Radio Frequency Energy Used to Shrink Fibroids and Reduce Symptoms in New Minimally Invasive Procedure

/PRNewswire/ -- Montefiore Medical Center recently became the only hospital on the East Coast to conduct the Radio Frequency Ablation procedure to shrink uterine fibroids in women 30 years and older. This minimally invasive procedure, initially used to treat liver cancer, uses a tiny needle that is inserted into the fibroid, applying low energy radio frequency electrical current, which creates localized tumor destruction by heat.

"More than 30% of all women suffer from fibroids, which can cause excessive menstrual bleeding and pain," said Erika Banks, MD, Director of the Fibroid Center at Montefiore and lead investigator of the study. "This procedure is another option for these women who wish to preserve their uterus -- an important advantage of this minimally invasive procedure."

Fibroids are benign tumors, which grow in the uterus. Fibroids are the most common tumor in the reproductive years, and are 2-3 times more common among African American women. Symptoms include heavy and or painful menstrual bleeding, a feeling of pressure in the pelvis, frequent urination, pain during intercourse, abdominal bloating and abdominal pain and/or back ache.

Montefiore is one of only five medical centers in the U.S. to test this procedure. The other centers are in California, Arizona, Michigan and Missouri. This study is currently enrolling women with fibroids and heavy bleeding who no longer desire fertility.

Treatment of 235 fibroid tumors in 70 women outside the U.S. resulted in significant reduction of symptoms and improvement in quality of life for about 90% of women, according to Dr. Banks.

Montefiore Medical Center encompasses 126 years of outstanding patient care, innovative medical "firsts," pioneering clinical research, dedicated community service and ground-breaking social activism. A full-service, integrated delivery system caring for patients in the New York metropolitan region and beyond, Montefiore is a 1,491-bed medical center that includes: four hospitals -- the Henry and Lucy Moses Division, the Jack D. Weiler Division, the North Division and The Children's Hospital at Montefiore; a large home healthcare agency; the largest school health program in the US; a 23-site medical group practice integrated throughout the Bronx and Westchester; and a care management organization providing services to 179,000 health plan members.

In 2008, The Children's Hospital at Montefiore was ranked as one of "America's Best Children's Hospitals" in US News & World Report's prestigious annual listing and also received honors in the magazine's 2009 edition. The Leapfrog Group lists Montefiore among the top one percent of all U.S. hospitals based on its strategic investments in sophisticated and integrated healthcare technology.

Montefiore is committed to meeting the healthcare needs of the future through medical education and manages one of the largest residency programs in the country. Montefiore is The University Hospital and Academic Medical Center for Albert Einstein College of Medicine and has an affiliation with New York Medical College for residency programs at the North Division.

Distinguished centers of excellence at Montefiore include cardiology and cardiac surgery, cancer care, tissue and organ transplantation, children's health, women's health, surgery and the surgical subspecialties. Montefiore is a national leader in the research and treatment of diabetes, headaches, obesity, cough and sleep disorders, geriatrics and geriatric psychiatry, neurology and neurosurgery, adolescent and family medicine, HIV/AIDS and social and environmental medicine, among many other specialties. For more information, please visit MACROBUTTON HtmlResAnchor www.montefiore.org or www.montekids.org .

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FDA Approves Lysteda to Treat Heavy Menstrual Bleeding

The U.S. Food and Drug Administration today approved Lysteda tablets (tranexamic acid), the first non-hormonal product cleared to treat heavy menstrual bleeding (menorrhagia). Lysteda works by stabilizing a protein that helps blood to clot.

Heavy menstrual bleeding is reported each year by about 3 million U.S. women of reproductive age. Women with uterine fibroids may experience heavy menstrual periods. But in most cases, there is no underlying health condition associated with the condition.

“Menorrhagia can be incapacitating for some women,” said Kathleen Uhl, M.D., FDA’s associate commissioner of women’s health. “Heavy menstrual periods can cause pain, mood swings, and disruptions to work and family life.”

Tranexamic acid was first approved by the FDA in 1986 as an injection, under the brand name Cyklokapron, and is used to reduce or prevent bleeding during and following tooth extraction in patients with hemophilia, a hereditary bleeding disorder caused by the lack of a blood clotting factor.

The most common adverse reactions reported during clinical trials by patients using Lysteda included headache, sinus and nasal symptoms, back pain, abdominal pain, muscle and joint pain, muscle cramps, anemia, and fatigue. There was a statistically significant reduction in menstrual blood loss in women who received Lysteda, compared with those taking an inactive pill (placebo).

Use of Lysteda while taking hormonal contraceptives may increase the risk of blood clots, stroke, or heart attack, according to Scott Monroe, M.D., director of the Division of Reproductive and Urologic Products in the FDA’s Center for Drug Evaluation and Research. Women using hormonal contraception should take Lysteda only if there is a strong medical need, and if the benefit of treatment will outweigh the potential increased risk.

Lysteda is manufactured by Xanodyne Pharmaceuticals of Newport, Ky.

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