HydroMARK Post-market Clinical Follow-up Study

Inclusion Criteria

• Inclusion Criteria: Safety Cohort - Subject was implanted during a breast biopsy procedure with a HydroMARK Breast Biopsy Site Marker manufactured at the Devicor Tijuana facility per the instructions for use - Subject has been followed at least 90 days according to the hospital's standard of care (SOC) - Subject was ≥ 18 years of age at the time of the breast biopsy procedure - Subject has accessible medical records documenting the breast biopsy procedure including, at minimum: age, sex, primary diagnostic indication and documentation of device-related adverse events which occurred, if any Performance Cohort - Subject was implanted during a breast biopsy procedure with a HydroMARK Breast Biopsy Site Marker manufactured at the Devicor Tijuana facility per the instructions for use - Patient is ≥18 years of age - Patient has provided informed consent to participate in study, including follow-up visit for ultrasound imaging at 6-12 weeks post-biopsy Exclusion Criteria: Safety Cohort • Biopsy area was infected at the time of implant Performance Cohort - Contraindication to HydroMARK Breast Biopsy Site Marker implantation - Biopsy area is infected at the time of implant - Patient has a breast biopsy marker (in the same breast) implanted from a previous procedure