BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 23843240 · Received December 18, 2025

    Report

    Report Number
    9617229-2025-22156
    Event Type
    Injury
    Date Received
    December 18, 2025
    Date of Event
    February 26, 2025
    Report Date
    March 11, 2026
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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. 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

    DEVICE EVALUATION: THE DEVICE RELATED TO THE REPORTED EVENTS RUPTURE WAS RECEIVED ON FEB 13, 2026 WITH LOT NUMBER 3103670. 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 BROKEN DEVICE THROUGH MICROSCOPIC INSPECTION ASSESSED AS FOLD FLAW OPENING, OBSERVED A MISSING PIECE OF SHELL THROUGH MICROSCOPIC INSPECTION ASSESSED AS INCONCLUSIVE, NO FURTHER ACTIONS ARE REQUIRED AS IT IS NOT RELATED TO THE MANUFACTURING PROCESS. NONE OF THE OTHER OBSERVATIONS PERFORMED DURING THE DEVICE ANALYSIS (NON-PENETRATING NICKS) ARE FOUND TO BE POTENTIALLY RELATED TO THE MANUFACTURING PROCESS, AND, THEREFORE, NO FURTHER ACTIONS ARE REQUIRED FOR THESE OBSERVATIONS.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". LATER HEALTHCARE PROFESSIONAL REPORTED "HOLE, NON-SPECIFIC". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.

    Description of Event or Problem · 0

    DEVICE WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258592 INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 3103670

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Female Required Intervention