BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORY GEL BREAST IMPLANT

    MDR report key: 8699801 · Received June 13, 2019

    Report

    Report Number
    MW5087354
    Event Type
    Injury
    Date Received
    June 13, 2019
    Date of Event
    May 29, 2019
    Report Date
    June 11, 2019
    Manufacturer
    JOHNSON AND JOHNSON / MENTOR WORLDWIDE LLC
    Product Code
    FTR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    MY RIGHT SIDE MENTOR SMOOTH ROUND MODERATE CLASSIC PROFILE 385CC IMPLANT (REF #350-7385MC, SN # (B)(4)) WAS INFECTED AFTER 3 WEEKS OF BEING REPLACED ON (B)(6) 2019 DUE TO CAPSULAR CONTRACTURE WITH A RUPTURED IMPLANT THAT WAS ONLY 19 MONTHS OLD. THE RUPTURED ONE WAS REF #350-7385MC, LOT #6745659, SN# (B)(4). MY PS DIDN'T KNOW WHEN MY IMPLANT RUPTURED OR LEAKED, ALL I KNOW IS THAT I HAVE FELT VERY SICK FOR THE MAJORITY OF THIS PAST YEAR. FOUR SURGERIES IN 20 MONTHS IS A LITTLE TOO MUCH WITH ALL THE ANESTHESIA AND ANTIBIOTICS. MY TISSUE WAS DEAD WITH THIS LAST INFECTION AND MY IMPLANT WAS EXPOSED. THAT IS AN IMAGE THAT WILL TRAUMATIZE ME FOR THE REST OF MY LIFE. NOW I AM LEFT WITH A BUTCHERED RIGHT BREAST THAT WILL NEVER LOOK THE SAME. MENTOR CLAIMS THAT THE IMPLANTS ARE SAFE IF A RUPTURE OCCURS AND THAT IF IT LEAKS, IT STAYS ON THE IMPLANT BECAUSE OF COHESION. WHY WOULD MY SURGEON HAVE TO SCRAPE AND THOROUGHLY CLEAN OUT MY CAPSULE AND BREAST IF IT DOESN'T HARM A WOMAN BREAST TISSUE? TELL ME WHY DID A PERFECTLY GOOD IMPLANT GIVE ME AN INFECTION THAT KILLED MY BREAST TISSUE? I COULD'VE GOTTEN SEPTIC. MY PS SAID IT NEEDED TO BE REMOVED RIGHT AWAY. I HAD TO CALL THE SURGERY CENTER THE NEXT DAY AND GOT A DATE FOR FRIDAY (B)(6). I WAS SICK TO MY STOMACH AND HAD PANIC ATTACKS ALL DAY FOR 2 DAYS. THIS IS UNACCEPTABLE. MY SURGEON SAID I DIDN'T NEED TO REMOVE THE CAPSULE ON MY LEFT BREAST, I PRAY TO GOD THAT LEAVING IT BEHIND DOESN'T CAUSE ME ANY FURTHER HEALTH PROBLEMS. I WAS PERFECTLY HEALTHY BEFORE IMPLANTS. I AM A TRAINER AT A LOCAL GYM AND I EAT RIGHT. I FELT SOMETHING WRONG FROM THE BEGINNING AND HAVE HAD NOTHING BUT PROBLEMS WITH THEM AND MY HEALTH SINCE THEN. I WAS EXTREMELY EXHAUSTED, ACHY JOINTS AND MUSCLES, BLURRY VISION, FLUTTERING IN MY EAR, BRAIN FOG, MEMORY LOSS, WEIGHT GAIN, NIGHT SWEATS, ANXIETY, HAIR LOSS, TEMPERATURE INTOLERANCE, DRY SKIN, MOOD SWINGS, DECREASES LIBIDO, INFLAMMATION, IBS, SHARP PAINS IN BREASTS, AND DRY SKIN. I WENT TO MY PRIMARY CARE SEEKING ANSWERS IN (B)(6). THOUGHT I HAD A THYROID ISSUE OR EARLY MENOPAUSE BUT EVERYTHING CAME BACK NORMAL. TWO WEEKS AND MY ENERGY IS SLOWLY COMING BACK AND MY BODY ISN'T AS ACHY BUT THE OTHER SYMPTOMS HAVE YET TO CLEAR. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    490344 MENTOR MEMORY GEL BREAST IMPLANT PROSTHESIS, BREAST, NON-INFLATABLE SILICONE GEL-FILLED FTR JOHNSON AND JOHNSON / MENTOR WORLDWIDE LLC 350-7385MC 6745659
    490345 MENTOR MEMORY GEL BREAST IMPLANT PROSTHESIS, BREAST, NON-INFLATABLE SILICONE GEL-FILLED FTR JOHNSON AND JOHNSON / MENTOR WORLDWIDE LLC 350-7385MC

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Disability