Contraception

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