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

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