BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 8824228 · Received July 24, 2019

    Report

    Report Number
    9617229-2019-09413
    Event Type
    Injury
    Date Received
    July 24, 2019
    Report Date
    November 24, 2020
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: A.2.

    Description of Event or Problem · 0

    HEALTH CARE PROFESSIONAL REPORTED "SUBGRANULAR IMPLANT WITH LOBULATED CONTOURS, EVIDENCING IN THE QIM AT 4 HRS A "STAIR STEP" SIGN, OFTEN RELATED TO INTRACAPSULAR COLLAPSE, WITH INCREASED ECHOGENICITY OF THE EXTRAVASATED FLUID INTO THE SPACE BETWEEN THE ENVELOPE (ELASTOMER) AND THE CAPSULE," AND RUPTURE. THE DEVICE REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN INITIATED. IF ANY NEW, CHANGED OR CORRECTED INFORMATION IS NOTED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED. REASON FOR REOPERATION WILL BE RUPTURE. THIS IS A KNOWN POTENTIAL ADVERSE EVENT ADDRESSED IN THE PRODUCT LABELING. FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    HEALTH CARE PROFESSIONAL REPORTED "SUBGLANDULAR IMPLANT WITH LOBULATED CONTOURS, EVIDENCING IN THE QIM AT 4 HRS A "STAIR STEP" SIGN, OFTEN RELATED TO INTRACAPSULAR COLLAPSE, WITH INCREASED ECHOGENICITY OF THE EXTRAVASATED FLUID INTO THE SPACE BETWEEN THE ENVELOPE (ELASTOMER) AND THE CAPSULE," AND RUPTURE. THE DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    615903 INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 2933592

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention