BEUDAMED
    FDA Adverse Event Summary report: N

    SCULPTRA

    MDR report key: 1121443 · Received August 13, 2008

    Report

    Report Number
    3002807108-2008-00027
    Date Received
    August 13, 2008
    Date of Event
    October 1, 2006
    Report Date
    November 7, 2006
    Manufacturer
    GLOBAL PHARMACOVIGILANCE AND EPIDEMIOLOGY/SANOFI-AVENTIS
    Product Code
    LMH
    PMA / PMN Number
    P030050
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    THIS POLY-L-LACTIC ACID (PLLA) SCULPTRA CASE IS BEING REPORTED BASED ON NEW INFO RECEIVED 30-JUL-30. CASE PREVIOUSLY REPORTED IN PMA ANNUAL REPORT, UNDER CONDITIONS OF APPROVAL. THIS CASE INFO REC IN 2 LIT REPORTS 30JUL08: SPECIFICALLY: DAYAN SH, ANTONUCCI CM, STEPHANY M, PAINFUL RED, HOT BUMPS AFTER INJECTABLE PLLA TREATMENT: A CASE REPORT. COSMETIC DERMATOLOGY 08; VOL. #7: 388-390; & DAYAN SH, BASSICHIS BA, FACIAL DERMAL FILLERS: SELECTION OF APPROPRIATE PRODUCTS & TECHNIQUES. AESTHETIC SURGERY JOURNAL 08; VOL 28, #3: 335-347. IN FIRST ARTICLE: 10 YR HX OF (B) (6), TYPE VI FACIAL LIPODYSTROPHY & SUBSTANTIAL SUBMENTAL LIPOPTOSIS. PLLA RECONSTITUTED WITH 5 CC SW 48 HRS PRIOR TO EACH TX, USING ASEPTIC TECHNIQUE, WITH PREP OF ALCOHOL PAD, THEN PROVIDINE IODINE. PLLA WAS SWIRLED & INJECTED VIA A 25 GAUGE NEEDLE. ONE YR AFTER LAST TX, PT COMPLAINED OF "PROGRESSIVE HOT, HARD, PAINFUL & DISTORTING BUMPS" AT INJ, CAUSING EXTREME DISCOMFORT & PREVENTING HIM FROM MOVING FACE. THREE WKS LATER, PT PRESENTED WITH WARM, ERYTHEMATOUS & FIBROTIC SKIN IN BOTH CHEEKS. PT HAD NO CHANGE IN MEDS, NO TRAUMA, NO RECENT INFECTION, OR CHANGE IN IMMUNE STATUS. PT THOUGHT TO HAVE A "DELAYED ALLERGIC REACTION." TX WITH TA, INTRALESIONAL (IL), & 4 WKS BIAXIN. SIX WKS LATER, PT 50% IMPROVED, ABLE TO OPEN MOUTH FULLY & NODULES HAD DECREASED. PT BX L ORBIT RIM; RESULTS INCONCLUSIVE: NO INFLAM LESIONS, NECROBIOSIS OR MALIGNANCY. ADDIT TX WITH TA, (IL) & STEROIDS (NOS). BUMPS PALPABLE BUT NO LONGER VISIBLE OR PAINFUL, PT HAD NORMAL FUNCTION OF MOUTH. ALL SIGNS & SYMPTOMS OF THE INFLAM LESIONS HAVE ULTIMATELY RESOLVED. REACTION DELAY OF 1 YR POST-TX IS CONSISTENT WITH A DEL HYPERSENSITIVITY REACTION (HR). ALTHOUGH UNLIKELY, AN UNDERLYING INFECTIOUS PROCESS COULD NOT BE RULED OUT. SECOND ARTICLE SHOWED PT'S PIC, CAPTION: GRANULOMATOUS REACTION 12 MONTHS AFTER 3 PLLA TX'S, & COMMENTED RE: CONCERNS OVER DEL-TYPE HR'S.

