Description of Event or Problem · 1
HI. I AM A (B)(6) SINGLE MOTHER OF 6. AGES (B)(6). ALL DELIVERED VAGINALLY. I BEGAN SUFFERING FROM URINARY INCONTINENCE AND FECAL INCONTINENCE IN 2009. I WAS DIAGNOSED WITH PELVIC ORGAN PROLAPSE, RECTOCELE AND CYSTOCELE, WITH MY PELVIC FLOOR SEVERELY TORN, NEEDING TO BE REPAIRED. I TRIED SEVERAL NON-SURGICAL DEVICES TO DEAL WITH THE PROBLEM, BUT NOTHING WORKED. MY DOCTOR TOLD ME THE ¿GOLD STANDARD TREATMENT¿ WAS TO HAVE A MESH SLING IMPLANTED USING THE DAVINCI ROBOT. HE HAD BEEN TRAINED AND DONE JUST A FEW, BUT WAS CONFIDENT THAT THIS WOULD TAKE CARE OF MY PROBLEMS. I HAD AN AMS INTELPRO-H- LPP Y-SLING, A VAGINAL MESH, SURGICALLY PLACED VIA THE DAVINCI ROBOT ABDOMINAL TO TREAT PELVIC ORGAN PROLAPSE ON (B)(6) 2010. I KNOW YOU HAVE HEARD ALL THE NIGHTMARES ASSOCIATED WITH TRANSVAGINAL MESH PLACEMENT, BUT YOUR FDA SAFETY COMMUNICATION: UPDATE ON SERIOUS COMPLICATIONS ASSOCIATED WITH TRANSVAGINAL PLACEMENT OF SURGICAL MESH FOR PELVIC ORGAN PROLAPSE, DATED (B)(6) 2011, FAILS HORRIBLY TO MENTION THAT THE ABDOMINAL APPROACH TO PLACING THE MESH HAS ALL THE SAME COMPLICATIONS AND LIFE-ALTERING EFFECTS. IN YOUR SAFETY WARNING, YOU LIST A LARGE NUMBER OF COMPLICATIONS. I HAVE HAD ALL THOSE COMPLICATIONS AND MORE. THE MANNER IN WHICH THE MESH IS PLACED REALLY HAS NO BEARING IN THESE CASES. IT IS THE MESH ITSELF THAT IS DEFECTIVE AND HARMS MOST WOMEN WHO HAVE IT IMPLANTED AND NOW I STRUGGLE TO GET ANY SORT OF REIMBURSEMENT FOR MY PAIN, SUFFERING, FAMILY, EMPLOYMENT, AND FINANCIAL LOSS. THE FDA HAS ONE SENTENCE STATING ¿MESH PLACED ABDOMINALLY FOR POP REPAIR APPEARS TO RESULT IN LOWER RATES OF MESH COMPLICATIONS COMPARED TO TRANSVAGINAL POP SURGERY WITH MESH¿. HAS THE FDA DONE ANY F/U TO THIS REPORT? I, MYSELF, HAVE SUFFERED AN INCREDIBLE AMOUNT OF PAIN, MULTIPLE SURGERIES, MESH EROSION, MESH ADHERING TO MY BLADDER AND BOWEL CAUSING LEAKS AND BOWEL OBSTRUCTIONS THAT ALMOST TOOK MY LIFE. I HAVE HAD SEVERAL SURGERIES TO CUT AWAY THE APEX OF MY VAGINA TO TRY TO REMOVE PIECES OF THE MESH PROTRUDING INTO MY VAGINA. I HAVE LOST MY LONG TERM RELATIONSHIP, DUE TO THE STRESS OF MANY SURGERIES, LENGTHY HOSPITAL STAYS, LENGTHY BED-REST, INABILITY TO HAVE SEXUAL INTERCOURSE, AND THE SUCH. I HAVE LOST MY HOME, MY CAR, 3 JOBS, AND FINALLY MY CHILDREN, AGES (B)(6) FOR AN ENTIRE YR WHEN I COULD NO LONGER CARE FOR THEM DUE TO SEVERE COMPLICATIONS FROM THE MESH AND FAILING HEALTH. I HAVE HAD SURGERY TO HAVE THE MESH REMOVED, ONLY TO FIND 6 WEEKS LATER THERE WAS MORE MESH EXPOSURE, PENETRATING THROUGH THE VAGINAL WALLS. NOW, I HAVE TO GO IN EVERY FEW WEEKS TO HAVE MESH CLIPPED OFF. NOT REMOVED; JUST CLIPPED. UNTIL MORE PROTRUDES AND THEY CAN CLIP MORE. THERE IS NO DIAGNOSTIC TOOL TO FIND THE MESH. SO, IT JUST FREELY BREAKS APART AND FINDS A HOME IN ONE OF MY ORGANS. I WILL NEVER BE RID OF THE MESH. I CAN NO LONGER HAVE SEXUAL INTERCOURSE. I AM (B)(6). I AM SINGLE. I WAS TRULY HOPING TO FIND AND KEEP A