Choosing a Treatment for Uterine Fibroids
by Eleanor Mayfield

     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."
     Side effects of GnRH analogs include many of the symptoms
experienced by women during menopause: "hot flashes," vaginal dryness,
and bone loss. Because of these side effects, the drugs are not approved
for use for longer than six months. And once the medication is stopped,
the fibroid usually starts to grow again.
     Some gynecologists are now experimenting with combining GnRH 
analogs with hormone replacement therapy to "add back" lost estrogen.
"This is not generally accepted clinical use as yet," says Barad. "We don't
know that simply adding back estrogen will address all the safety
considerations of long-term use of GnRH analogs."
     Barad and others have found a useful role for GnRH analogs as
preoperative therapy to shrink fibroids and stop heavy bleeding. "Both
anesthesia and surgery are easier and safer if you can first make the
fibroid smaller and stop the heavy bleeding so the patient isn't anemic,"
says Barad.
     The drug danazol (Danocrine), which is chemically similar to the
male sex hormone testosterone, may also be prescribed to stem heavy
menstrual bleeding caused by a fibroid. Like the GnRH analogs, danazol
is approved for treatment of endometriosis but not for treatment of
fibroids. Its main side effect is to increase male characteristics, such as
facial hair and deepening of the voice; however, not all patients
experience this side effect.

New Surgical Techniques
     The development of endoscopes, lasers, and electrosurgical devices
has led to new, less-invasive surgical techniques to remove fibroids. An
endoscope is a thin fiberoptic tube that surgeons insert into the body. It
can transmit an image to a television-like screen. Specialized endoscopes
for viewing the abdominal cavity are called laparoscopes. Endoscopes
designed to view the inside of the uterus are known as hysteroscopes. A
laser is a device that uses a thin, intense light beam to "cut" or vaporize
tissue, while electrosurgery or electrocautery devices use electricity to
destroy tissue by applying heat.
     These devices can be combined in several ways to perform a
variety of procedures. Some devices combine the visualization and
surgical functions in one instrument, such as the hysteroscopic
resectoscope, which consists of a hysteroscope with an electrosurgery
device built into it. This device is often used to remove submucous
fibroids, the type most likely to cause symptoms of heavy menstrual
bleeding (see "Fibroid Types").
     The most appropriate procedure for each patient will depend on
factors such as the size and position of the fibroid, the severity of
symptoms, and future childbearing plans. Hysterectomy, by removing the
uterus, makes it impossible to become pregnant or carry a baby.
     Endometrial ablation, in which an electrosurgical device is used to
remove the lining of the womb, may be recommended if a woman's major
fibroid-related symptom is heavy, debilitating menstrual bleeding. This
procedure also makes pregnancy impossible.
     Myomectomy, or surgical removal of a fibroid leaving the uterus
in place, may be an alternative to hysterectomy, particularly for women
who still want to have children. In determining whether to recommend a
myomectomy, a doctor will take into consideration the woman's overall
health as well as the number and location of the fibroids, says Grant
Bagley, M.D., of FDA's Office of Health Affairs.
     "A myomectomy can be a very simple procedure or it can be  very
complicated," says Bagley. "A thorough discussion is needed with each
patient as to whether their particular case will be difficult."
     According to Barad of Montefiore, myomectomies can result in
higher than average blood loss and scarring of the uterus that can
adversely affect a woman's chances of becoming pregnant. "The operation
you are performing to preserve reproductive potential may actually have
the opposite effect." However, Bagley says newer techniques can be used
to limit blood loss and preserve fertility.
     If the fibroid is approachable from inside the uterus, a
myomectomy may be performed using a hysteroscope. This procedure
may be done in a physician's office if the fibroids are small. In some
cases, patients can resume normal work and leisure activities within about
a week.
     A woman who has discomfort and heavy menstrual bleeding caused
by a large fibroid, and who does not want to become pregnant, may opt
to have a hysterectomy. A traditional abdominal hysterectomy is major
surgery, requiring a four- to five-day hospital stay and a recuperation
period of about six weeks.
     Women with relatively smaller fibroids may be able to have a
vaginal hysterectomy instead. In this procedure, the uterus is removed
through the vagina, thereby avoiding a large abdominal incision. Some
doctors will prescribe GnRH analogs for several months before surgery
to try to shrink the woman's uterus so that a vaginal hysterectomy can be
performed instead of an abdominal one. In some cases, a vaginal
hysterectomy is done with the assistance of a laparoscope. Most patients
will have a shorter hospital stay and recovery period for a vaginal
hysterectomy than for an abdominal procedure.
     Physicians differ in their approach to the treatment of fibroids,
Rarick points out. "Some will only do hysterectomies. Others will do
everything they can to preserve the uterus."
     And Williams advises: "Patients need to ask questions and be
aware of all their options." 