    Description of Event or Problem · 1

    (B) (4). INITIAL REPORT (REP) DATED 07NOV06: THIS SPONTANEOUS REP WAS MADE BY A CONSUMER (CONS). THIS MALE PATIENT (PT) UNKNOWN (UNK) AGE WAS TREATED (TX) WITH POLY-L-LACTIC ACID (PLLA) (SCULPTRA) IN (B) (6) 2005, (B) (6) 2005 & (B) (6) 2005 FOR AN UNSPECIFIED INDICATION. MEDICAL HISTORY (HX) & CONCOMITANT (CONC) DRUG INFORMATION (INFO) NOT REP. ON AN UNK, "IN THE LAST SEVERAL MONTHS" HE BEGAN TO NOTICE HARD BUMPS UNDER SKIN IN TX/S AREAS. AT TIME OF REP, BUMPS HAD GROWN & WERE "EXTREMELY NOTICEABLE". ADDENDUM (ADD) FOR FOLLOW-UP (F/U) 13NOV06 FROM PRODUCT TECHNICAL COMPLAINT (PTC) #(B) (4) SCULPTRA BATCH # UNK: BATCH RECORD REVIEW WITHOUT HINT TO ROOT CAUSE. NO FAULTS, DEFECTS, DAMAGES DETECTABLE. CONCLUSION: NO FAULTS DETECTABLE. ADD TO F/U 10JAN07: A (B) (6) MALE CONS REC PLLA 2 VIALS EACH VISIT IN (B) (6) 2005, (B) (6) 2005 & (B) (6) 2005 FOR TX OF LIPOATROPHY. MEDICAL HX INCLUDED HIV INFECTION & HIGH CHOLESTEROL. CONC MEDICATION (MED: LOPINAVIR/RITONAVIR (KALETRA), NEVIRAPINE (VIRAMUNE), TENOFOVIR (VIREAD) & FENOFIBRATE (TRICOR). CONS REP EXPERIENCING INJECTION SITE (INJS) GRANULOMAS & NODULES UNDER SKIN. TX INCLUDED STEROID INJ'S WHICH HAVE DECREASED INFLAMMATION (INFLAM) BUT GRANULOMAS STILL PRESENT. LOT #/EXP DATE UNK. ADD FOR F/U REC 18JAN07 FROM CONS: HE DESCRIBED EVENT AS "HARD", "DISTORTING" NODULES & GRANULOMAS AT INJS'S WHICH HAVE CAUSED "DISFIGUREMENT" & "EXTREME DISCOMFORT" & MAKE HIM UNABLE TO MOVE FACE "NORMALLY". HE PROVIDED PHOTO OF UPPER FACIAL PROFILE DATED (B) (6) 2006 WHICH SHOWS MULTIPLE SUBCUTANEOUS NODULES ALONG THE LEFT (L) ZYGOMATIC & TEMPORAL (TEM) BONES. EVENT STARTED IN (B) (6) 2006. HE WAS TX'D WITH STEROID INJ'S & CLARITHROMYCIN (BIAXIN), BUT EVENT CONTINUES. HE LAST VISITED PHYSICIAN (PHYS) (B) (6) 2006. (B) (6): ALSO GABAPENTIN (NEURONTIN) FOR NEUROPATHY. ADD FOR F/U REC 14MA07: ADD INFO RECEIVED FROM THE TX'ING PHYS. ADD MEDICAL HX INCLUDES DEPRESSION & ANXIETY. PHYSICIAN STATES THAT PT HAD "FACIAL DISFIGUREMENT SECONDARY TO LIPODYSTROPHY" PRIOR TO SCULPTRA INJ'S. ADD CONC MEDS: ESCITALOPRAM OXALATE (LEXAPRO), EZETIMIBE (ZETIA) & "VIRSTAD". ON (B) (6) 2005, PT REC 5CC OF PLLA SOLUTION & STERILE WATER (SW) INTO RIGHT (R) CHEEK REGION (REG) & SAME AMOUNT INTO L CHEEK REG. SUBSEQUENT INJ'S OF PLLA WERE ADMINISTERED (ADM) (B) (6) 2005, (B) (6) 2005 & (B) (6) 2005 INTO THE R & L CHEEK REGIONS. LOT#: A4001/EXP DATE SEP06. ON (B) (6) 2006, PT PRESENTED WITH ERYTHEMATOUS, FIBROTIC SKIN SLIGHTLY WARM TO TOUCH ON BOTH CHEEK AREAS, EXTENDING INTO TEM REG BILATERALLY (BILAT). THERE WERE DISTINGUISHABLE NODULES IN TEM REG & FLAT PLATEAUS IN THE CHEEK REG BILAT. AT TIME, WAS TX'D WITH TRIAMCINOLONE ACETONIDE (TA) (KENALOG), 20MG/CC, TOTAL OF 2 CC TO BOTH SIDES. AT 6-WEEK (WK) F/U 29JAN07, THERE WAS SIGNIFICANT IMPROVEMENT. BIOPSY (BX) OF AREA WAS TAKEN (RESULTS NOT PROVIDED) & 1.75CC (20MG/CC) OF TA INJECTED INTO EACH SIDE OF FACE. PHYS STATES THAT NODULARITY IMPROVED AFTER DISCONTINUATION OF PLLA & ADM OF TA OVER SUBSEQUENT OFFICE