BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 22021234 · Received May 14, 2025

    Report

    Report Number
    9617229-2025-07918
    Event Type
    Injury
    Date Received
    May 14, 2025
    Date of Event
    April 23, 2025
    Report Date
    June 18, 2025
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    UDI-DI
    5060191607506
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: D9, H3, H6 DEVICE EVALUATION: THE DEVICE RELATED TO THE REPORTED EVENTS OF RASH, HEADACHE, FATIGUE, DIZZINESS AND CAPSULAR CONTRACTURE WAS RECEIVED ON JULY 28, 2025, WITH LOT NUMBER 3192264. BASED ON THE PRODUCT ANALYSIS PERFORMED, THE ASSESSMENTS OF THE COMPLAINT CODES ARE: CAPSULAR CONTRACTURE: UNABLE TO OBSERVE AS IT IS NOT RELATED TO THE MANUFACTURING PROCESS. RASH: UNABLE TO OBSERVE AS IT IS NOT RELATED TO THE MANUFACTURING PROCESS. HEADACHE: UNABLE TO OBSERVE AS IT IS NOT RELATED TO THE MANUFACTURING PROCESS. FATIGUE: UNABLE TO OBSERVE AS IT IS NOT RELATED TO THE MANUFACTURING PROCESS. DIZZINESS: UNABLE TO OBSERVE AS IT IS NOT RELATED TO THE MANUFACTURING PROCESS. 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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: B5 B6 D6B H6.

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCE'S 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 IV.

    Description of Event or Problem · 0

    PATIENT REPORTED "CARCINOGENIC", "EXTREME FATIGUE", "DIZZINESS", "LIGHT HEADEDNESS", "HEADACHES", "RASHES", "ASIA SYNDROME". HEALTHCARE PROFESSIONAL LATER REPORTED "CAPSULAR CONTRACTURE BAKER GRADE IV", "SKIN ERYTHEMA" AND "CHRONIC INFLAMMATION" DIAGNOSED VIA ULTRASOUND. THE DEVICE HAS BEEN EXPLANTED. THIS RECORD IS FOR THE RIGHT SIDE.

    Description of Event or Problem · 0

    PATIENT FURTHER REPORTED ¿SKIN ERYTHEMA.¿ PREVIOUSLY REPORTED EVENTS OF "CARCINOGENIC", "EXTREME FATIGUE", "DIZZINESS", "LIGHT HEADEDNESS", "HEADACHES", "RASHES", AND "ASIA SYNDROME" WERE DETERMINED TO BE NOT DEVICE RELATED. THE DEVICE HAS BEEN EXPLANTED. PARTIAL CAPSULECTOMY PERFORMED.

    Description of Event or Problem · 0

    PATIENT REPORTED "CARCINOGENIC", "EXTREME FATIGUE", "DIZZINESS", "LIGHT HEADEDNESS", "HEADACHES", "RASHES", "ASIA SYNDROME". HEALTHCARE PROFESSIONAL LATER REPORTED CAPSULAR CONTRACTURE BAKER GRADE IV. THE DEVICE REMAINS IMPLANTED. THIS RECORD IS FOR THE RIGHT SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1089585 INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 3192264 5060191607506

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Female Required Intervention