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Focus On: One Treatment for Heavy Periods
Overview: GYNECARE THERMACHOICE® Uterine Balloon Therapy System
If you’ve been reluctant to talk to your friends or your doctor about your heavy periods, you may not realize how common they are – or that you don’t have to accept the limits heavy periods can put on your lifestyle.
One effective treatment for heavy periods is a global endometrial ablation (GEA) procedure called GYNECARE THERMACHOICE® Uterine Balloon Therapy System. GYNECARE THERMACHOICE® is an effective, nonhormonal, permanent 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.
A clinical study showed:
* 95% of women treated with GYNECARE THERMACHOICE® Uterine Balloon Therapy System reported normal to no periods up to 5 years later
* 3 out of 4 women treated had reduction of menstrual pain and cramping
* Nearly 2 out of 3 experienced either mild or no PMS symptoms after treatment
* 93% reported they were still satisfied with the results 5 years after treatment
A Solution: GYNECARE THERMACHOICE® Uterine Balloon Therapy System
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® Uterine Balloon Therapy System 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. Safe and effective
There are different 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 are also performed to treat heavy periods – in fact, 20% of the 600,000 hysterectomies performed annually are to treat heavy periods. 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.
How Does GYNECARE THERMACHOICE® Uterine Balloon Therapy System 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. If it’s right for you.
Clinically proven safe and effective
A clinical study showed:
* 95% of women treated with GYNECARE THERMACHOICE® reported normal to no periods up to 5 years later.
* 3 out of 4 women treated had reduction of menstrual pain and cramping.
* Nearly 2 out of 3 experienced either mild or no PMS symptoms after treatment.
* 93% reported they were still satisfied with the results 5 years after treatment.
With over half a million women treated worldwide, GYNECARE THERMACHOICE® is clinically proven safe and effective.
Who’s a Candidate for GYNECARE THERMACHOICE® Uterine Balloon Therapy System?
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® Uterine Balloon Therapy System 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
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® Uterine Balloon Therapy System?
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.
Risk Information
GYNECARE THERMACHOICE® Uterine Balloon Therapy with Fluid Circulation
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: 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; or who is pregnant or who wants to become pregnant in the future.
POTENTIAL ADVERSE EFFECTS that may occur 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); 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 a perforation is present, and the procedure is not terminated, thermal injury to adjacent tissue may occur if the heater is activated.
CAUTION: 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), and who have adequate training and familiarity with GYNECARE THERMACHOICE® System. Rx Only.
For more information, please consult your doctor or call 1-888-GYNECARE to speak with a nurse.
Read more articles about Heavy Periods:
- Heavy Periods Overview
- About Fibroids
- Treatments for Heavy Periods
Click here to check your symptoms:
http://www.pelvichealthsolutions.com/assess-your-symptoms/getStarted
Click here to download questions to ask your doctor: http://www.pelvichealthsolutions.com/thermachoice-talk-to-doctor
Click here to find a doctor in your area who can perform this procedure:
http://www.pelvichealthsolutions.com/physician_locator
GYNECARE THERMACHOICE® Uterine Balloon Therapy System is a registered trademark of ETHICON Women's Health & Urology, a division of ETHICON, INC., a Johnson & Johnson Company.