VISITS. HE REP EVENT AS ONGOING. ADD FOR CASE INFO, REC IN 2 LITERATURE REPORTS 30JUL08: SPECIFICALLY: DAYAN SH, ANTONUCCI CM, STEPHANY M, PAINFUL RED, HOT BUMPS AFTER INJECTABLE POLY-L-LACTIC ACID TREATMENT: A CASE REPORT. COSMETIC DERMATOLOGY 2008; VOL 21 #7: 388-390; & DAYAN SH, BASSICHIS BA, FACIAL DERMAL FILLERS: SELECTION OF APPROPRIATE PRODUCTS & TECHNIQUES. AESTHETIC SURGERY JOURNAL 2008; VOL 28, #3: 335-347. IN FIRST ARTICLE, ADDIT INFO INCLUDED: 10 YR HX OF HIV, TYPE VI FACIAL LIPODYSTROPHY & "SUBSTANTIAL SUBMENTAL LIPOPTOSIS." NO ADDIT CONC MEDS "MEDICATIONS & IMMUNE STATUS WERE STABLE." NO ENVIRONMENTAL OR DRUG ALLERGIES REP. PLLA RECONSTITUTED WITH 5 CC SW 48 HRS PRIOR TO EACH TX, USING ASEPTIC TECHNIQUE, WITH PREP OF ALCOHOL PAD, THEN PROVIDINE IODINE. NO ANAESTHETIC. PLLA WAS SWIRLED & INJECTED VIA A 25 GAUGE NEEDLE, WITH A "FANNING MOTION INTO THE DEFECT IN THE SUBCUTANEOUS & SUBDERMAL SPACES OF EACH CHEEK. MULTIPLE PASSES WERE PERFORMED TO ENSURE A MINIMAL CONSERVATIVE DEPOSIT WITH EACH PASS." A TOTAL OF 5CC GIVEN INTO EACH CHEEK. AFTER TX, PT WAS GIVEN GAUZE PAD AND ICE PACK TO HOLD OVER AREA FOR 20 MINUTES. NO MANIPULATION OR MASSAGE WAS DONE OR RECOMMENDED. PT RETURNED AT 4 WKS, 7 WKS, & 11 WKS POST-TX, FOR 3 ADDIT TX'S; SAME TX GIVEN, EXCEPT THAT AT LAST TX, 1 CC PLLA INJ INTO EACH TEM USING A SERIAL DEPOT METHOD. DEC06, APPROX 1 YR AFTER LAST TX, PT COMPLAINED OF "PROGRESSIVE HOT, HARD, PAINFUL & DISTORTING BUMPS" AT INJ SITES, WHICH WERE CAUSING EXTREME DISCOMFORT & PREVENTING HIM FROM MOVING FACE NORMALLY. THREE WKS LATER, PT PRESENTED WITH "WARM, ERYTHEMATOUS & FIBROTIC SKIN" IN BOTH CHEEKS, & EXTENDING INTO TEM REG. PT HAD BILAT NODULES IN TEM REG'S & FLAT, NON-FLUCTUANT PLATEAUS IN BOTH CHEEKS. PT HAD NO CHANGE IN MEDS, NO TRAUMA, NO RECENT INFECTION, OR CHANGE IN IMMUNE STATUS. PT WAS THOUGHT TO HAVE A "DELAYED ALLERGIC REACTION." TX WITH TA, INTRALESIONAL (IL) AS ABOVE, & 4 WKS BIAXIN. SIX WKS LATER, PT WAS 50% IMPROVED, ABLE TO OPEN MOUTH FULLY & NODULES HAD DECREASED. PT HAD BX L ORBIT RIM; RESULTS WERE "INCONCLUSIVE": "NO INFLAM LESIONS, NECROBIOSIS OR MALIGNANCY." HAD ADDIT TX WITH TA, (IL) & LATER TX WITH IL STEROIDS (NOS). BUMPS PALPABLE BUT NO LONGER VISIBLE OR PAINFUL, PT HAD NORMAL FUNCTION OF MOUTH. "ALL SIGNS & SYMPTOMS OF THE INFLAM LESIONS HAVE ULTIMATELY RESOLVED". REACTION DELAY (DEL) OF 1 YR POST-TX IS "CONSISTENT WITH A DEL HYPERSENSITIVITY REACTION (HR)." "ALTHOUGH UNLIKELY, AN UNDERLYING INFECTIOUS PROCESS COULD NOT BE RULED OUT AS AN ETIOLOGY SINCE THERE HAVE BEEN REP OF ATYPICAL SKIN & SOFT TISSUE ORGANISMS ASSOCIATED WITH DEL REACTIONS" IN FACIAL PROCEDURES. SECOND ARTICLE SHOWED PT'S PICTURE, CAPTION: "GRANULOMATOUS REACTION" 12 MONTHS AFTER 3 PLLA TX'S," & COMMENTED RE: "CONCERNS OVER DEL-TYPE HR'S OCCURING MONTHS FOLLOWING INJECTIONS"; NO ADDIT MEDICAL INFO ON PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCULPTRA INJECTABLE LMH GLOBAL PHARMACOVIGILANCE AND EPIDEMIOLOGY/SANOFI-AVENTIS NA A4001

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR