BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 22181049 · Received June 10, 2025

    Report

    Report Number
    9617229-2025-09607
    Event Type
    Injury
    Date Received
    June 10, 2025
    Date of Event
    December 1, 2022
    Report Date
    June 10, 2025
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    UDI-DI
    5060191600958
    PMA / PMN Number
    P040046
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS A FOLLOW-UP REPORT TO A MEDWATCH SUBMITTED UNDER MANUFACTURE REPORT NUMBER 9617229-2022-02841. A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. DEVICE EVALUATION: THE DEVICE RELATED TO THE REPORTED EVENT OF RUPTURE, PAIN, CAPSULAR CONTRACTURE AND GEL BLEED WAS RECEIVED ON AUGUST 09, 2024, WITH LOT NUMBER 2935927. BASED ON THE PRODUCT ANALYSIS PERFORMED, THE ASSESSMENTS OF THE COMPLAINTS ARE: RUPTURE: NOT OBSERVED. PAIN: UNABLE TO OBSERVED. CAPSULAR CONTRACTURE: UNABLE TO OBSERVED. GEL BLEED: NOT OBSERVED SINCE NO GEL IS OUT OF THE DEVICE AND THE WEIGHT IS WITHIN SPECIFICATION. AS PER THE INVESTIGATION PROCEDURE DEFORMATION, WEAR ABRASION AND CREASE WAS COMPLETED AND NONE OF THE OBSERVATIONS ARE FOUND TO BE POTENTIALLY RELATED TO THE MANUFACTURING PROCESS, NO FURTHER ACTIONS ARE REQUIRED. THE EVENT OF "CAPSULAR CONTRACTURE, BALER GRADE III" 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, BALER GRADE III, GEL BLEED, AND DEVICE RUPTURE.

    Description of Event or Problem · 0

    PATIENT REPORTING A SUSPECTED RUPTURE OF THE RIGHT DEVICE VIA ULTRASOUND. PATIENT LATER REPORTED SEVERE PAIN. HEALTHCARE PROFESSIONAL REPORTED BREAST PAIN, CONFIRMED DEVICE RUPTURE DIAGNOSED DURING GYNAECOLOGICAL EXAM. CAPSULAR CONTRACTURE BAKER GRADE III AND DEVICE RUPTURE, DIAGNOSED BY MRI. ADDITIONAL, HEALTHCARE PROFESSIONAL REPORTED SILICONE BLEEDING RIGHT SIDE. THE DEVICE HAS BEEN EXPLANTED AND REPLACED WITH NON ABBVIE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90119 STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 380665 5060191600958

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female Required Intervention