Post Approval NovaSure Essure Labeling Study

Exclusion Criteria

• •Subject has known or suspected endometrial carcinoma (uterine cancer) or pre-malignant conditions of the endometrium, such as unresolved (atypical) adenomatous hyperplasia.
• •Subject has abnormal/obstructive uterine cavity as confirmed by hysteroscopy or other imaging study (e.g. congenital malformation, large fibroid or large polyp)
• •Subject with any anatomic condition (e.g. history of previous classical cesarean section or transmural myomectomy) or pathologic condition (e.g. long term medical therapy) that could lead to weakening of the myometrium.
• •Subject has an active genital or urinary tract infection at the time of the procedure (e.g., cervicitis, vaginitis, endometritis, salpingitis, or cystitis).
• •Subject has an intrauterine device (IUD) currently in place.
• •Subject has active pelvic inflammatory disease or history of recent pelvic infection.
• •Subject has undiagnosed vaginal bleeding.
• •ECT unable to adequately assess bilateral tubal occlusion and proper micro-insert placement.
• •Subject has uterine sound measurement greater than 10 cm.
• •Subject with a uterine cavity length less than 4 cm.
• •Subject with a uterine cavity width less than 2.5 cm, as determined by the width dial of the disposable NovaSure device following device deployment.
• •Subject is unable to comply with the protocol and be available for follow up
• •In the opinion of the investigator, the subject has a medical condition that precludes safe participation in the study.