The GYNECARE THERMACHOICE Uterine Balloon Therapy System is a one-day treatment option designed to end heavy menstrual flows by removing the lining of the uterus.
This medical device resolves heavy menstrual periods (clinically known as menorrhagia) due to benign causes in premenopausal women who have completed childbearing. Unlike hysterectomy, which takes out the entire uterus, the device only treats the lining of the uterus with heat through a process called endometrial ablation.
GYNECARE THERMACHOICE has been used by physicians for 8 years and has been used in more than half a million women worldwide. It is now being used during a minimally invasive 8-minute treatment that can be performed with a local anesthetic in the convenience of a gynecologist's office, eliminating the need to go to the hospital and making it easier to schedule it into your busy life. Recovery is fast and most women can return to their normal activities by the next day.
Women are eligible for GYNECARE THERMACHOICE if they:
- Are unable to, or do not wish to, take long-term hormone therapies
- Have completed childbearing but wish to retain their uterus
- Do not have abnormal uterine conditions
- Have not reached menopause
Before the treatment starts, your gynecologist will talk to you about the procedure and how you may expect to feel during it. Then your doctor will give you a local anesthetic to minimize the discomfort you may feel while the treatment is taking place.
Then, a soft, flexible balloon attached to a thin catheter is inserted into the vagina, through the cervix, then into the uterus. The balloon is inflated with a small amount of sterile fluid and expands to conform to the shape of the uterus. Next, the fluid in the balloon is heated and the temperature is maintained for 8 minutes while the uterine lining is treated. When the treatment cycle is completed, the fluid is withdrawn and the catheter is removed and discarded. The uterine lining will slough off in the next 7 to 10 days.
The first postoperative check-up usually occurs within 7 to 10 days after the procedure, and 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 your doctor to determine whether GYNECARE THERMACHOICE might be the right choice for you.
Below you will find answers to frequently asked questions about GYNECARE THERMACHOICE.
What are the benefits of GYNECARE THERMACHOICE Endometrial Ablation?
GYNECARE THERMACHOICE Endometrial Ablation offers a treatment that is safe and effective. It can be performed right in your doctor's office and require no incision. Our soft and flexible balloon will conform to most uterine shapes and sizes for exceptional efficacy.
GYNECARE THERMACHOICE is the only technology of its kind with clinical term data at 1, 3, and 5 years, with 95% patient satisfaction at 5 years. GYNECARE THERMACHOICE has a proven safety profile with an extremely low rate of complications.
Are women satisfied with the results of GYNECARE THERMACHOICE?
Yes, they are. In fact, while there are other ablation technologies, GYNECARE THERMACHOICE is the only one where:
- 95.1% of women are satisfied with the result after 5 years.
- Prior to the procedure, more than 70% of these women felt that their heavy periods had been having a negative impact on their lives. Following treatment, only about 2% felt that way after 3 years.
- Nearly 3 out of 4 women treated 3 years (post-treatment) experienced a reduction in menstrual pain and cramping associated with their period.
- Nearly 2 out of 3 women reported mild or no PMS symptoms at 3 years.
- Three years after being treated, 79% of women had either normal, light or no bleeding at all.
What results can I realistically expect from the GYNECARE THERMACHOICE procedure?
If you are a good candidate for GYNECARE THERMACHOICE, you can expect excellent results. 95% percent of the women who had the GYNECARE THERMACHOICE treatment 5 years ago are still happy with the results. Successful treatment will result in a reduction of your menstrual flow to normal levels or less. Eighty-five percent of women can expect light to moderate periods. Some women even experience a complete elimination of uterine bleeding.
GYNECARE THERMACHOICE is a procedure designed for premenopausal women whose excessive bleeding is due to benign (non-cancerous) causes. It's also important to remember that this is not the right treatment for you if you plan on having children. This treatment destroys the endometrial lining of the uterus, which is necessary to carry a pregnancy to full term.
How does GYNECARE THERMACHOICE treat excessive menstrual bleeding?
GYNECARE THERMACHOICE Uterine Balloon Therapy System uses heat to treat the uterine lining (or endometrium) while leaving the rest of the uterus intact and in place. This process (thermal ablation) removes the primary source of menstrual bleeding.
How would you describe the GYNECARE THERMACHOICE procedure?
After local anesthesia and possible a sedative are administered (general anesthesia is also available for this procedure), a balloon catheter is inserted vaginally, through the cervix and into the uterus. The balloon is inflated with a small amount of sterile fluid to conform to the shape of the uterus. This fluid is then heated to approximately 87 degrees Celsius (188 degrees Fahrenheit). This temperature is maintained for 8 minutes. Although this may seem very hot, most women experience no pain or sensation of heat during the procedure.
After the treatment has been completed, the balloon is deflated and the balloon catheter is withdrawn and discarded. The heated balloon, in contact with the uterine lining, treats the endometrium, which will slough-off (or shed) over the next 7-10 days. Patients are usually able to go to work the very next day.
Will I be awake during the procedure?
GYNECARE THERMACHOICE can be performed using pure local anesthesia in your doctor's office as well as under general anesthesia as an outpatient procedure in the hospital according to the patient's preference.
Will I experience any pain during the procedure?
Most women, when treated under local anesthesia, will experience cramping, which can be managed effectively with medication. Most patients do not feel a strong sensation of heat during the procedure.
What kind of recovery time can I expect?
You can expect to rest under supervised care until comfortable. After resting at home, you will probably be able to resume normal activities the next day.
What post-procedural effects should I expect?
Although some patients experience minimal to no pain or cramping post-operatively, the majority of patients will experience moderate cramping during the first day. Your doctor will probably prescribe an anti-inflammatory pain reliever (such as Motrin IB) if necessary. Additionally, patients usually experience vaginal discharge or spotting, which normally changes to a watery discharge. This can last for several weeks. This discharge is normal and part of the healing process.
Are there fertility issues associated with the GYNECARE THERMACHOICE treatment?
Yes. This treatment is intended for use by women who have already completed childbearing. The procedure removes the endometrial lining that must be intact to bring normal pregnancy to term. However, because it does not always treat the entire uterine lining, there is still a chance pregnancy could occur. Contraception should be used after treatment.
What if the balloon breaks during the procedure?
In the rare event that the balloon breaks, fluid would leak out the vagina and a new balloon would be inserted.
I've never heard about GYNECARE THERMACHOICE Uterine Balloon Therapy System. Is this treatment widely used?
More than 500,000 women worldwide have been treated with GYNECARE THERMACHOICE. Ninety-five percent of the women who have had the therapy using GYNECARE THERMACHOICE are still happy with the results after 5 years.
Is GYNECARE THERMACHOICE procedure covered by insurance?
GYNECARE THERMACHOICE procedure is covered by most insurance plans.
Essential Product Information [pdf 430 KB]
