At Bayer, our mission is to create drugs and devices that help people.

Patient safety is very
important to us, and we have great sympathy for anyone who is experiencing pain, regardless of
the cause. We have also read the stories from women who are sharing their personal
experiences with Essure. These stories, while compelling, are not representative of the
hundreds of thousands of women who have relied on Essure since its FDA approval in 2002.

Per your question, we are aware of the majority of the adverse events reports that have been
filed with the FDA this year regarding Essure.

As the manufacturer of this product, we have a responsibility to share the facts about Essure
with you and your viewers:

• We take all adverse events seriously. Most of the side effects that have
been reported recently about Essure are known and included in the Essure
Instructions for Use information. This was confirmed by the FDA which found
that “[a]lthough there is evidence of complications, as there are with all medical
devices, overall results from [a five year safety] study did not demonstrate any
new safety problems or an increased incidence of problems already known.”
1

(http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/Implantsan
dProsthetics/ucm371014.htm)

• Essure has more than a decade of research and development in addition to
a decade of real world experience. More than 750,000 devices have been sold
worldwide. Essure has been shown to be highly effective in preventing
pregnancy (99.83% based on a 5 year study) and the safety profile has been
documented through numerous clinical trials. The American College of
Obstetricians and Gynecologists (ACOG) has recognized that “hysteroscopic
tubal occlusion for sterilization [Essure] has high efficacy and low procedure-
related risk!.”
2


• More than 600,000 tubal ligation procedures are performed in the United
States each year.
3
We stand by the benefit-risk profile of Essure as an
important option available to women who want non-surgical permanent
contraception.


No form of contraception is without risk, should be considered appropriate for every woman or is
100 percent effective. As with any drug or device, it is important that women discuss the risks
and benefits of any birth control option with their physicians.

Below is a link to a video statement from Edio Zampaglione, MD, FACOG, US Medical Affairs,
Bayer HealthCare, for your use.
https://elmcity.sharefile.com/d/s754aaca247445f48

(To download the video, only use the link provided. No email or password is required. If it asks
you for that, please reopen your server and try the link again.)

Per your question regarding the Annual General Meeting held in Germany last month. At Bayer,
our patients are our top priority, and we are reaching out to the woman who spoke at the Annual
General Meeting last month to better understand her position. We do acknowledge that the
comments made by this individual at Bayer AG’s Annual General Shareholders’ Meeting held in
Cologne, Germany were in German. This is required so that the vast majority of attendees can
understand the various speakers in their native language. The official meeting minutes taken by
the notary public are also submitted to the commercial register in German.

# # #
Indication
Essure is a permanent birth control procedure that works with your body to create a natural
barrier against pregnancy.

Important Safety Information

WARNING: You must continue to use another form of birth control until you have your
Essure Confirmation Test and your doctor tells you that you can rely on Essure for birth
control.
• You can rely on Essure for birth control only after your doctor has reviewed your
Essure Confirmation Test results. Your doctor will confirm that the inserts are
properly placed and both of your fallopian tubes are blocked. If you rely on Essure
for birth control before having your Essure Confirmation Test, you are at risk of
getting pregnant.
• Talk to your doctor about which method of birth control you should use for the 3
months after the procedure. Some women can remain on their current birth control.
Other women, such as those using an intrauterine device or contraceptive (IUD or
IUC), will need to switch to another method.
• It can take longer than three months for the Essure procedure to be effective. In rare
cases, it has taken up to 6 months. Make sure to continue using an alternate form of
birth control up until your doctor has reviewed your Essure Confirmation Test results
and confirmed that you can rely on Essure for birth control.

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.


References:
1 http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/Implantsand
Prosthetics/ucm371014.htm
2 Benefits and Risks of Sterilization (Obstet Gynecol 2013;121:392–404) February
2013
3 Benefits and Risks of Sterilization (Obstet Gynecol 2013;121:392–404) February
2013


Best regards,

Rosemarie Yancosek
Head, U.S. External Communications, Pharmaceuticals

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