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Risk Information

GYNECARE THERMACHOICE® III Uterine Balloon Therapy System
Essential Product Information - Patient

INDICATIONS: The GYNECARE THERMACHOICE III System is a thermal balloon 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 device 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); with known or suspected endometrial carcinoma (uterine cancer) or premalignant change of the endometrium, such as unresolved adenomatous hyperplasia; with any anatomic or pathologic condition in which weakness of the myometrium could exist, such as history of previous classical Cesarean sections or fibroid surgery; with active genital or urinary tract infection at the time of procedure (eg, cervicitis, vaginitis, endometritis, salpingitis, or cystitis) or with active pelvic inflammatory disease (PID); with an intrauterine device (IUD) currently in place.

ADVERSE EVENTS: include cramping/pelvic pain; nausea and vomiting; complications with pregnancy (Note: pregnancies following ablation can be dangerous for both mother and fetus); endometritis and risks associated with hysteroscopy, rupture of the uterus; post-procedure symptoms such as pain, fever, nausea, vomiting and difficulty with defecation or micturition; hematometra; thermal injury to adjacent tissue; heated liquid escaping into the vascular spaces and/or cervix, vagina, fallopian tubes, and abdominal cavity; electrical burn; hemorrhage; infection or sepsis; perforation; post-ablation tubal sterilization syndrome; complications leading to serious injury or death vesico-uterine fistula formation.

WARNINGS: The device is intended for use only in women who do not desire to bear children because the likelihood of pregnancy is significantly decreased following this procedure. Pregnancies following ablation can be dangerous for both mother and fetus . Endometrial ablation is not a sterilization procedure. Patients who have previously undergone tubal ligation are at increased risk of developing post ablation tubal sterilization syndrome, which can require hysterectomy. Endometrial ablation procedures do not eliminate the potential for endometrial carcinoma (uterine cancer) or premalignant changes of the endometrium and may mask the physician's ability to detect or make a diagnosis of such conditions. The GYNECARE THERMACHOICE ® III procedure and hysteroscopic tubal occlusion/sterilization cannot be performed on the same day. The GYNECARE THERMACHOICE® III procedure should only be performed after the 3-month tubal occlusion confirmation test.

PRECAUTIONS: Certain types of Cesarean section may increase the risk of patient injury. For the complete list of Precautions associated with the use of this device, consult the GYNECARE THERMACHOICE III System instructions for use. Rx Only.

For more information, please consult your doctor or call 1-888-GYNECARE to speak with a nurse. You may also visit www.PelvicHealthSolutions.com

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