**A New Method of Permanent Birth Control:**

**The**

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**Permanent Birth Control System**

**Patient Information Booklet**

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| **IMPORTANT**                                                         |
|                                                                       |
| This product is intended to prevent pregnancy.                        |
|                                                                       |
| It does not protect against HIV infection and other sexually          |
| transmitted diseases.                                                 |
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This brochure is designed to provide important information regarding
permanent female contraception using a device known as the **Essure
Permanent Birth Control System**. Use of this medical device requires
discussion with a qualified doctor. It is important that you read this
booklet carefully and discuss its contents with your doctor.

**The Essure Permanent Birth Control System**

**Your choice about permanent birth control**

You are reading this brochure because you are considering choices about
permanent birth control (female sterilization). Sterilization is
intended to prevent pregnancy for the rest of your life.

This brochure is about a new method of permanent birth control called
**Essure.** Because it is intended to permanently prevent pregnancy, it
is similar to other permanent birth control procedures such as tubal
ligation (\"having your tubes tied\") or vasectomy. **Essure** is a
lower impact approach than incisional tubal ligation and is gentler on
your body because it can be performed without general anesthesia, does
not involve cutting through the skin and recovery is quick.

This brochure will provide you with information about **Essure** as well
as the benefits and risks; however, this information is not intended to
be comprehensive as all women have individual needs and concerns. Your
doctor will advise you whether the procedure is appropriate for you with
regards to your circumstances and medical history.

**What is the Essure procedure?**

The **Essure** procedure involves placing a small, flexible device
called a Micro-insert into each of your two fallopian tubes (the tubes
where your eggs travel from your ovaries to your uterus). The
Micro-inserts are made from materials that have been well studied and
used successfully in the heart and other parts of the human body for
many years. Once the Micro-inserts are in place, your body tissue grows
into the Micro-inserts, blocking the fallopian tubes. Blocking the tubes
is intended to prevent sperm from fertilizing the egg, thereby
preventing pregnancy. Your doctor will be able to explain the procedure
to you in more detail.

**Is Essure right for you?**

The **Essure** procedure is only appropriate if you are sure you don\'t
want any more children, would like to have permanent birth control and
believe you will not change your mind. If there is any chance you may
want to have children in the future, you should choose another form of
birth control. You should avoid making this choice during times of
stress, such as a divorce or after a miscarriage, and NEVER under
pressure from a partner or others.

You should be aware that there are other methods of birth control, both
temporary/reversible and permanent. The table on the following page
shows pregnancy rates for various birth control methods. Your doctor
will explain these alternative methods to you and advise you whether
**Essure** is a suitable option for you. It is your right to decide what
method suits you. If, at any time before the **Essure** procedure, you
decide not to have it, you should tell your doctor and cancel the
procedure. You do not have to provide any explanation or reason for your
decision.

If you decide you want the **Essure** procedure, you will have a general
examination and laboratory tests to confirm that you are a good
candidate for the procedure. It may turn out that the **Essure**
procedure is not an option for you.

