2 The procedure

2.1 Indications

2.1.1 Image-guided vacuum-assisted core biopsy has been regularly used for gathering samples of tissue in women with breast lesions suspicious of breast cancer, or when histological evidence of a benign lesion is required. This procedure can also be used to remove benign breast lesions such as fibroadenomas. This can reduce the need for open surgical biopsy or excision.

2.1.2 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 for malignancy in all three tests may choose to have benign lumps removed.

2.2 Outline of the procedure

2.2.1 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 Small amounts of tissue are aspirated and the probe is withdrawn further into the lesion and the process repeated.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 takes between 13 and 60 minutes, depending on the size of lesion being removed. The procedure can be performed on an outpatient basis under local anaesthesia.

2.3 Efficacy

2.3.1 Complete removal was achieved in between 22% (21/95) and 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.

2.3.2 In one case series, 23% (3/13) of patients with incompletely excised lesions after vacuum-assisted biopsy had subsequent open surgery excision. For more details, refer to the Sources of evidence.

2.4 Safety

2.4.1 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 haematomas were classified as serious. In another study of 20 patients, no clinically problematic haematomas were reported.

2.4.2 In one large case series, 39% (73/186) of patients complained of mild postoperative pain, and 4% (8/186) of moderate pain. No patients reported severe pain.

2.4.3 Bleeding during the procedure occurred in 4% (2/56) of patients in one case series, and in 2% (3/186) in another. However, all three latter cases resolved with little or no intervention. For more details, refer to the Sources of evidence.

2.4.4 The Specialist Advisors noted that complications include haemorrhage, haematoma formation, vasovagal episodes and failure to excise the correct area. In addition, wound infection is a possible problem.

2.5 Other comments

2.5.1 It was noted that, despite prior biopsy, patients may occasionally be found to have a malignant cancer.

2.5.2 It was noted that benign lesions such as fibroadenomas may sometimes recur after this procedure.