The National Institute for Health and Clinical Excellence is examining image-guided vacuum-assisted excision biopsy of benign breast lesions and will publish guidance on its safety and efficacy to the NHS in England, Wales and Scotland. The Institute's Interventional Procedures Advisory Committee has considered the available evidence and the views of Specialist Advisors, who are consultants with knowledge of the procedure. The Advisory Committee has made provisional recommendations about image-guided vacuum-assisted excision biopsy of benign breast lesions.

This document summarises the procedure and sets out the provisional recommendations made by the Advisory Committee. It has been prepared for public consultation. The Advisory Committee particularly welcomes:

• comments on the preliminary recommendations
• the identification of factual inaccuracies
• additional relevant evidence.

Note that this document is not the Institute's formal guidance on this procedure. The recommendations are provisional and may change after consultation.

The process that the Institute will follow after the consultation period ends is as follows.

• The Advisory Committee will meet again to consider the original evidence and its provisional recommendations in the light of the comments received during consultation.
• The Advisory Committee will then prepare draft guidance which will be the basis for the Institute's guidance on the use of the procedure in the NHS in England, Wales and Scotland.

For further details, see the Interventional Procedures Programme manual, which is available from the Institute's website (www.nice.org.uk/ipprogrammemanual).

Closing date for comments: 22 November 2005
Target date for publication of guidance: February 2006

Note that this document is not the Institute's guidance on this procedure. The recommendations are provisional and may change after consultation.

Current evidence on the safety and efficacy of image-guided vacuum-assisted excision biopsy of benign breast lesions appears adequate to support the use of this procedure, provided that the normal arrangements are in place for consent, audit and clinical governance.

Clinicians wishing to perform this procedure should undergo training as recommended by the Royal College of Radiologists in Ultrasound Training Recommendations for Medical and Surgical Specialties (www.rcr.ac.uk/docs/radiology/pdf/ultrasound.pdf).

Diagnosis of benign breast disease is usually done by clinical examination, imaging and fine needle biopsy: this is known as the triple test. Women who have negative results in all three tests may choose to have benign lumps removed.

The procedure involves the use of a needle probe device with vacuum suction to remove breast tissue under imaging guidance (commonly ultrasound). The aim of the procedure is to continue using the biopsy device until the lesion visible on imaging has been removed. A small incision is made in the breast and an 8- or 11-gauge probe is inserted through the lesion. Small amounts of tissue are aspirated and the probe is withdrawn further into the lesion and the process repeated. When the device has been removed the site of incision is compressed for a short time. The procedure can be performed on an outpatient basis under local anaesthetic.

Complete removal of lesions was achieved in 22% (21/95) to 98% (121/124) of lesions. The success rate may depend on the gauge of the probe used and the size of the lesion to be removed (these are often dependent variables). The accuracy of determining complete removal may depend on the quality of the imaging technique used.

The procedure duration ranged from 13 to 60 minutes, depending on the size of lesion being removed. For more details, refer to the sources of evidence (see Appendix).

The most frequent complication of this procedure was haematoma. This complication was recorded in 13% (24/186) of patients in one case series, but none of these were classified as serious. In another study, no clinically problematic haematomas were reported in 20 patients.

The NHS Breast Screening Programme has produced guidelines for Breast Cancer Screening Assessment (www.cancerscreening.nhs.uk/breastscreen/publications/nhsbsp49.html).

The following document, which summarises the evidence, was considered by the Interventional Procedures Advisory Committee when making its provisional recommendations.

• Interventional procedure overview of image-guided vacuum-assisted excision biopsy of benign breast lesions, February 2005.

Available from www.nice.org.uk/ip188overview