1.1 Current evidence on the safety and efficacy of image-guided radiofrequency (RF) excision biopsy of breast lesions is inadequate in quantity and quality, and there are concerns about the possibility of false-negative biopsy results. Therefore, this procedure should only be used with special arrangements for clinical governance, consent and audit or research.
1.2 Clinicians wishing to undertake image-guided RF excision biopsy of breast lesions should take the following actions.
Inform the clinical governance leads in their Trusts.
Ensure that patients and their carers 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 patients ('Understanding NICE guidance') is recommended.
Audit and review clinical outcomes of all patients having image-guided RF excision biopsy of breast lesions (see section 3.1).
1.3 NICE encourages further research into image-guided RF excision biopsy of breast lesions. Research should be in the form of diagnostic studies aimed at quantifying the risk of false-negative results associated with the procedure. NICE may review the procedure on publication of further evidence.