BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 9517765 · Received December 25, 2019

    Report

    Report Number
    1645337-2019-26112
    Event Type
    Injury
    Date Received
    December 25, 2019
    Date of Event
    July 1, 2017
    Report Date
    November 25, 2019
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317003854
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. IT IS UNKNOWN AT THIS TIME IF THE DEVICE WILL BE MADE AVAILABLE FOR RETURN. AS A RESULT, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED, AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS CAN BE MADE. AS SUCH, THE INVESTIGATION WILL BE CLOSED. IF THE COMPLAINT DEVICE IS RECEIVED IN THE FUTURE, THE INVESTIGATION WILL BE REOPENED AND CONDUCTED AS APPROPRIATE. SINCE NO LOT NUMBER WAS PROVIDED, NO MANUFACTURING RECORD EVALUATION REVIEW COULD BE PERFORMED. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: N/A. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED (VIA FDA MEDWATCH 5090699) THAT A FEMALE PATIENT UNDERWENT BREAST SURGERY WITH 750CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED SEVERAL UNEXPLAINED SYSTEMIC SYMPTOMS, INCLUDING HAIR LOSS, CHRONIC PAIN, HEADACHES, FOOD INTOLERANCES, GUT ISSUES, BRAIN FOG, CHRONIC FATIGUE, JOINT PAIN, CHRONIC SINUSITIS, BREAST PAIN, LOSS OF FEELING IN HER BREAST, PELVIC PAIN, PAIN DURING INTERCOURSE, WEIGHT GAIN, INFLAMMATION, ANXIETY, PANIC ATTACKS, MEMORY LOSS, RINGING IN EARS, DEPRESSION, MOOD SWINGS, SHORTNESS OF BREATH, SHALLOW BREATHING, CHRONICALLY ILL, NOT FEELING LIKE HERSELF AND DEPRESSION. NO DEVICE ISSUE SUCH AS RUPTURE WAS REPORTED. THE ROOT CAUSE OF THE PATIENT¿S SYMPTOMS IS UNCLEAR. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT IS FOR THE PATIENT'S RIGHT-SIDED DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1312164 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 00081317003854

    Patients

    Seq Age Sex Outcome Treatment
    1 Other