Description of Event or Problem · 0
I HAD A SPINOLOGY, INC - OPTILIF AND OPTIMESH PROCEDURE WITH THEIR NEW IDE INVEST "OPTIMESH," WHICH FAILED APPROXIMATELY 4 DAYS AFTER IT WAS INSERTED BETWEEN MY 4/5 VERTEBRA. IT WAS ONLY THE APPROX. 30TH USE OR PROCEDURE USE OF THE OPTIMESH BY MY DOCTOR. I WENT INTO EXTREME PAIN BECAUSE THE BONE GRAFT MATERIAL BLEW OUT INTO MY NERVE ROOTS WHEN THE MESH BLEW A HOLE. IT WAS REQUIRED A RE-SURGERY. THE RE-SURGERY HAS YET TO STOP, FOR THE FIRST TIME IN MY LIFE, A TOTAL SURROUND OF MY LEFT LEG, NERVE PAIN DOWN THE INSIDE OF MY LEG, NERVE "BURNING" SENSATIONS FROM THE KNEE DOWN, CONSTANT GROIN PULL CHARLEY HORSE PAIN, AND RECENTLY BULLET-LIKE RANDOM HOT KNIFE NERVE PAINS SPASM INTO MY FOOT ALMOST LIKE A POWERFUL ELECTRIC SHOCKS THAT I COULD NOT STOP THE OUTBURST SCREAMS ON JAN 24. MY DOCTOR TALKED TO SOMEONE AT THE SPINEOLOGY RIGHT AFTER THE FIRST SURGERY AND THE OPTIMESH FAILURE, AND HE TOLD ME THAT SPINEOLOGY SAID THIS NEW "OPTIMESH" MESH FAILS BUT ONCE IN A THOUSAND. IRONICALLY HE TOLD ME, HE HAD ONLY USED IT APPROX. 30+/- TIMES. ONCE IT WAS REALIZED WHAT HAPPENED AFTER FOUR WEEKS I HAD A CATS SCAN AND MRI AND MY DOCTOR SENT ME TO AN ENDOSCOPIC SURGEON TO SEE IF HE COULD GET AT AND CLEAN OUT THE MESH AND GRAFTING MATERIAL INSIDE WITH THE LEAST AMOUNT OF PHYSICAL TRAUMA. THAT DOCTOR COULD NOT. MY DOCTOR HAD TO GO BACK IN AND CUT AWAY SOME OF THE LEFT TRANSVERSE PROCESS BONE OF THE SPINAL VERTEBRA AND TRY AND GET OUT THE GRAFTING AND MESH MATERIAL, SLIDE IN A NEW DIFFERENT METAL LIFT DEVICE AFTER REMOVING THE SCREWS AND PINS STABILIZING THE LEFT SIDE OF THE VERTEBRAS, AND TO REINSERT NEW GRAFTING MATERIAL AS WELL AS RE-INSERT THE SCREWS AND PINS. I STARTED, NOW, A MUCH HARDER AND LONGER RECOVERY PROCESS. TWO WEEKS AFTER THE SECOND OPERATION ON FOLLOW-UP, IT WAS DISCOVERED A SMALL PORTION OF THE ORIGINAL BLOWN-OUT GRAFTING MATERIAL WAS STILL AFFECTING THE NERVE ROOTS. IT WAS SAID BY THE ENDOSCOPIC CONSULTATION DOCTOR TO BE IN A HARD-TO-GET AREA. MY DOCTOR PRESENTED ON THE TWO WEEK FOLLOW UP OF THE SECOND SURGERY THAT THE SECOND SURGERY HAD NOT REMOVED ALL OF THE FIRST GRAFTING MATERIAL FROM THE FAILED MESH. I HAVE BEEN TOLD MY BODY WILL ABSORB IT EVENTUALLY, AND THE PAIN WILL STOP EVENTUALLY, HOW LONG THAT WILL TAKE, IF EVER, IS WHAT I AM MOST CONCERNED. AT THE END OF THAT 2ND SURGERY TWO WEEK FOLLOW UP SESSION