5 Safety

5 Safety

This section describes safety outcomes from the published literature that the committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the interventional procedure overview.

5.1 Intraoperative urethral or bladder perforation was reported in 3% to 17% of patients in a systematic review of 8 studies. Haematoma within 30 days of the procedure (first implantation) was reported in 1 patient in a case series of 52 patients; this was treated by deflation of the balloons.

5.2 Urethral erosion was reported in 2% to 15% of patients and cutaneous erosion of the port was reported in 3% to 8% of patients, during the first year of follow‑up, in the systematic review of 8 studies. Balloon migration during the first year was reported in 7% to 18% of patients in the same study and balloon dysfunction during the first year was reported in 0.6% to 6% of patients.

5.3 Device infection during the first year was reported in 0.6% to 9% of patients in the systematic review of 8 studies. Urinary tract infection was reported in 2% of patients in a case series of 162 patients.

5.4 Dysuria or acute urinary retention was reported in 2% to 7% of patients in the systematic review of 8 studies. De novo urgency during the first year of follow‑up was reported in 11% of patients in 1 study included in the systematic review of 8 studies.

5.5 The device was explanted in 18% (28/153) of patients during the first year of follow‑up in the case series of 162 patients. Of these, 50% (14/28) were reimplanted within 12 months. Reasons for explantation included port erosion, balloon migration, balloon erosion, worsening incontinence, pain, device failure, infection and port migration. Balloons were removed in 21% (12/57) of patients (3 bilateral and 9 unilateral) in a case series of 57 patients.

5.6 In addition to safety outcomes reported in the literature, specialist advisers are asked about anecdotal adverse events (events which they have heard about) and about theoretical adverse events (events which they think might possibly occur, even if they have never done so). For this procedure, specialist advisers did not describe any anecdotal adverse events. They considered that the following were theoretical adverse events: urethrovaginal fistula formation, urethral stricture, vaginal erosion, pelvic or genital pain, dyspareunia, development of overactive bladder, and urethral stenosis. One adviser noted that the procedure may make established techniques (as a secondary procedure) more technically difficult.

  • National Institute for Health and Care Excellence (NICE)