Essure (Model ESS310) Placement Rate Study

Exclusion Criteria

• •Subjects suspected of being or confirmed pregnant
• •Subjects post-partum or undergone pregnancy termination ≤6 weeks of scheduled insert placement
• •Subjects who have known proximal tubal occlusion in either fallopian tube
• •Subjects who have undergone fallopian tube sterilization procedure
• •Subjects who have had total or partial salpingectomies
• •Subjects diagnosed with tubal, endometrial, or myometrial pathology which may prevent fallopian tube ostia access
• •Subjects diagnosed with unicornuate uterus
• •Subjects diagnosed with active or currently being treated upper or lower pelvic infection
• •Subjects with gynecologic malignancy
• •Subjects who are currently taking corticosteroids
• •Subjects with a known allergy to all contrast media available for use in HSG (Hysterosalpingogram)
• •Subjects scheduled to undergo concomitant intrauterine procedures at the time of insert placement (e.g., endometrial ablation, fibroid resection by hysteroscopy, endometrial polypectomy). Intrauterine device removal is not considered a concomitant procedure.
• •Subjects with 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
• •Subjects with a close affiliation with the investigational site, e.g. closely related or affiliated with the investigator (such as dependent, employee or student of the investigational site, or sponsor's staff)