This document and Insertion of customised titanium implants, with soft tissue cover, for orofacial reconstruction (interventional procedure guidance 449) replace previous guidance on exposed customised titanium implants for orofacial reconstruction (interventional procedure guidance 28).
This guidance only covers the use of titanium implants for complex orofacial reconstruction, often involving multiple surfaces, including bony and cartilaginous structures, without soft tissue cover or the expectation of substantial soft tissue cover. It does not cover the use of titanium implants for orofacial reconstruction where the implants are covered or expected to become substantially covered with soft tissue.
1.1 Current evidence on the efficacy of inserting customised exposed titanium implants, without soft tissue cover, for complex orofacial reconstruction is based on very small numbers of patients. With regard to safety there is concern about the risk of recurrent infection and other complications resulting from long-term exposure of the implants. Therefore this procedure should only be used with special arrangements for clinical governance, consent and audit or research.
1.2 Clinicians wishing to undertake insertion of customised exposed titanium implants, without soft tissue cover, for complex orofacial reconstruction should take the following actions.
Inform the clinical governance leads in their trusts.
Ensure that patients understand the uncertainty about the procedure's safety and efficacy and provide them with clear written information. In addition, the use of NICE's information for the public is recommended.
Audit and review clinical outcomes of all patients having insertion of customised exposed titanium implants, without soft tissue cover, for complex orofacial reconstruction.
1.3 Patient selection is of fundamental importance. The procedure should only be offered to patients for whom there are no other options for reconstruction after consideration by head and neck surgeons and plastic surgeons.