Taboo Health Issue May Mean Needless Hysterectomy For Many; Millions of Women Suffer in Silence Without Knowing Alternatives

Apr 26, 2001, 01:00 ET from Ethicon, Inc.

    SOMERVILLE, N.J., April 26 /PRNewswire/ -- 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
 http://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 http://www.gynecare.com.
 
     * Capitalized product names are trademarks of Ethicon, Inc.
 
                     MAKE YOUR OPINION COUNT -  Click Here
                http://tbutton.prnewswire.com/prn/11690X46266171
 
 

SOURCE Ethicon, Inc.
    SOMERVILLE, N.J., April 26 /PRNewswire/ -- 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
 http://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 http://www.gynecare.com.
 
     * Capitalized product names are trademarks of Ethicon, Inc.
 
                     MAKE YOUR OPINION COUNT -  Click Here
                http://tbutton.prnewswire.com/prn/11690X46266171
 
 SOURCE  Ethicon, Inc.