What is IMPLANON?

IMPLANON is a type of birth control for women. It is a flexible, plastic, rod-shaped contraceptive about the size of a matchstick that is put under the skin of your arm. IMPLANON contains a hormone called etonogestrel. You can use a single IMPLANON for up to three years. Because IMPLANON does not contain estrogen, your healthcare provider may recommend IMPLANON even if you cannot use estrogen.

IMPLANON must be removed by the end of the third year and may be replaced with a new IMPLANON. It is not known if IMPLANON is as effective in very overweight women because studies did not include many overweight women.  Tell your healthcare provider about any medicines you are taking, or intend to take, including over-the-counter medicines, herbal remedies, and prescription medicines. Certain medicines may make IMPLANON less effective and you may need to use a barrier method of contraception as backup.

How do I know if IMPLANON is right for me?

Your healthcare provider will help you determine if IMPLANON is right for you. He or she will review the Patient Labeling with you, including the Patient Consent Form, to be sure you understand all of the potential risks and benefits of using IMPLANON. The information on this Web site does not take the place of a thorough discussion with your healthcare provider.

What is the most important information I should know about IMPLANON?

After you receive IMPLANON, check that it is in place by pressing your fingertips over the skin of your arm where IMPLANON was placed. You should be able to feel it. If IMPLANON is not placed properly, it may not prevent pregnancy or it may be difficult or impossible to remove.

The most common side effect of IMPLANON is a change in your menstrual periods. Expect your periods to be irregular and unpredictable throughout the time you are using IMPLANON. You may have more, less or no bleeding. The time between periods may vary, and in between periods you may have spotting.

How does IMPLANON work?

IMPLANON prevents pregnancy in several ways. The most important way is by stopping release of an egg from your ovary. IMPLANON also changes the mucus in your cervix and this change may keep sperm from reaching the egg. Also, IMPLANON changes the lining of your uterus.

How well does IMPLANON work?

If IMPLANON is inserted correctly, your chance of getting pregnant is very low (less than one pregnancy per 100 women who use IMPLANON for one year). It is not known if IMPLANON is as effective in very overweight women because clinical studies did not include many overweight women. You should tell your healthcare provider about any medications you are taking, or intend to take, including over-the-counter, herbal and prescription medicines. Certain medicines may make IMPLANON less effective, so you may need to use a barrier method of contraception as backup.

The following chart shows the chance of getting pregnant for women who use different methods of birth control. Birth control methods that are similar in effectiveness are grouped together.

The most effective methods are at the top of the chart. The bottom of the chart shows the chance of getting pregnant for women who do not use birth control and are trying to get pregnant.

How do I use IMPLANON?

Your healthcare provider will insert (or remove) IMPLANON in a minor surgical procedure in his or her office. IMPLANON is inserted just under the skin on the inner side of your upper arm.

The timing of insertion is important. Depending on your history, your healthcare provider may ask you to:

• Have a pregnancy test before insertion
• Schedule the insertion at a specific time of your cycle (for example, within the first days of your regular menstrual bleeding)
• Use a backup method of birth control, such as condoms, for seven days after IMPLANON insertion

Both you and your healthcare provider should check that IMPLANON is in your arm by feeling the IMPLANON implant.

If you and your healthcare provider cannot feel IMPLANON, use a non-hormonal birth control method such as condoms until your healthcare provider confirms that IMPLANON is in place. You may need special tests to check that IMPLANON is in place or to help find IMPLANON when it is time to take it out.

You will be asked to review and sign a consent form prior to inserting IMPLANON. You will also get a User Card to keep at home with your health records. Your healthcare provider will fill out the insertion and removal dates. Keep track of the removal date and schedule an appointment for removal with your healthcare provider on or before the removal date.

The insertion site is covered with two bandages. Leave the top bandage on for 24 hours. Keep the smaller bandage dry, clean, and in place for three to five days.

Be sure to have checkups as advised by your healthcare provider.

