THIS MDR IS BEING FILED AS EXPOSED IMPLANT MATERIAL. IT WAS REPORTED THAT FOLLOWING AN INITIAL TREATMENT WITH A URETHRAL BULKING IMPLANT MATERIAL IN 2006, THE PT EXPERIENCED FREQUENT URINARY TRACT INFECTIONS AND URETHRAL PAIN. A CYSTOSCOPY WAS PERFORMED THE NEXT DAY AND THE DR OBSERVED EXPOSED IMPLANT MATERIAL AND DESCRIBED THE EXPOSED AREA AS BEING SMALL IN SIZE, MEASURING 3 TO 4MM IN SIZE. NO TREATMENT WAS GIVEN. PT WILL BE OBSERVED. PT REMAINS INCONTINENT. INJECTION DETAILS ARE AS FOLLOWS. THE DR STATED THAT THIS WAS A DIFFICULT ANATOMY OR PROCEDURE. THERE WAS SOME EXTRUSION OF IMPLANT MATERIAL INTO THE BLADDER. TREATMENT VOLUME WAS 1.5ML ON RIGHT AND 1.0ML ON LEFT SIDE, TRANSURETHRAL APPROACH, 1 CC OVER 1 MIN RATE OF INJECTION, HELD FOR 1 MIN, 2CM DISTAL TO THE BLADDER NECK, AND NEEDLE EMBEDDED TO THE SHOULDER.
N
Patient 1
THE LOT NUMBER IS UNK THEREFORE, NO REVIEW OF THE DEVICE HISTORY RECORD COULD BE PERFORMED. THE INSTRUCTIONS FOR USE STATES THAT THE DEVICE FORMS A COHESIVE, SPONGY MASS THAT SERVES TO BULK SURROUNDING TISSUE AND IS NOT SUBJECT TO ABSORPTION OR ENYMATIC BREAKDOWN WITHIN THE BODY. THE LOW VISCOSITY OF THE IMPLANT SOLUTION AND THE COHESIVE MASS OF THE RESULTING IMPLANT REQUIRE SPECIFIC ATTENTION TO THE INJECTION SITE, NEEDLE ORIENTATION, DEPTH OF NEEDLE PLACEMENT, RATE OF INJECTION, AND INJECTION VOLUME, IN ORDER TO ACHIEVE THE HIGHEST RATE OF SUCCESS. DURING THE COURSE OF THE CLINICAL INVESTIGATION, 28 SUBJECTS RECEIVING THE URETHRAL IMPLANT TREATMENT EXPERIENCED EXPOSED BULKING MATERIAL IN THE URETHRAL MUCOSA. EXPOSED MATERIAL WAS ASSOCIATED WITH SHALLOW PLACEMENT AND INJECTION PROXIMAL TO THE BLADDER NECK. OVER TIME, THE URETHRA HEALED SPONTANEOUSLY AS THE MUCOSAL SURFACE RE-EPITHELIALIZED. A PHYSICIAN MAY CHOOSE TO REMOVE EXPOSED MATERIAL CYSTOSCOPICALLY WITH GRASPERS OR FORCEPS TO FACILITATE HEALING. THE IFU INSTRUCTS THE USER: THE UNIQUE CHARACTERISTICS OF THE BULKING MATERIAL REQUIRE INJECTION TECHNIQUES THAT MAY DIFFER SLIGHTLY FROM TECHNIQUES EMPLOYED WITH ALTERNATIVE BULKING AGENTS. CONTRAINDICATIONS INCLUDE PTS WITH THE FOLLOWING CONDITIONS; ACUTE CYSTITIS, URETHRITIS, OTHER ACUTE OR CHRONIC GENITOURINARY TRACT INFECTIONS, OR FRAGILE URETHRAL MUCOSAL LINING.