BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 8595472 · Received May 9, 2019

    Report

    Report Number
    9617229-2019-04529
    Event Type
    Injury
    Date Received
    May 9, 2019
    Date of Event
    September 15, 2012
    Report Date
    October 23, 2019
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P040046
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. 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. THE REASON FOR REOPERATION IS CAPSULAR CONTRACTURE, BAKER GRADE IV. FURTHER INFORMATION FROM THE REPORTER REGARDING THE EVENTS, PRODUCT, AND PATIENT DETAILS HAVE BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THIS IS A KNOWN POTENTIAL ADVERSE EVENT ADDRESSED IN THE PRODUCT LABELING.

    Description of Event or Problem · 1

    PATIENT REPORTED ¿HEALTH HAS DETERIORATED," ¿SEVERE IMMUNE DAMAGE AND CAUSED A GREAT DEAL OF EMOTIONAL, PSYCHOLOGICAL, AND PHYSICAL PAIN." HEALTHCARE PROFESSIONAL LATER REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV. THE DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    PATIENT LATER EXPRESSED CONCERN REGARDING IF "BIA-ALCL WAS DETECTED" AND REPORTED INFLAMMATION, "ARM HAND PAIN," "BODY PAIN," ¿CRITICAL LIFE ALTERING CHANGES TO HEALTH," "GETTING SICKER,¿ ¿LIFE CHANGING DISABILITIES,¿ AND ¿BRAIN FOG.¿ THE DEVICE HAS BEEN EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388525 STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 2223900

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention ADRENAL, VITAMIN D AND K, ANTI-INFLAMMATORIES