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
The neurostimulator device was removed in 14% (4 of 28) of patients in a case series of 40 patients: 2 because of infection, 1 because of pain and 1 because of the need for MRI. In the same study, neurostimulator revision was necessary in 21% (6 of 28) of patients because of battery expiry or device malfunction in 4 patients and infection in 2 patients. Device removal because of infection was reported in 2% (2 of 93) of patients in a case series of 93 patients. There were 63 surgical revisions in a case series of 60 patients during a total of 2878 months of sacral nerve stimulation. Device removal was reported in 4% of patients (actual numbers not reported) treated by sacral nerve stimulation at 18‑month follow‑up in a randomised controlled trial of 51 patients.
5.2
Infection was reported in 4% of patients in a systematic review of 14 articles, including a total of 1239 patients (actual numbers not reported). Infection was reported in 2% (2 of 93) of patients in the case series of 93 patients: both were successfully treated with antibiotics.
5.3
Lead migration was reported in 5% of patients in the systematic review of 14 articles, including a total of 1239 patients (actual numbers not reported). Lead migration was reported in 28% (17 of 60) of patients in the case series of 60 patients, 15 of whom were in the group of 30 patients who had a 1‑stage procedure for implanting the neurostimulator.
5.4
Pain at the implant site, pain at the lead site and new pain (unspecified) were reported in 10% (128 of 1,239), 2% and 4% of patients respectively, in the systematic review of 14 articles, including a total of 1,239 patients. Pain at the implant site was reported in 32% (19 of 60) of patients in the case series of 60 patients. Leg pain, pelvic pain and urethral pain were reported in 30% (18 of 60), 3% (2 of 60) and 3% (2 of 60) of patients respectively, in the same study.
5.5
Sensation of electric shock was reported in 2% of patients in the systematic review of 14 articles, including a total of 1,239 patients (actual numbers not reported).
5.6
Wound seroma was reported in 1 patient in the case series of 93 patients.
5.7
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 listed the following anecdotal adverse events: change in bowel function, and decubitus ulceration. They did not describe any theoretical adverse events.