BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEXTURED 390CC BREAST IMPLANTS (3RD SET) MADE IN 1990'S

    MDR report key: 8991641 · Received September 10, 2019

    Report

    Report Number
    MW5089689
    Event Type
    Injury
    Date Received
    September 10, 2019
    Date of Event
    April 1, 1999
    Report Date
    September 8, 2019
    Manufacturer
    ALLERGAN / MCGHAN
    Product Code
    FWM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    A (3RD SET) RAYNAUDS, (B)(6) (2 WKS IN HOSP), CHEST PAIN, BREAST PAIN, RASHES, ITCHING, ANXIETY, PANIC ATTACKS, BRAIN TUMOR (BENIGN), VISUAL DISTURBANCES, VERTIGO, FALLING, BRAIN FOG, ACHING JOINTS, LOW ENERGY / FIBROMYALGIA, MUSCLE PAIN, HEART PALPITATIONS, GERD, IBS, METALIC TASTE IN MOUTH, NIGHT SWEATS, TEMPERATURE INTOLERANCE, BURNING AROUND BREAST AREA, FOUL BODY ODOR, BACK AND NECK PAIN, LIGHT AND SOUND SENSITIVITY, CHEMICAL SENSITIVITIES, THYROID DYSFUNCTION. MY PS PASSES AWAY SEVERAL YEARS AGO. I HAD TEXTURED MCGHAN / ALLERGAN SALINE, 360CC AND HAD THEM REMOVED ON (B)(6) 2019 BY DR (B)(6). I HAVE IMPLANTS IN PROCESSION. MANY SYMPTOMS WERE GONE IMMEDIATELY, BUT MANY REMAIN. I SAW DR (B)(6) DUE TO RELENTLESS SHARP PAIN IN MY RIGHT BREAST. I AM NOW (B)(6) IN DEBT AS (B)(6) AND MY SUPPLEMENT DENIED COVERAGE. PAIN IS "MEDICALLY NECESSARY". I WAS NEVER GIVEN ANY POSSIBLE SYMPTOMS OF CANCER OR ASKED TO SEE PHYSICIAN BEFORE ANY 3 SURGERIES. MY SECOND SET WAS RUPTURED. THESE IMPLANTS ARE TOXIC. MAY HAVE DIED. MANY HAVEN'T BEEN WARNED OF THE SIDE EFFECTS. ALL BREAST IMPLANTS THAT HAVE ANY OF THE POISONS SHOULD BE BANNED. I AM GLAD TO HAVE MY LIFE BACK. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    780404 TEXTURED 390CC BREAST IMPLANTS (3RD SET) MADE IN 1990'S PROSTHESIS, BREAST, INFLATABLE INTERNAL SALINE FWM ALLERGAN / MCGHAN
    780406 BREAST IMPLANT PROSTHESIS, BREAST, INFLATABLE INTERNAL SALINE FWM UNK NOT GIVEN TO ME. PS DECEASED NOT AVAILABLE
    780407 BREAST IMPLANT PROSTHESIS, BREAST, INFLATABLE INTERNAL SALINE FWM UNK
    780408 BREAST IMPLANT PROSTHESIS, BREAST, INFLATABLE INTERNAL SALINE FWM UNK
    780409 BREAST IMPLANT PROSTHESIS, BREAST, INFLATABLE INTERNAL SALINE FWM UNK
    780410 TEXTURED 390CC BREAST IMPLANTS (3RD SET) MADE IN 1990'S PROSTHESIS, BREAST, INFLATABLE INTERNAL SALINE FWM ALLERGAN / MCGHAN

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Life Threatening| R