BEUDAMED
    FDA Adverse Event Other Summary report: N

    MENTOR BREAST IMPLANTS

    MDR report key: 1192244 · Received October 9, 2008

    Report

    Report Number
    MW5008583
    Event Type
    Other
    Date Received
    October 9, 2008
    Date of Event
    January 1, 2004
    Report Date
    September 29, 2008
    Product Code
    FTR
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    I AM WRITING TODAY TO LET YOU KNOW, THAT I WAS DAMAGED BY MENTOR BREAST IMPLANTS. I WILL TRY TO MAKE THIS SHORT AND TO THE POINT. I AM A WIFE AND MOTHER. TWENTY YEARS AGO, I GOT MY 1ST IMPLANTS (SILICONE). AFTER A FEW YEARS I GOT A "CAPSULE" AND LIVED WITH IT UNTIL THE FOLLOWING FIVE YEARS. AT THAT POINT, I WENT TO DR AND HAD THEM REPLACED WITH ANOTHER SET OF SILICONE IMPLANTS. I FEEL THAT HE DID A VERY GOOD JOB AND WAS HAPPY WITH THEM FOR ALMOST 10 YEARS. IN 2004, I STARTED FEELING SICK, IN MANY WAYS AND MY IMPLANTS FELT DIFFERENT TO ME. I FELT STRONGLY THAT ONE OR BOTH HAD BURST BUT BECAUSE OF LACK OF FUNDS I WAS UNABLE TO FIND OUT OR HAVE THEM REPLACED. EVER SINCE THE SPRING/SUMMER OF 2004, I "MYSTERIOUSLY" DEVELOPED VITILIGO (A VERY RARE DISEASE. ESPECIALLY IN CAUCASIANS). I ALSO CAME DOWN WITH INFECTION AFTER INFECTION, AFTER INFECTION, WITH NO BREAKS. MY DOCTORS RAN COUNTLESS TESTS AND COULD NOT FIGURE OUT WHAT WAS HAPPENING. I WAS TESTED FOR AIDS, HIV, LUPUS, STRESS ECO, ULTRA SOUNDS, THYROID, ETC... TOO MANY TO NOTE HERE. I WOULD GLADLY GIVE YOU PERMISSION TO TALK TO MY DOCTOR WHO HAS YET TO FIGURE OUT WHY I WAS BEING PLAGUED WITH ALL THIS ILLNESS. I ALSO CAME DOWN WITH HIGH BLOOD PRESSURE AT THAT SAME TIME. I WAS CONSTANTLY EXHAUSTED AND TORTURED BY MY ILLNESSES AND NOT KNOWING WHY. I WAS ON MANY ANTIBIOTICS EVERY 2-3 WEEKS, MOSTLY CIPRO, FROM 2004-2006. THE DEPRESSION I HAVE SUFFERED AND TIME LOST COULD NEVER BE REPLACED OR PAID FOR. IN 2006, I WAS FINALLY ABLE TO AFFORD TO HAVE THEM REPLACED BY DR. WHEN I EXPRESSED TO HIM THAT I FELT MY IMPLANTS HAD RUPTURED AND CAUSED MY ILLNESS HE SUDDENLY REFUSED TO DO MY SURGERY. HIS PARTNER DR AGREED TO DO THE SURGERY AND AFTER THE SURGERY ADMITTED THAT THE LONGEST AND MOST DIFFICULT PART OF THE SURGERY WAS REMOVING LARGE AMOUNTS OF SILICONE FROM MY BODY. HIS EXACT WORDS WERE THAT "IT WAS A MESS." THE DAY I LEFT HIS OFFICE THAT DAY, I HAVEN'T HAD ANYMORE INFECTIONS. HOWEVER, THE VITILIGO REMAINS AND IS GETTING WORSE. I BELIEVE THAT REGARDING THAT, THE DAMAGE HAS BEEN DONE AND CANNOT BE REVERSED. I FEEL MUCH BETTER SINCE THEY WERE REMOVED AND REPLACED. ALMOST A YEAR AFTER MY SURGERY, I CALLED FOR A CHECK UP, TO MAKE SURE THEY LOOKED RIGHT AND WERE AS THEY SHOULD BE. ONE DAY AFTER THAT I RECEIVED A CALL FROM DR'S OFFICE AND THEY TOLD ME THAT THEY HAD FORGOTTEN TO HAVE ME SIGN A CONSENT FORM BEFORE MY SURGERY (ALMOST A YEAR BEFORE) AND THAT THEY WERE SENDING IT TO ME IN THE MAIL TO SIGN AND SEND BACK TO THEM. THE FORM WAS FOR MY CONSENT TO HAVE MENTOR IMPLANTS PUT IN MY BODY AND BE PART OF THEIR STUDY. I NEVER RECEIVED OR SAW THIS PRIOR TO MY SURGERY. IF I HAD SEEN THAT IT WAS THE SAME COMPANY, THAT I STRONGLY BELIEVE, MADE ME SICK, I MAY HAVE CHOSEN ANOTHER OPTION. I WAS NOT GIVEN A CHOICE AND I AM NOW "PART OF A STUDY". AS I MENTIONED ABOVE, I'M SURE I'LL NEVER RECEIVE ANY COMPENSATION FOR MY SUFFERING BUT I WANT YOU TO KNOW MY STORY TO ADD IT TO THE OTHER CASES OF PEOPLE WHO STRONGLY FEEL (KNOW) THEY WERE DAMAGED BY MENTORS' BREAST IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MENTOR BREAST IMPLANTS NONE FTR

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR