SOMERVILLE, N.J., May 13, 2003 /PRNewswire via COMTEX/ --
GYNECARE, the women's health division of ETHICON, announced today that the U.S. Food and Drug Administration (FDA) has provided Pre-Market approval (PMA) for the new GYNECARE THERMACHOICE* III Uterine Balloon Therapy System, a device indicated to treat menorrhagia due to benign causes in premenopausal women. The new device offers greater cornual coverage and improved treatment of the lower uterine segment than the current system.
"THERMACHOICE has proven to deliver high patient satisfaction over the long term with minimal risk," said R. Wayne Whitted, M.D., director, Department of Obstetrics and Gynecology, University of Miami School of Medicine. "The new technology should enhance treatment outcomes for women who suffer with heavy menstrual periods."
In evaluating THERMACHOICE III, it was found that it allowed for more even necrosis of tissue throughout the entire endometrium.
A long-term follow-up study of women previously treated with the original GYNECARE THERMACHOICE device confirms efficacy and patient satisfaction. The data shows that five years after treatment, 95 percent of women still reported normal bleeding or less*, and 93 percent of women said they remained satisfied with the treatment. Overall, nearly 7 out of 10 patients avoided further surgical intervention for menorrhagia, such as hysterectomy, dilation and curretage (D&C) or repeat endometrial ablation. The five-year follow-up data also showed no reported endometrial carcinoma among the study participants.
In addition, clinical studies show that 78% of women evaluated three years after treatment with the original device are free from significant menstrual pain and cramping.
Approximately 20 percent of the 600,000 hysterectomies performed annually in the United States treat menorrhagia. The GYNECARE THERMACHOICE system, which has been used to treat more than 250,000 women worldwide, offers a less invasive option that allows women to preserve their uterus. It is used in a simple outpatient procedure that can be completed in under 30 minutes. Compared with hysteroscopic procedures, uterine balloon therapy is much simpler for a physician to perform.
During the procedure using the GYNECARE THERMACHOICE device, 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 When the treatment cycle is completed, all the fluid is withdrawn from the balloon and the catheter is removed.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 their normal activity the day after treatment.
GYNECARE THERMACHOICE is not recommended for women who still want to have children. Rare but possible safety risks include blood loss, burn of internal organs, perforation (hole) or rupture of the wall of the uterus, and leakage of heated fluid from the balloon or tissue into the cervix.
GYNECARE, the women's health division of ETHICON, Inc., a Johnson & Johnson company, is a global health care company dedicated to advancing healthcare for women worldwide. The company offers less-invasive options for the treatment of menorrhagia (excessive menstrual bleeding), fibroids, pelvic adhesions, and female urinary incontinence. For more information about GYNECARE, visit www.gynecare.com
* Based on evaluable patients with no further surgical intervention.
Loffer FD, Grainger D. Five year follow up of patients participating
in a randomized trial of uterine balloon therapy versus rollerball
ablation for treatment of menorrhagia. J Am Assoc Gynecol Laparosc.
2002: 9 (4): 429-435.
SOURCE ETHICON, Inc.
Jacqueline Russo of Ethicon, +1-908-218-2764
http://www.ethiconinc.com
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