BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 23379930 · Received October 24, 2025

    Report

    Report Number
    9617229-2025-18283
    Event Type
    Injury
    Date Received
    October 24, 2025
    Date of Event
    January 11, 2024
    Report Date
    May 26, 2026
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    LABORATORY ANALYSIS SUMMARY: THE DEVICE RELATED TO THE REPORTED EVENTS RUPTURE WAS RECEIVED ON MARCH 09, 2026, WITH LOT NUMBER 2935786. 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: NOT OBSERVED THROUGH VISUAL INSPECTION. NONE OF THE OTHER OBSERVATIONS PERFORMED DURING THE DEVICE ANALYSIS CREASES AND DEFORMATION ARE FOUND TO BE POTENTIALLY RELATED TO THE MANUFACTURING PROCESS, AND, THEREFORE, NO FURTHER ACTIONS ARE REQUIRED FOR THESE OBSERVATIONS.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: G.3. AWARE DATE IN SUPPLEMENTAL MEDWATCH 2 SHOULD HAVE BEEN LISTED AS 21APR2026.

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN INITIATED. IF ANY NEW, CHANGED OR CORRECTED INFORMATION IS NOTED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED. PHOTO 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: NOT OBSERVED THROUGH VISUAL INSPECTION. NONE OF THE OTHER OBSERVATIONS PERFORMED DURING THE DEVICE ANALYSIS CREASES AND DEFORMATION ARE FOUND TO BE POTENTIALLY RELATED TO THE MANUFACTURING PROCESS, AND, THEREFORE, NO FURTHER ACTIONS ARE REQUIRED FOR THESE OBSERVATIONS.

    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 "SUSPECTED EXTRACAPSULAR RUPTURE" CONFIRMED VIA MRI. THIS RELATES TO THE LEFT SIDE. THE DEVICE WAS EXPLANTED AND REPLACED BY ANOTHER COMPANY'S DEVICE.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED "SUSPECTED EXTRACAPSULAR RUPTURE" CONFIRMED VIA MRI. THIS RELATES TO THE LEFT SIDE. THE DEVICE WAS EXPLANTED AND REPLACED BY ANOTHER COMPANY'S DEVICE.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED "SUSPECTED EXTRACAPSULAR RUPTURE" CONFIRMED VIA MRI. THIS RELATES TO THE LEFT SIDE. THE DEVICE WAS EXPLANTED AND REPLACED BY ANOTHER COMPANY'S DEVICE.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED "SUSPECTED EXTRACAPSULAR RUPTURE" CONFIRMED VIA MRI. THIS RELATES TO THE LEFT SIDE. THE DEVICE WAS EXPLANTED AND REPLACED BY ANOTHER COMPANY'S DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299056 INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 2935786

    Patients

    Seq Age Sex Outcome Treatment
    1