Frequently Asked Questions
Dr. Suzanne LeBlang was the first doctor
in the US to perform MRgFUS as an FDA-approved procedure.
Dr. Leblang's videos on MRgFUS can be viewed on her profile page
here.
I think I might have fibroids
- how can I tell?
How will my physician tell if
I have fibroids?
What is ExAblate® 2000?
What is MRgFUS?
What are the benefits of MR
guided FUS?
What are the risks and complications
associated with MR guided FUS?
How do I know if I am eligible
for treatment?
What types of fibroids can be
treated with the ExAblate 2000?
Who performs the ExAblate treatment?
Where is the treatment available
in the U.S. ?
What should I know before the
MR guided FUS procedure?
What should I tell my doctor
about my health before this treatment?
What is the treatment like?
What will I be required to
do during the treatment?
How long will the treatment
last?
What will I feel during the
treatment?
What happens to me after the
MR guided FUS procedure?
What happens when I go home?
How long after the treatment
until I can return to normal activities?
Who will provide my post procedure
care after MR guided FUS?
Is the treatment covered by
insurance?
I recently had a myomectomy
but my fibroids are still bothering me - can I get this treatment?
I previously had a Uterine
Artery Embolization/Uterine Fibroid Embolization - can I still get this
treatment?
What are my other treatment
alternatives?
Where can I find more information?
I just heard of this new treatment
and I looked up everything on the internet - how do I sign up to be treated?
How many patients have been
treated so far?
What other tumors are being
treated using ExAblate 2000?
I think I might have fibroids
- how can I tell?
Only your physician can diagnose fibroids. If you are experiencing
any of the following symptoms of fibroids, you may wish to speak with
him or her:
- Very heavy and prolonged monthly periods, sometimes with
clots
- Pain in the back or in the legs
- Pelvic pain or pressure
- Pain during sexual intercourse
- Pressure on the bladder which leads to a constant need
to urinate, incontinence, or the inability to empty the bladder
- Pressure on the bowel which can lead to constipation
and/or bloating
An enlarged abdomen which may be mistaken for weight gain
or pregnancy.
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How will my physician tell
if I have fibroids?
During your gynecological examination, your doctor will
check the size of your uterus. If it feels enlarged, your doctor may order
an abdominal or transvaginal ultrasound or a magnetic resonance (MR) imaging
session, which can confirm the presence, location and size of fibroids.
After identifying the size and location of your fibroids, and possibly
after other diagnostic tests, your doctor may be able to rule out other
conditions, advise you of your options and recommend a course of treatment
for fibroids.
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What is ExAblate® 2000?
It is the only non-invasive surgical procedure that has
been approved by the FDA to treat uterine fibroids using focused ultrasound.
Ultrasound waves are high frequency sound waves that the human ear cannot
hear. When they are focused, similar to how a magnifying glass focuses
light waves, heating of fibroid tissue occurs at the focus. The ExAblate
device uses MR images to allow the doctor to see inside your body and
locate where the fibroid is. During the treatment, MR images allow the
doctor to see what temperatures the fibroid has reached, and after treatment,
MR images allow the doctor to see how successful the treatment has been.
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What is MRgFUS?
Magnetic Resonance guided Focused Ultrasound Surgery. The
MRI scanner provides three-dimensional images of the fibroid and surrounding
tissue, enabling precise guidance of the ultrasound waves to the target
tissue. Highly focused ultrasound waves are directed into the body, and
at the focal point, the ultrasound waves raise the temperature of the
tissue, leading to its destruction. The thermal imaging capabilities of
the MRI scanner provide real-time feedback of the temperature achieved
at the target tissue during treatment, helping to ensure a positive therapy
outcome. This is a non-invasive outpatient procedure.
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What are the benefits of
MR guided FUS?
- Effective alternative to surgery and hormonal treatment
- Completely non-invasive - no surgery and no blood loss
- No hospital stay
- Quick return to normal activities
- Preserves the uterus and cervix
- Significant improvement in your quality of life
- Decrease in menstrual bleeding from symptomatic fibroids
- Decrease in urinary dysfunction, pelvic pain and/or
pressure
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What are the risks and complications
associated with MR guided FUS?
