BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTHSHELL 325ML

    MDR report key: 33992 · Received May 22, 1996

    Report

    Report Number
    33992
    Event Type
    Injury
    Date Received
    May 22, 1996
    Date of Event
    August 4, 1995
    Report Date
    February 26, 1996
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FWM
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PT IS A 48 YR OLD WHITE FEMALE WHO UNDERWENT BILATERAL BREAST AUGMENTATION IN DECEMBER OF 1987 USING ANOTHER CO'S SALINE IMPLANT 325CC. AFTER IMPLANTATION, THE PT'S HEALTH BEGAN DETERIORATING WITH JOINT PAIN, ARM PAIN, MIGRAINE'S, NAUSEA, VOMITING, AND FATIGUE. SHE HAS BEEN DIAGNOSED WITH FIBROMYALGIA. ON PHYSICAL EXAM, SHE HAS NO CONTRACTURE IN HER BREASTS. THERE IS PAIN IN THE LEFT AXILLA BUT THERE IS NO SILICONE LYMPHADENOPATHY. BECAUSE OF SYSTEMIC SYMPTOMS AND LOCAL PAIN SYMPTOMS, THE PT DESIRES IMPLANT REMOVAL. TOTAL CAPSULECTOMY IS MEDICALLY NECESSARY BECAUSE THE CAPSULE CONTAINS IMPLANT COMPONENTS WHICH THE PT MAY BE REACTING TO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MENTOR SMOOTHSHELL 325ML Implant BREAST IMPLANT FWM BAXTER HEALTHCARE NA 20715

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention