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 overview.

5.1 Ulceration through the skin of titanium-coated hollow screw reconstruction plate (THORP) implants was reported in all patients with buccal placement of plates in the case series of 14 patients. Eight patients had been treated using THORP but it was not reported how many of them had buccal placement of the implant. It was noted that 1 patient was treated by fitting an acrylic cover plate over the exposed section of the THORP implant. Case reports described unintentional implant exposure in 2 patients that occurred after insertion of large titanium implants for nasal reconstruction. Both patients needed a number of additional procedures.

5.2 Infection due to methicillin-resistant Staphylococcus aureus (MRSA) resulting in removal of the implant was reported in 1 patient in the case series of 14 patients.

5.3 Fistulae were reported in 4 patients in the case series of 14 patients. Two of the fistulae were closed with relatively simple flap procedures, and a third was closed using adjuvant hyperbaric oxygen therapy. The fourth fistula was found after 2 years at the site of one of the rivet heads on the THORP implant. This orocervical fistula failed to close after 4 flap procedures and hyperbaric oxygen therapy; eventually titanium chain mail with a solid titanium diaphragm was used to close it.

5.4 The specialist advisers listed theoretical adverse events as recurrent infection, bone infection, possible septicaemia, externalisation, bone resorption, loosening of the implant, poor aesthetics and failure of the prosthesis.

  • National Institute for Health and Care Excellence (NICE)