BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 15 SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 22102563 · Received May 28, 2025

    Report

    Report Number
    9617229-2025-08803
    Event Type
    Injury
    Date Received
    May 28, 2025
    Date of Event
    September 1, 2009
    Report Date
    May 28, 2025
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INFORMATION CONTAINED IN THIS REPORT WAS PREVIOUSLY SUBMITTED THROUGH PSR ON 23JAN2012. THIS IS A FOLLOW-UP REPORT TO A MEDWATCH SUBMITTED UNDER MANUFACTURER REPORT NUMBER 9617229-2025-0000090. A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. DEVICE EVALUATION: BASED ON THE PRODUCT ANALYSIS PERFORMED, THE ASSESSMENTS OF THE COMPLAINT CODES ARE: CAPSULAR CONTRACTURE: UNABLE TO OBSERVE. PAIN: UNABLE TO OBSERVE. RUPTURE: OBSERVED BROKEN DEVICE ASSESSED AS FOLD FLAW OPENING AND OBSERVED A MISSING PIECE OF SHELL ASSESSED AS INCONCLUSIVE. AS PER THE INVESTIGATION PROCEDURE, CREASES, WEAR ABRASION AND NON-PENETRATING NICKS WERE OBSERVED AND NONE OF THE OBSERVATIONS ARE FOUND TO BE POTENTIALLY RELATED TO THE MANUFACTURING PROCESS, NO FURTHER ACTIONS ARE REQUIRED. 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: RUPTURE AND CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE REOPERATION DUE TO CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN. PATIENT REPORTED HAVING HAD LEFT SIDE MODERATE BREAST PAIN. HEALTHCARE PROFESSIONAL LATER REPORTED LEFT SIDE RUPTURE AND "EXTRACAPSULAR SILICONE IN THE INFEROMEDIAL REGIONS" DIAGNOSED VIA MRI. DEVICE HAS BEEN EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    598517 STYLE 15 SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 1693231

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Female Required Intervention