BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 21712414 · Received March 27, 2025

    Report

    Report Number
    9617229-2025-05028
    Event Type
    Injury
    Date Received
    March 27, 2025
    Date of Event
    September 23, 2024
    Report Date
    April 22, 2025
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. THE EVENT OF HYPERSENSITIVITY, SEROMA, ABSCESS, CAPSULAR CONTRACTURE, SWOLLEN LYMPH NODES/GLANDS AND BACTERIAL INFECTION ARE 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: RUPTURE, HYPERSENSITIVITY, SEROMA, ABSCESS, CAPSULAR CONTRACTURE, SWOLLEN LYMPH NODES/GLANDS AND BACTERIAL INFECTION.

    Additional Manufacturer Narrative · 0

    ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: B1, H.6.

    Description of Event or Problem · 0

    LEGAL REPRESENTATIVE REPORTED RIGHT SIDE INCREASE IN VOLUME, SWELLING AND PAIN, INTRACAPSULAR RUPTURE, PERI-IMPLANT FLUID, AS WELL AS SIGNS OF CAPSULITIS, BACTERIUM KLEBSIELLA AEROGENES, ALLERGIC CRISES, ABSCESSES, RECURRENT INFLAMMATION, PSYCHOLOGICAL TRAUMA OF FACING INVASIVE MEDICAL PROCEDURES, MASTITIS IN THE QIM, FOCAL SKIN THICKENING, LYMPH NODE WITH DIFFUSE, CAPSULAR CONTRACTURE, SKIN IS ADHERED TO THE CAPSULE DIAGNOSED BY MRI AND ULTRASOUND. DEVICE HAS BEEN EXPLANTED.

    Description of Event or Problem · 0

    LEGAL REPRESENTATIVE REPORTED RIGHT SIDE INCREASE IN VOLUME, SWELLING AND PAIN, INTRACAPSULAR RUPTURE, PERI-IMPLANT FLUID, AS WELL AS SIGNS OF CAPSULITIS, BACTERIUM KLEBSIELLA AEROGENES, ALLERGIC CRISES, ABSCESSES, RECURRENT INFLAMMATION, PSYCHOLOGICAL TRAUMA OF FACING INVASIVE MEDICAL PROCEDURES, MASTITIS IN THE QIM, FOCAL SKIN THICKENING, LYMPH NODE WITH DIFFUSE, CAPSULAR CONTRACTURE, SKIN IS ADHERED TO THE CAPSULE DIAGNOSED BY MRI AND ULTRASOUND. DEVICE HAS BEEN EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1358501 INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 2639650

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Female Required Intervention