BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 22344014 · Received June 27, 2025

    Report

    Report Number
    9617229-2025-10710
    Event Type
    Injury
    Date Received
    June 27, 2025
    Date of Event
    August 1, 2020
    Report Date
    June 27, 2025
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    UDI-DI
    5060191607278
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS A FOLLOW-UP REPORT TO A MEDWATCH SUBMITTED UNDER MANUFACTURE REPORT NUMBER 9617229-2020-18387. A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. THE REPORTED EVENTS ARE PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. 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 AND APPROPRIATE TERM/CODE NOT AVAILABLE (RECALL).

    Description of Event or Problem · 0

    PATIENT REPORTED "GRADE IV CAPSULAR CONTRACTURE" VIA US, "A LOT OF PAIN" AND "IT GOT OUT OF PLACE". PATIENT LATER REPORTED "PRESENCE OF PARTIAL ADIPOSE REPLACEMENT", "RADIAL FOLDS AND IMPLANT DEVIATED TO THE MEDIAL REGION" AND "FIBROUS CAPSULAR CONTRACTURE IN THE RIGHT BREAST" VIA US. HEALTHCARE PROFESSIONAL LATER REPORTED "GRADE IV CAPSULAR CONTRACTURE". LEGAL REPRESENTATIVE LATER REPORTED "CAPSULAR CONTRACTURE GRADE IV" VIA US AND MRI, "RECALL OF THE NATRELLE PROSTHESIS", "RECALL OF THE COMPANY", "LOT OF PAIN", "DISCOMFORT", "BREASTS ARE DEFORMED", "PATIENT HAS A GENETICAL CONDITION TO DEVELOP THE LYMPHOMA", "FAMILY HISTORY OF THE DISEASE", "RECALL MADE THE PATIENT FEEL ANGUISH", "SO MUCH WORRY", "PAIN", "ENCAPSULATED PROSTHESIS", "OUT OF PLACE", "RISK OF LYMPHOMA", "SEVERAL ANXIETY ATTACKS", "PANIC ATTACKS", "FEAR OF DYING", "UNDERGOING PSYCHIATRIC TREATMENT", "PATIENT WAS PHYSICALLY AND PSYCHOLOGICALLY HARMED", "CONTRACTURE PAINS", "ANGUISH", "TRAUMAS", "ANXIETY BEHAVIOR", "PANIC", "DEATH WISH", "DIFFICULTY IN ATTENTION", "CONCERN ABOUT THE RISK OF DEVELOPING SOME TYPE OF ALTERATION IN THE HEALTH OF HER BREASTS DUE TO THE RECALL INFORMATION". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1128021 INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 2509440 5060191607278

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Female Required Intervention