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Fibroid Patient Pamphlet
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Frequently Asked QuestionsI think I might have fibroids - how can I tell? How will my physician tell if I have fibroids? 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 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? 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? What are my other treatment alternatives? Where can I find more information? 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:
An enlarged abdomen which may be mistaken for weight gain or pregnancy. 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. 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. 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. What are the benefits of MR guided FUS?
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
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:
Additional risks
If you have any questions concerning risks and complications of the procedure, you should discuss them with your doctor. 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. 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. 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. 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 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. What should I tell my doctor about my health before this treatment? Before you undergo ExAblate treatment you should discuss:
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. 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. 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). 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. 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. 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. 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. 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. 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 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. 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. What are my other treatment alternatives? Your physician would be the best person to discuss treatment alternatives with you. Other available treatments are:
Where can I find more information? Please contact info@insightec.com or one of the treatment sites listed here if you have other questions. 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. How many patients have been treated so far? To date , over 3500 patients have been treated in the US and around the world. 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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