**Pregnancy Rates for Birth Control Methods**

**(For One Year of Use)**

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| The following table provides estimates of the percent of women likely |
| to become pregnant while using a particular contraceptive method for  |
| one year. These estimates are based on a variety of studies.          |
|                                                                       |
| **\"Typical Use\"** rates mean that the method either was *not always |
| used correctly* or was *not used with every act of sexual             |
| intercourse* (e.g., sometimes forgot to take birth control pill as    |
| directed and became pregnant), or was *used correctly* but *failed    |
| anyway*.                                                              |
|                                                                       |
| **\"Lowest Expected\"** rates mean that the method was *always used   |
| correctly* with *every act of sexual intercourse but failed anyway*   |
| (e.g., always took a birth control pill as directed but still became  |
| pregnant).                                                            |
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+---------------------------------+----------------+------------------+
| **Method**                      | **Typical      | **Lowest         |
|                                 | Use**          | Expected**       |
|                                 |                |                  |
|                                 | **Rate of      | **Rate of        |
|                                 | Pregnancy**    | Pregnancy**      |
+---------------------------------+----------------+------------------+
| **Sterilization:**              |                |                  |
+---------------------------------+----------------+------------------+
| Male Sterilization              | 0.15%          | 0.1%             |
|                                 |                |                  |
| Female Sterilization            | 0.5%           | 0.5%             |
+---------------------------------+----------------+------------------+
| **Hormonal Methods:**           |                |                  |
+---------------------------------+----------------+------------------+
| Implant *(Norplant ™ and        | 0.05%          | 0.05%            |
| Norplant ™ 2)*                  |                |                  |
|                                 | 0.3%           | 0.3%             |
| Hormone Shot *(Depo-Provera™)*  |                |                  |
|                                 | 5%             | 0.1%             |
| Combined Pill                   |                |                  |
| *(Estrogen/Progestin)*          | 5%             | 0.5%             |
|                                 |                |                  |
| Minipill *(Progestin only)*     |                |                  |
+---------------------------------+----------------+------------------+
| **Intrauterine Devices          |                |                  |
| (IUDs):**                       |                |                  |
+---------------------------------+----------------+------------------+
| Copper T                        | 0.8%           | 0.6%             |
|                                 |                |                  |
| Progesterone T                  | 2%             | 1.5%             |
+---------------------------------+----------------+------------------+
| **Barrier Methods:**            |                |                  |
+---------------------------------+----------------+------------------+
| Male Latex Condom^1^            | 14%            | 3%               |
|                                 |                |                  |
| Diaphragm^2^                    | 20%            | 6%               |
|                                 |                |                  |
| Vaginal Sponge *(no previous    | 20%            | 9%               |
| births)*^3^                     |                |                  |
|                                 | 40%            | 20%              |
| Vaginal Sponge *(previous       |                |                  |
| births)*^3^                     | 20%            | 9%               |
|                                 |                |                  |
| Cervical Cap *(no previous      | 40%            | 26%              |
| births)*^2^                     |                |                  |
|                                 | 21%            | 5%               |
| Cervical Cap *(previous         |                |                  |
| births)*^2^                     |                |                  |
|                                 |                |                  |
| Female Condom                   |                |                  |
+---------------------------------+----------------+------------------+
| **Spermicide:** *(gel, foam,    | 26%            | 6%               |
| suppository, film)*             |                |                  |
+---------------------------------+----------------+------------------+
| **Natural Methods:**            |                |                  |
+---------------------------------+----------------+------------------+
| Withdrawal                      | 19%            | 4%               |
|                                 |                |                  |
| Natural Family Planning         | 25%            | 1-9%             |
|                                 |                |                  |
| *(calendar, temperature,        |                |                  |
| cervical mucus)*                |                |                  |
+---------------------------------+----------------+------------------+
| **No Method:**                  | 85%            | 85%              |
+---------------------------------+----------------+------------------+

^1^ Used Without Spermacide ^2^ Used With Spermacide ^3^ Contains
Spermacide

> Data adapted from: Trussell J. Contraceptive efficacy. In Hatcher RA,
> Trussell J. Stewart F, et al Contraceptive Technology: Seventeenth
> Revised Edition. New York. NY: Ardent Media, 1998.

**THE ESSURE PROCEDURE: KEY CONSIDERATIONS**

**The procedure should be considered irreversible**

There are no data on the safety or effectiveness of surgery to reverse
the **Essure** procedure. It is only meant to be used by women who are
certain they no longer want to have children. There are also no data on
the safety or effectiveness of *in vitro* fertilization (IVF) after the
**Essure** procedure has been performed.

**Like all methods of birth control, the Essure procedure should not be
considered 100% effective**

No method of birth control is 100% effective and there is a small chance
you could become pregnant.

**There is a waiting period after the procedure**

A pelvic x-ray will be taken three months after the procedure to
determine the location of the Micro-inserts. Based on the results of the
x-ray, your doctor will advise you whether the **Essure** Micro-insert
can be relied on for permanent birth control. Because of this 3-month
waiting period, you will need to talk to your doctor (before the
procedure is performed) about alternative contraceptive options to cover
this time.

**The Essure procedure is newer than other procedures**

**Essure** is one of the newest methods of permanent birth control, so
it hasn't been studied in as many women or for as long as most birth
control methods.

**As with all procedures, there are risks associated with Essure**

You should be aware of these risks and discuss them in detail with your
doctor before you make your decision. There is a list of risks detailed
in this brochure. Many of them are rare. You should talk to your doctor
about the likelihood of these risks, particularly in relation to your
own situation.

**What is the Essure procedure like for women?**

Two separate trials of the effectiveness of the **Essure** procedure
have been conducted in women from the United States, Australia, and
Europe. This first trial involved approximately 200 women and the second
trial involved approximately 500 women. Based on data from these trials,
the **Essure** procedure is:

\- effective

\- quick

\- highly rated by women

**Effective**

If the Essure procedure is completed successfully, the one-year
effectiveness rate is greater than 99.8%.

**Quick**

The average procedure time was about 15 minutes in each trial.

**Essure is highly rated by women**

▪ 88-89% of women rated their tolerance of the procedure as \'good\' to
\'excellent\' in both trials.

