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 Blood transfusion was needed in 3% (2/74) of patients in the case series of 74 patients: in 1 patient, the neck had to be opened to control bleeding by ligating the terminal branches of the external carotid artery.
5.2 Temporary weakness of the temporal branch of the facial nerve was reported in 31% (23/74) of patients in the case series of 74 patients (this resolved within 6 months in all but 1 patient, who needed a brow lift because of long‑term weakness). Temporary marginal mandibular palsy was reported in 11% (8/74) of patients (resolved within 6 months), and total facial palsy was reported in 3% (2/74) of patients (resolved within 6 weeks). Sensory changes to the lip and tongue were reported in 4% (3/74) of patients (resolved within 6 weeks). Long‑term sensory loss to the distribution of the auriculotemporal nerve was reported in 14% (10/74) of patients.
5.3 Infection was reported in 2% (44/2106) and 3% (numbers not reported) of patients treated using different prostheses in a review of 2620 patients. Three per cent (14/442) of implants had 1 or 2 components removed because of heterotopic bone formation or infection in the case series of 288 patients. Infection was reported in 3% (2/74) of patients in the case series of 74 patients: the device was removed in both patients (with successful subsequent revision using a new prosthesis).
5.4 Dislocation of the prosthesis was reported in 1% (14/2106) of patients in the review of 2620 patients (no further details were reported). Dislocation of the prosthesis within a few hours of the operation was reported in 1 patient in the case series of 74 patients. This was treated by light elastic intermaxillary fixation for 1 week; the dislocation did not recur and the patient had a successful outcome at 1 year.
5.5 Malocclusion, malposition or displacement of the prosthesis was reported in 1% (19/2106) of patients in the review of 2620 patients (management not described).
5.6 Reoperation, sensitivity to material, fractured component, fractured bone screw, dehiscence or perforation, heterotopic bone or scarred tissue formation, and loosening of a component were each reported in less than 1% of patients in the review of 2620 patients.
5.7 The specialist advisers listed anecdotal adverse effects as changes in hearing, damage to the middle cranial fossa structures, early prosthetic failure and Frey's syndrome (gustatory sweating).