BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 20382181 · Received October 7, 2024

    Report

    Report Number
    9617229-2024-22085
    Event Type
    Injury
    Date Received
    October 7, 2024
    Date of Event
    September 17, 2024
    Report Date
    June 9, 2025
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P040046
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    THE RECORD IS REPORTABLE. CORRECTED DATA: B.5, B.6, D.6A, D.6B, H.6.

    Additional Manufacturer Narrative · 0

    ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: B5, H6.

    Description of Event or Problem · 0

    PATIENT REPORTED RIGHT SIDE RUPTURE. THE DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 0

    PATIENT REPORTED "I¿M HAVING MY BREAST IMPLANTS REMOVED DUE TO SUSPECTED RUPTURE OF MY RIGHT IMPLANT." "I DON¿T WANT REPLACEMENT AS THE RISK ASSOCIATED WITH THESE IMPLANTS HAVE PLAYED ON MY MIND SINCE THE PRODUCT RECALL AND I CAN¿T BEAR THE THOUGHT OF HAVING IT POTENTIALLY HAPPEN AGAIN. IT HAS AFFECTED MY MENTAL HEALTH". PATIENT LATER REPORTED ''IT TURNS OUT THE IMAGE ON THE SCAN THAT WAS SUSPECTED OF BEING RUPTURED WAS CAUSED BY CAPSULAR CONTRACTION." ¿APPEARANCES OF THE RIGHT BREAST IMPLANT ARE SUSPICIOUS FOR INTRACAPSULAR RUPTURE¿ ¿SUSPECTED RUPTURE OF MY RIGHT IMPLANT¿, AND ¿CONCERNS ABOUT RIGHT INTRACAPSULAR RUPTURE¿. THIS IS FOR THE RIGHT SIDE DEVICE. THE DEVICE HAS BEEN EXPLANTED.

    Description of Event or Problem · 0

    PATIENT LATER REPORTED ''IT TURNS OUT THE IMAGE ON THE SCAN THAT WAS SUSPECTED OF BEING RUPTURED WAS CAUSED BY CAPSULAR CONTRACTION, BAKER GRADE 1." UN-REPORTING RUPTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2539831 STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 2688513

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female Required Intervention