This week the U.S. Food and Drug Administration acted to broaden treatment options available to the millions of women who suffer from symptomatic uterine fibroids. First, the FDA approved a “next generation” focused ultrasound (FUS) system for the treatment of fibroids which is a more advanced version of the currently available “ExAblate” FUS system. In addition, the FDA also officially removed the requirement that women undergoing FUS treatment be “family complete,” confirming that women who want to maintain their fertility can consider FUS to treat their fibroids.
Treatment options for fibroids include hormone therapy and surgeries such as noninvasive focused ultrasound, uterine fibroid embolization, myomectomy, and hysterectomy. Focused ultrasound, such as ExAblate, is a no-incision, low-risk outpatient procedure that uses FUS in conjunction with image guidance to enable the treating physician to direct a focused beam of energy through the patient’s skin, superficial fat layer, and abdominal muscles to heat and destroy the fibroid tissue while leaving the surrounding tissue intact. The treatment is conducted with the patient awake and uses magnetic resonance (MRI) guidance, which enables the physician to target, control and monitor the treatment in real time. Many women undergoing FUS are able to return to their busy lives and normal activity level in just one or two days.
New FUS System
The new generation FUS technology will enable more precise treatment for women, aiming to improve overall success and increased relief from their fibroid symptoms. According to Professor Alan H. Matsumoto, MD, Radiology Chairman at the University of Virginia and President of the Society of Interventional Radiology, “The new version of the Exablate system enables treating physicians greater control of and more flexibility in treating fibroids with a clearer 3D view of the on-going treatment. With this new technology, treatment time is reduced allowing for treatment of more fibroid tissue in a given time.”
The FDA now specifies that FUS can be considered for women with symptomatic uterine fibroids who desire to maintain their fertility and spare their uterus. This update provides younger women suffering from symptomatic fibroids access to a treatment option that keeps their uterus intact without compromising their existing ability to get pregnant. The approval is based on accumulated, documented clinical data on 118 patients’ pregnancies after undergoing FUS treatment with ExAblate.
Said Professor Haywood Brown, MD, Chairman of Obstetrics and Gynecology, Duke University School of Medicine, “This is a major breakthrough in the treatment of symptomatic uterine fibroids. Gynecologists can now offer patients a treatment that is not only noninvasive and uterus sparing, but with the new labeling, this treatment is also an option for women who are not family complete.”
Both actions by the FDA this week bring new benefits to treating physicians and women alike, in the ongoing effort to treat this extremely common female health condition. Uterine fibroids are non-cancerous growths of the uterine muscle (or, myometrium) consisting of smooth muscle cells and connective tissue that usually go undetected unless they cause symptoms. The vast majority of women will experience uterine fibroids in their lifetime; nearly 8 in 10 women – and 9 in 10 African-American women – will develop fibroids by the age of 50, and often much earlier. At least one-quarter of women with fibroids will experience symptoms ranging from mild to debilitating – including heavy bleeding, menstrual pain, bloating, difficulty urinating, infertility, painful intercourse, and fatigue – and will require treatment.
A recent survey from Fibroid Relief found that women with fibroids wait an average of 3.5 years before seeking treatment – and one-third wait more than five years – which can greatly limit treatment options due to unnecessary growth of their fibroid(s). Though hysterectomy has been a common treatment for fibroids in the past, the same survey found that women strongly prefer treatment options that do not involve surgery of any kind and that preserve the uterus.