Authors' objectives:

This report aims to assess the effectiveness of advanced breast biopsy instrumentation (ABBI) for diagnostic biopsy of detected lesions of the breast.

Authors' results and conclusions: No randomised controlled trials comparing ABBI with any other therapeutic or diagnostic procedure or properly designed diagnostic studies have been completed to date. Studies have compared ABBI to core needle biopsy, mammotome and wire localised biopsy. Sensitivity and specificity of ABBI was comparable with core needle biopsy and mammotome in one study. Discordant rebiopsy rates appeared to be lower for ABBI compared with core needle biopsy and mammotome in the same study. Technical success was slightly lower for ABBI compared with core needle biopsy, mammotome and open wire localised biopsy. In another study all margins for ABBI and needle localisation with excisional breast biopsies were positive. Mean blood loss for ABBI was significantly less than for needle localisation with excisional breast biopsy. These comparative studies failed to provide detailed rebiopsy rates. For the case series studies that reported rebiopsies (occasions when the initial ABBI failed to obtain sufficient material for histopathological diagnosis), the rates varied from 0.05 to 2.9 per cent of all ABBI procedures initially performed. Between 1 and 23 per cent of ABBI procedures were converted to another form of biopsy or aborted before ABBI was completed. Malignancy of the ABBI biopsy varied from 11 to 44 per cent. Between 57 and 95 per cent of malignant biopsies obtained using the ABBI procedure had positive margins. Mean procedure time varied from 22 to 80 minutes. Five out of 13 studies reported some measure of patient satisfaction or cosmetic results. Patient satisfaction outcomes were generally good and the procedure was generally acceptable to women.

Authors' recommendations: MSAC recommended that, on the strength of evidence pertaining to ABBI, public funding should be supported for the diagnostic use of this procedure, as long as fees are such that health system costs do not exceed those of comparators. There is insufficient evidence for the use of ABBI in a therapeutic role for breast cancer. The use of the ABBI equipment is to be limited to surgeons and radiologists with sufficient training and expertise in the procedure, in order to reproduce in Australian practice the results reported in the literature. A costing study should be carried out to assist in the setting of the appropriate Medicare rebate.

Authors' methods: Systematic review

Project Status: Completed

URL for project: http://www.msac.gov.au/reports.htm

Year Published: 2001

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: Australia

Organisation Name: Medical Services Advisory Committee

Contact Address: MSAC (MDP 107), GPO Box 9848, Canberra, ACT 2601, Australia. Tel: +61 2 6289 6811; Fax: +61 2 6289 8799.

Contact Name: msac.secretariat@health.gov.au

Contact Email: msac.secretariat@health.gov.au

Copyright: Medical Services Advisory Committee (MSAC)