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 Infection was reported in 14% (2/14) of patients in the case series of 14 patients. One patient developed infection 9 days after the procedure and was treated with systemic antibiotics without success. The implant was removed after 47 days and the patient had a stoma. The other patient had a superficial wound infection 7 days after the procedure that was successfully treated with systemic antibiotics. Perineal abscess was reported in 1 patient at 6 months postoperatively in the case series of 24 patients; the device was explanted.
5.2 Swelling and erythema in both gluteal regions 2 weeks after the procedure was reported in 31% (5/16) of patients in a case series of 16 patients. This resolved after conservative treatment.
5.3 Obstructed defecation was reported in 1 patient in the case series of 14 patients. This resolved within 2 days after treatment with enemas.
5.4 Rectal bleeding that resolved spontaneously was reported in 1 patient in the case series of 14 patients. Vaginal bleeding that resolved spontaneously was reported in 1 patient in the case series of 16 patients.
5.5 Pain that resolved after medication was reported in 14% (2/14) of patients in the case series of 14 patients. Pain (not further described) was reported in 31% (5/16) of patients in the case series of 16 patients.
5.6 Device separation was reported in 1 patient in the case series of 14 patients; the patient reported hearing a 'crack' during defecation approximately 1 month after implantation. X-ray showed the device had separated and within a week the patient passed the device without evidence of ulceration on clinical examination.
5.7 The specialist advisers listed erosion and discomfort as anecdotal adverse events. Theoretical adverse events were chronic pain, device migration, constipation and loss of magnetism.