BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 15 SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 24251109 · Received February 3, 2026

    Report

    Report Number
    9617229-2026-02266
    Event Type
    Injury
    Date Received
    February 3, 2026
    Date of Event
    January 6, 2026
    Report Date
    April 30, 2026
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN INITIATED. IF ANY NEW, CHANGED OR CORRECTED INFORMATION IS NOTED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED. 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

    ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: B5, D6B, H6.

    Additional Manufacturer Narrative · 0

    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. DEVICE EVALUATION: THE DEVICE RELATED TO THE REPORTED EVENTS CAPSULAR CONTRACTURE AND RUPTURE WAS RECEIVED ON APRIL 13, 2026 WITH LOT NUMBER 2853852. PER THE INVESTIGATION PROCEDURE, THE DEVICE IS ANALYZED THROUGH VISUAL INSPECTION MICROSCOPIC INSPECTION IF OPENINGS ARE OBSERVED AND A WEIGHT VERIFICATION. PER THE ANALYSIS PERFORMED, THE ASSESSMENTS OF THE COMPLAINTS AND ANY POTENTIAL MANUFACTURING ISSUE ARE DISPLAYED ALONG WITH ANY FURTHER ACTIONS REQUIRED: RUPTURE: OBSERVED AN OPENING THROUGH MICROSCOPIC INSPECTION ASSESSED AS FOLD FLAW OPENING. NO FURTHER ACTIONS ARE REQUIRED AS IT IS NOT RELATED TO THE MANUFACTURING PROCESS. CAPSULAR CONTRACTURE: UNABLE TO OBSERVE THROUGH VISUAL INSPECTION AS IT IS A PHYSIOLOGICAL PHENOMENON. NONE OF THE OTHER OBSERVATIONS PERFORMED DURING THE DEVICE ANALYSIS CREASES, WEAR ABRASION AND NON-PENETRATING NICKS ARE FOUND TO BE POTENTIALLY RELATED TO THE MANUFACTURING PROCESS, AND, THEREFORE, NO FURTHER ACTIONS ARE REQUIRED FOR THESE OBSERVATIONS. REASON FOR REOPERATION: CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: B.5., D.9., H.2., H.3., H.6., H.11.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 0

    DEVICE WAS EXPLANTED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". HEALTHCARE PROFESSIONAL LATER REPORTED "CAPSULAR CONTRACTURE". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED. PATIENT UNDERGO A CAPSULECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172616 STYLE 15 SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 2853852

    Patients

    Seq Age Sex Outcome Treatment
    1