BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROUND SMOOTH SALINE BREAST IMPLANTS (NOW ALLERGAN NATRELLE SALINE FILLED IMPLANT

    MDR report key: 10586284 · Received September 24, 2020

    Report

    Report Number
    MW5096872
    Event Type
    Injury
    Date Received
    September 24, 2020
    Date of Event
    July 1, 1998
    Report Date
    September 22, 2020
    Manufacturer
    MCGHAN /ALLERGAN
    Product Code
    FWM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NV, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    BREAST IMPLANT ILLNESS CAUSED BY MCGHAN MEDICAL CORP SMOOTH SALINE IMPLANTS CATALOG NO 25-68421 NOW CALLED (ALLERGAN NATRELLE SALINE FILLED STYLE 68). I STARTED GETTING SICK A YEAR AFTER IMPLANTATION WITH NUMEROUS UNEXPLAINED ILLNESSES AND AM NOW VERY ILL WITH MANY AUTOIMMUNE DISEASES WHICH ARE NOW REQUIRING CHEMOTHERAPY TO CONTROL. I HAVE HAD NUMEROUS TESTS, STUDIES, PROCEDURES AND SURGERIES ALL RELATED TO BII (BREAST IMPLANT ILLNESS). THESE ILLNESS HAVE LEFT ME WITH NO QUALITY OF LIFE AND HAS COMPLETELY DESTROYED MY BODY, MIND AND PSYCHE. THESE DEVICES NEED TO BE RECALLED AND PATIENTS NEED TO BE COMPENSATED FOR REMOVAL OF THESE DEVICES. OVER THE LAST TWENTY YEARS I HAVE BEEN DIAGNOSED AND TREATED FOR THE FOLLOWING PROBLEMS - ALL TRACEABLE TO BREAST IMPLANT ILLNESS: SJOGREN'S AUTOIMMUNE SYNDROME, MULTIPLE SCLEROSIS, LARYNGOPHARYNGEAL REFLUX, GASTRITIS, LARYNGITIS, OPTIC NEURITIS, MIDDLE EAR EFFUSION, DRY EYES, DRY MOUTH, PREMATURE DENTAL CARIES AND TOOTH LOSS, BRAIN FOG, COGNITIVE DYSFUNCTION, MEMORY LOSS, HYSTERECTOMY, EARLY MENOPAUSE, UTERINE FIBROIDS, OVARIAN CYSTS, ENDOMETRIOSIS, ADHESIONS, TENDONITIS, TENOSYNOVITIS, FATIGUE, MUSCLE PAIN/WEAKNESS, JOINT PAIN OSTEOARTHRITIS, HAIR LOSS, DRY HAIR, PREMATURE AGING, ECZEMA, DERMATITIS, INSOMNIA SLEEP DISTURBANCES, SLOW HEALING, EASY/EXCESSIVE BRUISING, SLOW RECOVERY, VERTIGO, TINNITUS, HEADACHES, MIGRAINES, OCULAR MIGRAINE, EXCESSIVE MUCUS IN THROAT, THROAT CLEARING, COUGH, THROAT/VOCAL CORD IRRITATION, DIFFICULTY SWALLOWING/CHOKING, GERD, FREQUENT UTI'S, FREQUENT YEAST INFECTIONS, PERSISTENT BACTERIAL AND VIRAL INFECTIONS, SINUSITIS, PND, METALLIC TASTE IN MOUTH, HYPERSOMNIA, METALLIC SMELL, PALPITATIONS, RAPID HEARTBEAT, BP CHANGES, SWOLLEN PAINFUL LYMPH NODES ESPECIALLY AROUND BREASTS AND AXILLA, EXTREMELY DEHYDRATED, DIFFICULTY HYDRATING, FREQUENT URINATION, URINARY INCONTINENCE, IBS, NAUSEA, STOMACH DISTENTION, CHRONIC CONSTIPATION, NUMBNESS/TINGLING/PAIN/WEAKNESS IN ARMS, HANDS, FINGERS, FEET, TOES, COLD/DISCOLORED LIMBS, SHORTNESS OF BREATH, CHEST PAIN/HEAVINESS, PAIN/BURNING/ITCHING AROUND IMPLANT SITE, NERVE DAMAGE AROUND IMPLANT SITE, DEPRESSION, ANXIETY, PANIC ATTACKS, FEEL LIKE I AM SLOWLY DYING, FIBROMYALGIA, CONNECTIVE TISSUE DISORDERS, BENIGN TREMOR, SEIZURES, SINUS SURGERY, DEGENERATIVE DISC/JOINT/BONE DISEASE, STENOSIS, STUCK IN SLOW MOTION, DEFORMED BRITTLE NAILS, BREAST FIBROID CYSTS, STRETCHING/THINNING OF BREAST SKIN/TISSUE, SCAR ITCHING. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1047304 ROUND SMOOTH SALINE BREAST IMPLANTS (NOW ALLERGAN NATRELLE SALINE FILLED IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MCGHAN /ALLERGAN
    1047305 ROUND SMOOTH SALINE BREAST IMPLANTS (NOW ALLERGAN NATRELLE SALINE FILLED IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MCGHAN /ALLERGAN

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Disability