BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 22874940 · Received August 22, 2025

    Report

    Report Number
    9617229-2025-14373
    Event Type
    Injury
    Date Received
    August 22, 2025
    Report Date
    August 22, 2025
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    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: CAPSULAR CONTRACTURE BAKER GRADE III.

    Description of Event or Problem · 0

    PATIENT REPORTED A LEFT SIDE "HAVING ISSUES WITH THE CONTOUR OF BREASTS", "ALLERGAN TEXTURED IMPLANTS", "DRY EYES" NDR, "NECK PAIN", "BRAIN FOG" NDR, "NOW FOR THE LAST 12 MONTHS ALSO DRY PAINFUL PEELING LIPS" NDR, DEPRESSION AND ANXIETY, STOMACH ISSUES NDR, DRY PEELING CRACKING SORE NDR. PATIENT LATER REPORTED "AUTO IMMUNE PROBLEMS NDR, BREAST IMPLANT ILLNESS, ASYMMETRY, ESPECIALLY MY LEFT BREAST, LARGE HARD LUMP AND DISTORTION TO THE MIDDLE OF MY LEFT CHEST, SEVERE SPLIT LIPS AND DRY EYES AND DEPRESSION, MILD INFLAMMATORY INFILTRATE, BREAST CAPSULE VIA HISTOPATHOLOGY, MEMBRANOUS TISSUE, SMOOTH LINING, NO CYTOLOGIC ATYPIA, NO LYMPHOCYTE ATYPIA IS EVIDENT VIA MACROSCOPIC TEST". HEALTHCARE PROFESSIONAL ADDITIONALLY REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III". PATIENT UNDERGONE TOTAL CAPSULECTOMY. DEVICE HAS BEEN EXPLANTED AND DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2638307 INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 3086298

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention