5 Safety

Guidance

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 A case series of 187 patients with constipation reported 7 adverse events as being possibly or definitely related to the capsule: 2 cases of abdominal pain, 1 case of diarrhoea, 2 cases of dysphagia and 2 cases of nausea.

5.2 Device malfunction was reported in 4% (8/180) of those who ingested the wireless motility capsule in the case series of 187 patients with symptomatic constipation.

5.3 Software malfunction resulting in missing data was reported in 7% (12/165) of participants (group not specified) in a comparative study of 165 people (78 patients with chronic constipation versus 87 healthy subjects).

5.4 The specialist advisers stated theoretical adverse events included impaction of the capsule in patients with strictures, and the capsule not progressing beyond the stomach in patients with severe gastroparesis.