Eleanor Mayfield is a writer in Silver Spring, Md.

Fibroid Types
     Fibroids are classified by their position in the uterus. Intramural
fibroids, the most common type, grow inside the uterine wall. Subserous
or subserosal fibroids grow outward from the uterine wall into the
abdominal cavity. Submucous fibroids grow inward from the uterine wall,
taking up space within the uterus itself. This type of fibroid is the most
likely to cause symptoms of heavy, prolonged menstrual bleeding. A
fibroid can be as big as 20 centimeters (nearly 8 inches) in diameter and
can weigh more than 20 pounds.
     Small fibroids usually cause few if any symptoms. But, as a fibroid
grows larger, it may press on the bladder and the ureters, the pair of tubes
that connect the bladder to the kidneys. Pressure on the bladder can cause
urinary frequency; pressure on the ureters can lead to kidney and urinary
tract infections. Fibroids can sometimes be a cause of miscarriages and
infertility.
     A woman with a moderate-to-large fibroid may also notice a
protruding stomach and a sensation of heaviness in the abdomen. For
many women, the most distressing symptom is prolonged, heavy bleeding
at the time of their menstrual periods, as well as spotty vaginal bleeding
outside of the normal menstrual cycle. Women who lose too much blood
may become anemic.
     Sometimes a fibroid develops a thin stalk "like a balloon on a
string," says David Barad, M.D., head of reproductive endocrinology at
New York's Montefiore Medical Center. This is called a pedunculated
fibroid. In some cases, the stalk can become twisted, cutting off its own
blood supply, and causing severe pain.
     Fibroids tend to grow in spurts, with periods of rapid growth
punctuated by periods of no or very slow growth. As a woman approaches
menopause, a fibroid may begin to grow rapidly. After menopause,
however, fibroids stop growing and may start to shrink. n

--E.M.
One Woman's Decision
     In 1983, Diane Trent (not her real name), 42, began experiencing
pain on the left side of her abdomen during her monthly period. Then she
began to have extremely heavy periods lasting as long as two weeks. She
went to see her gynecologist, who performed a pelvic examination and
told her she had a fibroid in her uterus. The doctor recommended a
hysterectomy.
     Trent requested an ultrasound examination, which showed that the
fibroid was about 7 centimeters (2 3/4 inches) in diameter. She decided
she only wanted to undergo a hysterectomy as a last resort and asked her
doctor if there was a less drastic option.
     In response, the gynecologist performed an endometrial biopsy,
which showed no cancer, and a dilation and curettage (D&C), a procedure
that involves dilating the cervix (neck of the womb) and scraping the
uterine lining. The D&C stemmed Trent's heavy bleeding for a while. But
after a few months the problem recurred. At times, she says, the bleeding
"was so disabling that I couldn't go to work." Because the fibroid was
pressing on her bladder, she had to urinate frequently.
     Many women in Trent's situation would have opted for a
hysterectomy. Instead, Trent consulted a reproductive endocrinologist,
who agreed to monitor the fibroid's growth.
     After three years, it had grown to 10 centimeters (4 inches) in
diameter--about the size of a grapefruit. Her new doctor now
recommended a hysterectomy.
     "My feeling was that this was not life threatening and I didn't
know what the long-term outcome of surgery would be," Trent says. "I
decided I would rather put up with some discomfort that I knew would go
away eventually." So she found another specialist who was willing to
continue monitoring the fibroid.
     The mass did not enlarge during the next five to six years. Trent
is now 52. Since she reached menopause about two years ago, the fibroid
has shrunk slightly. She continues to have an ultrasound examination
every year. Her doctor says the fibroid should keep shrinking slowly, but
it will never disappear completely.
     Lisa Rarick, M.D., a medical officer in FDA's Center for Drug
Evaluation and Research, says Trent's experience illustrates that the "best"
treatment for a fibroid may be what the patient is most comfortable with.
     "The issue is whether you can live with the symptoms. It's very
individual. It depends how uncomfortable you are and how you feel about
having surgery."

--E.M.