Overall, MR guided FUS is a safe procedure for treating
symptomatic fibroids with minimal risk. Infrequent complications that
have been reported following MR guided FUS are listed below. You should
talk to your doctor about the likelihood that you may experience any of
these risks.
Short term
- Low blood pressure or fainting during or after procedure
- Abdominal pain/cramping, nausea and/or fever
- Allergic reaction to contrast media or medications
- Minor skin injury (burns)
- Back or leg pain that persists for a few days
- Urinary tract infection
Long term
The incidence of serious or long term risks reported for
this procedure is extremely low. However, you should be aware that there
have been rare reports following MR guided FUS of:
- Abdominal skin burn with ulceration
- Back or leg pain or weakness
Additional risks
- There is a risk that the treatment may not be successful
and you may require an alternative treatment therapy to improve your
symptoms.
- The treatment may be successful in reducing the symptoms
from the fibroids that are treated, but at a later time, more fibroids
may become symptomatic, requiring additional treatments. This is true
for all fibroid treatments, except hysterectomy.
If you have any questions concerning risks and complications
of the procedure, you should discuss them with your doctor.
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How do I know if I am eligible
for treatment?
Your doctor is the best person to ask
about this. He or she will be able to tell you if you are a suitable candidate
for the ExAblate treatment. In general, people who cannot go into an MRI
will not be able to have the ExAblate treatment - this includes patients
with metallic implants, patients who are claustrophobic, and patients
who are allergic to contrast agent, a dye used to see blood vessels during
MR imaging. ExAblate treatment is not intended for women who are pregnant
or desire future pregnancy. The effects of ExAblate on the ability to
become pregnant and carry a fetus to term, and on the development of the
fetus, have not yet been determined. A special diagnostic MRI will give
the doctors the information they need about size, number and location
of the fibroids and allow them to tell you if it's a good treatment option
for you.
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What types of fibroids can
be treated with the ExAblate 2000?
Your physician will determine if your
fibroids are suitable for treatment. ExAblate can be used for submucosal,
subserosal, and intramural uterine fibroids. These are terms that are
used to describe the location of the fibroid within the uterus. More than
one fibroid can be treated. Fibroids that are pedunculated (hanging from
a stalk), in close proximity to sensitive organs (such as bowel or bladder),
or in a location inaccessible by the focused ultrasound may be untreatable.
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Who performs the ExAblate
treatment?
While the procedure is performed by interventional radiologists,
patient care through the entire process is a joint effort between OB/GYNs
and interventional radiologists.
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Where is the treatment available
in the U.S. ?
Treatment is available at 15 sites in the U.S. and Canada.,
as well as 15 additional sites located around the world.
For details about locations, click
here
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What should I know before
the MR guided FUS procedure?
You should let your doctor know if you are allergic to certain
medications or contrast agents to avoid any type of reaction to the procedure.
You and your doctor also will decide what type of sedation works best
for you. Most doctors use conscious sedation, which means you are awake
during the procedure but you may feel groggy.
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What should I tell my doctor
about my health before this treatment?
Before you undergo ExAblate treatment you should discuss:
- Your personal health history, including any allergies
you may have
- Your families health history
- Any recent illnesses
- Medicines, include both prescription, over the counter
and herbal medicines or dietary supplements
- Recent activities, including travel
- Your level of normal physical activity
- Previous MR or CT imaging studies
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What is the treatment like?
The entire procedure takes place with you lying in an MR
scanner. The doctor will first take some MR images of your pelvic area
to locate your uterus and your fibroid(s). Then, he will use these images
to develop a treatment plan. When the treatment begins, a small beam of
focused ultrasound is directed at the target for approximately 15 seconds
and heats the tissue. MR images are taken during each heating cycle provide
an image of the target tissue and the degree of heating. The system then
moves to the next treatment point, and the process is repeated about once
every 90 seconds until the entire volume has been treated. Typically,
30-100 individual pulses are delivered over a 3-hour period to complete
a treatment. After the treatment, more MR images are taken to determine
how successful the treatment was.
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What will I be required
to do during the treatment?
In order to have a successful treatment,
it will be very important that you lie very still during the procedure.
The doctor will give you some sedatives and pain medication to help you
relax. The doctor also will talk with you throughout the procedure to
see how you are feeling. You will be able to talk to the doctor and tell
him or her if something is bothering you.
