BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 23305155 · Received October 15, 2025

    Report

    Report Number
    9617229-2025-17647
    Event Type
    Injury
    Date Received
    October 15, 2025
    Date of Event
    August 25, 2022
    Report Date
    October 15, 2025
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    UDI-DI
    10888628007406
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT OF CAPSULAR CONTRACTURE IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. REASON FOR REOPERATION: CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE". LATER HEALTHCARE PROFESSIONAL REPORTED THERE WAS NO CAPSULAR CONTRACTURE FOR THIS SIDE. LATER, PATIENT REPORTED "THEY ARE A BREAST CANCER PATIENT". LATER, PATIENT'S LEGAL REPRESENTATIVE REPORTED "CAPSULAR CONTRACTURE", "HARDENING" (NDR), "UNCOMFORTABLE FEELING" (NDR), "TIREDNESS, IRRITABILITY, FATIGUE" (NDR), "INADEQUACY AS A WOMAN" (NDR), "HEADACHES" (NDR), "DEPRESSION" (NDR) AND "JOINT PAIN" (NDR). THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2289534 INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 3344461 10888628007406

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female Required Intervention