The usual complications reported as the result of urethrotomy and/or dilatation can also be considered as potential complications for UroLume Prosthesis placement in the bulbar urethra or external sphincter. Other complications which may occur:

1. Infection could occur at the prosthesis site.
2. Prosthesis placement in the external sphincter will render the patient incontinent.
3. Removal of the prosthesis for any reason after epithelial ingrowth could result in significant trauma to the urethra. After epithelial tissue has grown over the prosthesis, it must be resected before the prosthesis is removed.
4. Longitudinal compression of the prosthesis by instrumentation could cause trauma to the urethra or dislodge the prosthesis.
5. Encrustation of the prosthesis may occur on wires that do not become covered by epithelium.
6. The prosthesis may migrate and/or shorten, resulting in incomplete coverage of the stricture or external sphincter mechanism, or prostatic urethra.
7. Hyperplastic ingrowth may obstruct the passage of urine.

Additional warnings for bulbar urethral stricture:

1. Stricture patients should be advised to expect mild discomfort, postmicturition dirbbling, urgency, nocturia or haematuria during the first few weeks after prosthesis placement. In most cases these symptoms resolve spontaneously.

Additional warnings for DESD:

1. DESD patients should not engage in rehabilitation or physical therapy for three weeks post-procedure.
2. Care must be taken in moving the DESD patient to ensure that pressure is not placed on the prosthesis prior to epithelisation.
3. The DESD patient must follow bowel evacuation programs carefully.
4. The use of the prosthesis in patients who have had previous external or internal gamma radiation therapy for prostate or proximal urethral cancer should be evaluated carefully, due to complications that may be caused by tissue damaged by irradiation.

Additional warnings for BPH:

1. The use of the prosthesis in patients who have had previous external or internal gamma radiation therapy for prostate or proximal urethral cancer should be evaluated carefully, due to complications that may be caused by tissue damaged by irradiation.
2. Sexual function may be affected. Pain with intercourse has been reported.
3. Patients should be advised to expect haematuria during the first few weeks after prosthesis placement.