Washington Family Magazine : October 2014
4 October 2014 washingtonFAMILY.com OCTOBER 2014 Essure, BAYER, and the Bayer Cross are registered trademarks of Bayer. © 2014 Bayer HealthCare Pharmaceuticals Inc., Whippany, NJ, 07981 All rights reserved. XXX-XX-XXXX-XXX Printed in USA September 2014 Important Safety Information (continued) WARNING: Be sure you are done having children before you undergo the Essure procedure. Essure is a permanent method of birth control. The younger a woman is when she chooses to end her fertility, the more likely she is to regret her choice later. During the procedure: You may experience mild to moderate pain, your doctor may be unable to place one or both Essure inserts correctly, part of an Essure insert may break off or puncture the fallopian tube requiring surgery to repair the puncture, or your body may absorb a large amount of the salt water solution. Your doctor may recommend a local anesthesia which numbs the cervix. Ask your doctor about the risks associated with this type of anesthesia. Immediately following the procedure: You may experience mild to moderate pain and/or cramping, vaginal bleeding, and pelvic or back discomfort for a few days. Some women experience nausea and/or vomiting or fainting. In rare instances, an Essure insert may be expelled from the body. During the Essure Confirmation Test: You will be exposed to very low levels of radiation, as with most x-rays. In rare instances, women may experience spotting and/or infection. Long-term Risks: There are rare reports of chronic pelvic pain in women who have had Essure. In rare instances, an Essure insert may migrate through the fallopian tubes into the lower abdomen and pelvis. It may be necessary to surgically remove the migrated device if the patient is experiencing an adverse event. No birth control method is 100% effective. If you do become pregnant after Essure, the risks to you, the fetus, the pregnancy and childbirth are unknown. Women who have the Essure procedure are more likely to have an ectopic pregnancy if they get pregnant. Ectopic pregnancy is when the pregnancy occurs outside of the uterus. Ectopic pregnancies can be very serious or life-threatening. If you have the NovaSure® procedure, a procedure that removes the lining of the uterus to lighten or stop menstrual bleeding, after the Essure procedure, your risk of pregnancy may increase. The Essure insert is made of materials that include a nickel-titanium alloy. Patients who are allergic to nickel may have an allergic reaction to the inserts. Symptoms include rash, itching and hives. Unknown Risks: The safety and effectiveness of Essure has not been established in women under 21 or over 45 years old. The safety and effectiveness of reversing the Essure procedure, of in vitro fertilization (IVF) after the procedure, or to you and your fetus if you get pregnant after the procedure are not known. Adverse Events: During the procedure, the most common problem reported was mild to moderate pain (9.3%). Some of the women in the study reported moderate pain (12.9%) and/or cramping (29.6%) on the day of the procedure. A smaller percentage of women reported nausea/vomiting (10.8%) and vaginal bleeding (6.8%). Essure inserts do not protect against HIV or other sexually transmitted diseases. Talk to your doctor about the Essure procedure and whether it is right for you. You are encouraged to report negative side effects or quality complaints of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.