Alternatives to Hysterectomy : Not For Everyone

by Food and Drug Administration (FDA)

(Page 2 of 4)

"Each type of ablation represents a simpler surgical procedure for doctors compared to traditional operative hysteroscopy," says Colin Pollard, a biomedical engineer and chief of the ob/gyn devices branch in the FDA's Center for Devices and Radiological Health. "All of the technologies have some things in common, but each delivers energy differently and each offers different feedback mechanisms to the doctor during the procedure."

The ThermaChoice Uterine Balloon Therapy System, manufactured by Gynecare, a division of Ethicon Inc. of Somerville, N.J., consists of a balloon that is inserted through the neck of the womb (cervix) and into the uterus. Through a catheter connected to a controller console, the balloon is inflated with fluid and heated to 188 F (87 C) for eight minutes to destroy the uterine lining.

The first of the three newer devices — the Hydro ThermAblator manufactured by BEI Medical Systems Inc. of Teterboro, N.J. — delivers hot salt water (saline solution) into the uterus through a tube inserted into the cervix. The hot water destroys the uterine lining in about 10 minutes. The doctor uses a hysteroscope for viewing the uterus during the procedure.

The second device — Her Option Uterine Cryoblation Therapy System made by CryoGen Inc. of San Diego — uses a probe capable of producing temperatures down to minus 148 F (minus 100 C) at the tip. This extreme cold is applied to the tissue for 10 minutes to freeze and destroy the uterine lining. Ultrasound is used to guide and monitor the procedure.

The third device — the NovaSure Impedance Controlled Endometrial Ablation System manufactured by Novacept of Palo Alto, Calif. — uses a metallic mesh triangular electrode that is expanded out of a slender tube into the uterus. A gentle suction brings the tissue into close contact with the triangular electrode, which delivers electrical current to the endometrial tissue, causing its destruction in about 90 seconds. With this method, there is no hysteroscope or ultrasound, so the doctor cannot view the uterus during the procedure.

Not For Everyone

Endometrial ablation is not advised for women who want to have children, and it is not a form of birth control. "Doctors must tell the patient she should still maintain contraception," says Pollard. "If she does get pregnant, it will be a very high-risk pregnancy." If pregnancy were to occur, the cells left lining the uterus may not be adequate for a fetus to attach and grow within the uterus.

The ThermaChoice balloon method has the longest track record of the newer, simpler ablation techniques. A three-year study of this device and one-year studies of the ablation devices approved this year — the Hydro ThermAblator, Her Option, and NovaSure — showed similar rates of effectiveness and were comparable to the effectiveness of operative hysteroscopy (such as the rollerball technique). They all reduced or stopped bleeding in 70 percent to 80 percent of the women tested.

Unlike a hysterectomy, the newer endometrial ablation procedures can be performed with local anesthesia. Ablation is usually done in the hospital on an outpatient basis; however, some women remain overnight to treat the severe abdominal pain they may experience. Most women are able to return to their regular activities several days later.

Common side effects after the procedure include nausea, vomiting, and a vaginal discharge that can last from days to weeks. "Expect to have bleeding up to four to six weeks," says Malcolm Munro, M.D., a professor and gynecologist at UCLA. "With ablation, you are traumatizing the surface whether you use electrosurgery, or burn it or freeze it."

Complications of ablation are rare, but may include blood loss requiring a transfusion, perforation of the uterus, or unintended damage to other internal organs.

Newer approaches to endometrial ablation are currently under investigation; these use other energy sources, such as laser and microwave, to destroy the endometrial tissue.

A Personal Choice

A woman must decide what she expects from a treatment for abnormal uterine bleeding. "Women need to know that articulating their problem is important for treatment," says Munro. "With abnormal bleeding, the desired outcomes vary. Some women want no period, some want a predictable period. Some want to slow the bleeding, for others pain is more important than volume. Some want to maintain their ability to get pregnant. Some don't want scars; some don't care about scars. Time off is a consideration. All of these factors are impossible for a doctor to aggregate for the patient. The woman has to make the decision."

Many women are satisfied with the outcomes of their endometrial ablations. But others, like Melissa Otto of Minneapolis, are disappointed.

Otto's hormonal introduction to womanhood — when she was 12 — was frightening. Shortly after the onset of menstruation, her monthly period became very heavy and lengthy. By the time she was 14, Otto was extremely anemic from the blood loss. "The doctors told my parents not to worry — that eventually I'd regulate and have a normal period. They said 'Let's just treat the anemia for now.'"

But Otto's bleeding was no more regular by the time she reached her 20s. Medical tests ruled out fibroids and other abnormalities. Despite trying many different types of birth control pills prescribed by her doctor, her periods continued to get heavier. They came about every 23 days and lasted for 12 to 13 days. Otto spotted during the 10 days a month she wasn't bleeding heavily.

In desperation, Otto tried hormone injections, homeopathic remedies, chiropractic medicine, blood-building supplements, and acupuncture. Nothing worked.

In May 1999 when she was 31, Otto had an endometrial ablation. Her doctor used a laser to destroy the endometrial tissue. After five weeks of watery discharge and spotting, Otto's periods resumed and became frequent and lengthy once more.

In July 2000, Otto checked into the hospital for a second endometrial ablation — this time a balloon ablation. Four weeks later, her period returned — a little lighter — but still long.

After 20 years of problem periods, a dozen different doctors, hormone treatments, two ablations, and a bout of cervical cancer along the way, Otto had had enough. In March 2001, she had a hysterectomy, and Otto says that she is very happy with the results.

About the Author

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