▪ General anesthesia was not required, however 4% of patients or
physicians elected to do the procedure under general anesthesia in the
first trial. In the second trial, less than 1% of patients or physicians
elected to do so.

▪ 92% of women missed only one day or less of work, not including the
day of the procedure. After three days, 99% of women were back at work.
This was evaluated in the second trial only.

▪ One year after the procedure, women rated the **Essure** Micro-inserts
very highly. Overall, over 500 women have used the Micro-inserts for
more than a year and 99% have rated their overall comfort as \'good\' to
\'excellent\'.

**Risks and adverse events of the Essure procedure and Micro-insert**

As with all procedures, there are risks associated with the **Essure**
procedure and Micro-insert. The Safety Summary below includes detailed
information on the known or possible risks associated with the **Essure
Permanent Birth Control System**. There may be more risks that have not
yet been identified. If you decide to have the procedure, your doctor
will provide more detailed information about these risks and their
likelihood for your particular circumstances. Many of these risks are
rare.

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  This section is not intended to be a substitute for a thorough
  discussion with you doctor about whether this treatment is right for
  you. Please read this section carefully, then talk to your doctor.

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**SAFETY SUMMARY**

**Indications for Use**

The **Essure Permanent Birth Control System** is indicated for permanent
birth control (female sterilization) by occlusion of the fallopian
tubes.

**Contraindications**

The **Essure Permanent Birth Control System** should not be used if you
are:

• Uncertain about your desire to end fertility.

• Currently taking systemic corticosteroids.

Or, if you have any of the following conditions:

• Pregnancy or suspected pregnancy.

• Delivery or termination of a second trimester pregnancy less than 6
weeks before **Essure** Micro-insert placement.

• Active or recent pelvic infection.

• Untreated acute cervicitis.

• Gynecological malignancy (suspected or known).

• Known abnormal uterine cavity or fallopian tubes that would make
visualization of the tubal opening and/or catheterization of the
proximal fallopian tube difficult or impossible.

• Known allergy to contrast media.

• Known hypersensitivity to nickel confirmed by skin test.

**Warnings**

• Whenever possible, Micro-insert placement should be performed during
days 7-14 of your menstrual cycle (where day 1 represents the first day
of bleeding). This will help your doctor to see your fallopian tube
openings and decrease the chance of your doctor placing the **Essure**
Micro-inserts when you may have an undiagnosed pregnancy.

• You cannot immediately rely on the **Essure** Micro-inserts for
contraception and must use alternative contraception until an x-ray
performed three months after the **Essure** procedure demonstrates
satisfactory Micro-insert location.

• You may, in future years, be offered intrauterine therapies that
utilize electrical energy. Due to the presence of the **Essure**
Micro-inserts, there may be risks associated with such procedures that,
at this time, have not been identified.

• Any intrauterine procedure performed following the **Essure**
procedure could interrupt the ability of the **Essure** Micro-inserts to
prevent pregnancy. In addition, the presence of the **Essure**
Micro-inserts could involve risks associated with such procedures that,
at this time, have not been identified.

• There are no data on the safety or effectiveness of surgery to reverse
the **Essure** procedure.

• In future years, you may decide to undergo *in vitro* fertilization
(IVF) to become pregnant. You should know that the effects of the
**Essure** Micro-inserts on the success of IVF are unknown. If pregnancy
is achieved, the risks of the Micro-inserts to your health, to the
health of your baby and to the continuation of your pregnancy are
unknown.

**Precautions**

Testing to ensure safety and compatibility with Magnetic Resonance
Imaging (MRI) has been conducted using a 1.5 Tesla magnet. The
**Essure** Micro-inserts were found to be MR safe at this field
strength. However, the presence of the Micro-inserts produces an MR
artifact which will obscure imaging of local tissue.

**Risk/Benefit Analysis**

The information derived from the clinical investigation of the **Essure
Permanent Birth Control System** indicates that the **Essure** procedure
provides an adequate alternative means of permanent birth control with a
reasonable assurance of safety and effectiveness. Following is a summary
of known risks and benefits associated with use of the device.

