BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 10 SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 14690636 · Received June 14, 2022

    Report

    Report Number
    9617229-2022-09891
    Event Type
    Injury
    Date Received
    June 14, 2022
    Date of Event
    September 25, 2013
    Report Date
    November 1, 2023
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    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: CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN.

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED.

    Description of Event or Problem · 0

    PATIENT REPORTED VIA REGULATORY AGENCY I HAVE SILICONE BREAST IMPLANTS. CAPSULAR CONTRACTURE" BAKER GRADE UNKNOWN, "DIAGNOSED WITH LCIS AND ATYPICAL HYPERPLASIA (NDR), "BRAIN FOG" (NDR), CHEST PAIN, BACK PAIN, EXTREME FATIGUE" (NDR), AND ANXIETY. THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE HAS BEEN EXPLANTED.

    Description of Event or Problem · 0

    DEVICE HAS BEEN EXPLANTED.

    Description of Event or Problem · 0

    PATIENT LATER ALSO REPORTED A RUPTURE. THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 0

    PATIENT REPORTED VIA REGULATORY AGENCY " I HAVE SILICONE BREAST IMPLANTS. CAPSULAR CONTRACTURE" BAKER GRADE UNKNOWN, "DIAGNOSED WITH LCIS AND ATYPICAL HYPERPLASIA" (NDR), "BRAIN FOG" (NDR), "CHEST PAIN, BACK PAIN", "EXTREME FATIGUE" (NDR), AND "ANXIETY". PATIENT REPORTED VIA REGULATORY AGENCY "CAPSULAR CONTRACTURE BAKER GRADE IV". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE HAS BEEN EXPLANTED.

    Description of Event or Problem · 0

    PATIENT REPORTED, VIA REGULATORY AGENCY. "CAPSULAR CONTRACTURE, BAKER GRADE IV".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1628777 STYLE 10 SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 2475711

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Female Required Intervention