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.
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
