONCENTRATION OF 10 MG/CM3 BEFORE A SIGNIFICANT ANTI-INFLAMMATORY RESPONSE WAS SEEN. DESPITE THE CONCENTRATION, SHE CONTINUED TO EXPERIENCE PERSISTENT AND RECURRENT NODULES AND WAS REFERRED TO A COLLEAGUE AT A UNIVERSITY WHO ULTIMATELY FOUND IT NECESSARY TO INJECT TRIAMCINOLONE AT 40 MG/CM3 TO RESOLVE THE INFLAMMATION. THE PT WAS ALSO SEEN YEARLY IN THE (B)(4) OFFICE, AND WHEN LAST SEEN THERE IN (B)(6) 2006, SHE HAD NO FURTHER EVIDENCE OF NODULES. NO FURTHER MEDICAL INFO REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCULPTRA INJECTABLE LMH GLOBAL PHARMACOVIGILANCE AND EPIDEMIOLOGY/SANOFI-AVENTIS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR