BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 9475546 · Received December 16, 2019

    Report

    Report Number
    1645337-2019-25732
    Event Type
    Injury
    Date Received
    December 16, 2019
    Date of Event
    November 10, 2015
    Report Date
    November 20, 2019
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317000549
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A MANUFACTURING RECORD EVALUATION (MRE) WAS PERFORMED FOR THE FINISHED DEVICE WITH NUMBER 6970489, AND NO NON-CONFORMANCE'S RELATED TO THE REPORTED COMPLAINT WERE IDENTIFIED. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    SINCE THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS, 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. A MANUFACTURING RECORD EVALUATION IS IN PROGRESS. ONCE COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: GENERALIZED ILLNESS. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE WHO UNDERWENT BREAST AUGMENTATION REVISION WITH A 500CC MENTOR MEMORYGEL BREAST IMPLANT (LEFT) AND A 550CC MENTOR MEMORYGEL BREAST IMPLANT (RIGHT) EXPERIENCED SEVERAL UNEXPLAINED SYSTEMIC SYMPTOMS POST PROCEDURE. AUTOIMMUNE ISSUES, WEIGHT GAIN, NUMBNESS IN ARMS AND SHOULDERS, INFLAMMATION, HEADACHES, MEMORY LOSS, BRAIN FOG, ANXIETY, JOINT PAIN, INSOMNIA, LOSS OF CONCENTRATING, HAIR LOSS, DIFFICULTY SWALLOWING, FOOD INTOLERANCE, AND FATIGUE WERE ALL NOTED. THE ROOT CAUSE OF THE PATIENT¿S SYMPTOMS IS UNCLEAR. THE PATIENT DID RECEIVE A MEDICAL DIAGNOSIS FOR LEFT SIDED BAKER GRADE III CAPSULAR CONTRACTURE WITH SUSPECTED RUPTURE AND ACCOMPANYING LEFT BREAST PAIN. AS A RESULT, AN EXPLANT WAS PERFORMED ON (B)(6) 2019. THIS REPORT RELATES TO THE LEFT PROSTHESIS. SEE 1645337-2019-25731 FOR CONTRALATERAL PROSTHESIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1271404 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 6970489 00081317000549

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention