More women are choosing NovaSure because it has been shown to be safe, simple, and successful.
NovaSure uses radio frequency (RF) energy to permanently remove the lining (endometrium) of the uterus, which reduces, or eliminates, future bleeding. Here's a look at what happens during the procedure to help you know what to expect:
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Menorrhagia is the clinical term for menstrual periods that are heavy and/or long lasting. In May 2007, the American College of Obstetricians and Gynecologists (ACOG) issued new guidelines for defining menorrhagia. They suggest that women with patient-perceived heavy menstrual bleeding should be considered candidates for FDA-approved treatment options for heavy periods.
According to the National Women’s Health Resource Center (NWHRC), problem periods caused by heavy menstrual bleeding afflict as many as one in five women. That means in the United States, approximately 10 million women suffer from the condition, including one-third of all baby boomers1.
Women suffering from heavy periods may experience symptoms ranging from severe pain and fatigue to emotional turmoil and embarrassment. No matter what the symptoms, heavy menstrual bleeding can be restrictive on a woman’s lifestyle and social activities and may result in missed time from work.
In a recent survey of women with problem periods caused by heavy menstrual bleeding, nearly 60 percent reported a lack of confidence because of their periods. Nearly 70 percent felt they could not perform effectively at work or other activities and often missed plans or athletic events. Approximately 80 percent claimed that their periods sapped them of energy and even caused anxiety2.
Heavy menstrual bleeding is also a common cause of iron deficiency anemia (low blood count with low iron). According to a 2005 survey conducted by the National Women’s Health Resource Center (NWHRC), nearly 40 percent of women with menorrhagia developed anemia3.
The NovaSure System, manufactured and marketed by Hologic, Inc., is an endometrial ablation device that uses precisely measured radio frequency energy delivered via a slender, hand-held wand to remove the uterine lining (also known as the endometrium). The NovaSure System provides an effective and minimally invasive outpatient alternative to hysterectomy, while avoiding the potential side effects and long-term risks of drug therapy.
In May 2007, the American College of Obstetricians and Gynecologists (ACOG) issued revised guidelines for treatment with endometrial ablation, concluding that the treatment is indicated for premenopausal women with patient-perceived heavy menstrual bleeding8. Potential NovaSure candidates are women who have completed their families and whose lifestyles are significantly impacted by their periods, meaning any woman who has to adjust her social and professional schedule or is otherwise restricted because of her period. According to the revised guidelines, a woman does not have to have failed hormone therapy before being considered for the NovaSure procedure9. Diagnostic tests should be performed to rule out other abnormal uterine conditions and a woman’s Pap test and biopsy must be normal.
The NovaSure procedure is typically performed in an outpatient surgery setting, involving local anesthesia with IV sedation or general anesthesia, depending on the surgeon’s recommendation. After slight dilation of the cervix, a slender wand is inserted through the cervix into the uterus, and a gold-plated mesh triangle is expanded out of the wand. This triangular mesh imitates the shape (both length and width) of the uterine cavity, allowing physicians to offer individualized treatment for each patient regardless of the size or shape of their uterus. Next, gentle suction is applied, bringing the uterine tissue into close contact with the mesh triangle. Radio frequency energy is then delivered to the entire endometrium for approximately 90 seconds. The triangle is then retracted and the wand removed. This application of energy is intended to permanently remove the lining of the uterus, thereby reducing or eliminating future menstrual bleeding.
The NovaSure procedure does not require general anesthesia. As a result, many doctors prefer to have their patients awake or lightly sedated during the procedure. Local anesthetic is injected in and around the cervix and physicians may administer an intravenous sedative to make patients more comfortable. While some women may feel slight, menstrual-like cramping during the procedure, others may experience no discomfort at all.
Patients may experience some post-operative uterine cramping and discomfort which can generally be treated with mild pain medication such as Ibuprofen. Some patients may experience nausea and vomiting as a result of the anesthesia. After the NovaSure procedure patients may spend approximately two hours recovering before being sent home. Watery and/or bloody discharge is also common after any endometrial ablation for several weeks after the procedure.
It is important to know that although the chances for pregnancy are reduced following an endometrial ablation procedure, it is still possible to become pregnant. Women who think they may want to have a child in the future should not have the NovaSure procedure. Pregnancy following the NovaSure procedure is very dangerous for both the mother and the fetus.
1.) The National Women’s Health Resource Center. Prevalence and Treatment Patterns of Pelvic Health Disorders Among U.S. Women. Pelvic Health Disorders. 2007.
2.) Hologic, NovaSure Clinical Trial Survey Data, 2007
3.) The National Women’s Health Resource Center. Survey of Women Who Experience Heavy Menstrual Bleeding. 2005.
4.) Cooper KG, Parkin DE, Garratt AM, et. Al. Br J Obstet Gynaecol Randomised comparison of medical and hystereoscopic management in women consulting a gynaecologist for treatment of heavy menstrual loss.1997;104:1360-1366.
