Description of Event or Problem · 1
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THE PATIENT WAS HEMORRHAGING BLOOD DURING A PROCEDURE USING A MESH DEVICE (EXACT TYPE UNKNOWN) ON (B)(6) 2006. THE MESH WAS IMPLANTED SUCCESSFULLY, HOWEVER, THE PATIENT BEGAN EXPERIENCING PAIN IMMEDIATELY FOLLOWING THE PROCEDURE. REPORTEDLY, THE PATIENT ALSO UNDERWENT A HYSTERECTOMY; IT IS UNKNOWN WHEN THIS OCCURRED. THE PATIENT HAS REPORTEDLY EXHIBITED VAGINAL BLEEDING SINCE THE IMPLANTATION PROCEDURE, AND ON (B)(6) 2011, UNDERWENT A PROCEDURE TO TREAT THE BLEEDING. DURING THIS PROCEDURE, THE PHYSICIAN DISCOVERED THAT THE PATIENT HAD SOME MESH EROSION AND SOME "HANGING" MESH. THE PHYSICIAN TREATED THE MESH EROSION (UNKNOWN METHOD), AND ATTEMPTED TO TREAT AS MUCH OF THE PATIENT'S VAGINAL BLEEDING AS POSSIBLE VIA CAUTERIZATION. FOLLOWING THIS PROCEDURE, THE PATIENT REPORTEDLY CONTINUED TO EXPERIENCE VAGINAL BLEEDING AND PAIN. THE PATIENT THEN VISITED ANOTHER PHYSICIAN, WHO OPINED THAT ANOTHER TWO TO THREE PROCEDURES WOULD BE NECESSARY IN ORDER TO TREAT THE PATIENT'S COMPLICATIONS. THIS PHYSICIAN SCHEDULED A MESH REMOVAL PROCEDURE WITH THE PATIENT FOR (B)(6) 2011. THE PATIENT REPORTEDLY HAS HAD HER VAGINAL WALL "REBUILT DUE TO THE MESH." ALL OTHER INFORMATION, INCLUDING THE PATIENT'S CURRENT CONDITION, IS UNKNOWN. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.