GYNECARE THERMACHOICE®

GYNECARE THERMACHOICE^® Uterine Balloon Therapy System 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.

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 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 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 When the treatment is completed, all the fluid is withdrawn from the balloon, and the catheter is removed.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.

Clinically proven safe and effective

Twelve month clinical study results showed:

• 81% of women treated with GYNECARE THERMACHOICE^® returned to normal levels of menstrual bleeding or lower¹

• 89% of patients in a study had a reduction of menstrual pain and cramping¹

• 96% of patients reported satisfaction with GYNECARE THERMACHOICE^® III¹

With over a million women treated worldwide² 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.

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.

What to Expect

Under local anesthesia, the doctor inserts a small silicone balloon into your uterus. The balloon is filled with fluid and then 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 that usually lasts about 2 weeks, but may last up to one month.

All medical procedures carry risks. Talk to a doctor to determine whether GYNECARE THERMACHOICE^® might be the right choice for you.

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..

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. However, pregnancies following ablation can be dangerous for both the mother and fetus. Therefore, 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

Talk to a Doctor About Heavy Periods

Many women don’t realize heavy periods – also known as menorrhagia – are a common, treatable condition.

GYNECARE THERMACHOICE^® Uterine Balloon Therapy System offers an effective, nonhormonal treatment for heavy periods.

Get the conversation started today. Based on your condition, there are questions you might want to ask your doctor or surgeon. The following questions are designed to help you find out more information about your particular condition and the kinds of treatment that may be right for you. The more informed you are, the more comfortable you'll be with the decision you, your family and your doctor make together.

1. What is the cause of my heavy periods?

2. What course of treatment do you recommend for me?

3. If I take hormones, will my condition improve?

4. What are the least invasive treatment options for heavy periods?

5. Am I a candidate for treatment with GYNECARE THERMACHOICE^® Uterine Balloon Therapy System?

6. Will treatment affect my ability to have children?

7. What are the potential risks associated with GYNECARE THERMACHOICE^®?

8. How soon after treatment can I resume normal activities?

9. Can this treatment be performed in your office?

10. Will I need to continue to use contraception after treatment?

11. May I talk to one of your patients who has been treated with GYNECARE THERMACHOICE^®?

12. If I need a hysterectomy, is there a minimally invasive option?

References:

1. Instructions For Use. Somerville, NJ: Ethicon, Inc; 2010

2. 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

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