BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DERMIK

    MDR report key: 1338309 · Received March 8, 2009

    Report

    Report Number
    MW5010245
    Event Type
    Injury
    Date Received
    March 8, 2009
    Date of Event
    December 21, 2007
    Report Date
    May 12, 2010
    Manufacturer
    SANOFI-AVENTIS/DERMIK
    Product Code
    LMH
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT SEEN BY MD IN 2007 FOR COSMETIC EVAL. MD SUGGESTED SCULPTRA FOR IMPROVING VOLOUME IN FACE. THIS IS OFF-LABEL USE. PT IS NOT HIV+. PT STATES WAS NOT TOLD OF RISKS, AND PHYSICIAN'S CONSENT FORM DOES NOT INDICATE RISKS. PT HAD 10 CC OF SCULPTRA WITH A 4 CC SALINE DILUENT INJECTED IN LAT. TEMPORAL,. NASOMALAR, COMMISURAL, AND PREJOWL SULCI AS WELL AS ZYGOMATIC AND INFRAORBITAL REGIONS. PT HAD NO RESPONSE AND WAS REINJECTED WITH 5 CC SIMILAR DILUTION OF PRODUCT IN SAME LOCATIONS AS WELL AS LATERAL LOWER MALAR AREAS. PT NOTED NODULE FORMATION 2 WKS POST PROCEDURE, AND MORE 6 WEEKS PP. ON RIGHT MALAR AND SUBOPHTHALMIC AREAS. WAS ASPIRATED AND MANIPULATED BY MD. FOLLOW UP IN 2008 NO RX. APPROX TWO AND A HALF MONTHS LATER, DEVELOPED REDNESS, SWELLING AND MORE LUMPS. I SAW PT IN CONSULTATION IN 2009. PT HAS LICHENIFICATION AND YELLOW-RED DISCOLORATION OF SKIN FROM INFRA ORBITAL AREA TO MID MALAR, WITH NODULES AND PLAQUES. ALSO ERYTHEMATOUS NODULES ->1 CM- IN NASOLABIAL FOLDS. NODULES AND PAPULES ARE EVIDENT IN THE PERIORAL AREAS WHEN SHE ANIMATES. NODULES ARE NOTICEABLE IN GENERAL AT FIRST GLANCE AND ARE DISFIGURING. DOSE OR AMOUNT: 10 CC OF 4CC; 5 CC OF 4CC DILUTION. ROUTE: SUBDERMAL. DATES OF USE: 2007 - ONGOING - 15 MONTHS SO FAR. DIAGNOSIS OR REASON FOR USE: ESTHETIC IMPROVEMENT/VOLUME. ESTHETIC IMPROVEMENT/VOLUME. EVENT ABATED AFTER USE STOPPED: NO. EVENT REAPPEARED AFTER REINTRODUCTION: YES.

    Description of Event or Problem · 1

    THIS IS AN UPDATE OF REPORT 5010245 IMMUNOCOMPETENT PT WAS INJECTED WITH SCULPTRA IN NASOMALAR GROOVES, COMMISSURES, MARIONETTE LINES, ZYGOMATIC REGIONS, LATERAL MALAR, AND SUPRAZYGOMATIC REGIONS BELOW ORBITS. PAPULES AND INFLAMMATORY NODULES DEVELOPED IN AREAS OF INJECTIONS. PT DEVELOPED SEVERE INTERMITTENT LANCINATING PAIN IN INFRAORBITAL REGION ON RIGHT. APPEARED THAT NERVE WAS AFFECTED. SYMPTOMS IMPROVED SOMEWHAT WITH INDOMETHACIN - OTHER SAIDS NOT HELPFUL - AND DOXYCYCLINE, WHICH HAVE BOTH BEEN CONTINUED FOR APPROX 6 MONTHS THUS FAR. PT HAS HAD BIOPSIES OF FOREIGN BODY GRANULOMAS WITH SCULPTRA MATERIAL VISIBLE WITHIN. NOW SOME OF MATERIAL IS COMING TO SURFACE OF SKIN, AND ALSO MORE APPARENT THROUGH ORAL MUCOSA. PT HAS LOST SIGNIFICANT WEIGHT BECAUSE OF PAIN SXS LEADING TO LOSS OF APPETITE, AND HAS PERIODS OF OVERWHELMING FATIGUE. MRI WITH CONTRAST WAS NEGATIVE FOR MASS LESION CAUSING SYMPTOMS. HAS SOUGHT CONSULTATION WITH NUMEROUS PLASTIC AND OCULOPLASTIC SURGEONS, MANY OF WHOM USE SCULPTRA, WITHOUT HELP. IN OUR OFFICE, INTRALESIONAL INJECTION WITH VERY DILUTED TRIAMCINOLONE ACETONIDE HAS HELPED INDIVIDUAL LESIONS BECOME LESS PROMINENT, BUT HAS NOT RELIEVED HER OVERALL SYMPTOMS. HAVE EXCISED THREE LARGE CHUNKS OF MATERIAL FROM LOWER LABIAL MUCOSA, AND ALSO RIGHT UPPER LIP WITH IMPROVEMENT OF DYSESTHESIAS OF ORAL AREA. THIS CONTINUES TO BE AN ONGOING PROBLEM WITH DISFIGUREMENT AND PAIN PERSISTING OVER SEVERAL YEARS. DIAGNOSIS OR REASON FOR USE: ESTHETIC IMPROVEMENT OF FACIAL FURROWS. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED? NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DERMIK SCULPTRA LMH SANOFI-AVENTIS/DERMIK A6015
    2 SCULPTRA NONE LMH DERMIK SANOFI/AVENTIS A7018

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other| R