Will I need to use a backup method?

This depends upon the timing of insertion. Talk to your healthcare provider about the timing of IMPLANON insertion. In some situations, you may need a backup method of contraception for seven days after insertion.

What if I am taking another medication? Should I use backup protection?

Certain medicines may make IMPLANON less effective and you may need to use back-up non-hormone birth control. Tell your healthcare provider about any medicines you are taking, or intend to take, including over-the-counter medicines and prescription medicines such as: barbiturates, griseofulvin, rifampin, phenylbutazone, phenytoin, carbamazepine, felbamate, oxcarbazepine, topiramate, and modafinil. Herbal remedies such as St. John’s Wort may also reduce the effectiveness of contraceptive drug products. This is not a complete list of drugs that may interact with IMPLANON.

When you are using IMPLANON, tell all of your healthcare providers that you have IMPLANON.

Who should not use IMPLANON?

IMPLANON is not for everyone. Do not use IMPLANON if you:

• Are pregnant or think you may be pregnant
• Have or have had serious blood clots, such as blood clots in your legs (deep venous thrombosis), lungs (pulmonary embolism), eyes (retinal thrombosis), heart (heart attack) or head (stroke)
• Have unexplained vaginal bleeding
• Have liver disease
• Have or have had breast cancer
• Are allergic to anything in IMPLANON

Tell your healthcare provider if you have ever had any of these conditions. He or she can suggest another method of birth control.

In addition, talk to your healthcare provider about using IMPLANON if you have or have had diabetes, high cholesterol or triglycerides, headaches, seizures or epilepsy, gallbladder or kidney disease, depression, high blood pressure or an allergic reaction to anesthetics or antiseptics.

What if I change my mind about birth control?

Your healthcare provider can remove IMPLANON at any time. If you want to become pregnant after IMPLANON removal, your ability to get pregnant may return quickly. If you don’t want to get pregnant, you should start another birth control method right away.

What if I want to become pregnant?

The ability to get pregnant usually returns quickly after your healthcare provider successfully removes IMPLANON. Some women have even become pregnant within days of having IMPLANON removed.

What if I become pregnant while using IMPLANON?

You should see your healthcare provider right away. It is important to remove IMPLANON and make sure that the pregnancy is not ectopic (occurring outside the womb). Based on experience with birth control pills, IMPLANON is not likely to cause birth defects.

Can I use IMPLANON when I am breast feeding?

Based on a small study, you may start IMPLANON if you are breast feeding and if you delivered your baby more than four weeks ago. A small amount of the active substance of IMPLANON passes into the breast milk. The health of breast fed children whose mothers were using IMPLANON has been studied up to three years of age in a small number of children. No effects on the growth and development of the children were seen. If you are breast feeding and want to use IMPLANON, talk with your healthcare provider.

Will IMPLANON be covered by insurance?

IMPLANON may be covered by your insurance plan. To determine if you have coverage, you should call the customer service number on the back of your insurance card. Ask if IMPLANON is covered under your policy. You may need to explain that IMPLANON is an implantable contraceptive. You may also be asked to provide the billing code for IMPLANON. You can ask your healthcare provider for the code. If IMPLANON is covered, ask the customer service representative to send verification of coverage to your healthcare provider. Learn more about health plan coverage.

How is IMPLANON inserted?

IMPLANON is inserted or removed through a minor surgical procedure performed by a trained healthcare provider in his or her office. A mild anesthetic is used to minimize discomfort for both the insertion and removal. IMPLANON is inserted just under the skin on the inner side of your upper arm.

IMPLANON must be inserted and removed only by a healthcare provider who has completed a clinical training program sponsored by Merck & Co., Inc. Be sure to thoroughly discuss any questions with your healthcare provider and read the Patient Labeling, including the Consent Form.

What are the possible complications of the insertion and removal procedure?

