This form is an example. You should review and modify this form as you deem appropriate based on your professional judgment.
ESSURE PROCEDURE CONSENT FORM (EXAMPLE)

I understand that the Essure procedure involves permanently placing an Essure® insert into each fallopian tube, which over time
causes the tubes to become blocked, thereby preventing pregnancy.

I understand that the Essure procedure is considered to be permanent and irreversible.

I understand that no birth control method is 100% effective, and that Essure permanent birth control is 99.8% effective (based on 5
year clinical study data), in preventing pregnancy in women who had successful placement in each fallopian tube, as confirmed by
the Essure Confirmation Test.

I understand that I should not have the Essure procedure if I have delivered or terminated a pregnancy fewer than 6 weeks ago or
have an active or recent pelvic infection.

I understand that some women may not have successful placement of both Essure® inserts, and should this occur, I will need another
form of birth control.

I understand that Essure does not protect against sexually transmitted infections and that barrier methods such as condoms should be
used for protection against sexually transmitted infections.

I understand that the Essure confirmation test is performed 3 months after the procedure and uses contrast media dye and x-ray to
verify that the inserts are correctly placed and my fallopian tubes are blocked. I understand that until this is confirmed by the doctor I
cannot rely on Essure for birth control.

I understand that until the Essure Confirmation Test has confirmed my fallopian tubes are blocked and the inserts are in the correct
place, another form of birth control must be used.

I am not allergic to contrast media (dyes).

I understand that I should tell my doctor if I am taking medication that may suppress my immune system.

I understand that the risks associated with the placement of the Essure inserts include, but are not limited to: pain, bleeding, infection,
perforation, expulsion, possible allergic reaction.

I understand that patients who are allergic to nickel may have an allergic reaction to this device, especially those with a history of
metal allergies. In addition, some patients may develop an allergy to nickel if this device is implanted.

I understand that should I become pregnant, I should immediately seek medical care for evaluation of the pregnancy.

I have been counseled on alternatives to Essure, including: surgical female sterilization, male sterilization and other forms of birth
control.

I have received and reviewed the Patient Information Booklet and understand the risks associated with the Essure procedure.
I have had the opportunity to ask questions regarding the Essure permanent birth control procedure and will proceed with the
placement of the Essure® inserts.
Patient’s Signature
Date/Time
Physician’s (or Healthcare Provider’s) Signature as Witness
Date/Time
Indication
Essure® is permanent birth control that works with your body to create a natural barrier against pregnancy.
Important Safety Information
Essure is not right for you if you are uncertain about ending your fertility, can have only one insert placed, are or have been pregnant
within the past 6 weeks, have had your tubes tied, have an active or recent pelvic infection, or have a known allergy to contrast dye.
Tell your doctor if you are taking immunosuppressants.
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. It can take longer than three months
for Essure to be effective. Talk to your doctor about which method of birth control you should use during this period.
PLEASE SEE ADDITIONAL IMPORTANT SAFETY INFORMATION ABOUT ESSURE ON NEXT PAGE.
Women using an intrauterine device need to switch to another method. If you rely on Essure for birth control before receiving
confirmation from your doctor, you are at risk of getting pregnant.
WARNING: Be sure you are done having children before you undergo the Essure procedure. Essure is a permanent method of
birth control.
Important Safety Information (continued)
During the procedure: In clinical trials some women experienced mild to moderate pain (9.3%). Your doctor may be unable to place
one or both Essure® inserts correctly. Although uncommon, part of an Essure insert may break off or puncture the fallopian tube
requiring surgery to repair the puncture. Your doctor may recommend a local anesthetic. Ask your doctor about the risks associated
with this type of anesthesia.
Immediately following the procedure: In clinical trials 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 experienced nausea and/or vomiting
(10.8%) 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 and may require surgery. No birth control method is 100% effective. Women who have Essure
are more likely to have an ectopic pregnancy (pregnancy outside the uterus) if they get pregnant. This can be life-threatening. 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.
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.
Talk to your doctor about Essure and whether it is right for you.
Essure is a registered trademark of Bayer.
PP-250-US-0569 February 2015