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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 familiar with GYNECARE® products who can perform this procedure.

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

 



Risk Information

GYNECARE THERMACHOICE® III Uterine Balloon Therapy System
Essential Product Information - Patient

INDICATIONS: The GYNECARE THERMACHOICE III 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; (pregnancies following ablation can be dangerous for both mother and fetus); 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 fibroid surgery; with active genital or urinary tract infection at the time of procedure (eg, cervicitis, vaginitis, endometritis, salpingitis, or cystitis) or with active pelvic inflammatory disease (PID); with an intrauterine device (IUD) currently in place.

ADVERSE EVENTS: include cramping/pelvic pain; nausea and vomiting; complications with pregnancy (Note: pregnancies following ablation can be dangerous for both mother and fetus); endometritis and risks associated with hysteroscopy, rupture of the uterus; post-procedure symptoms such as pain, fever, nausea, vomiting and difficulty with defecation or micturition; hematometra; 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 vesico-uterine fistula formation.

WARNINGS: The device is intended for use only in women who do not desire to bear children because the likelihood of pregnancy is significantly decreased following this procedure. Pregnancies following ablation can be dangerous for both mother and fetus . 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 do not eliminate the potential for endometrial carcinoma (uterine cancer) or premalignant changes of the endometrium and may mask the physician's ability to detect or make a diagnosis of such conditions. The GYNECARE THERMACHOICE® III procedure and hysteroscopic tubal occlusion/sterilization cannot be performed on the same day. The GYNECARE THERMACHOICE® III procedure should only be performed after the 3-month tubal occlusion confirmation test.

PRECAUTIONS: Certain types of Cesarean section may increase the risk of patient injury. For the complete list of Precautions associated with the use of this device, consult the GYNECARE THERMACHOICE III System instructions for use. Rx Only.

For more information, please consult your doctor or call 1-888-GYNECARE to speak with a nurse. You may also visit www.PelvicHealthSolutions.com

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It is intended for visitors from the US.
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