BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MCGHAN SAILINE TEXTURED IMPLANTS

    MDR report key: 13142264 · Received January 3, 2022

    Report

    Report Number
    MW5106415
    Event Type
    Injury
    Date Received
    January 3, 2022
    Date of Event
    August 1, 1999
    Report Date
    December 28, 2021
    Manufacturer
    MC GHAN AKA INAMED AKA ALLERGAN
    Product Code
    FWM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I HAD RECEIVED MCGHAN SALINE TEXTURED IMPLANTS IN (B)(6) MEDICAL CENTER IN (B)(6) 1993. ASSURED THEY WERE 100% SAFE AND WOULD OUT LAST MY LIFETIME. NOBODY TOLD ME THEY SPRAYED IT WITH POLYURETHANE. I HAD CERVIX CANCER FROM THEM IN 99 MY CHILD WHO WAS BORN LESS THEN 2 YRS AFTER MY IMPLANTS HAS A DEFORMED SPINE AND TUMOR IN THE BRAIN. THESE CANCERS NOT IN OUR FAMILY. NOBODY WOULD HELP WHEN ONE RUPTURED WHILE WATCHING TV WITH MY DAUGHTER IN 2008. I REALIZE NOW WHY. MCGHAN INTENDED TO SAVE HIMSELF MONEY AT OUR EXPENSE. BY USING INDUSTRIAL SILICONE INSTEAD OF MEDICAL SILICONE I GOT ONE ON THE RIGHT IMPLANTED INSIDE MY BODY. HAD I KNOWN ANY OF THIS WAS EVEN POSSIBLE. I WOULD HAVE NEVER EVEN GIVEN IT A THOUGHT. HALF MY LIFE AND WHAT LITTLE IS LEFT HAS BEEN DAMAGED IN WAYS UNIMAGINABLE. WORSE OF ALL MY CHILD IS AND TOO WILL SUFFER THROUGHOUT HIS. THAT ALONE IS THE BIGGEST HARDEST HEARTBREAK IN MY LIFE. WE BOTH HAVE AND HAD TUMORS, 'NODUALS' SUFFER ILLNESS TO THE POINT OF NEAR DEATH. I NOW HAVE A DIAGNOSIS MULTIPLE MYELOMA BECAUSE THE SURGEON SOMEHOW LEFT TOWN BEFORE ORDERING CD30 AT THE TIME OF EXPLANT AKA DOUBLE BILATERAL MASTECTOMY FINALLY APPROVED DUE TO THE SEVERE CAPSULE CONTRACTURE PULLING ON MY HEART. WHICH STILL TODAY 2 YRS LATER IS SEVERELY PAINFUL AND FRIGHTENING. I KNOW MY CAUSE OF DEATH WILL BE THIS. I FEAR ALTHOUGH FIGHTING TO LIVE. I WON'T LIVE MUCH LONGER. SO PLEASE STOP TESTING THE GOOD PEOPLE WHO PUT THEIR TRUST IN OUR LEADERS AND MED PROFESSIONALS. THIS KIND OF CRUELTY IS A SIN. PLEASE DON'T ALLOW THIS. MY CHILD IS SUFFERING FROM MY MISTAKE IN TRUSTING OUR MEDICAL PROFESSIONALS AND THIS IS NO LONGER ANYTHING TO BE COVERED UP. WE NEED TO STOP THIS AND FIX IT NOW. TODAY IT'S A SERIOUS CRIME AND SIN BEFORE GOD HIMSELF. DO NOT KILL. PLEASE I AM STILL LIVING WITH A MALIGNANT NODUAL AND TAKING DOG DEWORMER TO STAY ALIVE. BECAUSE A NICE HONEST CITIZEN SPOKE OUT IN TIME TO SAVE MY LIFE FOR NOW A DRUG THEY SHIPPED AWAY THAT WOULD HAVE SAVED THOUSANDS. PLEASE DO THE RIGHT THING. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643346 MCGHAN SAILINE TEXTURED IMPLANTS PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MC GHAN AKA INAMED AKA ALLERGAN 168
    643347 MCGHAN SAILINE TEXTURED IMPLANTS PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MC GHAN AKA INAMED AKA ALLERGAN 168

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Female Hospitalization| S| C| O| L SAFEGUARD DOG DEWORMER THE ONE TO FIGHT CANCER