BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOCELL TEXTURED AND SMOOTH SALINE FILLED BREAST IMPLANT RIGHT

    MDR report key: 16918456 · Received May 11, 2023

    Report

    Report Number
    MW5117469
    Event Type
    Malfunction
    Date Received
    May 11, 2023
    Report Date
    May 9, 2023
    Manufacturer
    ALLERGAN SALES, LLC.
    Product Code
    FWM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I AM A 64 YR OLD WOMAN WHO HAD BREAST IMPLANTS 20 YRS AGO ON (B)(6) 2003 BY PLASTIC SURGEON DR. (B)(6). I HAD MILD SYMPTOMS FOR YEARS NOW AND DID NOT THINK IT WAS THE IMPLANTS. THE SYMPTOMS HAVE GOTTEN WORSE IN THE PAST SEVERAL YEARS AND I BELIEVE MY SYMPTOMS MAY BE ASSOCIATED WITH THE IMPLANTS. SYMPTOMS: MUSCLE AND JOINT PAIN, BACK PAIN, BULGING DISK SINCE (B)(6) 2022, PRIOR TO THAT HAD HERNIA, NECK AND HEADACHE ONSET (B)(6) 2022, FULL BODY ARTHRITIS ONSET 1 YR AGO, CONSTANT DRY EYES IN THE PAST 15 YRS, DRY MOUTH ONSET 2-3 YRS AGO, HAIR LOSS ONSET 2020, BRAIN FOG SINCE 2021 AND FATIGUE THAT BEGAN 3 YRS AGO. I HAVE BEEN GOING TO PAIN MANAGEMENT AND PHYSICAL THERAPY. I HAVE AN UPCOMING APPOINTMENT WITH MY PRIMARY CARE DOCTOR, DR. (B)(6) 2023 FOR BLOOD WORK TO FIND OUT IF SYMPTOMS ARE BECAUSE OF THE IMPLANTS AND TO DISCUSS BEST COURSE OF TREATMENT AND POSSIBLE REMOVAL OF IMPLANTS. SERIAL: (B)(6) IMPLANTED (B)(6) 2003. REFERENCE REPORT: MW5117468.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1032115 BIOCELL TEXTURED AND SMOOTH SALINE FILLED BREAST IMPLANT RIGHT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN SALES, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Other