BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 21243629 · Received January 27, 2025

    Report

    Report Number
    9617229-2025-01475
    Event Type
    Injury
    Date Received
    January 27, 2025
    Date of Event
    July 1, 2023
    Report Date
    May 27, 2025
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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: "REPORTING RUPTURE WITH INTRACAPSULAR SILICONE DIFFUSION" DEFLATION, SILICONE PERSPIRATION, CHANGE OF DEVICES COLOUR, CAPSULAR CONTRACTURE ; BAKER GRADE III.

    Additional Manufacturer Narrative · 0

    ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: D9, H3, H6. DEVICE EVALUATION: THE DEVICE RELATED TO THE REPORTED EVENTS CAPSULAR CONTRACTURE, PRODUCT DISCOLORED AND RUPTURE WAS RECEIVED ON FEBRUARY 06, 2025 WITH LOT NUMBER 1830855. BASED ON THE PRODUCT ANALYSIS PERFORMED, THE ASSESSMENTS OF THE COMPLAINT CODES ARE: ¿ RUPTURE: OBSERVED BROKEN DEVICE ASSESSED AS FOLD FLAW OPENING. ¿ CAPSULAR CONTRACTURE: UNABLE TO OBSERVE AS IT IS NOT RELATED TO THE DEVICE. ¿ PRODUCT DISCOLORED: OBSERVED YELLOW DISCOLORATION OF THE DEVICE. AS PER THE INVESTIGATION PROCEDURE, CREASES AND NON PENETRATING NICKS 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: A2, B3, B6, H6.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED "REPORTING RUPTURE WITH INTRACAPSULAR SILICONE DIFFUSION" DEFLATION, SILICONE PERSPIRATION, CHANGE OF DEVICES COLOUR, CAPSULAR CONTRACTURE ; BAKER GRADE III ON THE LEFT SIDE (BREAST IS HARD AND DEFORMED BUT WITHOUT PAIN) THE DEVICE HAS BEEN EXPLANTED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED "REPORTING RUPTURE WITH INTRACAPSULAR SILICONE DIFFUSION" DEFLATION, SILICONE PERSPIRATION, CHANGE OF DEVICES COLOUR, CAPSULAR CONTRACTURE ; BAKER GRADE III ON THE LEFT SIDE (BREAST IS HARD AND DEFORMED BUT WITHOUT PAIN)/ THE DEVICE HAS BEEN EXPLANTED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED "REPORTING RUPTURE WITH INTRACAPSULAR SILICONE DIFFUSION" DEFLATION, SILICONE PERSPIRATION, CHANGE OF DEVICES COLOUR, CAPSULAR CONTRACTURE; BAKER GRADE III ON THE LEFT SIDE (BREAST IS HARD AND DEFORMED BUT WITHOUT PAIN)/ THE DEVICE HAS BEEN EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607373 INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 1830855

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Unknown Required Intervention