BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 14717867 · Received June 16, 2022

    Report

    Report Number
    9617229-2022-10880
    Event Type
    Injury
    Date Received
    June 16, 2022
    Date of Event
    August 18, 2017
    Report Date
    June 16, 2022
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    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 RIGHT SIDE "SWELLING AND PAIN", "LUMP" (NDR), "SILICONE DISEASE, RISK OF NEOPLASIA", "NODULAR IMAGE IN RIGHT BREAST, WHICH MAY CORRESPOND TO CYST OF THICK CONTENT OR SOLID NODULE". PATIENT REPRESENTATIVE ADDITIONALLY REPORTED RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE III, ¿THE PROSTHESIS IMPLANTED IN THE PATIENT IS THE SAME AS THE ONE LISTED IN THE RECALL. IT WAS INFORMED THAT THE OCCURRENCE OF DEATH OF PATIENTS WHO HAD THE PROSTHESIS IMPLANTED IN THE RECALL MADE THE PATIENT WITH FEELINGS OF ANGUISH, IMPOTENCE, CONSTANT STRESS AND SADNESS, ACQUIRING DEPRESSION¿, ¿PATIENT IS WORRIED BECAUSE WILL HAVE TO UNDERGO A NEW SURGERY AND THIS PROCEDURE PUTS PATIENT LIFE AT RISK¿, ¿BREAST NODULES¿ (NDR), ¿ANXIETY-DEPRESSIVE DISORDER¿ (NDR), "HEADACHE" (NDR), ¿LOW ENERGY¿ (NDR), ¿OBSESSIVE-COMPULSIVE DISORDER WITH PREDOMINANCE OF OBSESSIVE IDEAS OR RUMINATIONS, RESPECTIVELY¿, ¿DISCOURAGEMENT FOR DAILY ACTIVITIES¿, ¿COMPULSIVE THOUGHTS¿ (NDR), AND ¿BODY ACHES¿(NDR).THE DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2119740 INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 3049948

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Female Required Intervention