BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMOOTH BREAST IMPLANTS 15 LEFT

    MDR report key: 16459977 · Received February 28, 2023

    Report

    Report Number
    MW5115316
    Event Type
    Injury
    Date Received
    February 28, 2023
    Date of Event
    February 1, 2014
    Report Date
    February 27, 2023
    Manufacturer
    ALLERGAN SALES, LLC.
    Product Code
    FWM
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    ALLERGEN (15) SMOOTH BREAST IMPLANTS IN (B)(6) 2010. SERIAL # LEFT (B)(4), SERIAL # RIGHT (B)(4), 4 YEARS LATER, WENT INTO EARLY MENOPAUSE AT AGE 39 DESPITE BEING HEALTHY AND MOTHER AND SISTER HAVING NORMAL MENOPAUSAL AGE. I HAVE LOTS OF GUT ISSUES, CHRONIC FATIGUE, BRAIN FOG, INSOMNIA AND EXTREMELY DRY SKIN AND EYES. I'VE HAD DECLINING VISION DESPITE HAVING HAD LASIK IN 2008 BEFORE THE IMPLANTS AND HAVING STABLE VISION FOR YEARS. IT'S A SHAME THE FDA STILL ALLOWS BREAST IMPLANTS IN 2023, PUTTING MONEY AHEAD OF WOMEN'S HEALTH. COSMETIC SURGERY. REFERENCE REPORT: MW5115317.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1947840 SMOOTH BREAST IMPLANTS 15 LEFT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN SALES, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Female Disability CALCIUM.| VITAMIN D.