BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 21197780 · Received January 21, 2025

    Report

    Report Number
    9617229-2025-01109
    Event Type
    Injury
    Date Received
    January 21, 2025
    Date of Event
    October 24, 2024
    Report Date
    June 5, 2025
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: THE DEVICE RELATED TO THE REPORTED EVENT OF RUPTURE, SILICONE MIGRATION, LYMPHADENOPATHY AND CYST(S) WAS RECEIVED ON MAY 13, 2025 WITH LOT NUMBER 1842564. BASED ON THE DEVICE ANALYSIS GRID, THE ASSESSMENTS OF THE COMPLAINT ARE: RUPTURE AND SILICONE MIGRATION: OBSERVED AN OPENING ASSESSED AS UNIDENTIFIED (TEAR) OPENING. LYMPHADENOPATHY: UNABLE TO OBSERVE AS IT IS NOT RELATED TO THE MANUFACTURING PROCESS. CYST(S): UNABLE TO OBSERVE AS IT IS NOT RELATED TO THE MANUFACTURING PROCESS. AS PER THE INVESTIGATION PROCEDURE, CREASES AND WEAR ABRASION WERE COMPLETED AND NONE OF THE OBSERVATIONS ARE FOUND TO BE POTENTIALLY RELATED TO THE MANUFACTURING PROCESS, NO FURTHER ACTIONS ARE REQUIRED. ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: B5, D6B, D9, H3, H6.

    Additional Manufacturer Narrative · 0

    ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: A6, B1, B7, D6A, G2, H6.

    Additional Manufacturer Narrative · 0

    CONTINUED: E.1. PHONE NUMBER: (B)(6). A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. THE EVENT OF "LYMPHADENOPATHY" 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: SILICONE MIGRATION, RUPTURE AND LYMPHADENOPATHY.

    Description of Event or Problem · 0

    THE DEVICE HAS BEEN EXPLANTED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED "INTRA & EXTRACAPSULAR RUPTURE". HEALTHCARE PROFESSIONAL REPORTED "INTRA- AND EXTRACAPSULAR RUPTURE," "SEVERAL ENLARGED AXILLARY LYMPH NODES, SEVERAL OF WHICH ARE SILICONE-LADEN. ONE LYMPH NODE IS LOCATED HIGH BETWEEN THE PECTORALIS MINOR AND MAJOR MUSCLES. CAN BE STRICTLY CORRELATED WITH THE DEFINITIVE APO OF THE LYMPH NODES," "SEVERAL CYSTS" AND "LESIONS". RECORD IS FOR LEFT SIDE. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED "INTRA & EXTRACAPSULAR RUPTURE". HEALTHCARE PROFESSIONAL REPORTED "INTRA- AND EXTRACAPSULAR RUPTURE," "SEVERAL ENLARGED AXILLARY LYMPH NODES, SEVERAL OF WHICH ARE SILICONE-LADEN. ONE LYMPH NODE IS LOCATED HIGH BETWEEN THE PECTORALIS MINOR AND MAJOR MUSCLES. CAN BE STRICTLY CORRELATED WITH THE DEFINITIVE APO OF THE LYMPH NODES," "SEVERAL CYSTS" AND "LESIONS". RECORD IS FOR LEFT SIDE. DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    742635 INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 1842564

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Female Required Intervention