Post Approval NovaSure Essure Labeling Study

Inclusion Criteria:

• Subject is 18 years of age or older and premenopausal.

• Subject's gynecological history supports the use of NovaSure endometrial ablation forthe treatment of menorrhagia.

• Subject has had an Essure Permanent Birth Control System procedure.

• The Essure Confirmation Test has confirmed both bilateral tubal occlusion andsatisfactory placement of the Essure micro-inserts. A written report or ECT radiologicfilms need to be provided by the physician who performed the ECT. If neither isavailable, the ECT must be repeated prior to enrollment.

• Subject is able to provide informed consent

Exclusion Criteria:

• Subject has known or suspected endometrial carcinoma (uterine cancer) or pre-malignantconditions of the endometrium, such as unresolved (atypical) adenomatous hyperplasia.

• Subject has abnormal/obstructive uterine cavity as confirmed by hysteroscopy or otherimaging study (e.g. congenital malformation, large fibroid or large polyp)

• Subject with any anatomic condition (e.g. history of previous classical cesareansection or transmural myomectomy) or pathologic condition (e.g. long term medicaltherapy) 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-insertplacement.

• 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 dialof 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 precludessafe participation in the study.