BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 120 SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 22384181 · Received July 2, 2025

    Report

    Report Number
    9617229-2025-11060
    Event Type
    Injury
    Date Received
    July 2, 2025
    Date of Event
    February 27, 2025
    Report Date
    September 10, 2025
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    UDI-DI
    5060191600569
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT OF CAPSULAR CONTRACTURE, GRANULOMA AND MIGRATION ARE 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 IV, GRANULOMA AND MIGRATION.

    Additional Manufacturer Narrative · 0

    CLARIFICATION TO PARTIAL DATE OF IMPLANT D6A: 2006 WAS PROVIDED. A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN OR WILL BE INITIATED. IF ANY NEW, CHANGED OR CORRECTED INFORMATION IS NOTED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED. LABORATORY ANALYSIS SUMMARY THE DEVICE RELATED TO THE REPORTED EVENTS OF RUPTURE, SILICONE MIGRATION CAPSULAR CONTRACTURE AND GRANULOMA WAS RECEIVED ON JULY 28, 2025 WITH LOT NUMBER 1243115. BASED ON THE DEVICE ANALYSIS GRID, THE ASSESSMENTS OF THE COMPLAINT ARE: ¿ RUPTURE AND SILICONE MIGRATION: OBSERVED AN OPENING ASSESSED AS FOLD FLAW OPENING AND BROKEN DEVICE ASSESSED AS FOLD FLAW OPENING. ¿ CAPSULAR CONTRACTURE: UNABLE TO OBSERVE AS IT IS NOT RELATED TO THE MANUFACTURING PROCESS. ¿ GRANULOMA: UNABLE TO OBSERVE AS IT IS NOT RELATED TO THE MANUFACTURING PROCESS. AS PER THE INVESTIGATION PROCEDURE, CREASES, WEAR ABRASION AND NON-PENETRATING NICK WERE COMPLETED AND NONE OF THE OBSERVATIONS ARE FOUND TO BE POTENTIALLY RELATED TO THE MANUFACTURING PROCESS, NO FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE DIAGNOSED VIA ULTRASOUND, CAPSULAR CONTRACTURE BAKER GRADE IV AND SILICONOMA. DEVICE WAS EXPLANTED AND REPLACED BY ANOTHER MANUFACTURER'S DEVICE.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL FURTHER REPORTED LEFT SIDE SILICONOMAS HAD TO BE RESECTED WITH EN BLOC AND A CAPSULECTOMY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153232 STYLE 120 SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 1243115 5060191600569

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention