Research Reveals More Women with Fibroids Discussing Uterine Fibroid Embolization (UFE) with Their Physicians

Nov 8 2006, 7:47 AM EST

BIOWIRE

The National Women's Health Resource Center (NWHRC) and BioSphere Medical, Inc. (NASDAQ: BSMD), today announced a new survey that found more than 40 percent of women suffering from uterine fibroids discussed uterine fibroid embolization (UFE) when they met with their medical professional. More than one-third of these women went on to choose UFE as their treatment option, more than any of the surgical options such as hysterectomy and myomectomy or non-surgical alternatives like hormone therapy.

The survey was developed by BioSphere Medical in partnership with the not-for-profit NWHRC to better understand how uterine fibroid conditions - common, benign noncancerous tumors that grow on or within the muscle tissue of the uterus - impact a woman's quality of life, including career, overall health and relationships with family. Further, the study was also intended to uncover whether or not women are given accurate information about all treatment options - surgical and non-surgical, invasive and minimally invasive.

"This data tells us more about the lives of women who have uterine fibroids, and it is clear that significant progress has been made to educate women about the treatment alternatives available," said Elizabeth Battaglino Cahill, RN, executive vice president of NWHRC. "However, there is still plenty of opportunity to continue to increase the awareness of less invasive therapies and for women to discuss those therapies with their physician before making a treatment decision."

Until about 10 years ago, there were limited options for the treatment of symptomatic uterine fibroids. Today, there are numerous alternatives, yet hysterectomy still remains the primary treatment - nearly 250,000 women undergo this procedure each year to treat uterine fibroid conditions. Clinical studies have shown that a minimally invasive therapy like UFE, a non-surgical procedure that is used to treat more than 20,000 women each year in the United States, provides substantial improvement in major symptoms, including pelvic pain, bulking, bleeding, and urinary problems.

"We are starting to see more well informed patients who, along with their gynecologists, are making thoughtful decisions about fibroid treatment," says James B. Spies, MD, chief of service at the Department of Radiology at Georgetown University Hospital. "As every woman is different, it is important that all treatment options are discussed, especially since we now have the clinical data to support a shift away from more invasive procedures."

Seventy to eighty percent of all American women have uterine fibroids(i). While the majority of these women do not usually develop symptoms and might not even know they have fibroids, approximately six million American women have symptoms severe enough to require medical treatment. In fact, according to the survey results, just over a third of employed women stated that they miss at least one day of work a month due to their fibroid symptoms, and about half of the employed women in this survey miss more than two to three days of work per month while experiencing fibroid symptoms.

The survey was conducted by International Communications Research (ICR) between September 13, 2006, and October 17, 2006, among 233 U.S. adult women, ages 25-55, who at any point in the past seven years had symptomatic uterine fibroids and saw a medical professional.

Symptomatic uterine fibroids are typically diagnosed in women between the ages of 35 and 54, and are found to be more than three times as common in African-American women than Caucasians. Uterine fibroids can and do occur in women under the age of 35, even as young as the early 20s.

Myomectomy is another surgery that is commonly performed to treat uterine fibroids. It is a selective procedure that involves surgically removing the fibroids. Although it is uterine sparing, myomectomy is highly invasive and requires a long recovery period.

According to a recent article in Drug Benefit Trends, the annual national total cost of fibroid patients in 2003 was approximately $21.3 billion(ii), which includes direct costs such as third party payments to health care providers as well as indirect costs associated with missed work. Fibroid-related symptoms, such as bleeding and pain, also cause an estimated two to four million person days lost annually, and an additional three to seven million person days are lost after surgery to treat fibroids.(iii)

Additionally, the survey findings provide quantitative insight into the dialogue between physician and patient, as well as the personal cost to women with uterine fibroid conditions when it comes to their home, work and family lives.

-- Over 40 percent of women surveyed discussed UFE with their medical professional, and of those, about 35 percent chose UFE as their treatment for their fibroid condition

-- Nearly three out of ten women missed work because of their uterine fibroid condition

-- About three in eight patients (38 percent) say that their fibroid condition "severely" or "substantially" limits their recreational/athletic activities and their sex life

-- The vast majority (60 percent) of women who underwent UFE or uterine artery embolization (UAE) procedures experienced less than two weeks of recovery - the shortest timeframe of any of the three procedural options which also included myomectomy and hysterectomy

-- Hysterectomy was the most likely of the three surveyed procedure types to induce the highest level of post-operative pain 

 -- Using the familiar "1 to 10 scale" for assessing post-operative pain, the patients in the study indicate that their post-procedure pain levels are lowest for the UFE/UAE technique (4.4), compared to the myomectomy and hysterectomy (both 6.4)

-- Unfortunately, nearly a third (30 percent) of women experiencing uterine fibroid symptoms wait more than a year before seeking medical treatment

For more information about the survey, uterine fibroids, UFE and other treatment options, women should visit www.ask4UFE.com and www.healthywomen.org.

About the National Women's Health Resource Center

The National Women's Health Resource Center (NWHRC) is the leading independent health information source for women. The nonprofit organization develops and distributes up-to-date and objective women's health information based on the latest advances in medical research and practice. NWHRC believes all women should have access to the most trusted and reliable health information.

The mission of the National Alliance for Hispanic Health (the Alliance) is to improve the health and well-being of Hispanics. Founded in 1973, the Alliance is the nation's oldest and largest network of Hispanic health and human service providers. Alliance members deliver quality services to more than 14 million people annually. As the nation's action forum for Hispanic health and well-being, the programs of the Alliance strive to inform and mobilize consumers; support health care providers in the delivery of quality care; promote appropriate use of technology; improve the science base for accurate decision-making; and promote philanthropy.

About BioSphere Medical, Inc.

BioSphere Medical, Inc. (Nasdaq: BSMD), a medical device company based in Rockland, Massachusetts, has pioneered and is commercializing minimally invasive diagnostic and therapeutic products based on its proprietary bioengineered microsphere technology. The Company's core technologies, patented bioengineered polymers and manufacturing methods, are used to produce microscopic spherical materials with unique beneficial properties for a variety of medical applications. BioSphere's principal focus is the treatment of symptomatic uterine fibroids using a procedure called uterine fibroid embolization, or UFE. The Company's products continue to gain acceptance in this emerging procedure as well as in a number of other new and established medical treatments.

i "High cumulative incidence of uterine leiomyoma in black and white women: Ultrasound evidence"; Baird DD, Dunson DB; Hill MC; Counsins D; Shectman JM; Am J Obstet Gynecol, Volume 188, Number 1

ii "Lifetime Costs of Patients with Clinically-Detected Uterine Fibroids: An Employer's Perspective", Wu EQ, Ben-Hamadi R, Birnbaum H, Farrell MH, Spalding J, Stang P, Hartmann KE; Drug Benefit Trends, 2006, 18(7): 405-10

iii Broder MS, Harris K, Morton SC, Sherbourne C, Brook RH. "Uterine artery embolization: a systemic review of the literature and a proposal for research"; RAND report MR-1158; Santa Monica: RAND; 1999