Question: Can a new procedure called the NovaSure Ablation System be utilized in a Catholic health care setting?

This procedure is intended for the treatment of excessive menstrual bleeding called menorrhagia, due to benign causes in pre-menopausal women who have completed childbearing. It is estimated that 1 in 5 women experience excessive menstrual bleeding that can result in fatigue, anemia, embarrassing accidents and restricted activity. The NovaSure Ablation System is the newest endometrial ablation treatment option available to these women. The concerns raised about the procedure ranged from whether it was a form of direct sterilization to whether it could be performed in any Catholic medical facility considering that one of the contraindications for the procedure is that future pregnancy should be avoided. Pregnancies following endometrial ablation can be dangerous to both the mother and the fetus. As a result, it is recommended that women who use this procedure should use some form of birth control if they decide to undergo the NovaSure endometrial ablation procedure. This is a relatively new procedure that was approved by the Food and Drug Administration (FDA) on September 28, 2001 and declared safe and effective based on the results of pre-clinical and clinical studies.

Under the ethical principles of respect for persons, beneficence and nonmaleficence this procedure is ethical and can be performed in Catholic hospitals.

Respect for persons refers to the right of a person to exercise self-determination and to be treated with dignity and respect. One of the fundamental elements of a physician-patient relationship is the right of a patient to receive information from physicians and to discuss the benefits, risks, and costs of appropriate treatment alternatives. This obligation by physicians includes within the obligation to inform patients of all current medical options available to them for a particular condition. The NovaSure Ablation System is one of various options open to women who are experiencing menorrhagia. Because of the risks and benefits associated with  the other options, the first option should always be the drug therapy option of using estrogen-progestogen combinations or progestogens alone. This therapy is the safest and allows the woman to maintain her fertility. However, if this is unsuccessful then the D & C would be the next step to control the excessive bleeding. This does not provide the patient with long-term definitive results but in combination with the drug therapy it allows women to maintain their fertility. Of the ablation methods, it appears that the NovaSure System is the safest and most effective. It is also a less risky method and a less invasive alternative than a hysterectomy which should be the last option. While the NovaSure System has its risks, they are far less than a hysterectomy which is a major surgical procedure with its accompanying surgical and anesthesia risks and has a lengthy recovery period.  

Birth control is an issue with this procedure. The Ethical and Religious Directive for Catholic Health Care Services state clearly that “Catholic health institutions may not promote or condone contraceptive practices but should provide, for married couples and the medical staff who counsel them, instruction both about the Church’s teaching on responsible parenthood and in methods of natural family planning.”[1] The NovaSure Ablation procedure is for women who have excessive uterine bleeding that can cause serious health problems. Many of the women this effects are celibate women and birth control would not be an issue for them. Married women should be instructed about the dangers of becoming pregnant after the NovaSure Ablation procedure and should be instructed on the proper use of Natural Family Planning (NFP). In good conscience, however, the physician should explain to the women that there are other methods of birth control available to them that may also reduce their chances of becoming pregnant. Patients have a right to be informed about the advantages and disadvantages of any treatment as well as about all viable alternatives. Unless patients are told about the other birth control options available to them, they cannot give informed consent. Giving each person this information does not violate Directive 52 because the physician can clearly state that the Catholic Church only approves of NFP and that if used correctly and consistently it can help the woman avoid possible pregnancies in the future. Failure to give all the options available to protect the health of the woman and her fetus, if the woman should become pregnant, would violate the basic dignity and respect that all persons deserve.

Beneficence involves the obligation to prevent and remove harm to and to promote the good of the person by minimizing possible harms and maximizing possible benefits. Beneficence includes nonmaleficence, which prohibits the infliction of harm, injury, or death upon others. In medical ethics this principle has been closely associated with the maxim Primum non nocere: “Above all do no harm.” After examining the possible options for a woman with excessive uterine bleeding, it appears that the NovaSure Ablation System is both the most effective and the safest of the new generation of endometrial ablation devices. As stated above, drug therapy should be the first treatment option but it is only effective about 50% of the time and usually must be continued in order to remain effective. The D & C procedure can be a second tier option used if drug therapy is ineffective but it is only a temporary solution that reduces bleeding for a few cycles. Conventional endometrial ablation removes the lining of the uterus with an electrosurgical tool or laser and effectively reduces the bleeding in approximately 85% of patients. The risks however include perforation of the uterus, bleeding, infection and even heart failure due to fluids used to open or distend the uterus.[2] The new generation of endometrial ablation devices destroy the endometrium by using either heated fluid or freezing temperatures to destroy the tissue.  These options are intended for women who no longer desire to maintain their fertility.[3] The benefits of the NovaSure Ablation System clearly outweigh these alternative options because it is safer, more effective, less invasive, and does not destroy the endometrium and cause the woman to become sterilized. In addition, prior to other endometrial ablation procedures, patients often need to take a pretreatment drug such as Lupron for 1 to 2 months to thin the lining of the uterus. No pre-treatment drugs are needed with the NovaSure Ablation System.[4]

