BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 22317577 · Received June 24, 2025

    Report

    Report Number
    9617229-2025-10396
    Event Type
    Injury
    Date Received
    June 24, 2025
    Report Date
    June 24, 2025
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P040046
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS A FOLLOW-UP REPORT TO A MEDWATCH SUBMITTED UNDER MANUFACTURER REPORT NUMBER 9617229-2024-0011665. A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. 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 III AND RUPTURE DEVICE EVALUATION: BASED ON THE PRODUCT ANALYSIS PERFORMED, THE ASSESSMENTS OF THE COMPLAINTS ARE: ANXIETY-PRODUCT/PROCEDURE: UNABLE TO OBSERVE AS IT IS NOT RELATED TO THE DEVICE. CAPSULAR CONTRACTURE: UNABLE TO OBSERVE AS IT IS NOT RELATED TO THE DEVICE. RUPTURE: NOT OBSERVED. AS PER THE INVESTIGATION PROCEDURES DEFORMATION, CREASES AND WEAR ABRASION 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 "TEXTURED TO SMOOTH ". LATER HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III AND RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE HAS BEEN EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1671561 STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 1830417

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention