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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)

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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

This site is published by Ethicon Women's Health & Urology, a division of Ethicon, Inc., a Johnson & Johnson Company,
which is solely responsible for the content. It is intended for visitors from the US.
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