**Risks**

The following risks are possible with the **Essure Permanent Birth
Control System**:

• No placement or unsatisfactory placement of the Micro-inserts. In the
clinical trials, approximately 8% of women were not able to have the
Micro-inserts placed in at least one fallopian tube. At routine 3-month
follow-up, an additional 4.5% were found to be incorrectly placed. These
women could not *initially* rely on the **Essure** Micro-inserts for
birth control. The types of improper placement include:

> \- The Micro-insert placed in an unsatisfactory location
>
> \- Perforation (e.g., a small hole in the wall of the fallopian tubes
> or uterus)
>
> \- Movement of the Micro-insert after placement (including expulsion
> of the Micro-insert from the body due to improper placement)

• Breakage of the **Essure** Micro-insert

• Vaso-vagal response (e.g., nausea, sweating, slowness of the
heartbeat, and rapid fall in blood pressure)

• Fluid over-absorption (absorption by the body of the saline used in
the Micro-insert placement procedure in excessive quantities)

• Pain, cramping, vaginal bleeding

• Nausea/vomiting or fainting

• Regret

• Periods (menses) that are heavier or longer than normal, as well as
bleeding between periods.

• Risks associated with anesthesia use

• Infection

• Pregnancy and ectopic pregnancy

• Women who undergo the placement procedure during the second half of
their menstrual cycle (after ovulation) are at an increased risk of
unknowingly being pregnant at the time of the placement procedure.
Therefore, the Micro-insert placement procedure should be scheduled
during the first half of the menstrual cycle.

• Perforation (a small hole) in internal bodily structures other than
the uterus and fallopian tube.

• Potential for pelvic inflammatory disease.

• Risks associated with the hysterosalpingogram or x-rays.

• The effect that the **Essure** Micro-insert could have on future
medical procedures that involve the uterus or fallopian tube, especially
those that might use electrosurgical energy (a form of electricity used
in surgery).

• The effect of future medical procedures that involve the uterus or
fallopian tubes on the ability of the **Essure** Micro-insert to provide
protection against pregnancy.

• The risks and success of *in vitro* fertilization (IVF) with the
**Essure** Micro-inserts in place.

• There are no data on the safety or effectiveness of surgery to reverse
the **Essure** procedure.

**Benefits**

The **Essure Permanent Birth Control System** is an effective means of
permanent birth control (female sterilization). The **Essure Permanent
Birth Control System** allows:

• A non-incisional alternative to incisional tubal ligation - the device
is placed in the fallopian tubes using a delivery catheter, which is
passed through the cervix.

• Avoidance of general anesthesia - General anesthesia (being asleep
while surgery takes place) is not required, however a small percentage
of patients or physicians have elected to do the procedure under general
anesthesia.

• Fast Recovery - On average, patients are able to go home 45 minutes
after the procedure and return to normal activities in an average of 1-2
days.

• Quick - Your procedure time should be about 15 minutes.

• No scars - You will not have any scars because it does not involve
cutting into the skin.

• Rapid return to work - 92% of women treated in the clinical trial
missed one day or less of work following the procedure (not including
the day of the procedure).

**Glossary**

**Anesthesia** - Partial or complete loss of sensation with or without
loss of consciousness.

**Cervix** - The neck of the uterus.

**Contraceptive** - Any process, device or method that prevents
conception (pregnancy).

**Delivery Catheter** - A long tube-like device that assists in the
placement of the **Essure** Micro-inserts in the fallopian tubes.

**Ectopic Pregnancy** - Implantation of the fertilized egg outside of
the uterus.

**Effectiveness** - Producing, or able to produce a desired effect.

**Expulsion** - To force something out.

**Fallopian Tubes** - The tubes that carry the eggs from the ovary to
the uterus.

**Hysterosalpingogram** - An x-ray of the uterus and ovaries after
filling the organs with dye.

***In vitro* Fertilization** - Fertilizing an egg outside of the living
body (in a test tube).

**Occlusion -** To close up or block off.

**Perforation** - Making a hole through something.

**Permanent** - Not able to change back and forth.

**Reversible** - Able to change back and forth.

**Tubal Ligation** - Permanent female sterilization by means of cutting
and tying the fallopian tubes.

**Uterus** - An organ of the female reproductive system for containing
and nourishing the embryo and fetus (baby) from the time the fertilized
egg is implanted to the time of birth of the fetus.

**Vasectomy** - Permanent male sterilization by means of removal of all
or a segment of the vas deferens (the tube that transports the sperm).

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  For more information on the Essure procedure, please speak to your
  doctor.

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**Conceptus Incorporated**

1021 Howard Ave.

San Carlos, CA 94070

USA

Tel: 650.XXX.XXXX

Fax: 650.XXX.XXXX

www.conceptus.com

www.essure.com

 2002 Conceptus, Inc.

All Rights Reserved

Printed in USA

Conceptus~~ is a registered trademark of Conceptus, Inc.

**Essure** is a trademark of Conceptus, Inc.

U.S. and international patents pending,

MK2132 Rev. A (06/05/02)