ADMINISTRATION
CHIEF OPERATING OFFICER Bruce Potter
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.

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 inserts do not protect against HIV or other
sexually transmitted diseases.

Talk to your doctor about Essure 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.

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© 2015 Bayer HealthCare Pharmaceuticals Inc., Whippany, NJ, 07981
All rights reserved.

PP-250-US-0606 Printed in USA
February 2015
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