The purpose of this study is to assess the safety and performance of the HydroMARK Breast Biopsy Site Marker manufactured in the Devicor Medical Products, Inc. Tijuana facility.

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

Safety cohort: retrospective chart review of ~491 subjects who underwent a breast biopsy procedure with implant of a HydroMARK Breast Biopsy Site Marker manufactured at the Devicor Tijuana facility.

Performance cohort: ~341 subjects with a suspected breast cancer that will undergo as part of standard of care an ultrasound-guided breast biopsy procedure, including placement of HydroMARK Breast Biopsy Site Marker manufactured at the Devicor Tijuana facility, with an aim of achieving a minimum 239 evaluable subjects returning to the office at 6-12 weeks for ultrasound imaging to evaluate device visibility.