BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 23818289 · Received December 16, 2025

    Report

    Report Number
    9617229-2025-21935
    Event Type
    Injury
    Date Received
    December 16, 2025
    Date of Event
    April 11, 2025
    Report Date
    February 20, 2026
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    UDI-DI
    5060191601023
    PMA / PMN Number
    P040046
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CLARIFICATION TO D4 DEVICE INFORMATION: SERIAL/LOT NUMBERS WERE PROVIDED FOR UNKNOWN SIDES AS: SN (B)(6) / LOT 2760604. SN (B)(6) / LOT 2794063. AS THE SIDES ARE UNKNOWN, SPECIFIC DEVICE INFORMATION WAS NOT POPULATED. DEVICES SHARE THE SAME CATALOG NUMBER, WHICH HAS BEEN INCLUDED IN THIS MEDWATCH.

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: 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 UNIDENTIFIED (TEAR) 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) ARE FOUND TO BE POTENTIALLY RELATED TO THE MANUFACTURING PROCESS, AND, THEREFORE, NO FURTHER ACTIONS ARE REQUIRED FOR THESE OBSERVATIONS. A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED.

    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.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED "BREAST IS SUPPLE". LATER HEALTHCARE PROFESSIONAL REPORTED "INTRACAPSULAR RUPTURE WITHOUT ASSOCIATED EFFUSION" CONFIRMED BY INTRAOPERATIVE PROCEDURE. LATER HEALTHCARE PROFESSIONAL REPORTED THROUGH REGULATORY AGENCY "INTRACAPSULAR RUPTURE, CAPSULAR CONTRACTURE BAKER GRADE I". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED "BREAST IS SUPPLE". LATER HEALTHCARE PROFESSIONAL REPORTED "INTRACAPSULAR RUPTURE WITHOUT ASSOCIATED EFFUSION" CONFIRMED BY INTRAOPERATIVE PROCEDURE. LATER HEALTHCARE PROFESSIONAL REPORTED THROUGH REGULATORY AGENCY "INTRACAPSULAR RUPTURE, CAPSULAR CONTRACTURE BAKER GRADE I". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED "BREAST IS SUPPLE". LATER HEALTHCARE PROFESSIONAL REPORTED "INTRACAPSULAR RUPTURE WITHOUT ASSOCIATED EFFUSION" CONFIRMED BY INTRAOPERATIVE PROCEDURE. THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1875160 STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 2760604 5060191601023

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Female Required Intervention