BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 21842809 · Received April 15, 2025

    Report

    Report Number
    9617229-2025-06163
    Event Type
    Injury
    Date Received
    April 15, 2025
    Date of Event
    October 30, 2024
    Report Date
    April 15, 2025
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P040046
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS A FOLLOW UP REPORT TO A MEDWATCH SUBMITTED UNDER MANUFACTURER REPORT NUMBER 9617229-2024-0011625. A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. THE EVENTS OF CAPSULAR CONTRACTURE AND SEROMA ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. 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 GRADE 3 AND SEROMA-LATE.

    Description of Event or Problem · 0

    PATIENT REPORTED FOR RIGHT SIDE "ITCHING AROUND THE BREAST AND CHEST INTO SIDE, "TENDERNESS THAT IS SIMILAR TO PREMENSTRUAL SYMPTOMS" ALSO REPORTED "CONSISTENT COUGH" WHICH IS NOT RELATED TO THE DEVICE. PATIENT LATER REPORTED "SEROMA FLUID", "MISSHAPED", AND "HARD". HEALTHCARE PROFESSIONAL LATER REPORTED CAPSULAR CONTRACTURE, BAKER GRADE III AND REMOVAL FROM TEXTURED TO SMOOTH DUE TO THE CONCERNS OF THE PRODUCT. DEVICE HAS BEEN EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    109338 STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 2881692

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female Required Intervention