WITH MY DOCTOR, HE TOLD ME THE ENDOSCOPIC DOCTOR HAD "THREE OTHER SUCH CASES" LIKE MINE OF THIS MESH FAILING. THIS IS IN THE (B)(6) AREA. I HAVE FILED AN FDA REPORT, I THINK, OF THE FAILURE. BEFORE AUTHORIZING THE SURGERY, I HAD PRE-FIRST SURGERY REVIEWED SPINOLOGY'S WEB PAGE, WHICH DID NOT MENTION ONLY ONE IN A THOUSAND DATA AS THE FAILURE RATE. I COULD NOT FIND ON THE CDC AND FDA GOVERNMENT WEBSITES ANY REAL DATA AS YOU CAN ON THE VAERS [VACCINE ADVERSE EVENT REPORTING SYSTEM], JUST THE ADMISSION BY MY DOCTOR OF WHAT HE WAS TOLD BY SPINEOLOGY, HIS OWN EXPERIENCE, AND WHAT HE TOLD ME ABOUT THE THREE OTHER POSSIBLE FAILURES FROM THE SPINAL ENDOSCOPIC REFERRED DOCTOR IN (B)(6) AREA HAD TOLD HIM. THAT DOCTOR APPEARED TO ME, AFTER HIS CONSULTATION PRE-SECOND SURGERY, WAS "MR. FIX IT" FOR THE TYPES OF NEAR NERVE PROCEDURES THAT OTHER DOCTORS LIKE MINE SEND THEIR PATIENTS TO LOOK AND SEE IF ENDOSCOPIC REENTRY AND REMOVAL IS POSSIBLE AND BEST PRACTICE. WHY DOCTORS ARE NOT LEGALLY REQUIRED TO REPORT PROBLEMS LIKE MINE IMMEDIATELY TO THE FDA IS A DISTURBING DISCOVERY. EVEN CAR AND AIRCRAFT PART FAILURES REQUIRE REPORTING. NO REAL PATIENT DATA REPORTING AND MAYBE OFFICIAL FEEDBACK RESULTS TO MAKE AN INFORMED DECISION WERE FOUND ON SEARCHING THE PRODUCT NAMES, AND THE COMPANY. I HAVE SINCE DISCOVERED THAT ONLY 102 SUBJECTS IN A SHORT DATA STUDY, TWO YEARS, WERE USED TO GET, LIKE THE COVID-19 VACCINE, AN "IDE" EXEMPTION PROCESS THAT ALLOWED, IN WHAT APPEARS TO BE, THESE DEFECTIVE NEW MESH PROCEDURES, TO MOVE FORWARD INTO THE PUBLIC DOMAIN. (B)(6). I THOUGHT HIPA LAWS WOULD BE BINDING ON THE FDA AS WELL AS ANY OTHER ENTITY; "IN THE CASE OF A SERIOUS ADVERSE EVENT OR HEALTH HAZARD, FDA MAY PROVIDE NAME, ADDRESS AND PHONE NUMBER OF THE REPORTER DENOTED IN THE NAME FIELD TO THE MANUFACTURER OF THE SUSPECT PRODUCT. PROVIDING YOUR IDENTITY ALLOWS THE MANUFACTURER TO FOLLOW-UP AND INVESTIGATE THE COMPLAINT (I.E. COLLECT SAMPLES) BY SEEKING ADDITIONAL INFORMATION FROM THE REPORTER. CHECKING THIS BOX COULD DELAY FOLLOW-UP ON YOUR COMPLAINT. IF YOU DO NOT WANT YOUR IDENTITY RELEASED TO THE MANUFACTURER, PLEASE CHECK THIS BOX." ** NOTE; IF YOU HAD A LEGAL REQUIREMENT FOR DOCTORS TO REPORT FAILURES YOU WOULD HAVE EXPERT INFORMATION IMMEDIATELY. SOMETHING I WILL RECOMMEND TO THE TRUMP ADMINISTRATION AND MY CONGRESSIONAL LEADERS FROM BOTH STATES I PAY TAXES IN.