BEUDAMED
    FDA Adverse Event Other Summary report: N

    BARD

    MDR report key: 2337076 · Received November 8, 2011

    Report

    Report Number
    MW5023068
    Event Type
    Other
    Date Received
    November 8, 2011
    Date of Event
    April 28, 2011
    Report Date
    November 8, 2011
    Manufacturer
    BARD
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KS, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD SURGERY TO REPAIR MY PROLAPSE. VAULT SUP W/MESH. DR USED BARD MARLEX MESH. I HAD SEVERE PAIN RIGHT AFTER HAVING THIS SURGERY AND STILL NOW 6 1/2 MONTHS LATER. I REPEATEDLY CALLED MY DR AFTER MY POST 6 WEEK CHECK UP TELLING HIM I HURT I HURT. HE NEVER ONCE TOLD ME IT'S FROM MY SURGERY AND THIS (B)(6) MESH. TELLING ME IT'S DUE TO MY BACK. I WAS NEVER ASKED TO COME IN FOR HIM TO CHECK ON ME TO FIND OUT WHY I WAS HAVING THIS PAIN. I HURT IN MY PELVIC SHOOTING DOWN MY RIGHT LEG ROTATING TO THE LEFT SIDE OF MY LEG. THE PAIN IS ACROSS MY STOMACH AND IT ITCHES AT TIMES ON BOTH RIGHT AND LEFT HIPBONES. MY LOWER BACK HURT ALONG WITH MY BUTT. I STILL PEE MYSELF FROM THE SMALL THING OF JUST STANDING TO COUGHING. I WAS TOLD MANY TIMES BY THE DR TO JUST TAKE ALEVE. THIS DON'T GET IT. THE PAIN IS MUCH MORE THAN AN ALEVE CAN HANDLE IT. THERE WAS NO INFO OF WHAT OTHERS WHO HAVE EXPERIENCED WITH HAVING THIS (B)(6) MESH. I WAS NEVER TOLD ANYTHING OTHER THAN HE HAD GOOD SUCCESS RATE WITH THIS AND I WOULD HAVE A 95% CURE RATE. I TRUSTED MY DR WHICH BY THE WAY HE HAD PERFORMED MY HYSTERECTOMY IN 1995. MY VAGINA IS WEIRD LOOKING NOW. THE MINORA LABIA HAS TURNED BROWN FROM A ROSY PINK, MY OPENING OF MY VAGINA IS THE SIZE A GOLF BALL NOW. IT LOOKS LIKE A 90 YEAR OLD WOMAN'S VAGINA. I CAN'T STAND THIS PAIN UNLESS I TAKE 10.325 MG OF HYDROCODONE 3 TIMES A DAY JUST TO MAKE IT THRU THE DAYS. THIS MESH IS A TERRIBLE THING TO INTRODUCE TO A WOMAN. ANY KIND OF MESH. I COULD GO ON AND ON BUT I THINK YOU GOT THE MESSAGE.

    Description of Event or Problem · 1

    I WAS TOLD BY MY DR I HAVE A PROLAPSE OF MY BLADDER, RECTUM, AND VAGINA, IN APRIL OF THIS YR. HE TOLD ME HE USES THE BARD MARLEX MESH. I DID RESEARCH ON THIS PROCEDURE, BUT FAILED TO DO RESEARCH ON THIS MESH. I TRUSTED MY DR SINCE HE HAD PERFORMED MY HYSTERECTOMY IN 1995. THE PAIN WAS UNBEARABLE WHEN I GOT BACK TO MY ROOM AFTER SURGERY. PAIN IN MY GROIN AND LOWER BACK. I DIDN'T THINK ANYTHING ABOUT THIS SINCE I HAD JUST HAD SURGERY. MY DR TOLD ME I PUT A HOLE IN YOU AND YOU WILL HURT. I WAS RELEASED ON SATURDAY AND THE FOLLOWING MONDAY I WENT TO THE ER COMPLAINING ABOUT UNBEARABLE PAIN. THE DR DID A URINE TEST AND EVERYTHING HE TOLD ME WAS FINE I JUST HAD AIR IN ME. FOR THE NEXT 6 WEEKS I HURT. BUT TRUSTED MY DR. AFTER RETURNING BACK TO WORK I STILL HURT BUT TRIED TO MUDDLE THRU EACH DAY UNTIL ONE DAY THE PAIN HAS GOTTEN TO THE POINT I REQUESTED AN APPOINTMENT WITH MY DR. I WAS TOLD IT WILL TAKE AT LEAST 6 MONTHS TO GET BACK TO FEELING BETTER AND TO TAKE ALEVE. I CALLED HIM MORE THAN A DOZEN TIMES COMPLAINING ABOUT THE PAIN AND I WOULD EITHER NOT GET A RESPONSE FROM HIM OR I WAS TOLD TO TAKE ALEVE. I FINALLY GOT MAD AS HELL AND DEMANDED AN APPOINTMENT WITH THE DR. HIS OFFICE HELP WAS REALLY RUDE WITH ME WANTING TO KNOW IF MY TUMMY HURT. I NEEDED TO SEE THE DOCTOR. IN SHORT, I DID GET IN TO SEE HIM AND HE ACTED LIKE THERE WAS NO PROBLEM AFTER I HAVE TOLD HIM I HAVE BEEN HAVING PAIN WHILE I PEED HAVING TO STAND UP IN A SQUATTING POSITION TO FULLY EMPTY MY BLADDER, PELVIC PAIN, BUTT PAIN, BACK PAIN, THIGH PAIN, CALF PAIN, MY FEET HURT, ITCHING ACROSS MY BELLY, CRAMPS, MY MINORA LABIA HAS TURN BROWN, MY VAGINA OPENING IS THE SIZE OF A GOLF BALL LOOKING AT IT WITHOUT OPENING IT UP. THE LIST GOES ON. HE DID EXAM ME AND SAID THE SLING IS FINE IN POSITION WHERE IT NEEDED TO BE. I WAS IN PAIN THE WHOLE TIME HE WAS INSIDE ME WITH HIS FINGERS. I SAT UP AND THE PAIN IN MY RIGHT BUTT WOULD NOT STOP; IT RAN DOWN INTO MY RIGHT LEG. I TOLD HIM THIS AND HE TOLD ME I MUST HAVE STRAINED MYSELF. TO THIS DAY, THE PAIN IN MY BUTT HAS NOT LET UP FROM THIS. HE ORDERED A MRI AND LOWER RIGHT PELVIC SCAN OF ME AND FOUND NOTHING EXCEPT I HAVE BURSITIS AND DEEP TISSUE FLUID. I TOLD HIM HE WOULD NOT FIND ANYTHING WHY I'M HURTING SINCE I HAVE READ MANY REPORTS ABOUT THIS. NOW HE WANTS TO DO BIGGER POINT INJECTIONS INTO MY APPEX. WHY DON'T YOU ADMIT THIS MESH SHOULD BE TAKEN OFF THE MARKET? THERE ARE SO MANY OF US WHO ARE SUFFERING NEEDLESS IN THE NAME OF MONEY AND KICKBACKS. I COULD SAY A LOT MORE BUT IT WOULD ONLY AFFECT MY LAWSUIT I'M PLANNING ON FILING AGAINST MY DR ON MALPRACTICE OF ADVERSE AND NEGLECT OF THIS INFO AND ACTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD BARD MARLEX MESH FTL BARD

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other