Taboo Health Issue May Mean Needless Hysterectomy For Many

April 2001 (Newstream) -- More than 10 million American women suffer from excessive menstrual bleeding or heavy periods, a condition known as menorrhagia. In fact, more than 20 percent of the 600,000 hysterectomies performed annually in the United States treat menorrhagia. But because this health issue is so rarely discussed, few women realize that the condition can be easily treated during a 30-minute outpatient procedure as opposed to having a hysterectomy.

Until a few years ago, the only alternatives to hysterectomy for treating heavy periods were complex procedures that required a high level of skill to perform. Today, however, a simple, minimally-invasive outpatient procedure using the GYNECARE THERMACHOICE Uterine Balloon Therapy System is available for women. More than 100,000 women worldwide have been treated with uterine balloon therapy. A new long-term study published in the Journal of the American Association of Gynecologic Laparoscopists (February 2001) proves the treatment is a safe and effective method for treating menorrhagia due to benign causes and avoiding hysterectomy. The new data also found that uterine balloon therapy decreases painful menstruation and premenstrual symptoms and significantly improves quality of life.

"Excessive menstrual bleeding is a very common problem for women of reproductive age and an extremely burdensome one. However, too many women undergo hysterectomy to treat their condition when far less invasive treatments like uterine balloon therapy can significantly lighten a period or even stop it completely," said Franklin D. Loffer, M.D., associate clinical professor, Department of Obstetrics and Gynecology at the University of Arizona and author of the three-year study.

Heavy Periods Devastating for Women

Menorrhagia, defined as excessive bleeding during menstruation or too-frequent menstruation, can have a devastating impact on a woman's life. In the three-year study, 70 percent of women reported that prior to treatment heavy bleeding had a major impact on their lives and almost 40 percent of women reported the inability to work outside the home during their menstrual period. A recent survey conducted by Opinion Research Corporation/CARAVAN of 445 women aged 30-54 found similar results - 44 percent of those polled have adjusted their lives to accommodate their period and 40 percent reported suffering an embarrassing moment because of heavy bleeding.

Balloon Therapy Proven to Lighten Heavy Periods, Improve Quality of Life

The new data prove that treatment with the GYNECARE THERMACHOICE Uterine Balloon Therapy System can relieve women of heavy periods. Women treated with balloon therapy experienced significant improvements in their condition:

• 86 percent of patients were reduced to normal or no bleeding without any additional treatment.
• More than 95 percent of patients remained satisfied with the treatment.
• Less than two percent of women said that bleeding still had a major impact on their lives.

"THERMACHOICE was developed to be a safe, easily performed method of uterine ablation," said Dr. Loffer. "I've found that following treatment with balloon therapy my patients experience lighter periods, less pain and overall less burden on daily life."

About the Study

The study followed 214 women for three years who underwent treatment with either the GYNECARE THERMACHOICE Uterine Balloon Therapy System or with one of the older, more complex hysteroscopic endometrial ablation procedures called rollerball ablation. The results in the two treatment groups were comparable and proved that balloon therapy is as effective as rollerball ablation. However, balloon therapy is a more easily performed method of treating women with heavy periods.

Hysteroscopic endometrial ablation techniques use a hysteroscope to view the uterus and an energy source to remove the uterine lining. They usually require a high level of skill. Most women will return to normal activity within a few days. Compared with hysteroscopic procedures, uterine balloon therapy is much simpler for a physician to perform. A balloon catheter is inserted into the uterus and inflated with a small amount of sterile fluid that is heated for eight minutes to break down the uterine lining. When the treatment cycle is completed, all the fluid is withdrawn from the balloon and the catheter is removed. Nothing stays in the uterus. The uterine lining has been treated and will slough off like a period in the next seven to 10 days. Women typically return to normal activity the day after treatment.

About GYNECARE THERMACHOICE Uterine Balloon Therapy System

The GYNECARE THERMACHOICE Uterine Balloon Therapy System is not recommended for women who still want to have children since much of the uterine lining - necessary to sustain conception - is destroyed. Rare but possible safety risks include blood loss, heat burn of internal organs, electrical burn, perforation (hole) or rupture of the wall of the uterus, and leakage of heated fluid from the balloon or tissue into the cervix.

For more information about excessive menstrual bleeding and the GYNECARE THERMACHOICE Uterine Balloon Therapy System, visit www.controlheavyperiods.com.

About GYNECARE

GYNECARE, a global health care company, currently offers less invasive options for the treatment of adhesions, uterine disorders, female urinary incontinence and infertility. Information about the company and its products can be found on the World Wide Web at www.gynecare.com.

References:

Produced for Johnson & Johnson

Jackie Russo

908/218-2764

Alison Roselli

Ogilvy PR

212/880-5257