RELATIONSHIP. NOW, IT APPEARS I AM FORCED TO BE ALONE AND LONELY. I AM NOT ABLE TO HAVE A NORMAL, HEALTHY RELATIONSHIP, SINCE THAT INCLUDES A NORMAL, HEALTHY SEX-LIFE. THE EXACT DIAGNOSIS IN WHICH I HAD TO HAVE THE MESH IMPLANTED IN THE FIRST PLACE, IS NOW BACK. THE MESH DID NOT SOLVE MY INCONTINENCE PROBLEMS AND EVEN MADE IT WORSE. AGAIN, I¿M (B)(6). I SHOULD NOT HAVE TO WORRY ABOUT FECAL OR URINARY INCONTINENCE. I CAN NOT LEAVE MY HOME UNTIL AFTER I HAVE A BOWEL MOVEMENT, BECAUSE IF I NEED TO HAVE ONE AND AM NOT NEAR A BATHROOM, IT WILL LEAK OUT ALL OVER ME. DO YOU HAVE ANY IDEA WHAT THAT IS LIKE? HAVING TO BUY DEPENDS AT (B)(6)? WHAT MAN WOULD WANT A WOMAN WHO NEEDS INCONTINENCE SUPPLIES AT (B)(6) AND CAN¿T HAVE SEX AND IS ALWAYS HAVING SURGERY? TWICE NOW, I HAVE BEEN RUSHED TO THE HOSPITAL, HEMORRHAGING BADLY AND RUSHED INTO SURGERY. ON THE 3RD DAY AFTER A SURGERY, ON (B)(6) 2011, I WAS TAKEN BY AMBULANCE TO THE HOSPITAL FOR A VERY PAINFUL, SEVERELY DISTENDED ABDOMEN, ONLY TO FIND OUT THROUGH CT SCAN, THAT I HAD BOWEL FLUIDS LEAKING INTO MY ABDOMEN AS WELL AS HEMORRHAGING INTO MY ABDOMEN. THAT NIGHT, I WAS TOLD TO SAY GOODBYE TO MY NOW EX-BOYFRIEND AND CHILDREN. MY DOCTOR STOOD IN MY HOSPITAL ROOM WITH TEARS RUNNING DOWN HIS EYES. HE MAY ACTUALLY LOSE HIS PT, DUE TO MESH COMPLICATIONS. BEFORE (B)(6) 2010, I WAS A VERY HEALTHY, VERY HAPPY, VERY ACTIVE MEMBER OF SOCIETY AND THE SOLE PROVIDER FOR MY CHILDREN. I HAD A HOME, A CAR, A SAVINGS ACCOUNT, FRIENDS, A STRONG LONG-TERM RELATIONSHIP WITH A MAN I TRULY LOVED, AND 3 OF MY CHILDREN, STILL MINORS, LIVING AT HOME. BY (B)(6) 2011, I HAD NOTHING. I LOST IT ALL, INCLUDING MY CHILDREN AND IN (B)(6) THE LOVE OF MY LIFE DECIDED HE COULD NO LONGER BE HAPPY WITH ME. IT WAS ALL TOO MUCH FOR HIM. I LOST IT ALL. MY POINT OF THIS: IT DOES NOT MATTER HOW THE MESH IS IMPLANTED, TRANSVAGINALLY OR ABDOMINALLY. IT IS THE MESH THAT IS DEFECTIVE AND BECAUSE THE FDA ONLY PUT OUT A SAFETY WARNING ON TRANSVAGINAL PLACEMENT, THERE ARE HUNDREDS OF WOMEN WITH THE SAME PROBLEMS I HAVE, WHO HAD THEIRS PLACED ABDOMINALLY, WHO CAN¿T GET ANY TYPE OF REIMBURSEMENT FROM THE MFR, BECAUSE THE FDA ONLY SAID IT WAS DUE TO TRANSVAGINAL PLACEMENT. SO, YOU HAVE GIVEN THE MFR, AMS IN MY CASE, AN OUT. A LOOP HOLE. A MEANS IN WHICH TO IGNORE ME AND MY CASE AND THEY ARE INSISTENT THAT SINCE THE FDA NEVER WARNED OF COMPLICATIONS WITH MESH PLACED THE WAY MINE WAS, THAT IT ISN¿T SOMETHING THEY WILL LOOK AT. MY LIFE IS FOREVER CHANGED AND I AM DISABLED. I CAN¿T KEEP A JOB DUE TO NEEDING SO MANY ON-GOING SURGERIES, I STRUGGLE WITH PAIN IN MY ABDOMEN EVERYDAY, I HAVE MULTIPLE SCARS AND MASSES ON MY ABDOMEN. I CAN¿T HAVE A RELATIONSHIP WITH A MAN. I HAVE URINARY AND FECAL INCONTINENCE, I STRUGGLE EVERYDAY WITH FINANCES, AND I AM SURE, ONE DAY, THIS MESH WILL FINALLY KILL ME. IT HAS ALREADY TRIED TO TWICE. AGAIN¿ I AM (B)(6). PLEASE, TELL ME WHO TO TALK TO. I WANT TO FIND OUT WHY NOTHING HAS BEEN SAID ABOUT¿