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Wed, 03/25/2009 - 19:03 — admin

What to Expect

GYNECARE THERMACHOICE® Uterine Balloon Therapy with Fluid Circulation offers an effective, nonhormonal treatment for heavy periods, also known as menorrhagia. GYNECARE THERMACHOICE® is a minimally invasive, 8-minute procedure that can be performed in your doctor's office or in a hospital. What happens during the procedure? GYNECARE THERMACHOICE® uses a method called global endometrial ablation (GEA) to remove the endometrium, the lining of the uterus (womb).

Under local anesthesia, the doctor inserts a small silicone balloon into your uterus, which is filled with fluid and then gently heated to treat the lining of your uterus. No incision is required. You may feel a slight warmth or pressure during the treatment time, which is 8 minutes; the entire appointment usually lasts approximately 30 minutes. See step by step how GYNECARE THERMACHOICE® works.

In most cases, patients can resume their normal activities the next day.

What happens after the procedure?

The first postoperative check-up usually occurs within 7 to 10 days after the procedure, and your doctor may determine that sexual activity can resume after that check-up. Your first few periods after the procedure may continue to be heavy, with improvement thereafter. Some women experience a pinkish watery discharge for about 2 weeks that can last as long as 1 month.

All medical procedures carry risks. Talk to a doctor to determine whether GYNECARE THERMACHOICE® might be the right choice for you. Find a doctor familiar with GYNECARE® products who can provide treatment.

What are the risks with GYNECARE THERMACHOICE®?

All medical procedures present risks, so talk to a doctor about whether GYNECARE THERMACHOICE® is right for you. Find a doctor familiar with GYNECARE® products who can provide treatment.

As with all procedures of its type, GYNECARE THERMACHOICE® poses a risk of injury to the uterus and surrounding tissues. Most common side effects include discharge, cramping, nausea and vomiting.

Global endometrial ablation procedures, including GYNECARE THERMACHOICE® III Uterine Balloon Therapy System, are intended for pre-menopausal women with heavy bleeding due to benign causes who do not wish to become pregnant in the future. It is not appropriate for a patient who is pregnant or wants to become pregnant in the future. Becoming pregnant after this procedure can be dangerous for both the mother and the fetus.

Pregnancy after ablation is unlikely, but if it does occur, you and your baby could be at risk because the endometrial lining of the uterus has been removed. After treatment, you will need to continue to use a birth control method that is appropriate for you. There are several options available for birth control. You should discuss these options with your doctor.

For a complete description of risks related to this treatment, please see the Potential Adverse Effects section of the Risk Information.

The information represents no statement, promise or guarantee by Ethicon, Inc., concerning insurance coverage, levels of reimbursement, payment, or charge. Please consult your payor organization with regard to local or actual coverage determination processes.

Next: Talk to a Doctor About Heavy Periods

Risk Information

GYNECARE THERMACHOICE®
GYNECARE THERMACHOICE® Uterine Balloon Therapy with Fluid Circulation

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: 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; or who is pregnant or who wants to become pregnant in the future.

POTENTIAL ADVERSE EFFECTS that may occur 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); 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 a perforation is present, and the procedure is not terminated, thermal injury to adjacent tissue may occur if the heater is activated.

CAUTION: 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), and who have adequate training and familiarity with
GYNECARE THERMACHOICE® System. Rx Only.

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

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