BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 110 SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 24872507 · Received April 14, 2026

    Report

    Report Number
    9617229-2026-06742
    Event Type
    Injury
    Date Received
    April 14, 2026
    Report Date
    May 13, 2026
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CLARIFICATION TO H6: HEALTH EFFECT - CLINICAL CODE E180101 WAS REPORTED IN ERROR IN THE PREVIOUS EMDR AS IT HAS BEEN DEEMED NOT DEVICE RELATED. REASON FOR REOPERATION: RUPTURE.

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCE'S NOTED. THE EVENT OF "CANCER" 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: RUPTURE AND CANCER - BREAST.

    Description of Event or Problem · 0

    THE REPORTED BREAST CANCER HAS BEEN DEEMED NOT RELATED TO THE DEVICE.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED "RUPTURE" DIAGNOSED VIA MRI. LATER HEALTHCARE PROFESSIONAL REPORTED "BIOPSY CAME BACK POSITIVE FOR BREAST CANCER". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602127 STYLE 110 SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 1547952

    Patients

    Seq Age Sex Outcome Treatment
    1