BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK MAMMARY IMPLANT

    MDR report key: 18823167 · Received March 1, 2024

    Report

    Report Number
    9617229-2024-03562
    Event Type
    Injury
    Date Received
    March 1, 2024
    Date of Event
    July 7, 2023
    Report Date
    March 1, 2024
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Removal / Correction Number
    2011068-7/2/19-001-R
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENTS OF LYMPHADENOPATHY, BREAST MASS, AND BREAST IMPLANT ASSOCIATED ANAPLASTIC LARGE CELL LYMPHOMA (BIA ALCL) ARE PHYSIOLOGICAL COMPLICATIONS 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/WILL BE REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THE REASON FOR REOPERATION IS: LYMPHADENOPATHY, LUMP/NODULE, AND BREAST IMPLANT ASSOCIATED ANAPLASTIC LARGE CELL LYMPHOMA (BIA ALCL). ARTICLE CITATION: GALVAN, JOAB RAFAEL ET AL. ¿BREAST IMPLANT-ASSOCIATED ANAPLASTIC LARGE CELL LYMPHOMA PRESENTING AS A BREAST MASS: A CASE REPORT AND LITERATURE REVIEW.¿ INTERNATIONAL JOURNAL OF SURGERY CASE REPORTS VOL. 108 (2023): 108482. DOI:10.1016/J.IJSCR.2023.108482.

    Description of Event or Problem · 0

    THROUGH JOURNAL ARTICLE, "BREAST IMPLANT-ASSOCIATED ANAPLASTIC LARGE CELL LYMPHOMA PRESENTING AS A BREAST MASS: A CASE REPORT AND LITERATURE REVIEW", A HEALTH PROFESSIONAL REPORTED A PATIENT "PRESENTED WITH A 3-MONTH HISTORY OF A RIGHT [SIDE ATYPICAL PRESENTATION OF BIA-ALCL AS A] BREAST MASS LOCATED IN THE LOWER MEDIAL QUADRANT, WITH ASSOCIATED RIGHT AXILLARY LYMPHADENOPATHY". PATHOLOGICAL MARKERS CD30+ AND ALK- CONFIRMING ALCL HAVE BEEN RECEIVED. ULTRASOUND AND MAMMOGRAPHY IDENTIFIED A 5 CM TUMOR IN THE LOWER MEDIAL QUADRANT. PATHOLOGY REVIEW AND IMMUNOHISTOCHEMICAL ANALYSIS CONFIRMED THE DIAGNOSIS OF BREAST IMPLANT-ASSOCIATED ANAPLASTIC LARGE CELL LYMPHOMA, ALK NEGATIVE WITH IMMUNOPHENOTYPE CD30, EMA, CD4, CD45R0 (POSITIVE) TIA-1 (FOCAL POSITIVE). A FDG PET-CT IDENTIFIED HYPERMETABOLIC LESIONS IN THE RIGHT BREAST AND RIGHT AXILLA, AS WELL AS MILD UPTAKE IN THE BONE MARROW". THE DEVICE WAS EXPLANTED. A CAPSULECTOMY WAS PERFORMED AND ADJUVANT CHEMOTHERAPY AND IMMUNOTHERAPY WERE ADMINISTERED. WITH THESE INTERVENTIONS, THE PATIENT HAD COMPLETE RESOLUTION OF SYMPTOMS AND ABSENCE OF TUMOR ACTIVITY DETECTABLE BY POSITRON EMISSION TOMOGRAPHY WITH FLUORODEOXYGLUCOSE (PET-CT FDG) AT A 2.5-YEAR FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228122 UNK MAMMARY IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN (COSTA RICA) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Female Life Threatening