Uterine Fibroids

Background

Uterine fibroids (leiomyomas or myomas) are the most common neoplasms of the female pelvis. These benign tumors arise from the smooth muscle cells of the uterus, are generally oval shaped, are often highly vascular, and occur in up to 50% of women of reproductive age. Their size can range from few millimeters to 10 cm or more. Fibroids, particularly when small, may be entirely asymptomatic. Important symptoms include abnormal gynecologic hemorrhage, heavy or painful periods, abdominal discomfort or bloating, painful defecation, backache, urinary frequency or retention, and in some cases, infertility. There may also be pain during intercourse, depending on the location of the fibroid.

Uterine fibroids are often multiple, and if a uterus contains too many leiomyoma to count, it is referred to as “diffuse uterine leiomyomatosis.”

Measures of the clinical success of fibroid treatment are subjective and thus evaluated by the patient in terms of rapid and long-lasting improvement in the symptoms that caused her to seek treatment (decrease in pain, bladder, or bowel symptoms or reduction in vaginal bleeding) along with a minimum of adverse effects from the treatment itself.

Treatment

Treatment alternatives cover a wide range of approaches--from conservative to interventional procedures. Conservative treatment options include close follow-up, drug therapy (e.g., non-steroidal anti-inflammatory drugs), and hormone therapy (standalone or embedded into an intra-uterine device).

One of the most common surgical treatments is hysterectomy (removal of the uterus), which can be performed via traditional surgery or laparoscopically. Another option is myomectomy (surgical removal of only the fibroid), which is preferred in cases that require a uterus-conserving approach (e.g., to maintain future fertility), and this can also be done via traditional surgery or laparoscopically.

Minimally invasive treatment options include uterine artery embolization (occlusion of the fibroid blood vessels via intravascular catheter injection of plastic or gel particles), endometrial ablation (destruction of the lining of the uterus), and myolysis (destruction of the fibroid using a needle that freezes or thermally coagulates the tissue).

Focused Ultrasound Treatment

Focused ultrasound is a completely noninvasive way to treat uterine fibroids. Using this treatment modality in conjunction with image guidance, the physician directs a focused beam of acoustic energy through the patient’s skin, superficial fat layer, and abdominal muscles to thermally coagulate the fibroid tissue, thereby destroying it without damaging nearby tissue or the tissues that the beam passes through on its way to the target. Uterine fibroids can be visualized using ultrasound or magnetic resonance imaging (MRI).

Benefits of Focused Ultrasound

The potential benefits of using focused ultrasound to treat symptomatic uterine fibroids are:

It is a noninvasive, low morbidity treatment with a short recovery time and a quick return to work and the activities of normal life (usually the next day).
It offers rapid and durable resolution of fibroid symptoms (sometimes within days of treatment).
It has a low rate of complications.
It preserves the possibility of retaining fertility after fibroid treatment; anecdotal clinical evidence is showing that a substantial percentage of women are able to conceive after treatment.

Focused Ultrasound Patient Selection Criteria

The patient has a definitive diagnosis of a uterine fibroid as the source of the symptoms.
The patient should be able to tolerate the procedure with conscious sedation or no sedation. Note: the procedure does not require general anesthesia.
The patient should be able to communicate sensations to the physician during the procedure and be able to activate a “Stop Sonication” button.
The patient is not pregnant.
Focused ultrasound treatment has a lower success rate in patients with more than four clinically relevant fibroids or with a total fibroid load of more than 1000 cc.
Care should be taken when performing focused ultrasound treatment on patients where the path of the ultrasound beam travels through scar tissue or skin folds.
Focused ultrasound treatment is contraindicated when the path of the ultrasound beam must travel through bowel, pubic bone, an intrauterine device, surgical clips, or any hard implant that cannot be removed.
Focused ultrasound treatments performed using MRI guidance are contraindicated in women with MRI--related issues (e.g., the presence of metallic implants that are incompatible with MRI, sensitivity to MRI contrast agents, or the inability to fit into the MRI bore).

Clinical Trials

Physicians have used focused ultrasound to treat close to 20,000 patients worldwide for symptomatic uterine fibroids. Most of these procedures were performed in commercial (non-research) settings: approximately half using MRI-guided high intensity focused ultrasound systems and the other half using ultrasound-guided high intensity focused ultrasound systems.

Clinical studies* conducted at such world-renowned medical centers as the University of California (San Francisco/Los Angeles/San Diego), the Mayo Clinic, Duke University Health System, Sunnybrook Health Sciences Centre (Toronto), the University of Virginia health system, and the National Institutes of Health (NICHD):

*Studies listed at www.clinicaltrials.gov

Regulatory Approval

The following geographical regions have one or more focused ultrasound devices approved to treat symptomatic uterine fibroids: the United States (Food and Drug Administration), Europe (CE Mark), Korea (KFDA), Japan, (MHLW), India, Australia, and many more. Medical centers in 13 states in the United States and in 16 countries around the world now offer this treatment option.

Similar, yet less widespread, approval exists for the use of focused ultrasound to treat adenomyosis.

Reimbursement

In the United States, none of the major insurance carriers have a positive coverage policy, but Blue Cross/Blue Shield, AETNA, and United have all approved cases on an individual basis.

In the United Kingdom, Germany, and Russia, individual patients have gained local level approval. In Israel, some of the private payers offer coverage in their extended program.

In most of cities and areas of mainland China, healthcare insurance partially or fully covers the cost of this therapy.

Patient Advocacy

To increase patient awareness and access to new treatment options for uterine fibroids (including focused ultrasound), the Focused Ultrasound Surgery Foundation manages a patient support initiative called Fibroid Relief.

The Fibroid Relief website (http://www.fibroidrelief.org/) provides a patient forum for information on fibroid treatments, blog posts, patient stories, educational offerings, events, and clinical trial updates.

A China-based website http://www.savewomb.org, provides similar patient information on the ultrasound-guided focused ultrasound treatments offered by Chonqinq Haifu Technology LTD.

Treatment Sites

Below is a list of treatment centers that offer MR guided focused ultrasound for uterine fibroids.

Click on the map pin to display contact information at the site and a link to their website. You can also use the map zoom controls in the upper left to navigate down to the street level.

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Equipment Manufacturers

ExAblate One for women’s health by InSightec LTD
http://www.insightec.com/ExAblate-One.html

Sonalleve MR-HIFU by Philips
http://www.healthcare.philips.com/main/products/mri/systems/sonalleve/applications.wpd#Uterine+fibroid+ablation+therapy

Model JC and Model JC200 by Chongqing Haifu Technology Ltd
http://www.haifu.com.cn/en_main_3.asp

Notable Papers

Stewart EA, Gostout B, Rabinovici J, Kim HS, Regan L, Tempany CM. Sustained relief of leiomyoma symptoms by using focused ultrasound surgery. Obstet Gynecol 2007 Aug;110(2 Pt 1):279-87.
Okada A, Morita Y, Fukunishi H, Takeichi K, Murakami T. Non-invasive magnetic resonance-guided focused ultrasound treatment of uterine fibroids in a large Japanese population: impact of the learning curve on patient outcome. Ultrasound Obstet Gynecol 2009 Nov;34(5):579-83.
Rabinovici J, David M, Fukunishi H, Morita Y, Gostout BS, Stewart EA. Pregnancy outcome after magnetic resonance–guided focused ultrasound surgery (MRgFUS) for conservative treatment of uterine fibroids. Fertil Steril 2010 Jan;93(1):199-209.

Focused Ultrasound Foundation

Uterine Fibroids