5.) Cooper KG, Jack SA, Parkn DE, Grant AM, et. Al. Five-year follow up of women randomized to medical management or transcervical resection of the endometrium for heavy menstrual loss: clinical and quality of life outcomes. Br J Obstet Gynaecol. 2001;108:1222-1228.
6.) BioVid Corporation. Menorrhagia Treatment Wave 4 Tracking Study Report. June 2007.
7.) Munro, Malcom D , “ACOG Practice Bulletin Clinical Management Guidelines for Obstetrician-Gynecologists: Endometrial Ablation.” Obstetrics and Gynecology Vol. 109, no.5 pp 1233-1248 May 2007.
8.) Ibid. 9.) Ibid. 10.) Gallinat, A. The Journal of Reproductive Medicine NovaSure impedance controlled system for endometrial ablation: Five-year follow-up on 107 patients. 2007;7: 467-472.
11.) See note 2 above.
Answer the questions below. If you answer "yes" to any of these questions, you may be a candidate for this minimally invasive treatment.
Endometrial ablation procedures commonly reported post-operative events include the following¹:
As with all endometrial ablation procedures, serious injury or death can occur. The following adverse effects could occur or have been reported in association with the use of NovaSure¹:
It is important to know that although the chances for pregnancy are reduced following an endometrial ablation procedure, it is still possible to become pregnant.
However, pregnancy following endometrial ablation is very dangerous for both the mother and the fetus. You should not have an endometrial ablation if you think you want to have a baby in the future. After an endometrial ablation, you should use some form of birth control. Please discuss these issues with your physician.
1. NovaSure Instructions for Use, Hologic Inc.
"We want women to know there is a safe and simple alternative for the treatment of menstrual problems," said Dr. Scott Schade M.D., an obstetrician/gynecologist at Rockwood Clinic in Spokane, Washington, who treated the one millionth NovaSure patient.
Dr. Schade has performed more than 500 NovaSure procedures and believes the "NovaSure system is the safest, simplest and most effective ablative technique now available. It often can be performed in the office setting and requires minimal anesthesia; many patients go to work the next day. Hysterectomy or long-term hormonal therapies are no longer the only choices; women need not suffer in silence."
Yvette Cornmesser, a mother of two, was the one-millionth NovaSure patient. Yvette began experiencing heavy and prolonged menstrual periods approximately one year ago. "Around my fortieth birthday, I first told my doctor that my menstrual periods were getting heavier. My doctor tried to regulate my cycle by changing my birth control prescription, but this new pill did not help to lessen my bleeding. I became increasingly worried that I’d have an accident in public. After speaking with some friends and almost canceling my birthday dinner, I decided to talk to my doctor again about my cycle to discuss alternative options."
Yvette’s doctor referred her to Dr. Schade who suggested she have the NovaSure procedure. NovaSure effectively treated Yvette’s symptoms in a matter of minutes, allowed her to avoid hysterectomy and regain the confidence that living with problem periods took away from her. "NovaSure gave me back my life," says Yvette.
1. Hologic, Data on file, 2009.
The NovaSure procedure is a quick, safe, simple, one-time endometrial ablation treatment. This minimally invasive procedure controls heavy bleeding by using energy to remove the lining of the uterus. The average treatment time is about 90 seconds¹ , and only needs to be performed once to lighten or stop your periods. No pretreatment drugs are required and NovaSure can be performed in the hospital or in your doctor's office.
Without the side effects of hormones or the risks of hysterectomy, NovaSure has a quick recovery time so you can get back to your life sooner. Most women experience no pain after the procedure, and can return to work and regular activities the next day.
With more than 500,000 patients treated to date², NovaSure is proven safe and successful. A clinical trial has shown that more than 9 out of 10 women return to normal or lower than normal bleeding levels following treatments with NovaSure .³ For some women, their periods even stopped completely.
Many women also experienced a reduction in PMS and painful periods, as well as other benefits such as less anxiety, greater self-confidence, and a boost in energy. NovaSure clinical trial post treatment survey results reveal,
Many women find that treatment with NovaSure frees them up to enjoy more of what life has to offer. According to the NovaSure clinical trial post treatment survey, 4 out of 5 women report spending more time at work and daily activities and missing fewer social and athletic events because of heavy bleeding.
A half a million women to date have chosen NovaSure to reduce or eliminate their heavy periods and improve their quality of life. Women are very pleased with the results of the NovaSure procedure; 97% say they would recommend NovaSure to other women.³
NovaSure is a procedure for premenopausal women for whom childbearing is complete. If you do not plan to have children in the future, you may want to consider endometrial ablation. In a small percentage of patients, side effects included cramping, nausea/vomiting, discharge, and spotting.
1. NovaSure Instructions for Use.
2. Hologic, Data on file.
3. Cooper J, Gimpleson R, Laberge P, Galen D, Garza-Leal J, Scott J, Leyland N, Martyn P, Liu J: A randomized, multicenter trial of safety and efficacy of the NovaSure® System in the treatment of menorrhagia. J Am Assoc Gynecol Laparoscop 2002;9(4):418-28.
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