HHS NEWS

 
P97-43                       FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE        Sharon Snider:       301-827-6242
December 12, 1997            
                             Consumer Inquiries:  800-532-4440
  
  
  FDA APPROVES NEW DEVICE TO TREAT EXCESSIVE MENSTRUAL BLEEDING
  
     FDA today approved a new type device to treat excessive
menstrual bleeding.  This thermal balloon ablation device may  
provide an alternative to hysterectomy or hysteroscopic  
surgical ablation in premenopausal women whose abnormal uterine
bleeding cannot be adequately controlled with drugs.  The device
is indicated for the treatment of menorrhagia (excessive uterine
bleeding) due to benign causes in premenopausal women for whom
child bearing is complete.
     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   
(87øC/188øF) 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,   
balloon 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% 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 pre-cancer, 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
post-menopausal 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 re-treated periodically, or will ultimately
need to have a hysterectomy.
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