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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.


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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