BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INAMED AESTHETICS BREAST IMPLANT

    MDR report key: 16254118 · Received January 26, 2023

    Report

    Report Number
    MW5114536
    Event Type
    Injury
    Date Received
    January 26, 2023
    Report Date
    January 25, 2023
    Manufacturer
    INAMED/ ALLERGAN
    Product Code
    FTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    BREAST IMPLANT SIDE EFFECTS (BREAST IMPLANT ILLNESS, BII) EXTREME FATIGUE EVEN ON INC MED (ALMOST DOUBLE) TRIED DIFFERENT MEDS, GOT SPINAL TAP AND BLOOD WORK TO TEST FOR DIFFERENT THINGS. NOTHING OUTSIDE OF STANDARD TYPE 2 NARCOLEPSY, PUFFY AND TINGLY HANDS AND FEET, ONGOING FEELINGS OF INFLAMMATION THROUGHOUT, EXTREMITIES, ABDOMEN, SWOLLEN/SCALLOPED TONGUE, ETC., NAIL CHANGES, DIFFICULTY LOSING/WEIGHT BUILDING MUSCLE DESPITE VIGOROUS WORKOUT, POST EXERTION FATIGUE HAVE HAD TO STOP WORKING OUT AS HARD BECAUSE IF I PUSH TOO MUCH I'M WIPED OUT FOR THE DAY. EXOTROPIA - BRAIN MRI NEGATIVE AND LABS FINE; OPHTHALMOLOGIST BLAMED UNCONTROLLED NARCOLEPSY FUZZY VISION, SQUIGGLY LINES, DIFFICULTY FOCUSING DURING FATIGUE HIGH LDLS DESPITE EXERCISE AND CLEAN DIET DIZZINESS OR VERTIGO ESPECIALLY MOVING A LOT AND HEAT. ORTHOSTATIC HYPOTENSION, FOGGY BRAIN, POOR MEMORY, HAIR LOSS, HAD ONE HIGH TSH THOUGH THYROID HORMONES WERE FINE. THEY STILL TRIED SYNTHROID AND IT MADE ME FEEL WORSE BECAUSE THEN IT STOPPED MY THYROID FROM MAKING ITS OWN. MY T3 AND T4 WERE LOWER AFTER STARTING IT. NIGHT SWEATS ALMOST DAILY, RHINITIS WITH EXCESSIVE SNEEZING AFTER EXERCISE AND OCCASIONAL UNTRIGGERED - STARTED AT 20YR POST IMPLANTS RANDOM RASHES AND ECZEMA - STARTED AT 20 YR POST IMPLANTATION ARM FOLLICULITIS, INTERMITTENT BOILS ON HEAD, ABDOMINAL TENDERNESS AND BLOATING, BLADDER FREQUENCY AND SOME PRESSURE ISSUES, FACIAL FLUSHING, VAGINAL ATROPHY IF NOT USING ESTROGEN CREAM. HEADACHES, ANXIETY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1069007 INAMED AESTHETICS BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR INAMED/ ALLERGAN STYLE 20 SILICONE
    925144 INAMED AESTHETICS BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR INAMED/ ALLERGAN STYLE 20 SILICONE

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Female Disability ADDERALL, SYEDA.