Get to Know Your Permanent Birth Control Options

Get to Know Your
Permanent Birth
Control Options
As a woman, there comes a time when you’re faced with an important question: “Am I done
having children?” Behind every yes lies a reason. Maybe you have just the number of children
you always dreamed of or want to focus on your future. Whatever the reason, it may be time to
explore permanent birth control options. But do you really know what your options are?
Tubal ligation
Also known as “getting your tubes tied,” tubal ligation is a permanent birth control method in
which the fallopian tubes are blocked so that sperm is unable to reach the eggs.1
Vasectomy
A male surgical permanent birth control method in which the vas deferens (tubes that propel
sperm through the urethra) are tied in two places with permanent sutures that prevent sperm from
entering into the seminal stream.1
Essure®
Essure is non-surgical permanent birth control. The procedure can be done in 10 minutes in a doctor’s
office and involves placing soft, flexible inserts into the fallopian tubes. The Essure® inserts do not
contain or release hormones and there is no downtime to recover. Most women go home 45 minutes
after the procedure and return to normal activities within a day or two.1
Over a period of about 3 months, tissue forms around the inserts which keeps sperm from reaching
the eggs and prevents conception. After 3 months, a doctor administers an Essure Confirmation Test
to confirm that both inserts are placed correctly, the fallopian tubes are completely blocked and the
woman can rely on Essure for permanent birth control. Until this confirmation is received from the
doctor, an alternate form of birth control must be used to prevent pregnancy.
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.
Please see additional Important Safety Information about Essure on the next pages.
During the procedure, the most common problem reported was mild to moderate pain (9.3%).
Some women 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%).
There are additional risks and considerations with this procedure. Women should discuss all risks
with their doctor to see if Essure is right for them.
* The risk for pregnancy may be high, even with Essure.
False, Essure is proven to be 99.83 percent effective based on five year clinical study data.
No form of birth control is 100 percent effective.
Important: Another form of birth control must be used to prevent pregnancy until a woman has her
Confirmation Test and is told by her doctor that she can rely on Essure for birth control.
* With the procedure for Essure, most women return to normal activity within one to two days.
True. The procedure to place Essure is non-surgical and can be done in 10 minutes in a doctor’s office.
Most women leave the office 45 minutes after the procedure and return to normal activities within
one to two days.
There are additional risks and considerations. Please see Important Safety Information below.
* My doctor doesn’t offer Essure. It must not be available in my area.
This may not be true.
To find physicians in the U.S. trained to perform the procedure, visit www.essure.com and click
“Find a Doctor.”a
Important Safety Information (cont’d)
Talk to 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. 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.
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.
Please see additional Important Safety Information about Essure on the next pages.
Important Safety Information (cont’d)
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.
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.
You can also report any adverse events or product technical complaints involving the Essure system
immediately by calling 877-ESSURE1 (877.377.8731).
1
Essure Patient Information Booklet (PIB), Bayer Healthcare Pharmaceuticals, December 2013.
Bayer maintains a list of physicians who have been trained and are willing to accept referrals. Physicians are listed according to proximity
to address and site of service criteria. Physician participation on this list is voluntary and free. Some of the listed physicians may be paid
consultants for Bayer. Physicians may be removed from the list at their or Bayer’s request. Bayer does not guarantee the accuracy of the
listings and is not responsible for the medical advice or care given by the physicians.
a
BAYER, the Bayer Cross, and Essure are registered trademarks of Bayer.
© 2015 Bayer HealthCare Pharmaceuticals. 100 Bayer Blvd, Whippany, NJ, 07981-0915
All rights reserved. PP-250-US-0717 May 2015