Rarely, removal of IMPLANON is difficult or even impossible because IMPLANON is not where it should be. If IMPLANON cannot be removed then the effects of IMPLANON will continue for a longer period of time. Rarely, IMPLANON is not inserted at all due to a failed insertion, or the implant has fallen out of the needle, and then you may become pregnant. After insertion, and with direction from your healthcare provider, you should be able to feel IMPLANON under your skin. If you can’t feel IMPLANON, tell your healthcare provider.

Some other problems related to insertion include:

• Pain, irritation, swelling or bruising
• Scarring, including a thick scar called a keloid
• Infection
• IMPLANON breaks, making it difficult to remove IMPLANON
• Thick scar tissue forming around IMPLANON making removal difficult
• Rarely, expulsion of the implant
• Rarely, the need for surgery in the hospital for removal of IMPLANON
• Removals of deeply inserted implants can lead to scarring or complications such as damage to nerves or blood vessels

IMPLANON must be inserted and removed only by a healthcare provider who has completed a clinical training program sponsored by Merck & Co., Inc. Be sure to thoroughly discuss any questions with your healthcare provider and read the Patient Labeling, including the Consent Form.

Is it okay to leave IMPLANON in my arm for three years?

IMPLANON is made of a medical material that can be left in your body for up to three years. However, IMPLANON must be removed by the end of the third year and can be replaced by a new IMPLANON if continued contraceptive protection is needed.

IMPLANON must be inserted and removed only by a healthcare provider who has completed a clinical training program sponsored by Merck & Co., Inc. Be sure to thoroughly discuss any questions with your healthcare provider and read the Patient Labeling, including the Consent Form.

When should I have IMPLANON inserted?

Your healthcare provider will help you determine when to have IMPLANON inserted. The timing will depend upon whether you are currently using birth control and which method you are using. You should not be pregnant when you start using IMPLANON.

IMPLANON must be inserted and removed only by a healthcare provider who has completed a clinical training program sponsored by Merck & Co., Inc. Be sure to thoroughly discuss any questions with your healthcare provider and read the Patient Labeling, including the Consent Form.

What do I have to do when it is time to have IMPLANON removed?

You must schedule an appointment with your healthcare provider and have IMPLANON removed no later than three years after the date of insertion. Although IMPLANON is designed to last up to three years, a trained healthcare provider can remove it at any time. When IMPLANON is inserted, your healthcare provider will give you a User Card that lists the date of insertion and expected date of removal. Keep this card at home with your other important health records.

If you switch to a new healthcare provider before IMPLANON is removed, be sure to ask if he or she is trained to insert and remove IMPLANON. If you need help finding a healthcare provider who has been trained at a program sponsored by Merck & Co., Inc. to perform these procedures, call 1-877-IMPLANON (1-877-467-5266) or find a clinician now.

IMPLANON must be inserted and removed only by a healthcare provider who has completed a clinical training program sponsored by Merck & Co., Inc. Be sure to thoroughly discuss any questions with your healthcare provider and read the Patient Labeling, including the Consent Form.

How is IMPLANON removed?

A trained healthcare provider can remove IMPLANON at any time with a minor surgical procedure in the office. He or she will make a small incision in your arm and remove IMPLANON. A mild anaesthetic is used to minimize any discomfort. Some minor bruising, redness, swelling and/or pain may occur where IMPLANON was removed. Your healthcare provider should not attempt to remove IMPLANON unless its location has been firmly established (e.g., by palpation [touching]).

IMPLANON must be inserted and removed only by a healthcare provider who has completed a clinical training program sponsored by Merck & Co., Inc. Be sure to thoroughly discuss any questions with your healthcare provider and read the Patient Labeling, including the Consent Form.

Will the insertion or removal of IMPLANON leave a permanent mark?

You may get a scar from insertion or removal of IMPLANON. Talk to your doctor for more information about the insertion or removal of IMPLANON leaving a permanent mark.

