Essure

IMPORTANT SAFETY INFORMATION
WARNING: Some patients implanted with the Essure System for Permanent Birth Control have experienced and/or reported adverse events, including perforation of the uterus and/or fallopian tubes, identification of inserts in the abdominal or pelvic cavity, persistent pain, and suspected allergic or hypersensitivity reactions. If the device needs to be removed to address such an adverse event, a surgical procedure will be required. This information should be shared with patients considering sterilization with the Essure System of Permanent Birth Control during discussion of the benefits and risks of the device. Continue below

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Could Essure® Be Right For Me?

Only you and your doctor can decide if Essure is right for you. As you discuss your options with your doctor, there are a number of things you should consider. Take the quiz below to see if Essure might be right for you.

  1. Are you sure you don’t want any more children?
  2. Are you seeking a birth control that does not contain hormones?
  3. Are you interested in a permanent form of birth control?
  4. Are you interested in permanent birth control, but don’t want to have a procedure with cutting or visible scars?
  5. Are you looking for a birth control procedure that does not require general anesthesia and the risks and complications associated with it?
YOUR RESULT

Essure may be right for you!

Based on your responses, it sounds like you may want to consider talking to your doctor about Essure.

E-mail yourself these results and bring them with you to discuss with your doctor at your next appointment.

You might be more interested in a long-acting, reversible method

Based on your responses, you don’t seem to be ready for permanent birth control (not just yet, anyway)! You may want to consider talking to your doctor about long-acting reversible birth control options that give you lasting, but not permanent, birth control. To learn more, click here.

E-mail yourself these results and bring them with you to discuss with your doctor at your next appointment.

E-mail addresses will be used solely to send this information. Bayer will not retain or sell e-mail addresses or personal information.

Essure is NOT right for you if:

  • You are uncertain about ending your fertility
  • You suspect you are pregnant
  • You have only one fallopian tube
  • You have one or both fallopian tubes closed or obstructed
  • You have had your “tubes tied” (tubal ligation)
  • You are allergic to contrast dye used during x-ray exams
  • You are unwilling to undergo the Essure Confirmation Test
  • You have unexplained vaginal bleeding
  • You have suspected or known cancer of the female reproductive organs

You should wait to have the Essure procedure if:

  • You are or have been pregnant within the past 6 weeks
  • You have an active gynecological infection
  • You are in the second half (weeks 3 and 4) of your menstrual cycle. During that time there is an increased risk of being pregnant prior to having the Essure procedure

You should speak to your doctor if:

  • You are taking or receiving therapy that suppresses your immune system. Examples include chemotherapy or corticosteroids, such as prednisone. Therapy that suppresses the immune system may make the Essure procedure less effective for birth control
  • You have, or think you may have, a history of metal allergies or an allergy to polyester fibers, nickel, titanium, platinum, silver-tin, or stainless steel or any other components of the Essure system
  • You are currently using an IUD for birth control
  • You have already had, or are considering a procedure to reduce bleeding from the uterus (such as endometrial ablation) tell your doctor as it may affect the Essure procedure
    • The ablation procedure should not be performed on the same day as your Essure placement procedure
    • If you have Essure placed, your doctor must confirm that it is in a satisfactory location (via the Essure Confirmation Test) before performing an ablation procedure

Talk to your doctor about the Essure procedure and if it is right for you. Refer to the Patient-Doctor Discussion Checklist and review it with your doctor.

Questions About Essure?

Find answers to frequently asked questions.

Female Model for Essure Frequently Asked Questions

Talking to Your Doctor

Not sure how to begin the conversation with your doctor about Essure®?

Indication

Essure is indicated for women who desire permanent birth control (female sterilization) by bilateral occlusion of the fallopian tubes.

Important Safety Information

WARNING: Some patients implanted with the Essure System for Permanent Birth Control have experienced and/or reported adverse events, including perforation of the uterus and/or fallopian tubes, identification of inserts in the abdominal or pelvic cavity, persistent pain, and suspected allergic or hypersensitivity reactions. If the device needs to be removed to address such an adverse event, a surgical procedure will be required. This information should be shared with patients considering sterilization with the Essure System of Permanent Birth Control during discussion of the benefits and risks of the device.

