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 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
Who should not use IMPLANON®?
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 breast cancer, now or in the past
- Are allergic to anything in IMPLANON®
Tell your healthcare provider if you have ever had any of the conditions just listed. Your healthcare provider can suggest another method of birth control.
In addition, talk to your healthcare provider about using IMPLANON® if you have or had:
- diabetes
- high cholesterol or triglycerides
- headaches
- seizures or epilepsy
- gallbladder or kidney disease
- depression
- high blood pressure
- allergic reaction to anesthetics or antiseptics. These medicines will be used when IMPLANON® is inserted into your arm.
If you have any of these conditions, your healthcare provider can explain what to do.
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Indication
IMPLANON® (etonogestrel implant) is for the prevention of pregnancy in women.
IMPORTANT SAFETY INFORMATION
IMPLANON® does not protect against HIV (AIDS) or other sexually transmitted diseases.
IMPLANON® must be removed by the end of the third year and may be replaced by a new IMPLANON® at the time of removal, if continued contraceptive protection is desired. Failure to remove IMPLANON® may result in infertility, ectopic pregnancy, or inability to stop a drug related adverse event.
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.
Serious consequences may be associated with the insertion and removal of IMPLANON®. This may result in the need for a surgical procedure in an operating room in order to remove IMPLANON®. Difficult removals may cause pain and scarring, and may result in damage to nerves and blood vessels. In clinical trials, 9 out of 942 (1.0%) patients had complications at implant insertion and 15 out of 942 (1.7%) had complications at implant removal.
You should not use IMPLANON® if you are pregnant or think you may be pregnant, have or have had blood clots, have unexplained vaginal bleeding, have liver disease, have or have had breast cancer, or if you are allergic to anything in IMPLANON®.
The use of IMPLANON® and other progestin-only hormonal contraceptives have been associated with ectopic pregnancy, bleeding irregularities, and ovarian cysts. The use of hormonal contraceptives is associated with increased risks of several serious side effects including blood clots which may lead to stroke or heart attack. Blood clots are a side effect of birth control pills and pregnancy. It is unknown if the risk of blood clots with IMPLANON® is different than with birth control pills. Some examples of blood clots are deep vein thrombosis (legs), pulmonary embolism (lungs), retinal thrombosis (eyes), stroke (head) and heart attack (heart). There have been reports of blood clots, including pulmonary emboli and strokes, in patients using IMPLANON®. Tell your doctor at least 4 weeks before if you are going to have surgery or will need to be on bed rest because you have an increased chance of experiencing blood clots during surgery or bed rest.
Cigarette smoking increases the risk of serious cardiovascular side effects from the use of hormonal contraceptives. The risk increases with age (women >35), and with heavy smoking. Women who use hormonal contraceptives are strongly advised not to smoke.
The most common side effect of IMPLANON® is a change in your menstrual periods. In studies, about 1 in 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. Other common side effects reported in women using IMPLANON® during clinical trials include: headache; vaginitis; 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; and pain at the site of insertion.
Please click here for additional important product information.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
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