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Skyla and Pregnancy

The intrauterine device Skyla is classified as a pregnancy Category X medication, meaning it should not be used by women who are pregnant or may be pregnant. Using this device during pregnancy may cause problems such as infections, miscarriage, or premature birth.

Can Pregnant Women Use Skyla?

Skyla™ (levonorgestrel-releasing intrauterine system) is a hormone-releasing intrauterine device (IUD). It is placed in your uterus by your healthcare provider, where it can protect against pregnancy for up to three years. This device can cause problems during pregnancy, and should not be used by women who are pregnant or may be pregnant.

What Is Pregnancy Category X?

The U.S. Food and Drug Administration (FDA) uses a category system to classify the possible risks to a fetus when a specific medicine is taken during pregnancy. Like other hormonal contraceptives, Skyla is classified as a pregnancy Category X medication.
Pregnancy Category X is given to medicines that show problems to the fetus in animal studies or in human use of the medication. With this category, the potential risks clearly outweigh the possible benefits.

What If I Become Pregnant During Skyla Treatment?

Although Skyla is quite effective at preventing pregnancy (less than 1 in 100 women will become pregnant on Skyla each year), there is a small chance that a woman will become pregnant during treatment. The risk increases if the device becomes displaced or comes out on its own. About half of the pregnancies that occur with the device in place will be ectopic pregnancies.
An ectopic pregnancy is a pregnancy that occurs outside the uterus (the womb), most commonly in the fallopian tube (the tube that carries the egg from the ovary to the uterus). However, an ectopic pregnancy can also occur in other areas, such as the ovary, cervix, or abdominal (stomach) area.
Ectopic pregnancies are very serious. They can be life-threatening to the mother, and may cause internal bleeding or permanent damage that leads to infertility. A baby cannot survive an ectopic pregnancy. Let your healthcare provider know right away if you have unusual vaginal bleeding or abdominal (stomach) pain, which could be signs of an ectopic pregnancy. Ectopic pregnancies often require surgical treatment.
Skyla can also cause problems during a normal pregnancy in the uterus. Leaving the device in place during a pregnancy can cause serious infections, miscarriage, and premature birth. In addition, the developing fetus will be directly exposed to levonorgestrel, the hormone released by Skyla.
It is unknown at this time if exposure to levonorgestrel increases the risk for birth defects or other problems in the fetus. Studies to date have not shown that levonorgestrel is harmful to a fetus, but those studies have been done on oral levonorgestrel. At this time, there is not enough information available to completely rule out all potential problems to a fetus exposed to Skyla.
Because of the potential risks, it is recommended that Skyla be removed if a pregnancy occurs. Removing Skyla may also cause miscarriage, however. If Skyla cannot be removed, and you wish to continue the pregnancy, you will need to be followed closely. Let your healthcare provider know immediately if you experience any signs of infection, such as:
  • Fever
  • Chills
  • Cramping
  • Bleeding
  • Unusual vaginal discharge.
Pregnancy and Pain

Skyla Birth Control Information

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