BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 9565262 · Received January 8, 2020

    Report

    Report Number
    1645337-2020-00486
    Event Type
    Injury
    Date Received
    January 8, 2020
    Date of Event
    October 5, 2010
    Report Date
    December 13, 2019
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317000341
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION OF THE PHOTO PROVIDED WAS COMPLETED BY THE FAILURE ANALYSIS LAB ON 2/11/2020. DEVICE EVALUATION SUMMARY: ACCORDING WITH THE INFORMATION REPORTED THE PATIENT EXPERIENCED MULTIPLE SYMPTOMS OF GENERALIZED ILLNESS AND A RUPTURE IN THE BREAST IMPLANT. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 5970162 NUMBER, AND NO NON-CONFORMANCE RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. UPON VISUAL INSPECTION OF THE PICTURES, IT WAS OBSERVED THAT THE IMPLANT WAS RUPTURED. THE PHOTOS DO NOT PROVIDE ENOUGH EVIDENCE TO DETERMINE ROOT CAUSE. HANDS ON ANALYSIS SHOULD PROVIDE THE EVIDENCE NECESSARY TO CONFIRM THE ROOT CAUSE. AT THE PRESENT TIME, THERE IS NO SUFFICIENT EVIDENCE TO SHOW AN ASSOCIATION BETWEEN BREAST IMPLANTS AND GENERALIZED ILLNESS (ASSESSING THE RISKS OF BREAST IMPLANTS AND FDA¿S VISION FOR THE NATIONAL BREAST IMPLANT REGISTRY). AN INVESTIGATION OF THE EVIDENCE PROVIDED WAS PERFORMED, AND MENTOR COULD NOT UNCOVER A DEVICE FAILURE THAT WE COULD CONNECT TO THE REPORTED MEDICAL SYMPTOMS. MENTOR PRODUCT IS 100% VISUAL INSPECTED PRIOR TO RELEASE. 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) YEAR-OLD CAUCASIAN FEMALE WHO UNDERWENT BREAST AUGMENTATION REVISION WITH 500CC MENTOR MEMORYGEL BREAST IMPLANTS SEVERAL UNEXPLAINED SYSTEMIC SYMPTOMS POST PROCEDURE. IT WAS NOTED THAT THE PATIENT BEGAN FEELING ILL AFTER SHE REPLACED HER SALINE IMPLANTS WITH THESE GEL ONES. AN UNSPECIFIED FEELING OF SICKNESS, CHRONIC OBSTRUCTIVE PULMONARY DISEASE, ARTHRITIS, ASTHMA, HYPERTENSION, THYROID ISSUES, AND CHRONIC FATIGUE WERE NOTED. THE ROOT CAUSE OF THE PATIENT¿S SYMPTOMS IS UNCLEAR. A MAMMOGRAM WAS PERFORMED ON (B)(6) 2019 AND NO DEVICE ISSUES SUCH AS RUPTURE WERE FOUND. ON (B)(6) 2019 REMOVAL WITHOUT REPLACEMENT WAS PERFORMED AND RIGHT SIDED RUPTURE WAS DISCOVERED. THIS REPORT RELATES TO THE RIGHT PROSTHESIS. SEE 1645337-2020-00489 FOR CONTRALATERAL PROSTHESIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26857 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 3505001BC 5970162 00081317000341

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention