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

Inclusion Criteria: * Female, 21 to 44 years of age, inclusive * Body weight within range of 90-300 lbs (40 - 136 kg) * Sexually active (minimum of 4 coital acts per cycle) * Willing to accept the risk of pregnancy while relying solely on the inserts for contraception * Medical history indicates bilateral viable and patent fallopian tubes * Agrees to fulfill local requirements for counseling and consent to contraception and sterilization, including any required waiting periods 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