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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 When the treatment is completed, all the fluid is withdrawn from the balloon, and the catheter is removed.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 familiar with GYNECARE® products who can provide treatment.

Clinically proven safe and effective

A clinical study showed:

  • 81% 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 cramping3

  • 96% of patients reported satisfaction with GYNECARE THERMACHOICE® III3

With over a million women treated worldwide,4 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 familiar with GYNECARE® products 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. GYNECARE THERMACHOICE® III Uterine Balloon Therapy System Instructions For Use. Somerville, NJ: Ethicon, Inc
4. Data on file, Ethicon, Inc., Somerville, NJ

 


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

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.
© Ethicon, Inc. 2000-2013.

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