Post Approval NovaSure Essure Labeling Study

A prospective, single arm, multi-center, post approval study that is designed to provide
additional information on the safety of performing a NovaSure Impedence Controlled
Endometrial Ablation System in the presence of Essure Permanent Birth Control System,
following the Essure Confirmation Test has confirmed both bilateral tubal occlusion and the
satisfactory location of the Essure micro-inserts. The study will be conducted at up to 15
clinical sites and enroll 318 patients. Patients who meet the inclusion and none of the
exclusion criteria will have the study explained to them and be invited to participate.
Enrolled subjects will have baseline data collected at the time of their NovaSure procedure
and will be followed for 1 month after the NovaSure procedure to be assessed for adverse
events.

Inclusion Criteria:

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

- Subject's gynecological history supports the use of NovaSure endometrial ablation for
the treatment of menorrhagia.

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

- The Essure Confirmation Test has confirmed both bilateral tubal occlusion and
satisfactory placement of the Essure micro-inserts. A written report or ECT radiologic
films need to be provided by the physician who performed the ECT. If neither is
available, 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-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.