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Wed, 03/25/2009 - 18:20 — admin

A Solution: GYNECARE THERMACHOICE® Uterine Balloon Therapy System

GYNECARE THERMACHOICE® is a soft, flexible balloon that a doctor inserts in the uterus (womb) to treat the endometrium, the lining of the uterus. GYNECARE THERMACHOICE® is an effective, nonhormonal 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.

There are a number of options for managing heavy periods. Most doctors recommend birth control pills initially to manage heavy periods, but for many women, this option is either ineffective or undesirable. They can cause weight gain, moodiness and breast tenderness, and may not ultimately be effective in reducing heavy periods.

Hysterectomies may also be performed to treat heavy periods. There are approximately 600,000 hysterectomies performed annually in the US.1 A hysterectomy is major surgery with a long recovery time and may be avoidable.

If birth control pills have not been effective in reducing your heavy periods, global endometrial ablation (GEA) treatments like GYNECARE THERMACHOICE® may offer an effective option.2

How does GYNECARE THERMACHOICE® work?

GYNECARE THERMACHOICE® uses a method called global endometrial ablation (GEA) to remove the endometrium, the lining of the uterus.

Here’s how it works:

  1. A small soft, flexible balloon attached to a thin catheter (tube) is first passed through the vagina and cervix, and then placed gently into the uterus. No incision is required. The balloon is made of silicone material, eliminating the risk of allergy for latex-sensitive women.

  2. The balloon is then filled with fluid so that it inflates to the unique contours of the uterus.

  3. The fluid is gently heated and circulated in the uterus for 8 minutes while the lining of the uterus is treated.

  4. When the treatment is completed, all the fluid is withdrawn from the balloon, and the catheter is removed. Nothing remains in the uterus. The treated uterine lining will shed, like during a period, over the next 7-10 days.

In most cases, patients can resume normal activities the next day. Learn more about what to expect from treatment or find a doctor who can provide treatment.

Clinically proven safe and effective

A clinical study showed:

  • 95% of women treated with GYNECARE THERMACHOICE® returned to normal levels of menstrual bleeding or lower3

  • 89% of patients in a study had a reduction of menstrual pain and cramping4

  • 96% of patients reported satisfaction with GYNECARE THERMACHOICE® III4

With over a million women treated worldwide,5 GYNECARE THERMACHOICE® is clinically proven safe and effective.

Who’s a candidate for GYNECARE THERMACHOICE®?

You may be a candidate for GYNECARE THERMACHOICE® if you meet the following criteria:

  • You are a premenopausal woman who is finished having children but wish to retain your uterus

  • Your heavy periods are the result of hormonal imbalance or associated with certain fibroids.

  • You have normal Pap smears and biopsy (tissue samples from inside the uterus) and no abnormal uterine conditions, including uterine cancer or precancerous conditions.

  • You prefer not to take hormone therapy, or if treatment with birth control pills has failed to reduce your heavy periods.

Women using an intrauterine device (IUD) for birth control must have the device removed before treatment.

A doctor can help you determine if GYNECARE THERMACHOICE® is right for you. Find a doctor who can provide treatment.

You may not be a candidate for GYNECARE THERMACHOICE® if you are pregnant or plan on becoming pregnant, if you’ve had a prior classical Caesarean section, or if you’ve had malignant (cancerous) tissue in this area of the body before. Again, a doctor can help you make the best treatment choice for you.

References:
1. Keshavarz H, Hillis SD, Kieke BA, Marchbanks PA, Hysterectomy Surveillance -- United States, 1994-1999. Morb Mortal Wkly Rep CDC Surveill Summ. 2002; 51 (SS05): 1-8.
2. ACOG Practice Bulletin. Clinical Management Guidelines for Obstetrician-Gynecologists. Number 14, March 2000.
3. 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 Gyn Lap. 2002; 9(4): 429
4. Instructions For Use. Somerville, NJ: Ethicon, Inc; 2009
5. Data on file, Ethicon, Inc., Somerville, NJ

 

Next: What to Expect

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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