Essure is not right for you if you are uncertain about ending your fertility, suspect you are pregnant, can have only one insert placed, have had your tubes tied, have a known allergy to contrast dye, are unwilling to undergo the Essure Confirmation Test, have unexplained vaginal bleeding, or have suspected or known cancer of the female reproductive organs.

You should delay having the Essure procedure if you are or have been pregnant within the past 6 weeks, have an active gynecological infection, or are in the second half of your menstrual cycle.

Tell your doctor if you are taking immunosuppressants, have, or think that you may have, a history of metal allergies, or an allergy to polyester fibers, nickel, titanium, platinum, silver-tin, or stainless steel or any other components of the Essure system, are currently using an IUD for contraception, or have had or are considering a procedure to reduce bleeding from the uterus such as endometrial ablation.

WARNING: Be sure you are done having children before you undergo the Essure procedure. Essure is a permanent method of birth control.

WARNING: You must continue to use another form of birth control until you have your Essure Confirmation Test (3 months after the procedure) and your doctor tells you that you can rely on Essure for birth control. For some women, it may take longer than 3 months for Essure to be effective, requiring a repeat confirmation test at 6 months. Talk to your doctor about which method of birth control you should use during this period. If you rely on Essure for birth control before receiving confirmation from your doctor, you are at risk of getting pregnant.

During the Procedure: In the premarketing study, some women experienced mild to moderate pain (9.3%). Your doctor may be unable to place one or both Essure inserts correctly. In rare cases, part of an Essure insert may break off during placement. If breakage occurs, your doctor will remove the piece, if appropriate. There is a risk of perforation of the uterus or fallopian tube by the hysteroscope, Essure system or other instruments used during the procedure. In the original premarket studies, perforation due to the Essure insert occurred in 1.8% of women. A perforation may lead to bleeding or injury to bowel or bladder, which may require surgery. Your doctor may recommend a local anesthesia. Ask your doctor about the risks associated with this type of anesthesia.

Immediately Following the Procedure: In the premarketing study, some women experienced mild to moderate pain (12.9%) and/or cramping (29.6%), vaginal bleeding (6.8%), and pelvic or back discomfort for a few days. Some women experience headaches, nausea and/or vomiting (10.8%), or dizziness and/or fainting. You should arrange to have someone take you home after the procedure. In rare instances, an Essure insert may be expelled from the body.

During the Essure Confirmation Test: As one of the Essure Confirmation Tests (a modified HSG) requires an x-ray, you may be exposed to very low levels of radiation, as with most x-rays, if this test is used. Some women may experience nausea and/or vomiting, dizziness and/or fainting, cramping, pain or discomfort. In rare instances, women may experience spotting and/or infection

Long-term Risks: Pain (acute or persistent) of varying intensity and length of time may occur and continue following Essure placement. This is also more likely to occur in women with a history of pain. There are reports of an Essure insert being located in the lower abdomen and pelvis. If this occurs, you cannot rely on Essure for birth control. Patients with known hypersensitivity to any of the components of the Essure system may experience an allergic reaction to the insert. In addition, some patients may develop an allergy to nickel or other components of the insert following placement. Symptoms reported in women using Essure that may be associated with an allergic reaction include hives, rash, swelling and itching. There is no reliable test to predict who may develop a reaction to the inserts. No birth control method is 100% effective. Ectopic pregnancies (pregnancy outside the uterus) may occur with Essure. This can be life-threatening. If insert removal is indicated, surgery will be necessary.

The safety and effectiveness of Essure has not been established in women under 21 or over 45 years old.

Essure does not protect against HIV or other sexually transmitted diseases.

Prescription Only

Talk to your doctor about Essure and whether it is right for you. Review the Patient-Doctor Discussion Checklist in the Patient Information Booklet with your doctor before deciding to have the Essure procedure.

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.

BAYER, the Bayer Cross and Essure are registered trademarks of Bayer. All other trademarks are property of their respective owners.These trademark owners are not affiliated with Bayer and do not sponsor or endorse Bayer or this product.
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Site last modified: 4/2017

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