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Updated: Jun 17, 2026
Optimization of Breast Biopsy and Mastectomy Sample Collection Procedures for Biobanking, Personalized Medicine, and Research Applications
Published on: September 2, 2025
Systematic review: comparative effectiveness of core-needle and open surgical biopsy to diagnose breast lesions
Wendy Bruening1, Joann Fontanarosa, Kelley Tipton
1ECRI Institute, 5200 Butler Pike, Plymouth Meeting, PA 19462-1298, USA.
Background:
Most women undergoing breast biopsy are found not to have cancer.
Purpose:
To compare the accuracy and harms of different breast biopsy methods in average-risk women suspected of having breast cancer.
Data Sources:
Databases, including MEDLINE and EMBASE, searched from 1990 to September 2009.
Study Selection:
Studies that compared core-needle biopsy diagnoses with open surgical diagnoses or clinical follow-up.
Data Extraction:
Data were abstracted by 1 of 3 researchers and verified by the primary investigator.
Data Synthesis:
33 studies of stereotactic automated gun biopsy; 22 studies of stereotactic-guided, vacuum-assisted biopsy; 16 studies of ultrasonography-guided, automated gun biopsy; 7 studies of ultrasonography-guided, vacuum-assisted biopsy; and 5 studies of freehand automated gun biopsy met the inclusion criteria. Low-strength evidence showed that core-needle biopsies conducted under stereotactic guidance with vacuum assistance distinguished between malignant and benign lesions with an accuracy similar to that of open surgical biopsy. Ultrasonography-guided biopsies were also very accurate. The risk for severe complications is lower with core-needle biopsy than with open surgical procedures (<1% vs. 2% to 10%). Moderate-strength evidence showed that women in whom breast cancer was initially diagnosed by core-needle biopsy were more likely than women with cancer initially diagnosed by open surgical biopsy to be treated with a single surgical procedure (random-effects odds ratio, 13.7 [95% CI, 5.5 to 34.6]).
Limitation:
The strength of evidence was rated low for accuracy outcomes because the studies did not report important details required to assess the risk for bias.
Conclusion:
Stereotactic- and ultrasonography-guided core-needle biopsy procedures seem to be almost as accurate as open surgical biopsy, with lower complication rates.
Primary Funding Source:
Agency for Healthcare Research and Quality.
