BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 115 SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 25113882 · Received May 7, 2026

    Report

    Report Number
    9617229-2026-08493
    Event Type
    Injury
    Date Received
    May 7, 2026
    Report Date
    May 7, 2026
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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. 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 GRADE UNKNOWN. LAB ANALYSIS: VISUAL ANALYSIS OF THE RETURNED DEVICE IDENTIFIED: WEIGHT TO THE SPEC, YELLOW BIOLOGICAL TISSUE IN THE SURFACE OF THE SHELL. CLOUDY AND VOIDS WERE OBSERVED AFTER AUTOCLAVE DISINFECTION PROCESS. BASED ON THE DEVICE ANALYSIS THE FINAL ASSESSMENT IS: - NO ISSUES FOUND RELATED WITH THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 0

    LAB ANALYSIS: THE DEVICE RELATED TO THE REPORTED EVENTS DOUBLE CAPSULE, CAPSULAR CONTRACTURE AND ANXIETY - PRODUCT/ PROCEDURE WAS RECEIVED ON NOVEMBER 23, 2021 WITH LOT NUMBER 1770888. 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: - DOUBLE CAPSULE: UNABLE TO OBSERVE THROUGH VISUAL INSPECTION AS IT IS A PHYSIOLOGICAL PHENOMENON. - CAPSULAR CONTRACTURE: UNABLE TO OBSERVE THROUGH VISUAL INSPECTION AS IT IS A PHYSIOLOGICAL PHENOMENON. - ANXIETY - PRODUCT/ PROCEDURE: UNABLE TO OBSERVE THROUGH VISUAL INSPECTION AS IT IS A PHYSIOLOGICAL PHENOMENON. NO ADDITIONAL OBSERVATIONS PERFORMED ON THE DEVICE. NO FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED "EXCHANGE FROM TEXTURED TO SMOOTH DUE TO CONCERN WITH THE PRODUCT" AND DOUBLE CAPSULE. AND LATER REPORTED VIA NBIR "CONTRACTURE/TEXTURED", BAKER GRADE UNKNOWN. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED "EXCHANGE FROM TEXTURED TO SMOOTH DUE TO CONCERN WITH THE PRODUCT" AND DOUBLE CAPSULE. AND LATER REPORTED VIA NBIR "CONTRACTURE/TEXTURED", BAKER GRADE UNKNOWN. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433588 STYLE 115 SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 1770888

    Patients

    Seq Age Sex Outcome Treatment
    1