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