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About Your Period

For most women, menstrual periods are a simple fact of life. But if you’re one of the 3 in 10 women of reproductive age who suffers from heavy periods1 – or menorrhagia (pronounced men-or-ah-jah) – your period can be a serious disruption.

What’s an abnormal period?

Women’s menstrual cycles can differ widely from one another and still be considered “normal.” However, you may be suffering from excessively heavy periods if any of the following happens regularly to you:

  • Your period lasts longer than 7 days – usually periods last 4 to 6 days.

  • Your period contains blood clots.

  • Your period soaks through a tampon or pad every hour for 2 hours or more.

Heavy periods can exhaust you, cause serious discomfort, and interrupt your routine. You may need to change menstrual pads or tampons constantly, or wear dark clothing to avoid embarrassing accidents. The pain and exhaustion can be debilitating – something women with “normal” menstruation cycles don’t always understand.

Heavy bleeding may be only half your story

Here are some additional questions to ask yourself:

  • Are your periods painful?

  • If yes, how often do you have pain?

  • Do painful periods ever get in the way of your activities?

If you suffer from heavy bleeding during your periods, GYNECARE THERMACHOICE® III Uterine Balloon Therapy System may be a treatment option for you and also may be able to help with the pain secondary to menorrhagia.

GYNECARE THERMACHOICE® is not indicated for treatment of pain. GYNECARE THERMACHOICE® when used to treat heavy bleeding, has been shown to reduce pain in women surveyed in a prospective clinical trial as a secondary quality of life endpoint.

Stop Coping. Start Living.™

You don’t have to live with heavy periods. Learn more about GYNECARE THERMACHOICE® or find a doctor who can provide treatment.

Reference:
1. The Lewin Group, Prevalance and treatment patterns of pelvic health disorders among US women. 2007.

 



Risk Information

GYNECARE THERMACHOICE® Uterine Balloon Therapy System
Essential Product Information

INDICATIONS: The GYNECARE THERMACHOICE® System is a thermal balloon ablation device intended to ablate the endometrial lining, of the uterus in premenopausal women with menorrhagia (excessive uterine bleeding) due to benign causes for whom childbearing is complete.

CONTRAINDICATIONS: The device is contraindicated for use in a patient: who is pregnant or who wants to become pregnant in the future; with known or suspected endometrial carcinoma (uterine cancer) or premalignant change of the endometrium, such as unresolved adenomatous hyperplasia; with any anatomic or pathologic condition in which weakness of the myometrium could exist, such as history of previous classical cesarean sections or transmural myomectomy; with active genital or urinary tract infection at the time of procedure (eg, cervicitis, vaginitis, endometritis, salpingitis, or cystitis); with an intrauterine device (IUD) currently in place.

ADVERSE EVENTS include: rupture of the uterus; thermal injury to adjacent tissue; heated liquid escaping into the vascular spaces and/or cervix, vagina, fallopian tubes, and abdominal cavity; electrical burn; hemorrhage; infection or sepsis; perforation; post-ablation tubal sterilization syndrome; complications leading to serious injury or death; complications with pregnancy (Note: pregnancy following ablation is dangerous to both the mother and the fetus); vesico-uterine fistula formation; cramping/pelvic pain; nausea and vomiting; endometritis and risks associated with hysteroscopy.

WARNINGS: Failure to follow all instructions or to heed any warnings or precautions could result in serious patient injury. If uterine perforation is present, and the procedure is not terminated, thermal injury to adjacent tissue may occur if the heater is activated. Endometrial ablation is not a sterilization procedure. Patients who have previously undergone tubal ligation are at increased risk of developing post ablation tubal sterilization syndrome which can require hysterectomy. Endometrial ablation procedures using the GYNECARE THERMACHOICE® System should be performed only by medical professionals who have experience in performing procedures within the uterine cavity, such as IUD insertion or dilation and curettage (D&C), who have adequate training and familiarity with GYNECARE THERMACHOICE® System.

PRECAUTIONS: Never use other components with the GYNECARE THERMACHOICE® System. Rx Only.

For more information, please consult your doctor or call 1-888-GYNECARE to speak with a nurse.

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