BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCULPTRA

    MDR report key: 23109411 · Received September 22, 2025

    Report

    Report Number
    MW5176279
    Event Type
    Injury
    Date Received
    September 22, 2025
    Date of Event
    October 5, 2023
    Report Date
    September 16, 2025
    Manufacturer
    GALDERMA LABORATORIES, L.P.
    Product Code
    LMH
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I HAD 2 VIALS OF SCULPTRA (ONE IN EACH CHEEK) DONE BY DR. ON (B)(6) 2023. THIS WAS TO HELP FILL OUT THE CHEEKS AND ALSO TO HELP WITH ACNE SCARRING. THIS PAST (B)(6) 2025, I STARTED TO DEVELOP HYPERTROPHIC SCARS IN THE AREAS THAT WERE INJECTED. I HAVE SEVERAL OF THEM CAUSING TETHERING AND THE APPEARANCE OF INDENTATIONS NEXT TO THEM DUE TO THE TETHERING. I HAVE BEEN GETTING TREATMENT INCLUDING KENALOG, 5FU AND SUBCISION WITH (B)(6), WHO IS WONDERFUL, BUT WE HAVE MADE VERY LITTLE PROGRESS. I AM INCREDIBLY FRUSTRATED AND WANTED YOU TO KNOW ABOUT THIS COMPLICATION. MY SKIN IS NO LONGER SMOOTH BUT IS LUMPY WITH INDENTATIONS AND RAISED AREAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201667 SCULPTRA IMPLANT, DERMAL, FOR AESTHETIC USE LMH GALDERMA LABORATORIES, L.P.

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Female Required Intervention BIOTIN.| BIRTH CONTROL PILLS.| FLUOROURACIL.| KENALOG.| MAGNESIUM.| MINOXIDIL 2.5 MG.| MULTIVITAMIN.| RETIN A.