Description of Event or Problem · 1
I WAS IN A CLINICAL TRIAL FOR THE ENDOBARRIER FROM GI DYNAMICS. IT WAS INSERTED IN MY SMALL INTESTINE IN (B)(6) 2014. I WAS INFORMED OF ITS SAFETY BECAUSE THERE WAS NO INCISION INVOLVED. I FELT BAD IMMEDIATELY AND INFORMED THEM. I WAS TOLD PAIN WAS NORMAL. I WENT FOR MY CHECKUPS AS INSTRUCTED. I FOLLOWED THEIR DIET OF 1500 CALORIES PER DAY. THEY TOOK BLOOD WORK ON EVERY VISIT. I STARTED FEELING VERY SICK IN (B)(6) 2014. I THOUGHT I HAD THE FLU. BUT IT GOT WORSE OVER THE NEXT TWO WEEKS. I HAD FEVER AND CHILLS AND MY ABDOMEN WAS HURTING. ON (B)(6), 2015 I FELT LIKE I WAS DYING. I KNEW IT COULDN'T BE THE FLU. MY WIFE CALLED MY DOCTOR AND DR (B)(6) WHO WAS IN CHARGE OF THE CLINICAL TRIAL. DR (B)(6) SAID "I HOPE ITS NOT A LIVER ABSCESS." THIS WOULD BE THE FIRST TIME WE HAD EVER HEARD OF A LIVER ABSCESS. I WENT ON TO MY REGULAR DOCTORS APPOINTMENT ON (B)(6). I COULD NOT BARE TO TOUCH MY ABDOMEN AND MY WHITE BLOOD CELL COUNT WAS VERY HIGH. I WAS TOLD TO CONTACT THE CLINICAL TRIAL AND DR (B)(6), WE EMAILED MY BLOOD WORK TO HER. SHE FINALLY CALLED BACK LATE THAT EVENING AND TOLD ME I SHOULD COME TO THE EMERGENCY ROOM. WE DROVE THE 1 1/2 DRIVE THE NEXT MORNING ON (B)(6). WHEN I GOT THERE MY WHITE BLOOD CELL COUNT WAS 15.5 MY TEMPERATURE WAS 103. THEY DID ULTRASOUNDS AND CT SCANS. I HAD A HEPATIC ABCESS THE SIZE OF A FIST ON MY LIVER. IT WAS 7.5 X 6.1 CENTIMETERS. I ALSO HAD SEPSIS. THEY HOSPITALIZED ME IMMEDIATELY. THE NEXT MORNING (B)(6) THE ENDOBARRIER WAS REMOVED. THEN LATER A DRAIN WAS PUT INTO MY LIVER. THEY PUMPED TWO BOTTLES OF INFECTION FROM MY ABDOMEN. I WAS PUT ON ANTIBIOTICS. IT WOULD TAKE NEARLY 5 DAYS FOR THE BACTERIA TO GROW IN A PETRIE DISH. I HAD STREP ANGINOSUS. I THEN WAS REFERRED TO THE INFECTIOUS DISEASE DOCTOR. I WAS RELEASED ON (B)(6) WITH THE DRAIN TUBE AND A PICC LINE. I WOULD HAVE TO HAVE MY WIFE GIVE ME ANTIBIOTICS DAILY (SASH) FOR 6 WEEKS. I HAD A NURSE EVERY WEEK FOR 6 WEEKS. I FOUND OUT ON (B)(6) THAT I WAS THE 4TH CLINICAL TRIAL PATIENT TO GET A LIVER ABSCESS. NO ONE EVER INFORMED ME THAT THIS WAS AN ISSUE. I SHOULD HAVE BEEN ADVISED AFTER THE FIRST. THEN MAYBE I WOULD HAVE HAD SOME IDEA OF WHAT WAS HAPPENING TO ME AND I COULD HAVE CAUGHT IT EARLIER. WHY DID THEY NOT CHECK MY BLOOD WORK IF THIS WAS A KNOW ISSUE? I WAS NOT FORMALLY INFORMED UNTIL (B)(6) 2015 ABOUT THIS ADVERSE EVENT. THIS WAS NEARLY 2 MONTHS AFTER I NEARLY DIED FROM IT. IN (B)(6) 2015 I WENT BACK FOR A CLINICAL TRIAL APPOINTMENT AND WAS ASKED TO SIGN A CONSENT FROM (B)(6) REGARDING THE LIVER ABSCESS. I REFUSED! THEY HAD NOT PAID MY BILLS AND I ALMOST DIED. I DIDN'T SEE THE NEED BECAUSE I NO LONGER HAD THE IMPLANT. WHEN I REFUSED TO SIGN THEY TOLD ME THEY COULD NO LONGER HELP ME. I HAD TO FIGHT TO GET THEM TO PAY MY MEDICAL BILLS. MY PERSONAL INSURANCE WAS BILLED. THE FDA HALTED THE CLINICAL TRIAL AFTER I GOT SICK. THEN 3 MORE PEOPLE GOT AN ABSCESS. THE CLINICAL TRIAL WAS SHUT DOWN AND EVERYONE EXPLANTED IN (B)(6) 2015. NOW I FIND OUT THAT THEY ARE ATTEMPTING TO START A NEW TRIAL. I WANT MY INFORMATION HEARD. HOW I WAS NOT INFORMED OF THE ADVERSE EVENT, HOW I WAS FIRED FROM THE TRIAL FOR REFUSING TO SIGN A CONSENT FROM THE ADVERSE EVENTS. AND HOW I HAD TO FIGHT FOR THEM TO PAY MY MEDICAL BILLS. I THOUGHT I COULD HELP A LOT OF PEOPLE WITH DIABETES. I WAS TOLD HOW SAFE IT WAS. IT ALMOST KILLED ME. AND PROBABLY WOULD HAVE IF MY WIFE HAD NOT BEEN SO DILIGENT WITH MY CARE.