BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK GEL BREAST IMPLANT

    MDR report key: 10094522 · Received May 27, 2020

    Report

    Report Number
    9617229-2020-08369
    Event Type
    Injury
    Date Received
    May 27, 2020
    Report Date
    May 27, 2020
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ARTICLE CITATION: EVANS, MARK G., MIRANDA, ROBERTO N., YOUNG, PATRICIA A ET AL. B-CELL LYMPHOMAS ASSOCIATED WITH BREAST IMPLANTS: REPORT OF THREE CASES AND REVIEW OF THE LITERATURE. ANNALS OF DIAGNOSTIC PATHOLOGY: VOLUME 46, JUNE 2020, 151512. FACILITY NAME: DEPARTMENT OF PATHOLOGY AND LABORATORY MEDICINE, UNIVERSITY OF CALIFORNIA IRVINE). THE EVENT OF LYMPHOMA - ALCL 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: LYMPHOMA - ALCL.

    Description of Event or Problem · 1

    THROUGH JOURNAL ARTICLE ¿B-CELL LYMPHOMAS ASSOCIATED WITH BREAST IMPLANTS: REPORT OF THREE CASES AND REVIEW OF THE LITERATURE,¿ HEALTHCARE PROFESSIONAL REPORTED IN CASE STUDY 2, PATIENT EXPERIENCED ¿MONTHS OF LEFT-SIDED BREAST SWELLING AND PAIN. BREAST MRI DEMONSTRATED AN INTACT TEXTURED IMPLANT SURROUNDED BY A LARGE VOLUME OF FLUID AND A THICKENED FIBROUS CAPSULE WITH DEPENDENT DEBRIS. IMMUNOHISTOCHEMICAL TESTING SHOWED THAT THE LARGE CELLS WERE STRONGLY POSITIVE FOR CD30 AND NEGATIVE FOR ANAPLASTIC LYMPHOMA KINASE (ALK).¿ THE PATIENT WAS REFERRED FOR ONCOLOGIC EVALUATION AND NO ADDITIONAL THERAPY WAS RECOMMENDED FOR THE ALCL. IN THE FIVE YEARS SINCE COMPLETING THIS THERAPY, THE PATIENT HAS REMAINED WITHOUT RADIOLOGIC OR CLINICAL EVIDENCE OF DISEASE. THE FOLLOWING REPORTED EVENTS HAVE BEEN DEEMED NOT RELATED TO THE DEVICE: ¿IN ADDITION, THE DEEPER PORTION OF THE CAPSULE WAS DIFFUSELY AND UNIFORMLY INFILTRATED BY SMALL, ROUND-TO-OVAL, HYPERCHROMATIC LYMPHOCYTES; NO KARYORRHEXIS OR NECROSIS WAS OBSERVED. BY IMMUNOHISTOCHEMISTRY, THE SMALL LYMPHOCYTES WERE POSITIVE FOR CD45RB/LEUKOCYTE COMMON ANTIGEN AND CD20, BUT WERE NEGATIVE FOR CD3, CD5, CD10, CD30, CD43, AND CD68, CONSISTENT WITH EXTRANODAL MARGINAL ZONE LYMPHOMA.¿ AFFECTED SIDE IS LEFT. THE DEVICE HAS BEEN EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    556725 UNK GEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention