BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 20 SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 22530954 · Received July 17, 2025

    Report

    Report Number
    9617229-2025-11995
    Event Type
    Injury
    Date Received
    July 17, 2025
    Date of Event
    September 15, 2014
    Report Date
    July 17, 2025
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. REASON FOR REOPERATION: RUPTURE.

    Description of Event or Problem · 0

    PATIENT REPORTED "RIPPLING AND LOOKS LIKE COLLAPSING." HEALTHCARE PROFESSIONAL LATER REPORTED "SHIFTING" AND "RIPPLING." PATIENT LATER REPORTED "DIRE PAIN, COLLAPSING BREAST, INABILITY TO LIFT THE ARM, ABILITY TO FEEL THE PLASTIC ON THE TOP, NOT BEING ABLE TO TAKE DEEP BREATHS DUE TO PAIN, AND INDENTIONS ALL OVER THE TOP OF THE RIGHT BREAST." HEALTHCARE PROFESSIONAL LATER CALLED AND REPORTED "DISTORTED AND WAVY AND FRACTURE IN THE GEL." PATIENT LATER REPORTED ¿PLASTIC SHOWING THROUGH THE SKIN, LOOKS LIKE A HANDPRINT OF RIPPLING AND BACK PAIN." THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671463 STYLE 20 SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 2112809

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female Required Intervention