November 10, 2006
Study Reports GYNECARE THERMACHOICE III Helps Most Women With Heavy Periods Return to Normal or Less Bleeding
SOMERVILLE, N.J., Nov. 10 /PRNewswire/ -- Results from a multicenter, prospective clinical trial showed that nine out of 10 women undergoing treatment with GYNECARE THERMACHOICE* III Uterine Balloon Therapy System to treat menorrhagia, or heavy menstrual periods, returned to a normal bleeding rate or less. The data were presented earlier this week at the American Association of Gynecologic Laparoscopists meeting in Las Vegas.
Women in the 250-patient trial were randomized to receive postablation curettage (PAC) or to no postablation curettage (NPAC) following treatment with GYNECARE THERMACHOICE III. The success rates in the two groups were comparable. At the 12-month follow up point, the intent-to-treat analysis showed that 37 percent of women experienced amenorrhea (or no menstrual bleeding). The study also compared this amenorrhea rate to that of historic patient-matched controls. Among the intent-to-treat matched patients, the amenorrhea rate was 32.6%, which is significantly greater than the 13.7% reported in the matched patients from the THERMACHOICE I study.
Additionally, more than 50 percent of women reported experiencing no premenstrual symptoms, including severe pain, fatigue and bloating following treatment. In fact, almost 90 percent of participants reported less pain associated with their periods (dysmenorrhea).
"These results show that GYNECARE THERMACHOICE III is a safe and effective choice for women who are candidates for endometrial ablation therapy," said Jose Garza Leal M.D., lead investigator of the study. "In addition, this treatment can actually help to 'normalize' a woman's menstrual flow so that it no longer interferes with her day-to-day activities, helping improve her quality of life."
Before receiving treatment, 80 percent of the women reported missing social activities due to their heavy periods. After treatment, more than 90 percent of women said they had not missed a social occasion or activity because of their period. Similarly, prior to treatment, more than half of women reported missing work because of their period. After 12 months, less than 3 percent reported absences.
Participants were premenopausal women, aged 30 years or older, who had completed childbearing, used contraception, and either failed or refused medical therapy.
The study was funded by ETHICON Women's Health & Urology. About Menorrhagia
Menorrhagia, or heavy periods, wreaks havoc on the lives of approximately 10 million pre-menopausal women ages 30 to 55 in the United States each month. These women lose 10 to 25 times the normal amount of blood during their menstrual cycle and must often contend with iron deficiencies, pain, fatigue and inability to participate in normal daily activities.
About GYNECARE THERMACHOICE
The GYNECARE THERMACHOICE III Uterine Balloon Therapy System is a one-day treatment option designed to end heavy menstrual flows by removing the lining of the uterus. This medical device resolves heavy menstrual bleeding due to benign causes in premenopausal women who have completed childbearing. Unlike hysterectomy, which takes out the entire uterus, the device only treats the lining of the uterus with heat through a process called endometrial ablation.
GYNECARE THERMACHOICE is used in a minimally-invasive procedure that can be performed in a hospital, outpatient or office setting. Recovery is fast and most women can return to their normal activities by the next day. The treatment has been used to treat more than 500,000 women worldwide.
As with all endometrial ablation procedures, GYNECARE THERMACHOICE III should not be used in women who might want to become pregnant in the future. There is still a chance that pregnancy could occur, however, so it is very important that women use birth control correctly and consistently after any endometrial ablation procedure.
All surgical procedures present risks. 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.
GYNECARE THERMACHOICE is from ETHICON Women's Health & Urology, a division of ETHICON, Inc., a Johnson & Johnson company. For more information, visit http://www.endheavyperiods.com/.
About ETHICON Women's Health & Urology
ETHICON Women's Health & Urology is dedicated to providing innovative, minimally invasive treatments for common urologic and women's health conditions. The division offers solutions for enlarged prostate (benign prostatic hyperplasia); female stress urinary incontinence; pelvic floor repair; post-surgical adhesions; heavy periods (menorrhagia); and benign uterine conditions, such as fibroids and polyps.
ETHICON Women's Health & Urology
CONTACT: Jackie Russo Jankewicz for ETHICON Women's Health & Urology,+1-908-218-2764, or [email protected]
Web site: http://www.endheavyperiods.com/