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Wed, 03/25/2009 - 19:15 — admin

Talk to a Doctor About Heavy Periods

Many women don’t realize heavy periods – also known as menorrhagia – are a common, treatable condition.

GYNECARE THERMACHOICE® Uterine Balloon Therapy System offers an effective, nonhormonal treatment for heavy periods. It involves a minimally invasive, 8-minute procedure that can be performed in the doctor’s office or in a hospital.

Stop Coping. Start Living.™

Get the conversation started today. Based on your condition, there are questions you might want to ask your doctor or surgeon. The following questions are designed to help you find out more information about your particular condition and the kinds of treatment that may be right for you. The more informed you are, the more comfortable you'll be with the decision you, your family and your doctor make together.

  1. What is the cause of my heavy periods?
  2. What course of treatment do you recommend for me?
  3. If I take hormones, will my condition improve?
  4. What are the least invasive treatment options for heavy periods?
  5. Am I a candidate for treatment with GYNECARE THERMACHOICE® Uterine Balloon Therapy System?
  6. Will treatment affect my ability to have children?
  7. What are the potential risks associated with GYNECARE THERMACHOICE®?
  8. How soon after treatment can I resume normal activities?
  9. Can this treatment be performed in your office?
  10. Will I need to continue to use contraception after treatment?
  11. May I talk to one of your patients who has been treated with GYNECARE THERMACHOICE®?
  12. Can you take care of this problem or can you refer me to a doctor specializing in treating heavy periods?
  13. If I need a hysterectomy, is there a minimally invasive option?

Click here to print these questions to ask your doctor (381 kb)

Next: Find a Doctor


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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