IMPLANON must be inserted and removed only by a healthcare provider who has completed a clinical training program sponsored by Merck & Co., Inc. Be sure to thoroughly discuss any questions with your healthcare provider and read the Patient Labeling, including the Consent Form.

What if I want to continue using IMPLANON?

A new IMPLANON can be inserted in the same place where the old one was, or it can be inserted in the other arm. A trained healthcare provider will decide the best place to insert IMPLANON.

IMPLANON must be inserted and removed only by a healthcare provider who has completed a clinical training program sponsored by Merck & Co., Inc. Be sure to thoroughly discuss any questions with your healthcare provider and read the Patient Labeling, including the Consent Form.

What are the most common side effects I can expect while using IMPLANON?

The most common side effect is a change in your menstrual periods. In studies, about 10% of women stopped using IMPLANON because of bleeding problems. Expect your menstrual periods to be irregular and unpredictable throughout the time you are using IMPLANON.

You may have more bleeding, less bleeding or no bleeding. The time between periods may vary, and in between periods you may have spotting.

Talk with your healthcare provider if you think you may be pregnant or if your vaginal bleeding is heavy and prolonged.

Besides irregular bleeding, some of the most frequent side effects that caused women to stop using IMPLANON in studies were:

• Mood swings
• Weight gain
• Headache
• Acne
• Depression

The most common side effects reported by women using IMPLANON in clinical trials were:

• Irregular and unpredictable bleeding
• Headache
• Vaginitis (inflammation of the vagina)
• Weight gain
• Acne
• Breast pain
• Viral infections such as colds, sore throats, sinus infections or flu-like symptoms
• Stomach pain
• Painful periods
• Mood swings, nervousness or depression
• Back pain
• Nausea
• Dizziness
• Pain
• Pain at the site of insertion

Rare side effects that have been reported include: extra hair on your face and body, trouble using contact lenses, and spotty darkening of the skin, especially of the face. This is not a complete list of possible side effects. Talk to your healthcare provider if you experience any side effects that concern you.

This answer provides you with helpful information about side effects patients may experience while using IMPLANON. Be sure to read the Patient Labeling, including the Consent Form, and discuss any concerns or questions you have with your healthcare provider.

What are the possible risks of using IMPLANON?

Complications of Insertion and Removal

Rarely, removal of IMPLANON is difficult or even impossible because IMPLANON is not where it should be. If IMPLANON cannot be removed, then the effects of IMPLANON will continue for a longer period of time.

Rarely, IMPLANON is not inserted at all due to a failed insertion, or the implant has fallen out of the needle, and then you may become pregnant. After insertion, and with direction from your healthcare provider, you should be able to feel IMPLANON under your skin. If you can’t feel IMPLANON, tell your healthcare provider.

Some other problems related to insertion and removal are:

• Pain, irritation, swelling or bruising
• Scarring, including a thick scar called a keloid
• Infection
• IMPLANON breaks making it difficult to remove
• Thick scar tissue forming around IMPLANON making removal difficult
• Rarely, expulsion of the implant
• Rarely, need for surgery in the hospital for removal of IMPLANON
• Removals of deeply inserted implants can lead to scarring or complications such as damage to nerves or blood vessels

Ectopic Pregnancy

If you become pregnant while using IMPLANON, you have a slightly higher chance that the pregnancy will be ectopic (occurring outside the womb) than do women who are not using birth control. Ectopic pregnancies can cause serious internal bleeding and even death.

Interaction with Other Medicines

Certain medicines may make IMPLANON less effective and you may need to use back-up non-hormone birth control. Tell your healthcare provider about any medicines you are taking, or intend to take, including over-the-counter medicines and prescription medicines such as: barbiturates, griseofulvin, rifampin, phenylbutazone, phenytoin, carbamazepine, felbamate, oxcarbazepine, topiramate and modafinil. Herbal remedies such as St. John’s Wort may also reduce the effectiveness of contraceptive drug products. This is not a complete list of drugs that may interact with IMPLANON.

