BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 153 SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 17011421 · Received May 26, 2023

    Report

    Report Number
    9617229-2023-09062
    Event Type
    Injury
    Date Received
    May 26, 2023
    Date of Event
    September 27, 2022
    Report Date
    May 26, 2023
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. HEALTH EFFECT - IMPACT CODE: F2203, F2305. ALCL DIAGNOSIS DATE: (B)(6) 2022. THE EVENTS OF LYMPHOMA-ALCL-SUSPECTED AND LYMPHADENOPATHY ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. NO CONTACT INFORMATION WAS PROVIDED FOR THE INITIAL REPORTER, THEREFORE ADDITIONAL EVENT, PRODUCT, AND/OR PATIENT DETAILS ARE NOT ATTAINABLE. REASON FOR REOPERATION: BIA-ALCL (HISTOPATHOLOGICAL MARKERS NOT REPORTED), "SEVERE INFLAMMATION OF LYMPH NODES."

    Description of Event or Problem · 0

    PATIENT REPRESENTATIVE REPORTED "PLAINTIFF ALLEGES THAT ONE OR MORE BIOCELL DEVICES CAUSED PERSONAL INJURIES AND DAMAGES, INCLUDING BUT NOT LIMITED TO THE FOLLOWING: A DIAGNOSIS OF BIA-ALCL, RASHES, SEVERE INFLAMMATION OF LYMPH NODES, INVASIVE SURGERIES TO REMOVE BREAST IMPLANTS, CAPSULES, LYMPH NODES AND TOTAL MASTECTOMY LEAVING PERMANENT SCARS", "FEAR OF CANCER RECURRENCE, EMOTIONAL DISTRESS, PAIN AND SUFFERING." PATIENT REPRESENTATIVE ADDITIONALLY REPORTED "OPEN SKIN SORES," "TRIGGERED VASCULITIS," "DRY AND PAINFUL EYES AND MOUTH," "HAIR LOSS,", "TINGLING SKIN" AND "SICCA SYNDROME"; MULTIPLE CONTRAST-REQUIRING AND/OR RADIATION-EXPOSING SCANS, SUBSTANTIAL HOSPITAL, MEDICAL AND PHARMACEUTICAL EXPENSES, LOSS OF EARNINGS" THESE EVENTS ARE NOT DEVICE RELATED. HISTOPATHOLOGICAL MARKERS CONFIRMING ALCL HAVE NOT BEEN RECEIVED. THIS RELATES TO THE UNKNOWN SIDE. DEVICE HAS BEEN EXPLANTED. TREATMENT: EXPLANT, CHEMOTHERAPY, RADIATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1916130 STYLE 153 SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention