NovaSure FAQs

NovaSure FAQ

What is menorrhagia?

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.

How many women in the United States suffer from 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.

If left untreated, what are the physical and psychological consequences of heavy menstrual bleeding?

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.

What are the current treatment options for menorrhagia?

 

  • Hormone Therapy: Oral contraceptives or hormones to control a woman’s cycle are commonly used to treat problem periods caused by heavy menstrual bleeding. In May 2007, the FDA approved a new oral contraceptive that can stop a woman’s period altogether4. For women who would like to keep their child-bearing options open, this new type of hormone therapy may help to alleviate problem periods caused by heavy bleeding. However, research shows hormone therapy is effective in reducing or eliminating heavy periods in less than 50 percent of cases4 In another study, 77 percent of women who tried hormone therapy to treat heavy periods sought surgical treatment within five years5. A recent study demonstrates that the number one reason for discontinuation of hormone therapy is side effects, including headaches, weight gain and nausea6. Additionally, hormone therapy is not an option for women who are over 35, smokers, or have a history of cardiovascular disease, blood clots, diabetes or breast cancer.
  • Hysterectomy: The complete removal of the uterus and, in half of all cases, the ovaries — remains a very common treatment option for problem periods caused by heavy menstrual bleeding because it guarantees complete cessation of bleeding (amenorrhea). Six hundred thousand hysterectomies are performed each year in the United States: more than one-third of these are performed to alleviate heavy periods. However, hysterectomy remains a radical and highly invasive procedure that can be associated with a lengthy recovery period (typically six weeks) and potentially serious long-term side effects.
  • Endometrial Ablation: A minimally invasive outpatient procedure that permanently removes the uterine lining that causes menstrual bleeding. Endometrial ablation is safe, effective and requires minimal recovery time. The American College of Obstetricians and Gynecologists (ACOG) suggests that it is an appropriate first-line treatment option for women suffering from menorrhagia or patiently perceived heavy bleeding who have completed childbearing, bypassing the potentially less successful option of hormone therapy7.

 

What is the NovaSure System?

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.

Who is a candidate for the NovaSure procedure?

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.

What are the benefits of the NovaSure procedure?

 

  • Yields high overall success rates: A 2007 study published in The Journal of Reproductive Medicine found that five years after the NovaSure procedure, 75 percent of patients achieved amenorrhea (complete cessation of periods), and 98 percent had a reduction in bleeding significant enough to avoid hysterectomy10.
  • Improves Quality of Life: After treatment with the NovaSure procedure, women often see a dramatic improvement in their quality of life. They are significantly less restricted; anxiety, PMS symptoms and pain are reduced while self-confidence and energy levels increase11.
  • Performed in approximately 90 seconds: The length of time in which energy is delivered to the patient’s uterus is shorter than with any treatment currently available. The entire procedure takes an average of 4.5 minutes.
  • Performed in an outpatient or office setting: The procedure can be used with local anesthesia, with or without IV sedation, enabling rapid patient recovery. Furthermore, when performed at their own OB/GYN’s office, patients enjoy an added benefit of convenience when undergoing the procedure.
  • Requires no endometrial pretreatment: Patients need not undergo any kind of mechanical pretreatment (i.e. D&C) or hormone therapy to prepare for this procedure. Pretreatment can add 4-6 weeks to the therapy and is expensive. Furthermore, many women cannot tolerate the hormonal side effects of the pretreatment drugs. Eliminating the need for pretreatment also enables the procedure to be performed at any time during the menstrual cycle, even during active bleeding, thereby increasing flexibility for both the patient and the physician.
  • Provides ease of use: The NovaSure System is easy for physicians to learn and perform. Following insertion and deployment of the device, the ablation process is automated. Additional safety features make it the only technology that is designed to detect a perforated uterine wall prior to treatment.
  • Enables controlled and safe removal of the endometrium: The NovaSure System controls the amount of energy delivered to the uterine lining with its proprietary gold mesh electrode that conforms to the uterine cavity. The device continuously monitors tissue impedance and automatically terminates the procedure when the tissue impedance reaches a predetermined level, ensuring a controlled depth of ablation.
  • Reimbursement: The NovaSure System is covered by most insurance companies.

 

How is the NovaSure procedure performed?

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.

What do patients experience during and after the NovaSure procedure?

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.

Can women still become pregnant after having the NovaSure 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.

How can I find out more about NovaSure?

You can learn more about the NovaSure System, by reviewing all of the materials provided on our website, at www.NovaSure.com, and www.AboutHeavyPeriods.com; where you may read about the NovaSure clinical trial results, and hear patient testimonials.

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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