BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 21505957 · Received March 3, 2025

    Report

    Report Number
    9617229-2025-03600
    Event Type
    Injury
    Date Received
    March 3, 2025
    Date of Event
    November 19, 2024
    Report Date
    April 3, 2025
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: THE DEVICE RELATED TO THE REPORTED EVENTS RUPTURE AND CAPSULAR CONTRACTURE WAS RECEIVED ON MARCH 18, 2025, WITH LOT NUMBER 3124018. BASED ON THE PRODUCT ANALYSIS PERFORMED, THE ASSESSMENTS OF THE COMPLAINT CODES ARE: ¿ CAPSULAR CONTRACTURE: UNABLE TO OBSERVE. ¿ RUPTURE: OBSERVED BROKEN DEVICE ASSESSED AS UNIDENTIFIED (TEAR) OPENING. NO ADDITIONAL OBSERVATIONS PERFORMED ON THE DEVICE. NO FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: B1, B3, B5, B6, D6A, D6B, D9, H3, H6.

    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 III. 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 BAKER GRADE III" CONFIRMED VIA MRI. PATIENT LATER REPORTED RUPTURE. HEALTHCARE PROFESSIONAL LATER REPORTED INTRACAPSULAR RUPTURE CONFIRMED VIA MRI AND MAMMOGRAM. RECORD IS FOR RIGHT SIDE. DEVICE HAS BEEN EXPLANTED.

    Description of Event or Problem · 0

    PATIENT ADDITIONALLY REPORTED "I HAD A RUPTURED IMPLANT WITHIN 5 YEARS." HEALTHCARE PROFESSIONAL LATER REPORTED INTRACAPSULAR RUPTURE CONFIRMED VIA MRI AND MAMMOGRAM. THE DEVICE HAS BEEN EXPLANTED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III" CONFIRMED VIA MRI. RECORD IS FOR RIGHT SIDE. DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    677192 INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 3124018

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Female Required Intervention