BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NATRELLE SILICONE BREAST IMPLANT

    MDR report key: 19426225 · Received May 29, 2024

    Report

    Report Number
    MW5155543
    Event Type
    Injury
    Date Received
    May 29, 2024
    Date of Event
    May 1, 2009
    Report Date
    May 22, 2024
    Manufacturer
    ALLERGAN
    Product Code
    FTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    FIRST SURGERY REQUIRED AFTER IMPLANT SURGERY (B)(6) 2008) TO REMOVE TONSILS. HAD GALLBLADDER SURGERY IN (B)(6) 2009, SUFFERED A BILATERAL PULMONARY EMBOLISM 2014, HIATAL HERNIA SURGERY 2015, UMBILICAL HERNIA (B)(6) 2023, RIGHT KNEE MICROFRACTURE 2023, HIATAL HERNIA SURGERY 2023, DEVIATED SEPTUM 2024, LABIAPLASTY 2024, BREAST IMPLANT REMOVAL(B)(6) 2024. ALSO DIAGNOSED WITH TACHYCARDIA, ENLARGED LEFT ATRIUM AND RIGHT VENTRICAL, MITRAL REGURGITATION, TRICUSPID REGURGITATION, HEART MURMUR; SERONEGATIVE RHEUMATOID ARTHRITIS; FIBROMYALGIA; CHRONIC FATIGUE SYNDROME; RAYNAUD'S SYNDROME; HYPERMOBILITY SPECTRUM DISORDER; ENLARGED THYROID; IBS; OVERACTIVE BLADDER, INCONTINENCE; HEAVY MENTRUAL PERIODS, ALSO TOO FREQUENT; MULTIPLE FIBROADENOMAS IN BOTH BREASTS; DEXTROCURVATURE OF THE THORACIC SPINE, LEVOCURVATURE OF THE LUMBAR SPINE; DEPRESSION, ANXIETY, PTSD(PSYCHOLOGICAL TRAUMA AND SOCIAL AVOIDANCE), ADHD(ATTENTION DEFICIT HYPERACTIVITY DISORDER); WORSENED ASTHMA; WORSENED ALLERGIES. ALL ISSUES DUE TO SUSPECTED BREAST IMPLANT ILLNESS, WITH THE EXCEPTION OF RIGHT KNEE SURGERY AND BILATERAL PULMONARY EMBOLISM. REF REPORT: MW5155542.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311587 NATRELLE SILICONE BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN 15-533

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Female Hospitalization| S| O ACYCLOVIR| ALBUTEROL| ATARAX| BREZTRI| COGNIUM| FLEXERIL| FLONASE| IRON SUPPLEMENT| PLAQUENIL| PRAZOSIN| PROBIOTICS| PUMPKIN SEED EXTRACT| RESTASIS| UBIQUINOL COQ10| VERAPAMIL| WELLBUTRIN| XIFAXAN| XYZAL