Indications:

The NovaSure System is intended to ablate the endometrial lining of the uterus in premenopausal women with menorrhagia (excessive bleeding) due to benign causes for whom childbearing is complete.

Contraindications:

NovaSure Endometrial Ablation is contraindicated for use in patients who:

• Are pregnant or want to become pregnant in the future; pregnancies following ablation can be dangerous for both mother and fetus.
• Have known or suspected endometrial carcinoma (uterine cancer) or pre-malignant conditions of the endometrium, such as unresolved hyperplasia.
• Have 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.
• Have active genital or urinary tract infections at the time of the procedure (e.g., cervicitis, vaginitis, endometritis, salpingitis, or cystitis).
• Have an intrauterine device (IUD) in place.
• Have a uterine cavity length less than 4 cm and width less than 2.5 cm. (The minimum length of the electrode array is 4 cm; treatment of a shorter uterine cavity will result in thermal injury to the endocervical canal).
• Have active pelvic inflammatory disease.
• Have a uterine cavity width less that 2.5 cm, as determined by the Width Dial of the Disposable Device following Device deployment.
• Have a thermally conductive object (eg, metal implant) present in the uterus or in the uterine cavity, where the object could potentially come in direct contact with or close proximity to the heat-generating portion of the endometrial ablation device. If this occurs, heat will be drawn away from the intended treatment area toward other tissue and/or organs in contact with the coductive object, which may be sufficient to cause localized burns.