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GYNECARE THERMACHOICE® Uterine Balloon Therapy System Logo

You can solve heavy periods.
Treat your menorrhagia now.

Overview: GYNECARE THERMACHOICE® Uterine Balloon Therapy System

If you’ve been reluctant to talk to your friends or your doctor about your heavy periods, you may not realize how common they are – or that you don’t have to accept the limits heavy periods can put on your lifestyle.

One effective treatment for heavy periods is a global endometrial ablation (GEA) procedure called GYNECARE THERMACHOICE® Uterine Balloon Therapy System. GYNECARE THERMACHOICE® is an effective, nonhormonal, permanent treatment for heavy periods. It involves a minimally invasive, 8-minute procedure that can be performed in your doctor’s office or in a hospital.

Studies have shown that:

  • 95% of women treated with GYNECARE THERMACHOICE® returned to normal levels of menstrual bleeding or lower1

  • 89% of patients had a reduction of menstrual pain and cramping2

  • 96% of patients reported satisfaction with GYNECARE THERMACHOICE® III2

You don’t have to live with heavy periods. Learn more about your period, read more about GYNECARE THERMACHOICE® or Find a doctor who can provide treatment.

References:
1. Loffer FD, Grainger D. Five-year follow-up of patients participating in a randomized trial of uterine balloon therapy versus rollerball ablation for treatment of menorrhagia. J Am Assoc Gynecol Lap. 2002; 9(4): 429
2. Instructions For Use. Somerville, NJ: Ethicon, Inc; 2009

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Risk Information

GYNECARE THERMACHOICE® Uterine Balloon Therapy System
Essential Product Information

INDICATIONS: The GYNECARE THERMACHOICE® 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; 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 transmural myomectomy; with active genital or urinary tract infection at the time of procedure (eg, cervicitis, vaginitis, endometritis, salpingitis, or cystitis); with an intrauterine device (IUD) currently in place.

ADVERSE EVENTS include: rupture of the uterus; 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; complications with pregnancy (Note: pregnancy following ablation is dangerous to both the mother and the fetus); vesico-uterine fistula formation; cramping/pelvic pain; nausea and vomiting; endometritis and risks associated with hysteroscopy.

WARNINGS: Failure to follow all instructions or to heed any warnings or precautions could result in serious patient injury. If uterine perforation is present, and the procedure is not terminated, thermal injury to adjacent tissue may occur if the heater is activated. 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 using the GYNECARE THERMACHOICE® System should be performed only by medical professionals who have experience in performing procedures within the uterine cavity, such as IUD insertion or dilation and curettage (D&C), who have adequate training and familiarity with GYNECARE THERMACHOICE® System.

PRECAUTIONS: Never use other components with the GYNECARE THERMACHOICE® System. Rx Only.

For more information, please consult your doctor or call 1-888-GYNECARE to speak with a nurse.

This site is published by Ethicon Women's Health & Urology, a division of Ethicon, Inc., a Johnson & Johnson Company,
which is solely responsible for the content. It is intended for visitors from the US.
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