BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GALAFLEX SCAFFOLD P4HB

    MDR report key: 15380577 · Received September 7, 2022

    Report

    Report Number
    MW5111923
    Event Type
    Injury
    Date Received
    September 7, 2022
    Report Date
    September 5, 2022
    Manufacturer
    BECTON DICKINSON AND COMPANY / TEPHA, INCORPORATED
    Product Code
    OOD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE P4HB BASED MESH PHASIX HAS BEEN USED OFF-LABEL, BY A (B)(6) PLASTIC SURGEON FOR BREAST RECONSTRUCTION IN WOMEN WITH BREAST CANCER, POST-MASTECTOMY. UNFORTUNATELY, P4HB MATERIALS CAN ACTIVATE A PRO-ONCOGENIC IMMUNE RESPONSE NAMED THE "M2 MACROPHAGE" RESPONSE. BECAUSE P4HB ACTIVATES M2 MACROPHAGES, ITS USE IN WOMEN WITH BREAST CANCER PATIENTS IS POTENTIALLY DANGEROUS. ADDITIONALLY, INTRODUCTION OF ANY PRO-INFLAMMATORY MESH PRODUCT IN A BREAST CANCER RESECTION SPACE, COULD INTERFERE WITH SUBSEQUENT SURVEILLANCE OF CANCER RECURRENCES AND, THUS, LEAD TO A LIFE-THREATENING DELAY IN DIAGNOSIS. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2645931 GALAFLEX SCAFFOLD P4HB SURGICAL FILM OOD BECTON DICKINSON AND COMPANY / TEPHA, INCORPORATED
    2645932 PHASIX MESH MESH, SURGICAL, POLYMERIC OOD DAVOL INC., SUB. C.R. BARD, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening