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 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