Endometrial Ablation for Menorrhagia

Prescriptive Information

The Hydro ThermAblator System (HTA System) is a hysteroscopic thermal ablation device intended to ablate the endometrial lining of the uterus in premenopausal women with menorrhagia (excessive uterine bleeding) due to benign causes for whom childbearing is complete.

Contraindications

The HTA System is contraindicated for use in a patient: who is pregnant or wants to be pregnant in the future, as pregnancy after ablation can be dangerous to both mother and fetus; who has known or suspected endometrial carcinoma or premalignant change of the endometrium, such as adenomatous hyperplasia; who has active pelvic inflammatory disease or pyosalpinx; hydrosalpinx; who has any anatomical or pathologic condition in which weakness of the myometrium could exist, such as, prior classic cesarean section or transmural myomectomy; who has an intrauterine device in place; or who has active genital or urinary tract infection, e.g., cervicitis, endometritis, vaginitis, cystitis, etc., at the time of treatment.

Warnings

Failure to follow any instructions or to heed any Warnings or Precautions could result in serious patient injury.

Potential Adverse Effects

Potential adverse effects that may occur include: thermal injury to adjacent tissue; heated saline escaping from the device system into the vascular spaces; hemorrhage; perforation of uterus; complications with pregnancy (Note: pregnancy following ablation is dangerous to both the mother and the fetus); risks associated with hysteroscopy; and thermal injury to cervix, vagina, vulva and/or perineum.

Cautions

Federal (USA) law and governing law outside the USA restrict this device to sale by or on the order of a physician. The physician using the device must be trained in diagnostic hysteroscopy.