FAQs

Your healthcare provider will help you determine if IMPLANON^® is right for you. He or she will review the Patient Labeling including the Consent Form with you 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.

After you receive IMPLANON^®, check that it is in place by pressing your fingertips over the skin in your arm where IMPLANON^® was placed. You should be able to feel the IMPLANON^® rod. 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 menstrual period 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.

IMPLANON^® is a type of birth control for women. It is a flexible plastic rod 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^® rod for up to three years. Because IMPLANON^® does not contain estrogen, your healthcare provider may recommend IMPLANON^® even if you cannot use estrogen.

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.

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 studies did not include many overweight women.

The following chart shows the chance of getting pregnant for women who use different methods of birth control. Each box on the chart contains a list of birth control methods that are similar in effectiveness. The most effective methods are at the top of the chart. The box on 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.

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.

If IMPLANON^® is inserted as recommended in the product labeling, backup contraception is not necessary. Talk to your healthcare provider about the timing of IMPLANON^® insertion. In some situations, you may need a backup method of contraception for 7 days after insertion.

It is important to tell your healthcare provider about any medications you are taking or intend to take, including prescription medicines, over-the-counter medicines, and herbal remedies or supplements, such as St. John’s Wort. There may be interactions with some of these medications that could decrease the effectiveness of IMPLANON^®, and you may need to use a back-up non-hormonal birth control method. Please see the Patient Labeling and talk with your healthcare provider about this.

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.

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.

Once IMPLANON^® is successfully removed, your ability to get pregnant usually returns quickly. Some women have become pregnant within days after removal of 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.

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.

IMPLANON^® insertion should be a minor procedure that can be performed in a healthcare provider's office. IMPLANON^® is inserted just under the skin on the inner side of your upper arm. The entire procedure is done using a local anesthetic and generally takes a few minutes.

Rarely, IMPLANON^® is not inserted at all due to a failed insertion or if the implant has fallen out of the needle. If this happens, 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
  
• Expulsion of the implant (occurs rarely)

IMPLANON^® is made of a medical material that can be left in your body for up to 3 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.

Some women may feel a pinch, similar to a shot or injection, when IMPLANON^® is inserted. A local anesthetic is used to minimize discomfort. After the insertion, a woman might feel some mild soreness or tenderness at the insertion site. It shouldn’t last more than a day or two and shouldn’t interfere with your usual activities. During clinical studies that included 942 women, only about 1% (nine women) had complications at insertion. Complications expected of a minor surgical procedure, such as pain, numbness/tingling, bleeding, bruising, scarring, or infection have been reported. If your symptoms do not resolve in a day or two, you should contact your healthcare provider.

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^®.

You must schedule an appointment and have IMPLANON^® removed no later than 3 years after the date of insertion. Although IMPLANON^® is designed to last up to 3 years, your 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.

After removal, if you do not want to become pregnant, you should start another birth control method right away.

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 Schering-Plough Corporation to perform these procedures, call 1-877-IMPLANON (1-877-467-5266).

Your 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 local anesthetic is used for the procedure. 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]).

During clinical trials, only 15 out of 942 women (1.7%) had complications at implant removal. Complications expected of a minor surgical procedure, such as pain, bleeding, bruising, scarring, keloid (thick scar) formation, and infection have been reported. Rarely, removal of IMPLANON^® is difficult or even impossible because IMPLANON^® is not where it should be or because thick scar tissue has formed around IMPLANON^®. If IMPLANON^® cannot be removed, then the effects of IMPLANON^® will continue for a longer period of time. There have been rare reports of IMPLANON^® breaking during removal, making it difficult to remove. Deep insertions may result in the need for a surgical procedure in an operating room in order to remove IMPLANON^®. Any of the possible complications of surgery may occur. Removals of deeply inserted implants can lead to scarring, or complications such as damage to nerves or blood vessels.

Failure to remove IMPLANON^® may result in infertility, pregnancy outside of the womb (ectopic pregnancy), or inability to stop a drug-related adverse event.

There is a slight risk that you will get a scar from insertion or removal of IMPLANON^®. Women with a personal or family history of developing raised, thickened scars (keloids) should be sure to tell their healthcare providers. Women with this condition may be more likely to scar.

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

The most common side effect of IMPLANON^® is a change in your menstrual periods. In studies, about 10% 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 our 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 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

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 IMPLANON^®
  
• 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

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.

In clinical trials involving 942 women, 11% 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.

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)
  
• Breast lumps
  
• Difficulty in sleeping, weakness, lack of energy, tiredness, or sadness (possible severe depression)
  
• Heavy vaginal bleeding

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.