BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 23732780 · Received December 5, 2025

    Report

    Report Number
    9617229-2025-21152
    Event Type
    Injury
    Date Received
    December 5, 2025
    Report Date
    December 5, 2025
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    UDI-DI
    5060191606585
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS A FOLLOW-UP REPORT TO A MEDWATCH SUBMITTED UNDER MANUFACTURE REPORT NUMBER 9617229-2024-0011646. 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: RUPTURE, CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN

    Description of Event or Problem · 0

    PATIENT REPRESENTATIVE REPORTED THROUGH ABBVIE REPRESENTATIVE "SIGNIFICANT PHYSICAL AND MENTAL STRESS ASSOCIATED WITH DEVICE RECALL, WORRY ABOUT THE CONSEQUENTIAL OR DELAYED DAMAGE, NUMBNESS AND FEELING OF TENSION IN THE BREAST, BACKACHE, HEADACHES, BREAST ASYMMETRY". PATIENT REPRESENTATIVE LATER REPORTED "PAIN, PRESSURE FEELING, GENERAL MALAISE, POSSIBLE CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN AND SILICONE LEAKAGE". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2108683 INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 1729810 5060191606585

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention