Description of Event or Problem · 1
RPTR WRITES: "MY STORY IS REALLY LIKE A NIGHTMARE FOR 2 YEARS, SINCE I HAD AN OPEN HEART SURGERY" IN ANOTHER COUNTRY. "I ONLY HAD A CONNECTION BETWEEN THE TWO EARS OF MY HEART: IT IS CALLED A CIA IN FOREIGN COUNTRY. THE SURGERY SHOULD HAVE BEEN VERY EASY." THE SURGEON WHO DID THE SURGERY HAS USED AN AMERICAN STEREO VIEW ENDOSCOPIC SYSTEM CALLED: THE INTUITIVE SURGICAL SYSTEM. THE MAJOR PROBLEM IS THAT NO ONE TOLD ME I WOULD BE THE FIRST PT IN THE WORLD (KNOWN BY THE MEDIA) AND THE SURGERY WAS DONE WITHOUT TAKING ALL THE VITAL PRECAUTIONS SUCH AS TAKING 3 POUCHES OF MY BLOOD IN ORDER TO TRANSFUSE ME AFTER SUCH AN OPERATION. SO WHEN I LEFT THE HOSP I WAS IN A VERY BAD STATE IN TERMS OF RED CELLS. I SPENT A VERY LONG TIME VERY TIRED. I HAD THE INFO OF THIS EXPERIENCE DONE ON MY BODY THROUGH THE TV AND THE PRESS! 15 DAYS AFTER THE PREMIERE. I FELT MISTREATED AND VERY SAD. UNTIL NOW, THE ONLY BAD LUCK IS NOT KNOWING THAT I HAVE BEEN A HUMAN GUINEA PIG! BUT 5 WEEKS AFTER THE OPERATION I HAD TO GO BACK TO THE HOSP BECAUSE OF A TERRIBLE INFECTION. I STAYED 3 WEEKS UNDER 3 ANTIBIOTICS (VANCOMYCIN, FLAGYL, GENTAMICIN). I LOST 25 POUNDS IN 3 WEEKS, AND I REALLY GOT VERY SCARED. I SPENT SEVERAL BAD MONTHS BACK AT WORK BUT MY HEALTH WAS VERY, VERY BAD. I ALSO HAVE A LARGE LATERAL SCAR UNDER MY BREAST WHEN THE MEDIA HAVE BEEN TOLD THAT THIS NEW FANTASTIC "ROBOT" DOES AN ATRAUMATIC SURGERY: ONLY 3 LITTLE HOLES ON THE STOMACH, QUICK RECOVERY, NO TIREDNESS, NO SIDE EFFECTS, AND BACK TO WORK MUCH FASTER THAN WITH A NORMAL STERNOTOMY. IT IS A LIE! MAYBE IN TEN YEARS TIME, BUT NOT NOW. THE MACHINE IS NOT AT ITS PEAK! YOU MUST DO SOMETHING TO STOP THAT. "IN MY CASE THE EXPERIENCE WITH THE INTUITIVE SURGICAL SYSTEM KEPT ME UNDER ANESTHESIA TOO LONG, AS IT WAS A PREMIERE IN THE WORLD. NORMALLY A CASE LIKE MINE REQUIRES 2 HR 30 MIN OF SURGERY. MINE LASTED MORE THAN 3 TIMES, AND I HAD ANESTHESIA FOR 14 HRS. I STILL FEEL THE SIDE EFFECT OF SUCH A LONG DUMBNESS, LOSS OF MEMORY, FEARS AT NIGHT, NERVE PROBLEMS IN MY TWO HANDS AND FEET, AND ON MY BREAST, SKIN PROBLEMS UNDER IT. BECAUSE I WAS YOUNG AND IN GOOD SHAPE ASIDE FROM MY GENETIC DEFECT, THEY DECIDED TO TAKE MY BODY (AND ALSO BECAUSE THE PERSON WHO WAS SUPPOSED TO HAVE A SURGERY THE DAY I HAD MINE, NEVER GAVE ANY FEEDBACK AFTER THEIR MEETING WITH THE SURGEONS). "I GUESS PT WAS TOLD ABOUT THE EXPERIMENTATION & GOT SCARED. NO ONE WAS THERE FOR THE TV REPORTING, EVERYTHING WAS SET UP...BUT NO MORE PT.... AND I SUDDENLY ARRIVED FOR AN APPOINTMENT.... 'THAT'S THE RIGHT CASE FOR OUR PREMIERE.' IN 2/99 I COLLAPSED. I HAD TO STOP WORKING FOR ONE MONTH, & THEN OUR HEALTH ORGANIZATION - THE SOCIAL SECURITY GAVE ME ONE YEAR OF PART TIME JOB IN MY CO, A BIG AMERICAN GROUP OF DENTAL, MEDICAL AND VETERINARIAN BUSINESSES. MY TEAM GOT THE INFO ABOUT THE FDA APPROVAL GIVEN TO THIS SYSTEM, THEIR LAWYER GOT A COPY OF THE FILE ON THE INTERNET AND I DISCOVERED THAT WHEN THEY DID SURGERIES IN EUROPE, THIS MACHINE WAS NOT APPROVED BY FDA. FDA GAVE THE APPROVAL ONE YEAR AFTER THE HUMAN GUINEA PIGS. AFTER SEARCHING, I FOUND OUT THAT THE ROBOT IS A VERY HEAVY MACHINE (2 TONS5), THAT THERE IS A CABLE BETWEEN THE OPERATOR AND THE PT AND THIS CABLE CANNOT BE DECONTAMINATED AND OF COURSE IMPOSSIBLE TO STERILIZE. (IF I COMPARE WITH THE OTHER ROBOT I HEARD ABOUT: COMPUTER MOTION - ZEUS - WHICH GOT THE APPROVAL IN THE USA FOR SURGERIES ON HUMAN BEINGS, ON LAPAROSCOPIES, AND HEART PROBLEMS IN THE SAME TIME YOU DID NOT GIVE YOUR APPROVAL TO INTUITIVE. SINCE THIS SYSTEM HAS BEEN ON THE MARKET THEY HAVE NEVER HAD ANY INFECTIONS. I HAVE CONTACTED THEM AND THEY ARE VERY OPEN TO GIVING TO THE COURT (I HAVE STARTED A TRIAL AGAINST MY SURGEON) ALL THEIR MEDICAL RECORDS IN TERMS OF SIDE EFFECTS OR INFECTION (THEY HAD NONE). I DO THINK THAT THIS CO IS VERY SERIOUS COMPARED TO INTUITIVE TO WHOM I SENT A LONG LETTER EXPLAINING MY CASE. THEY JUST SAID THEY DON'T FEEL CONCERNED. THERE HAD ALSO BEEN SURGERIES IN MEXICO, LIKE MINE: WHAT HAPPENED TO THE POOR PERSONS? DID FDA EVER RECEIVE ANY RECORDS FROM INTUITIVE AS THEY SHOULD REPORT TO FDA FREQUENTLY WHEN A NEW MACHINE IS ON THE MARKET." RPTR WRITES TO CO: "I AM, UNFORTUNATELY, THE FIRST HUMAN WHO HAD A SURGERY WITH YOUR "ROBOT" (COMPUTER ENHANCED DE VINCI SYSTEM), LAST YEAR. IF I DO DARE TO WRITE YOU THIS LETTER IT IS ONLY BECAUSE I HAVE MET MANY HEALTH PROBLEMS AFTER THE EVENT VERY WELL KNOWN AS "A FIRST TIME IN THE WORLD!!!" AND I STILL HAVE A LOT. FIRST THING YOU MUST KNOW: I WAS NOT AWARE THAT THIS NEW TECHNIQUE WOULD BE USED ON MY BODY - INCREDIBLE BUT TRUE. 5 WEEKS AFTER THE COMPUTER ASSISTED SURGERY I HAD TO GO BACK TO THE SAME HOSP BECAUSE I HAD A BIG INFECTION INSIDE ME! DO YOU KNOW THAT? PRECISION: I ALSO HAVE A LATERAL SCAR UNDER MY BREAST FROM LEFT TO RIGHT. AFTER THE FIRST OPERATION I WAS SENT TO A REST HOME, WHICH SPECIALIZED IN HEART PROBLEMS. FROM THE VERY BEGINNING I HAD HORRIBLE EDEMA OVER MY BREAST. IT WAS VERY PAINFUL WITH A VERY HOT SENSATION, AND A SMALL FEVER. I DEVELOPED THE INFECTION AFTER THE OPERATION, AND ONE MONTH LATER, I WAS LARGELY INFECTED. I FELL IN A BIG HOLE - I COULD NOT WALK - TOO WEAK. I WAS DRIVEN IN A WHEELCHAIR TO THE RESTAURANT, I COULD NOT EAT, AND I COULD NOT START THE PHYSICAL TRAINING FOR MANY DAYS. COMPARED TO ALL MY SICK COLLEAGUES WHO WERE THERE (WITH MUCH MORE SERIOUS PATHOLOGIES LIKE 3 BYPASSES, HEART ATTACKS, VALVES) I WAS IN A REALLY BAD STATE. ALL THE PERSONS AND SECRETARIES, OR NURSES THOUGHT I WAS GOING TO DIE IN FRONT OF EVERYBODY. MY HEART WAS GOING WELL, JUST A LITTLE FAST. BUT ALL THE REST WAS GOING VERY WRONG. EVEN THE STERNOTOMIES LOOKED BETTER THAN ME, NOBODY HAD SUCH PARESTHESIAS IN HANDS AND FEET. I WAS WONDERING WHAT HAPPENED TO ME UNTIL MY SISTER CALLED ME BECAUSE SHE SAW ON TELEVISION THE ANNOUNCEMENT OF THE FIRST ROBOT SURGERY THAT HAPPENED. SO, I WAS THIS PREMIERE! EASY TO CHECK. IT WAS SUCH A SHOCK FOR ME TO HEAR THAT, THAT ALL THE DR'S AND THE PSYCHOLOGIST HAD TO REASSURE ME. B6.