INDICATIONS: The Genesys 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 Genesys 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; in whom a tight cervical seal cannot be established and maintained around the procedure sheath; 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.
POTENTIAL ADVERSE EFFECTS that may occur include: pain, cramping, nausea, vomiting, bleeding, infection, laceration, Endometritis, thermal injury to adjacent tissue including cervix, vagina, vulva, and/or perineum; 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, complications leading to serious injury and death, post-ablation tubal sterilization syndrome, and delayed diagnosis of cancer of the endometrium.
WARNINGS:NOTE: Failure to follow any instructions or to heed any Warnings or Precautions could result in serious patient injury.
CAUTION:Federal Law restricts this device to sale by or on the order of a physician. The physician using the device must be trained in diagnostic hysteroscopy.
Product Type
Endometrial Ablation System
Used in Procedures
Endometrial Ablation for MenorrhagiaRelated Medical Areas
Women's HealthRelated Conditions
Women's Health Conditions
