BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 21966045 · Received May 6, 2025

    Report

    Report Number
    9617229-2025-07316
    Event Type
    Injury
    Date Received
    May 6, 2025
    Date of Event
    April 3, 2025
    Report Date
    September 8, 2025
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    UDI-DI
    10888628033368
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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, BAKER GRADE III.

    Additional Manufacturer Narrative · 0

    ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: B5, D6B, H.6.

    Additional Manufacturer Narrative · 0

    ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: D9 H3 H6 LABORATORY ANALYSIS SUMMARY THE DEVICE RELATED TO THE REPORTED EVENTS CAPSULAR CONTRACTURE WAS RECEIVED ON JUL 22, 2025, WITH LOT NUMBER 3033352. BASED ON THE PRODUCT ANALYSIS PERFORMED, THE ASSESSMENTS OF THE COMPLAINTS ARE: ¿ CAPSULAR CONTRACTURE: UNABLE TO OBSERVE SINCE IT IS A MEDICAL EVENT AND IS NOT RELATED TO THE DEVICE. AS PER THE INVESTIGATION PROCEDURE, CREASES, DEFORMATION AND WEAR ABRASION WERE OBSERVED 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 "CAPSULAR CONTRACTURE BAKER GRADE III". THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 0

    DEVICE WAS EXPLANTED AND REPLACED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1884449 INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 3005921 10888628033368

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Female Required Intervention