The NovaSure system is intended to ablate the endometrial lining of the uterus in pre-menopausal women with menorrhagia (heavy bleeding) due to benign causes for whom childbearing is complete.
Contraindications:
The NovaSure impedance controlled endometrial ablation system is contraindicated for use in:
A patient who is pregnant or who wants to become pregnant in the future. Pregnancies following ablation can be dangerous for both mother and fetus.
A patient with known or suspected endometrial carcinoma (uterine cancer) or pre-malignant conditions of the endometrium, such as unresolved adenomatous hyperplasia.
A patient 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.
A patient with active genital or urinary tract infection at the time of the procedure (e.g., cervicitis, vaginitis, endometritis, salpingitis, or cystitis).
A patient with a intrauterine device (IUD) currently in place.
A patient with a thermally conductive object (e.g., 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 generation 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 conductive object, which may be sufficient to cause localized burns.
A patient with a uterine cavity length less than 4 cm. The minimum length of the electrode array is 4 cm. Treatment of a uterine cavity with a length less than 4 cm will result in thermal injury to the endocervical canal.
A patient with a uterine cavity width less than 2.5 cm, as determined by the WIDTH dial of the disposable device following device deployment.
A patient with active pelvic inflammatory disease.
