IT WAS REPORTED THAT FOLLOWING RETREATMENT IN 2006 WITH A URETHRAL BULKING IMPLANT MATERIAL, A PATIENT EXPERIENCED URINARY RETENTION. PATIENT WAS TAUGHT TO SELF CATHETERIZE. RESOLUTION WAS NOTED AFTER 35 DAYS. THE PATIENT'S STATUS WAS DESCRIBED AS MARKED IMPROVED CONTINENCE WITH USE OF IMIPRAMINE. TREATMENT DETAILS ARE AS FOLLOWS: TREATMENT VOLUME WAS 2.0 ML., TRANSURETHRAL APPROACH, RATE OF INJECTION WAS 60 SECONDS, NEEDLE HELD AT INJECTION SITE FOR 90 SECONDS, POSITION OF INJECTION WAS 2CM DISTAL, NEEDLE WAS IMBEDDEDTO SHOULDER, NO BLANCHING, BLEBING OR COAPTATION NOTED. PHYSICIAN FELT PATIENT WAS A GOOD CANDIDATE FOR TEGRESS, URETHRAL TISSUE APPEARED HEALTHY, NO PALE, ATROPHIC OR POORLY VASCULARIZED MUCOSAL LINING NOTED, TISSUE ELASTICITY WAS NORMAL. THE INITIAL TREATMENT WAS PERFORMED ONE DAY BEFORE RE TREATMENT DATE.
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Patient 1
A REVIEW OF THE DEVICE HISTORY RECORD FOR THE REPORTED LOT NUMBER FOND NOTHING THAT WOULD CAUSE OR CONTRIBUTE TO THE REPORTED PROBLEM. 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 ENZYMATIC BREAKDOWN WITHIN THE BODY. POSSIBLE CAUSES OF RETENTION MAY INCLUDE EXCESSIVE IMPLANT VOLUME AND TISSUE TRAUMA FROM CYSTOSCOPY (SWELLING). TREATMENT RELATED ADVERSE EVENTS REPORTED DURING CLINICAL STUDIES INCLUDED DELAYED VOIDING. THIS CONDITION OCCURRED IN 18% OF THE 174 STUDY PATIENTS. MOST TREATMENT RELATED ADVERSE EVENTS OCCURRED WITHIN 24 HOURS OF TREATMENT AND SUBSEQUENTLY RESOLVED WITHIN 30 DAYS. THE IFU INSTRUCTS THE USER: THE UNIQUE CHARACTERISTICS OF THE BULKING MATERIAL REQUIRE INJECTION TECHNIQUES THAT MAY DIFFER SLIGHTLY FORM TECHNIQUES EMPLOYED WITH ALTERNATIVE BULKING AGENTS. THE LOW VISCOSITY OF THE BULKING 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 INJECTED VOLUME, IN ORDER TO ACHIEVE THE HIGHEST RATE OF SUCCESS.