Uterine Fibroids Treatments

by Food and Drug Administration (FDA)

Uterine fibroids, one of the most common noncancerous gynecological conditions occurring in reproductive-age women, are estimated to affect more than 1 out of 5 women under 50 and account for 3 out of every 10 hysterectomies performed annually in the United States.

A fibroid, or myoma, is a noncancerous mass of muscle and connective tissue in the uterus (womb). No one knows what causes fibroids, but scientists believe their growth may be stimulated by the female sex hormone estrogen.

"A fibroid can be as small as a pinhead or as large as a watermelon," says Gene Williams, M.D., a medical officer in the obstetrics and gynecological devices branch of FDA's Center for Devices and Radiological Health. "It can cause no symptoms or a lot of symptoms. To the woman who has one, a fibroid may feel like a rock-hard bulge in the lower abdomen."

Every year, about 175,000 American women — most of them 35 to 55 — undergo hysterectomy, or surgical removal of the uterus, as treatment for fibroids. According to American College of Obstetricians and Gynecologists guidelines, a fibroid that makes a woman's uterus bigger than it would be at 12 weeks of pregnancy, even if the woman is suffering no other symptoms, is an indication for a hysterectomy.

However, the practice of routinely recommending hysterectomy for fibroids has come under increasing scrutiny from both consumer organizations and doctors concerned about the high rate of hysterectomy in the United States. By age 60, more than a third of American women have had a hysterectomy, a rate higher than in any other Western country.

Blue Cross/Blue Shield of Illinois, in a study of all the hysterectomies performed in the state between 1987 and 1989, concluded that one-third were unnecessary. Most of the unnecessary surgeries, the insurer found, were performed for fibroids and other benign (noncancerous) conditions.

Options Increase

New medications and less-invasive surgeries have made more treatment options available to women whose fibroids cause them problems. A number of doctors interviewed for this article say the most important consideration in treating a fibroid should be how the patient feels about her condition and what level of intervention she is comfortable with.

"The physician should look objectively at the patient's symptoms, inform her of the treatment choices, and give her the autonomy to decide what she wants to do," says David Barad, M.D., director of reproductive endocrinology and infertility services at Montefiore Medical Center, Bronx, New York, and an associate professor at the Albert Einstein College of Medicine.

"There are probably hundreds of thousands of women who have fibroids on their uteruses that don't need to have anything done to them. At the other end of the spectrum, if a woman who has completed her family has a large fibroid that is causing distressing symptoms — like painful cramps, heavy menstrual bleeding, and anemia — she would be a candidate for hysterectomy."

In the March 1993 issue of the American Journal of Obstetrics and Gynecology, Andrew J. Friedman, M.D., and Susan T. Haas, M.D., of Harvard Medical School, write that the recommendation for surgery when fibroids make a woman's uterus larger than a 12-week pregnancy is based on three main concerns: Ovarian cancer might go undetected because the presence of a fibroid makes it difficult for the doctor to feel the ovaries during a pelvic examination. A rapidly growing fibroid may signal uterine cancer. A growing fibroid may produce more debilitating symptoms and add to the risks of surgery later on.

Friedman and Haas, advocating a less aggressive approach to fibroid treatment, respond to these concerns this way: The development of ultrasound (the use of high-frequency sound waves to produce an image of a part of the body) makes it possible to look at a woman's ovaries even when a fibroid prevents a manual examination. In any case, ovarian cancer is rare before age 50, and most hysterectomies for fibroids are done on women ages 35 to 44. Ultrasound and magnetic resonance imaging can be used to screen for uterine cancer, also rare in women under 50. Studies of hysterectomies done because of fibroids have not shown that removing a larger uterus poses a greater risk of surgical complications. "Watchful waiting" and treatment of problematic symptoms with medication or minimally invasive surgery may be just as effective as hysterectomy.

Exploring Drug Therapy

Many doctors prescribe drugs chemically similar to gonadotropin releasing hormone (GnRH) to treat fibroids. GnRH, produced by the pituitary gland, stimulates the production of estrogen. The drugs, known as GnRH analogs, block release of the hormone, thereby preventing the production of estrogen. These drugs, which include leuprolide (Lupron), nafarelin (Synarel), and goserelin (Zoladex), are approved by FDA to treat endometriosis in women and prostate cancer in men. Although FDA has not approved these drugs for treatment of fibroids, as with other approved medications, doctors may prescribe them if in their professional judgment a patient will benefit from them.

"Placing a woman on these drugs creates a false menopause," says Lisa Rarick, M.D., a medical officer in the division of metabolism and endocrine drug products of FDA's Center for Drug Evaluation and Research. "Her periods stop. The lack of estrogen usually causes the fibroid to shrink, just as they do after natural menopause. Sometimes other symptoms, such as pressure or pain, can be relieved by the shrinkage."

About the Author

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FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.