HydroMARK Post-market Clinical Follow-up Study

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