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How long will the treatment
last?
You will lie on the patient table inside
an MRI for 3-4 hours depending on the size of your fibroid(s).
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What will I feel during
the treatment?
Women have reported feeling a warming
sensation on their skin or inside the pelvic region. You may feel a 'pinch'
or something like a brief menstrual cramp when the energy is being delivered.
During the treatment, the doctor will advise you of sensations that are
normal and instruct you to stop the treatment if you experience sensations
that are not normal, using a button that you will hold in your hand.
You rest on a specially equipped table in an MRI machine
and can communicate fully with the treatment team at all times.
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What happens to
me after the MR guided FUS procedure?
MR guided FUS is performed as an outpatient procedure that
takes 3 to 4 hours. Following the treatment you will rest for an additional
1 to 2 hours until the sedation wears off. After that you will be released
and can go home.
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What happens when I go home?
You will receive discharge instructions from your doctor,
depending upon how you are feeling. Usually nothing is required, although
the doctor may recommend over-the-counter pain relief medication. Occasionally
women may experience some cramping, similar to menstrual period cramping
or shoulder/back pain from lying in the treatment position. Most women
are able to return to work and normal activity the day after the procedure.
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How long after the treatment
until I can return to normal activities?
Depending on the initial symptoms, most patients find relief
of their fibroid-related symptoms within three months, as shown by a clinical
study conducted by InSightec. In a 109-patient clinical trial, women returned
to normal activities on average in less than three days, missing only
1.4 work days.
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Who will provide my post
procedure care after MR guided FUS?
It is important that you and your doctor discuss who will
handle your follow-up care, phone calls and/or office visits, after the
procedure. You should also know whom to contact in case of an emergency
after your procedure. This is especially important if you experience fever,
pelvic pain, or foul-smelling vaginal discharge that increases over time
and lasts more than 24 hours.
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Is the treatment covered
by insurance?
Since MRgFUS is a new technology, many health plans may
not yet cover it as a routine benefit. Despite this, increasing numbers
of patients have obtained pre-authorization of treatment coverage by their
carriers, on a case by case basis.
For assistance with obtaining pre-authorization status for
the procedure with your insurer, please visit the MRgFUS reimbursement
center by clicking here
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I recently had a myomectomy
but my fibroids are still bothering me - can I get this treatment?
Your doctor would be the best person to
talk to about this. Depending on how the surgery was performed, patients
that have scar tissue on their abdomen from myomectomy or a previous surgery/C-section
may not be eligible for the treatment since focused ultrasound may cause
heating or skin burns when large scar tissue is present.
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I previously had a Uterine
Artery Embolization/Uterine Fibroid Embolization - can I still get this
treatment?
Uterine Artery Embolization involves the
injection of microbeads made of poly-vinyl alcohol or other materials
that block the small vessels of the fibroid and uterus. There were no
patients with previous UFE/UAE treatment in the previous clinical studies,
and the risks are unknown at this time.
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What are my other treatment
alternatives?
Your physician would be the best person
to discuss treatment alternatives with you. Other available treatments
are:
- Watchful waiting
- Hysterectomy
- Abdominal myomectomy
- Laparoscopic or hysteroscopic myomectomy
- Uterine artery embolization
- Hormone Therapy
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Where can I find more information?
Please contact info@insightec.com
or one of the treatment sites listed here
if you have other questions.
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I just heard of this new
treatment and I looked up everything on the internet - how do I sign up
to be treated?
You should contact the center
nearest you. It is also good to consult your OB/Gyn or general physician.
He/she may not yet be familiar with this new treatment. If you would like,
we can send you a brochure to share with them.
Your doctor will be able to discuss treatment
alternatives and, together with you, determine what is best for you. If
your doctor currently doesn't perform this treatment, he or she may be
able to refer you to a physician or hospital that does.
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How many patients have been
treated so far?
To date , over 4000 patients have been
treated in the US and around the world.
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What other tumors are being
treated using ExAblate 2000?
Clinical trials for verifying the safety and efficacy of
the MRgFUS technology (or ExAblate) are being conducted for, breast cancer,
liver and bone tumors. For more information please check the InSightec
website.
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Contact us with your questions
about uterine fibroid treatment options.
Find an MR guided Focused
Ultrasound Surgery treatment center near you.
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