Percutaneous Excision Trial (I-Pet): A Multi-Center Clinical Study Of The Intact Breast Lesion Excision System (Bles) To Demonstrate That A Definitive Diagnosis Can Be Made From The Tissue Sample Collected With The Intact Bles.

Inclusion Criteria:

- Patient must be a female at least 18 years of age at the time of Intact BLES biopsy

- Patient must have had an imaged abnormality found via mammography or sonography that
warrants a biopsy for further diagnosis

Exclusion Criteria:

- Patients who have pre-pectoral breast implants

- Patients who have implantable devices such as pacemakers and defibrillators

- Patients who are pregnant or lactating

- Patients in whom the device is contraindicated

- Patients who are contraindicated for surgery due to factors such as anti-coagulant
use which cannot be safely reversed or who exhibit fever or other clinical evidence
of infection