When you are using IMPLANON, tell all of your healthcare providers that you have IMPLANON.

Ovarian Cysts

Cysts on the ovaries usually go away without treatment. Sometimes surgery is needed.

Breast Cancer

It is not known whether IMPLANON changes a woman’s risk for breast cancer. If you have breast cancer now, or have had it in the past, do not use IMPLANON because some breast cancers are sensitive to hormones.

Blood Clots (Thrombosis)

It is not known whether IMPLANON changes a woman’s risk for serious blood clots called thrombosis. Thrombosis is a side effect of birth control pills and pregnancy. Because IMPLANON contains one of the two hormones that are in birth control pills, thrombosis may be a side effect of IMPLANON. There have been post-marketing reports of thrombosis among IMPLANON users.

Some examples of thrombosis are:

• Legs (deep vein thrombosis)
• Lung (pulmonary embolism)
• Brain (stroke)
• Heart (heart attack)
• Eyes (blindness)

The risk of thrombosis is increased in women who smoke. If you smoke, you should quit. Your healthcare provider may be able to help.

Tell your healthcare provider at least four weeks before if you are going to have surgery or will need to be on bed rest. You have an increased chance of getting thrombosis during surgery or bed rest.

Other Risks

A few women who use birth control that contains hormones may get:

• High blood pressure
• Gallbladder problems
• Rare cancerous or noncancerous liver tumors

This answer provides you with helpful information about side effects patients may experience while using IMPLANON. Be sure to read the Patient Labeling, including the Consent Form, and discuss any concerns or questions you have with your healthcare provider.

How will my bleeding change?

Expect your menstrual periods to be irregular and unpredictable throughout the time you are using IMPLANON. You may have more bleeding, less bleeding or no bleeding. The time between periods may vary, and, in between periods, you may have spotting.

You should discuss any questions you may have about irregular bleeding with your healthcare provider. Be sure to let him or her know if you think you may be pregnant or if your bleeding is heavy and prolonged.

This answer provides you with helpful information about side effects patients may experience while using IMPLANON. Be sure to read the Patient Labeling, including the Consent Form, and discuss any concerns or questions you have with your healthcare provider.

What are the side effects that caused women to stop using IMPLANON?

In clinical trials involving 942 women, 11% of women stopped using IMPLANON because of bleeding changes. Besides irregular bleeding, some of the most frequent side effects that caused women to stop using IMPLANON in clinical trials were mood swings, weight gain, headache, acne and depression. This is not a complete list of possible side effects.

This answer provides you with helpful information about side effects patients may experience while using IMPLANON. Be sure to read the Patient Labeling, including the Consent Form, and discuss any concerns or questions you have with your healthcare provider.

When should I call my healthcare provider?

Call your healthcare provider right away if you get any of the symptoms listed below. They may be signs of a serious problem.

• Sharp chest pain, coughing blood or sudden shortness of breath (possible clot in the lung)
• Persistent pain in the calf (back of lower leg) (possible clot in the leg)
• Crushing chest pain or heaviness in the chest (possible heart attack)
• Sudden severe headache or vomiting, dizziness or fainting, problems with vision or speech, weakness or numbness in an arm or leg (possible stroke)
• Sudden partial or complete blindness (possible clot in the eye)
• Yellowing of the skin or whites of the eyes (jaundice), especially with fever, tiredness, loss of appetite, dark colored urine or light colored bowel movements (possible liver problems)
• Severe pain, swelling, or tenderness in the abdomen (possibly indicating an ectopic pregnancy, a ruptured or twisted ovarian follicle or gallbladder or liver problems)
• Difficulty in sleeping, weakness, lack of energy, tiredness or sadness (possible severe depression)
• Breast lumps
• Heavy vaginal bleeding

This answer provides you with helpful information about side effects patients may experience while using IMPLANON. Be sure to read the Patient Labeling, including the Consent Form, and discuss any concerns or questions you have with your healthcare provider.