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Date: Friday, Dec. 12, 1997
FOR IMMEDIATE RELEASE
Contact: FOOD AND DRUG ADMINISTRATION Sharon Snider: 301­827­6242, Broadcast Media: 301­827­3434,Consumer Inquiries: 800­532­4440

FDA Approves New Device To Treat Excessive Menstrual Bleeding

The product is a uterine balloon catheter heat therapy system, called ThermaChoice(TM), manufactured by Gynecare/Ethicon Inc. of Menlo Park, Calif.

The device consists of a balloon inserted into the vagina, through the cervix and into the uterus; the balloon is connected by a catheter to a controller console which contains a microprocessor and imbedded software.

The balloon catheter is inflated with fluid and heated (87 C/188 F) to destroy much of the lining of the uterus. Pressure, temperature, and time are controlled by the computer connected to the catheter. After eight minutes of treatment, catheter is

removed. The entire procedure takes about 30 minutes and can be performed without general anesthesia in most women on an outpatient basis.

"Uterine balloon therapy devices offer premenopausal women a new alternative for treating excessive menstrual bleeding," said FDA Lead Deputy Commissioner Michael A. Friedman, M.D.

The device is only intended for women who have decided not to have children in the future. While the likelihood of pregnancy is significantly decreased following this procedure, it is still possible for some women to get pregnant because treatment may not

always destroy all endometrial tissue in the uterus. Very limited information is available on pregnancies following endometrial ablation; but it is believed that such pregnancies would carry considerable risk to both the mother and fetus. To avoid pregnancy, women who undergo this procedure must use an effective contraceptive method or undergo surgical sterilization.

The FDA's approval of this device was based on a review of clinical data on safety and effectiveness submitted by the manufacturer and on the recommendation of the Obstetrics and Gynecology Devices Advisory Committee.

The firm studied 125 women who were treated with the device at 14 medical centers in the U.S. and Canada and compared to a similar number of women treated with hysteroscopic rollerball ablation, a standard surgical treatment for excessive menstrual bleeding. The women, ages 30 to 50, had excessive menstrual bleeding, and drug therapy was either not tolerated or failed to adequately control the bleeding. In both groups, ablation treatments were shown to be safe and were able to control excessive bleeding in over 80 percent of the women at 12 months.

Of the many women in the U.S. who are currently considered candidates for surgical ablation therapy of excessive uterine bleeding, this new uterine balloon therapy may be suitable in a high percentage of cases. However, this device should not be used to treat women with uterine cancer or pre­cancer, because it is not designed to eliminate all the cancerous tissue. Moreover, its effectiveness has not been shown for women with uterine fibroids or other structural uterine abnormalities, nor for post­menopausal women.

FDA is requiring the firm to follow the 125 study subjects in a post marketing study to assess the devices effectiveness over a longer period. It is not known whether the procedure permanently reduces excessive menstrual bleeding, or whether some women will need to be re­treated periodically, or will ultimately need to have a hysterectomy.