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 interventional procedure overview.

5.1 Tenolysis was needed in 3% (2/78) of patients at 6‑month follow-up in a non-randomised comparative study of 153 patients needing digital nerve repair comparing processed nerve allograft (PNA) repair (n=72) with tension-free suture nerve repair (n=81).

5.2 Neuroma was reported after 1 nerve repair of 132 nerves in a case series of 108 patients needing nerve repair.

5.3 Local infection that improved after treatment (not specified) was reported in 1 patient in a case series of 15 patients treated by PNA grafting.

5.4 In addition to safety outcomes reported in the literature, specialist advisers are asked about anecdotal adverse events (events which they have heard about) and about theoretical adverse events (events which they think might possibly occur, even if they have never done so). For this procedure, specialist advisers listed the following anecdotal adverse events: immunological reaction or rejection, and inflammatory reaction to preservatives. They considered that the following were theoretical adverse events: immunological reaction or rejection, inflammatory reaction to preservatives and sub-optimal results because of preference in using the allograft when patients could be treated by more established interventions.

  • National Institute for Health and Care Excellence (NICE)