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.
Localised involuntary muscle contractions and a sensation of a jolt or shock associated with the electric pulses were reported in the study of 34 patients and 3 case series of 50, 24 and 15 patients. They stopped immediately when the electric pulses were discontinued.
A septal cartilage perforation was reported in 1 patient receiving treatment in the right nasal vestibule in the case series of 6 patients. This occurred after a biopsy performed 8 weeks after treatment. No further details were reported.
Slight burning of the skin was reported in 87% (7 out of 8) of patients on whom the plate electrodes were used in the study of 34 patients. This healed within 6 to 8 weeks. No further details were reported.
Erythema and oedema 72 hours after treatment were reported in the case series of 24 patients. No further details were reported.
Increased tear production in the ipsilateral eye was reported in 2 patients who received treatment for tumours in the medial canthus in the case series of 6 patients. This caused no visual impairment and resolved within 2 months. No further details were reported.
Post-treatment pain was described as 'moderate' and was managed with paracetamol and diclofenac for 5 to 7 days in the case series of 6 patients.
Other side effects attributed to the chemotherapy agent such as slight nausea and allergic reactions were also reported.
The specialist advisers listed additional key safety outcomes as increase in wound exudate after the procedure and chemotherapy toxicity, specifically pulmonary fibrosis as a result of chemotherapy (bleomycin).