A prospective study of the removal rate of imaged breast lesions by an 11-gauge vacuum-assisted biopsy probe system

Presented at the Second Annual Meeting of the American Society of Breast Surgeons, La Jolla, California, May 3–6, 2001.
https://doi.org/10.1016/S0002-9610(01)00723-1Get rights and content

Abstract

Background: More than 1,000,000 breast biopsies are performed each year as a result of abnormalities identified by imaging techniques. This prospective study was designed to determine whether complete removal of the imaged evidence of an abnormal mammogram or ultrasonogram could be achieved with percutaneous image-guided procedures using an 11-gauge vacuum-assisted biopsy probe.

Methods: Forty-five women over the age of 18 years entered the study; 50 breast lesions were identified by ultrasonography or mammography. Biopsies were obtained using an 11-gauge vacuum-assisted probe. At 6 months after biopsy, ultrasonography or mammography examinations of the biopsy site were performed.

Results: Forty-five lesions (90%) were completely removed. At 6 months after biopsy, 82% of the sites were lesion free. The percentage of nonrecurring lesions at 6 months after surgery was inversely related to the size of the original lesion.

Conclusion: This device allows biopsies to be successfully combined with complete removal of the imaged lesion in a one-step minimally invasive procedure.

Section snippets

Methods

This was an open, prospective, single-center study. From September 1999 to November 1999, women referred to The Breast Center with breast lesions visualized by mammography or ultrasonography qualified for voluntary enrollment in the study if they were at least 18 years of age, not pregnant, not lactating, and did not have prosthetic breast implants. Qualifying patients who had given written informed consent were then scheduled for the biopsy and a 6-month follow-up visit.

Prior to the biopsy,

Results

Forty-six patients were enrolled in the study. One patient had the scheduled biopsy performed with a nonstudy device and was therefore discontinued from the study. That patient’s data were not included in the summary analysis.

The 45 evaluable patients ranged in age from 23 to 75 years with a mean age of 47.4 years. The patients were predominately Caucasian (89%); 4 blacks (9%) and 1 Asian/Pacific Islander (1%) were also included in the study population. Of the 45 evaluable patients, 33 (73%)

Comments

Innovative technology has now combined stereotactic or ultrasonography imaging with a minimally invasive biopsy system for the diagnosis of nonpalpable lesions identified by mammogram or sonogram. Using the Mammotome breast biopsy system, a diagnosis can be made through a single, sutureless incision, avoiding an open surgical biopsy. This vacuum-assisted biopsy device has the potential to completely remove the image evidence of the lesion at the time of the initial diagnostic biopsy procedure.

Conclusion

Minimally invasive percutaneous image-guided breast biopsy is becoming a more widely accepted method to diagnose the abnormal lesions that can be visualized with mammography or ultrasonography. Many physicians performing these procedures prefer that the imaged evidence of the lesion be removed to potentially increase accuracy in biopsy and follow-up, and provide reassurance to the patient that the lesion in question has been adequately sampled. This study demonstrates that complete removal of

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