Description of Event or Problem · 1
I HAD THE ESSURE PROCEDURE FOR PERMANENT BIRTH CONTROL ON (B)(6) 2011. I HAD THE REQUIRED ESSURE "CONFIRMATION TEST" ON (B)(6) 2011. THE RESULTS OF THE HSG WERE EVALUATED BY BOTH A HIGHLY RESPECTED DOCTOR AND THE RADIOLOGIST WHO CONFIRMED THAT BOTH FALLOPIAN TUBES WERE FULLY BLOCKED AND THE PROCEDURE WAS SUCCESSFUL. ACCORDING TO ESSURE LITERATURE, AFTER A SUCCESSFUL CONFIRMATION TEST "...YOU CAN START ENJOYING THE FREEDOM THAT COMES FROM NEVER WORRYING ABOUT UNPLANNED PREGNANCY AGAIN." THIS STATEMENT IS AN OUTRIGHT LIE! IT NEEDS TO BE CHANGED TO SOMETHING LIKE "...999 OUT OF 1000 WOMEN CAN ENJOY THE FREEDOM THAT COMES FROM NEVER WORRYING ABOUT UNPLANNED PREGNANCY AGAIN!" OTHERWISE, THEY ARE DECEIVING 1 OUT OF EVERY 1000 WOMEN! ON (B)(6) 2013, I BEGAN THE START OF WHAT I BELIEVED TO BE MY PERIOD. ON (B)(6) 2013, I WENT TO THE EMERGENCY ROOM WITH SEVERE BLEEDING. IT WAS IN THE EMERGENCY ROOM THAT THE STAFF DISCOVERED THAT I WAS PREGNANT AND MISCARRYING. THEY DID AN ULTRASOUND, DETERMINED THAT THE BABY/FETUS WAS DEAD, AND THE DOCTOR REMOVED THE GESTATIONAL SAC TO STOP THE MAJORITY OF THE BLEEDING. PLEASE UNDERSTAND, THE LOSS OF MY BABY IS DEVASTATING TO ME. I WOULD HAVE DONE ANYTHING TO SAVE THIS LITTLE ONE, BUT IT WAS TOO LATE! THE START OF MY PREVIOUS MENSTRUAL CYCLE WAS (B)(6) 2013, BUT SINCE I HAD BEEN HAVING IRREGULAR PERIODS THIS WAS NOT A CAUSE FOR CONCERN. THE ESSURE LITERATURE AND DOCTOR INFORMATION WAS SO CONVINCING THAT I DID NOT EVEN THINK THAT I COULD EVER AGAIN BECOME PREGNANT. THANKS TO ESSURE, I HAVE NOW SUFFERED THE LOSS OF MY UNBORN BABY, AWAIT A STACK OF EMERGENCY ROOM BILLS, HAVE NO RELIABLE FORM OF BIRTH CONTROL, AND HAVE IMPLANTS INSIDE OF ME THAT PUT ME AT AN INCREASED RISK FOR ECTOPIC PREGNANCY AND MISCARRIAGE. HOWEVER, I CANNOT HAVE THE IMPLANTS REMOVED! I ALSO PAID FOR THIS HIGHER COST PROCEDURE IN 2011 SO THAT I WOULDN'T HAVE TO DEAL WITH WHAT I AM GOING THROUGH RIGHT NOW! I NEED CONCEPTUS TO STAND BEHIND THEIR PRODUCT AND DETERMINED WHY THIS "SUCCESSFUL PROCEDURE" HAS NOW FAILED. I WAS CONVINCED IN 2011 TO HAVE THE ESSURE PROCEDURE SINCE IT WAS THE MOST EFFECTIVE PERMANENT BIRTH CONTROL METHOD. CONCEPTUS AND ESSURE HAVE PUT ME INTO THIS HORRIBLE POSITION AND I NOW NEED THEIR HELP TO MOVE FORWARD! PLEASE DO NOT ALLOW THEM TO IGNORE ME. THE ESSURE MARKETING IS SO CONVINCING AND SIMPLY BLAMES THE FAILURES ON PT AND DOCTOR MISTAKES. HOWEVER, THESE STATEMENTS SERIOUSLY NEED TO BE EVALUATED AS TO WHETHER THEY ARE OVERLY CONVINCING. WHEN A PT, LIKE MYSELF, READS THE FOLLOWING ESSURE STATEMENT, IT GIVES AN INCREDIBLE SINCE OF CONFIDENCE -- ESPECIALLY WHEN THE PROCEDURE IS DONE BY A VERY RESPECTED PHYSICIAN! "...THE ESSURE PROCEDURE IS 99.83% EFFECTIVE. IN FIVE YEARS OF CLINICAL TRIALS, THERE HAVE BEEN NO PREGNANCIES AMONG WOMEN WHO SUCCESSFULLY COMPLETED ALL 3 STEPS OF THE ESSURE PROCEDURE. A FEW PREGNANCIES HAVE BEEN REPORTED AMONG THE HUNDREDS OF THOUSANDS OF WOMEN WHO HAVE COMPLETED THE PROCEDURE SINCE IT BECAME COMMERCIALLY AVAILABLE. MOST OF THOSE PREGNANCIES WERE A RESULT OF NOT HAVING COMPLETED THE PROCEDURE OR NOT FOLLOWING INSTRUCTIONS." I COULD NOT FIND A SINGLE PLACE IN THE ESSURE LITERATURE WHERE THEY LIST THE FAILURES THAT ARE NOT DUE TO PT/DOCTOR MISTAKES OR MISINTERPRETED TEST RESULTS. THEY SIMPLY GROUP THESE AS "UNABLE TO DETERMINE CAUSE". IN THE CASE OF MY PREGNANCY, IT WAS A "TRUE" FAILURE. THE HSG WAS EVALUATED BY A VERY RESPECTED AND THOROUGH DOCTOR AND A RADIOLOGIST BACK IN 2011 AND THIS PREGNANCY OCCURRED AFTER THE HSG WAS CONFIRMED. ESSURE NEEDS TO OWN UP TO THE FACT THAT THEIR IMPLANTS ARE NOT PERFECT (THEY DO FAIL) AND SPECIFICALLY LIST FAILURES SUCH AS THIS AS "TRUE FAILURES" SO AS NOT TO MISLEAD MORE WOMEN! A SIMPLE NOTE STATING THAT "NO FORM OF BIRTH CONTROL SHOULD BE CONSIDERED 100% EFFECTIVE" WHILE THEY SUGAR-COAT THEIR RESULTS IS UNFAIR! I ORIGINALLY TRIED TO SUBMIT THIS ON-LINE, BUT SOME OF THE INFORMATION WAS LOST. I HAVE TRIED TO CONTACT THE FDA VIA PHONE/EMAIL, BUT HAVE NOT RECEIVED ANY RESPONSE. THIS FORM SHOULD REPLACE MY FAILED ATTEMPT TO FILE ON-LINE. THANKS, (B)(6).