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.
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