Evaluation of Safety and Effectiveness of the Essure (Model ESS505) Device to Prevent Pregnancy in Women

Exclusion Criteria

• •Post-menopausal woman
• •Suspected or confirmed pregnancy
• •Post-partum or pregnancy termination ≤6 weeks of scheduled insert placement
• •Past fallopian tube sterilization procedure and/or total or partial salpingectomies
• •Diagnosis of any of the following: tubal, endometrial, or myometrial pathology (which may prevent fallopian tube ostia access), proximal tubal occlusion in either fallopian tube, unicornuate uterus, active or recent upper or lower pelvic infection, gynecologic malignancy
• •Currently taking corticosteroids
• •Known allergy to all contrast media available for use in hysterosalpingogram
• •Scheduled to undergo concomitant intrauterine procedures at the time of insert placement (intrauterine device removal is not considered a concomitant procedure)
• •Any general health condition or systemic disease that may represent, in the opinion of the physician, a potential increased risk associated with device use or pregnancy