BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK MAMMARY IMPLANT

    MDR report key: 23632010 · Received November 24, 2025

    Report

    Report Number
    9617229-2025-20367
    Event Type
    Injury
    Date Received
    November 24, 2025
    Date of Event
    April 1, 2020
    Report Date
    November 24, 2025
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    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: SILICONE MIGRATION AND CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN.

    Description of Event or Problem · 0

    PATIENT REPORTED ¿INCREASING CADENCE IN FLARE-UPS, INCLUDING SWELLING IN BOTH BREASTS¿, ¿HOT /BURNING FEELING¿, ¿GENERAL FEELING OF MALAISE¿ (NOT DEVICE RELATED), ¿STABBING PAIN IN LEFT BREAST¿, ¿BACK AND UNDER BREAST CRAMPING¿, ¿RESULTING IN BOTH IMPLANTS COMPLETELY CAPSULATED AND POTENTIALLY FIXED TO CHEST WALL¿. PATIENT LATER REPORTED "LIKELY A RETURN OF MY BREAST CANCER, ALSO IN MY LIVER AND POSSIBLY LUNG", "SOME KIND OF SEVERE AUTO-IMMUNE DISEASE, PARTICULARLY IN CONTACT WITH PLASTICS" (WHICH ARE BOTH NOT DEVICE RELATED), AND "CT SCANS ALSO SHOW THAT I HAVE LYMPH NODES THAT APPEAR TO STILL HAVE SILICON". THIS RECORD IS FOR THE LEFT SIDE. DEVICE HAS BEEN EXPLANTED. DEVICE RETURN UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2341673 UNK MAMMARY IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN (COSTA RICA) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Female Required Intervention