The only other treatment alternative is a hysterectomy. As stated above, a hysterectomy is a major surgical procedure performed in the hospital under general anesthesia and is associated with the risks and complications of major surgery. Some complications include blood clots, infection, excessive bleeding or an adverse reaction to the anesthesia. Other risks are:

  1. Damage to the urinary tract, bladder or rectum during surgery, which may require further surgical repair.
  2. Loss of ovarian function.
  3. Early onset of menopause[5]

In addition to the hospitalization, depending on the technique used, a recovery period of up to six weeks is not uncommon. By contrast, the pre-clinical, clinical and post-approval data on the NovaSure Ablation System shows this procedure to be more beneficial to women than a hysterectomy. One major advantage over a hysterectomy is that this procedure is a minimally invasive outpatient alternative.  General anesthesia and its possible complications are avoided because the NovaSure procedure is usually done with local anesthesia with or without IV sedation. The NovaSure Ablation System has also been shown to improve the quality of life of those women who have undergone this procedure. In randomized, controlled clinical studies on this procedure a majority of patients had their bleeding reduced to light or moderate periods, and many reported that their bleeding had stopped completely. In addition, many women have experienced significant reduction in painful menstruation as well as meaningful reduction in PMS symptoms.[6] There are certain post-procedure complications that can be associated with this procedure. These include the fact that one can develop a fever, nausea, vomiting, shortness of breath, dizziness, bowl or bladder problems, and/or a greenish vaginal discharge. However, clinical studies have shown these complications to be minimal. Most women can return to normal activities within a day or two of their treatment. Sexual activity can be resumed after the patient’s first check-up, usually 7 to 10 days after the procedure. Surgical risks can be perforation of the uterus, bleeding, infection, injury to organs within the abdomen and pelvis and the accumulation of blood within the uterus due to scarring. Another important risk is that it may decrease the doctor’s ability to diagnose cancer of the endometrium.[7] Despite these possible complication and risks, the clinical data collected to date confirms that the benefits and advantages of the NovaSure Ablation procedure clearly outweigh its risks. By comparison to the other endometrial ablation procedures and a hysterectomy, the NovaSure Ablation procedure is safer, less invasive and more cost effective.  Ethically, the NovaSure Ablation procedure respects the autonomy of the patient by giving the woman a procedure that is safer and more effective and it clearly passes the test of beneficence and nonmaleficence.

Conclusion: The NovaSure Ablation procedure is not only an effective and safe modality in the treatment of patients suffering from excessive menstrual bleeding; it also has a very low complication rate and avoids all endometrial pretreatments. This procedure is accomplished within 90 seconds and can easily be performed under IV sedation and paracervical block anesthesia in an office setting. The medical benefits and the cost effectiveness of this procedure make it a very viable option to a hysterectomy, which under most circumstances is the last option for a woman with menorrhagia. There is the issue that women who undergo this procedure should avoid future pregnancies for their own health and the health of the fetus. However, in many circumstances, particularly with celibate women, this is not an issue. For those who are married, the physician should explain the option of NFP, along with other options to satisfy the ethical principle of informed consent. This should satisfy the birth control issue that concerns some about allowing this procedure in a Catholic health care facility.  Under these circumstances, it appears that the NovaSure Ablation System is not only ethical but should be utilized in Catholic facilities for the good of women suffering from menorrhagia.

 


[1]United States Conference of Bishops, Ethical and Religious Directives for Catholic Health Care Services, fourth edition, Washington, D.C., 2002, Directive 52, p. 28.

[2] Education Department-Novacept, Inc, p. 4.

[3] Education Department-Novacept, Inc, p. 4.

[4] Education Department-Novacept, Inc, p. 2.

[5] Mayo Clinic Staff, “Hysterectomy: Benefits and Alternatives,” Mayo Clinic Health Information, March 15, 2004, pp. 1-5. http://www.mayoclinic.com/invoke.cfm?id=HQ00905

[6] Education Department-Novacept, Inc., p. 4. See also, FDA, “Summary of Safety and Effectiveness Data,” p. 19.

[7] Education Department Novacept, Inc., p. 5.