BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGIPLAS IMPLEO GEL TEXTURED MAMMARY PROSTHESIS EXTRA HIGH RANGE EHR 520

    MDR report key: 24872378 · Received April 14, 2026

    Report

    Report Number
    MW5186796
    Event Type
    Injury
    Date Received
    April 14, 2026
    Date of Event
    April 8, 2026
    Report Date
    April 9, 2026
    Manufacturer
    GC AESTHETICS (GCA)
    Product Code
    FTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AS
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    THIS IS ONGOING. I HAVE COMPLETE MEMORY LOSS - I AM UNABLE TO REMEMBER BASIC EVERYDAY THINGS. GETTING WORSE TO THE POINT WHERE I CANT EVEN REMEMBER WHAT I'M DOING AT THE TIME. BRAIN FOG, EVERYTHING IS SO CLOUDED. CONSTANT PAIN IN MY BREASTS I HAD TEXTURED IMPLANTS IN 2011 AND HAVE NOT BEEN EVEN ABLE TO AFFORD TO GET CHECKED AS IT'S OVER $(B)(6) FOR THE CONSULT PLUS GETTING CHECKED FOR BIA-CAL. WHICH I BELIEVE I HAVE. I HAVEN'T HAD A PERIOD IN OVER 3 YEARS AND I'M ONLY 32 YEARS OLD. I HAVE CONSISTENT SWELLING. THEN BEING SKINNIER- AND SWELLING OVER 2 FULL SIZES IN CLOTHES WITHIN DAYS. THEN IT GOES DOWN AGAIN, AND SWELLING COMES BACK UP. CONSTANTLY HAVING MIGRAINES AND HOT FLUSHES. I CAN'T WORK. I CAN'T STUDY. I CAN'T EVEN THINK. I'M SO DEPRESSED AND I TRULY BELIEVE THESE IMPLANTS HAVE AND ARE MAKING ME INCREDIBLY SICK. PATIENT CODE: 1958, 2553, 4504, 1959, 4577, 1880, 2153, 2361. DEVICE CODE: 2682, 4001. REFERENCE REPORT MW5186797.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    929077 SURGIPLAS IMPLEO GEL TEXTURED MAMMARY PROSTHESIS EXTRA HIGH RANGE EHR 520 PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR GC AESTHETICS (GCA)

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Female Disability| O ANTIBIOTICS.