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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 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 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.

The procedure with GYNECARE THERMACHOICE® should not be performed on women who are pregnant or wish to become pregnant in the future. Pregnancy after the treatment is unlikely, but if it does occur, it may be risky for you and your baby because the endometrial lining of the uterus has been removed. That’s why it’s important to continue using effective birth control after treatment.

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® 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.

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