BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MENTOR MEMORYGEL XTRA BREAST IMPLANTS

    MDR report key: 25240983 · Received May 20, 2026

    Report

    Report Number
    MW5188500
    Event Type
    Malfunction
    Date Received
    May 20, 2026
    Date of Event
    January 3, 2023
    Report Date
    May 5, 2026
    Manufacturer
    MENTOR TEXAS LP
    Product Code
    FTR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    PRIOR TO 2021, MENTOR WORLDWIDE LLC DID WITHHOLD INFORMATION DETAILS ON RISK/SAFETY/ WARNING REGARDING THEIR BRAND OF MEMORYGEL BREAST IMPLANTS FOR PATIENT REVIEW WITH PLASTIC SURGEON. 2021 MENTOR WORLDWIDE LLC RELEASED A" MENTOR PATIENT DECISION CHECKLIST" ON THEIR BRAND OF MEMORYGEL BREAST IMPLANTS THAT STATES THE RISK/SAFETY/WARNING INFORMATION DETAILS WHICH THEN BECAME PART OF AN EDUCATIONAL PATIENT BROCHURE THAT MENTOR WORLDWIDE LLC RELEASED IN 2022. CURRENTLY PLASTIC SURGEONS ARE REQUIRED TO PROVIDE PATIENTS THE EDUCATIONAL PATIENT BROCHURE INCLUDING THE "PATIENT DECISION CHECKLIST" FOR PRE-OPERATIVE REVIEW WITH PLASTIC SURGEON. A REQUIREMENT ON EACH SECTION OF THE" MENTOR PATIENT DECISION CHECKLIST" IS A SPACE FOR PATIENT INITIALS (IF AGREED) TO CONFIRM UNDERSTANDING ON RISK/SAFELY/WARNING OF MENTOR MEMORYGEL BREAST LMPLANT PRIOR TO SURGERY. UPON PATIENT APPROVAL THE" MENTOR PATIENT DECISION CHECKLIST" WILL BECOME PART OF PATIENT MEDICAL FILE. "MEMOR PATIENT DECISION CHECKLIST." AFFIRMS IN THE "RISK OF BREAST IMPLANT SURGERY" PARAGRAPH THAT MENTOR MEMORYGEL XTRA IMPLANTS WERE NOT INCLUDED IN THE MENTOR MEMORYGEL CORE STUDY. I AM A PATIENT AND HAVE BEEN IMPLANTED WITH MENTOR MEMORYGEL XTRA IMPLANTS SINCE 2018 AND CURRENTLY HAVE A INJURY. MENTOR WORLDWIDE LLC "FAILURE TO WARN" PATIENTS PRIOR TO 2021 ON RISK/SAFETY WARNING IS UNACCEPTABLE AND MENTOR WORLDWIDE NEEDS TO BE HELD RESPONSIBLE FOR JEOPARDIZING PATIENTS. I WILL LEAK THIS ESSENTIAL INFORMATION WITH PROOF OF MY GRIEVANCE TO THE PRESS IF THIS REMAINS UNRESOLVED. PATIENT: 4580. DEVICE: 2993. REFERENCE REPORT: MW5188501.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    480900 MENTOR MEMORYGEL XTRA BREAST IMPLANTS PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS LP

    Patients

    Seq Age Sex Outcome Treatment
    1