GYNECARE THERMACHOICE III Returns Women's Heavy Periods to Normal or Less Bleeding

Filed in archive Diagnostics , Studies , Treatment on November 12, 2006

Nine out of 10 women treated for menorrhagia, or heavy menstrual periods with GYNECARE THERMACHOICE* III Uterine Balloon Therapy System returned to a normal bleeding rate or less. Such were the results of a multicenter, prospective clinical trial presented at the American Association of Gynecologic Laparoscopists meeting in Las Vegas.

Women in the 250-patient trial were randomized to receive postablationcurettage (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.

According to the clinical study's lead investigator Jose Garza Leal M.D., the study results show that GYNECARE THERMACHOICE III is a safe and effective choice for women who are candidates for endometrial ablation therapy and that this particular treatment can actually help 'normalize' a woman's menstrual flow so that it no longer interferes with her day-to-day activities, thereby helping improve her quality of life.

Menorrhagia (or heavy periods) disrupts the lives of some 10 million pre-menopausal women (ages 30 to 55) each month in the U.S. alone. These women lose 10 to 25 times the normal amount of blood during their menstrual cycle and are most prone to iron deficiencies, pain, fatigue and inability to participate in normal daily activities.

From ETHICON Women's Health & Urology, a division of ETHICON, Inc., a Johnson & Johnson company. 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.

Find more details from the press release.