Uterine Fibroid Embolization

This section describes clearances in countries other than the United States, and therefore may contain indications and information that are outside the scope of the FDA-cleared labeling.

Uterine fibroids are benign tumors which can cause symptoms such as excessive bleeding, pain and disfigurement. If left untreated, the symptoms can persist until menopause, which severely impacts the patient's quality of life. They afflict approximately 25 million women in the U.S. Industry sources indicate that 200,000 - 300,000 of the 600,000 hysterectomies performed in the U.S. each year are due to fibroids. Further, there is a large pool of approximately six million women in the U.S. who are symptomatic enough to see their doctor. Today, many of these women take drugs that are not curative and often have severe side effects such as osteoporosis, or they simply suffer silently.

Journal Articles Related to Uterine Fibroid Embolization:

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There are different types of fibroids which are classified based upon where they are located in the uterus. Their location also can determine the type of symptoms that will be present within the patient. In many cases, however, there is more than one fibroid, which is why many patients have a combination of symptoms such as excessive bleeding, painful bowel movements, frequent urination, infertility, and disfigurement.

Uterine artery embolization (UAE), similar to UFE, has been performed for various other bleeding problems, such as post-partum or post-surgical hemorrhage since 1972, with a success rate of 86% to 100%.¹

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Uterine fibroid embolization (UFE) is a minimally invasive, catheter-based procedure in which tiny microspheres are injected into the blood vessels supplying the fibroids to occlude their blood supply, reduce their size and alleviate associated symptoms. A catheter is threaded through a very small incision in the leg to the uterine artery. Then, our tiny, round Embosphere® Microspheres or EmboGold™ Microspheres are injected into the artery. They travel to the blood vessels feeding the fibroid tumors and block their blood supply, causing them to shrink and die. The woman typically leaves the hospital within a day and is generally back to normal activities in just eight to eleven days.

It is believed that many women will choose to have UFE procedures as they become more knowledgeable about the typical benefits of UFE versus the traditional recommendation of a hysterectomy, myomectomy or hormonal therapy. A hysterectomy requires at least a hospital stay of three to five days, with a recuperation time of six to eight weeks. Furthermore, this treatment does not accommodate those patients who want to retain their fertility. A myomectomy is the surgical removal of the fibroids, and although the patient's fertility usually remains in tact, it is generally performed only on those patients with a few small fibroids. Multiple myomectomies have been associated with increased blood loss, operating time, pain and postoperative morbidity, as well as longer hospital stays as compared to hysterectomy.

Hormonal treatment is considered to be a temporary treatment since long term use is associated with osteoporosis, menopausal symptoms, and amenorrhea in premenopausal women. Despite evidence that indicates fibroid size shrinks with hormonal treatment, symptoms usually return to pretreatment levels within six months to a year after ceasing the hormonal therapy.

¹ BBI Newsletter, February 2002, "Advance of 'Leading Edge' Technologies is Focal Point of AAGL", Diana Tucker, BBI Contributing Editor

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