Important Safety Information
If you have an untreated genital infection, get infections easily, or have certain cancers, don’t use Skyla. Less than 1% of users get a serious pelvic infection called pelvic inflammatory disease (PID). If you have persistent pelvic or stomach pain, excessive bleeding after placement or if Skyla comes out, tell your healthcare professional (HCP). ...Continue reading below

Frequently Asked Questions

Here are answers to some frequently asked questions about Skyla®.

    An IUD is a small, t-shaped device that’s placed in your uterus by your healthcare professional during a routine in-office visit.

    Getting an IUD is nonsurgical. Once in place, it provides continuous, highly effective birth control.

    You may experience pain, bleeding or dizziness during and after placement. If your symptoms do not pass within 30 minutes after placement, Skyla may not have been placed correctly. Your healthcare professional will examine you to see if Skyla needs to be removed or replaced. You should return to your healthcare professional for a follow-up visit 4 to 6 weeks after Skyla is placed to make sure that Skyla is in the right position.

    Skyla is intended for use up to 3 years but you can stop using Skyla at any time by asking your healthcare professional to remove it. You could become pregnant as soon as Skyla is removed, so you should use another method of birth control if you do not want to become pregnant. Talk to your healthcare professional about the best birth control methods for you, because your new method may need to be started 7 days before Skyla is removed to prevent pregnancy.

    Yes, you should check that Skyla is in proper position by feeling the removal threads. It is a good habit to do this 1 time a month. Your healthcare professional should teach you how to check that Skyla is in place. First, wash your hands with soap and water. You can check by reaching up to the top of your vagina with clean fingers to feel the removal threads. Do not pull on the threads. If you feel more than just the threads or if you cannot feel the threads, Skyla may not be in the right position and may not prevent pregnancy. Avoid intercourse or use non-hormonal back-up birth control (such as condoms or spermicide) and ask your healthcare professional to check that Skyla is still in the right place.  

    Call your healthcare professional if you have any questions or concerns. Otherwise, you should return to your healthcare professional for a follow-up visit 4 to 6 weeks after Skyla is placed to make sure that Skyla is in the right position.

    If Skyla is accidentally removed and you had vaginal intercourse within the preceding week, you may be at risk of pregnancy, and you should talk to a healthcare professional.

    Call your healthcare professional if you have any concerns about Skyla. Be sure to call if you:

    • think you are pregnant
    • have pelvic pain, abdominal pain, or pain during sex
    • have unusual vaginal discharge or genital sores
    • have unexplained fever, flu-like symptoms or chills
    • might be exposed to sexually transmitted infections (STIs)
    • are concerned that Skyla may have been expelled (came out)
    • cannot feel Skyla's threads
    • develop very severe or migraine headaches
    • have yellowing of the skin or whites of the eyes. These may be signs of liver problems.
    • have had a stroke or heart attack
    • become HIV positive or your partner becomes HIV positive
    • have severe vaginal bleeding or bleeding that lasts a long time or concerns you

    Yes, tampons or menstrual cups may be used with Skyla. Change tampons or menstrual cups with care to avoid pulling the threads of Skyla. If you think you may have pulled Skyla out of place, avoid intercourse or use a non-hormonal back-up birth control (such as condoms or spermicide), and contact your healthcare professional.  

    You and your partner should not feel Skyla during intercourse. Skyla is placed in the uterus, not in the vagina. Sometimes your partner may feel the threads. If this occurs, or if you or your partner experience pain during sex, talk with your healthcare professional.

    Your healthcare professional will confirm if you need to use non-hormonal back-up birth control, like condoms and spermicide, after Skyla is placed.

    Your healthcare professional can remove Skyla at any time. You may become pregnant as soon as Skyla is removed. About 3 out of 4 women who want to become pregnant will become pregnant sometime in the first year after Skyla is removed.

    Skyla is placed by your healthcare professional during an in-office visit.

    First, your healthcare professional will examine your pelvis to find the exact position of your uterus. Your healthcare professional will then clean your vagina and cervix with an antiseptic solution and slide a slim plastic tube containing Skyla through the cervix into your uterus. Your healthcare professional will then remove the plastic tube and leave Skyla in your uterus. Your healthcare professional will cut the threads to the right length. You may experience pain, bleeding or dizziness during and after placement. If your symptoms do not pass within 30 minutes after placement, Skyla may not have been placed correctly. Your healthcare professional will examine you to see if Skyla needs to be removed or replaced.

    For the first 3 to 6 months, your period may become irregular and the number of bleeding days may increase. You may also have frequent spotting or light bleeding. Some women have heavy bleeding during this time. You may also have cramping during the first few weeks. After you have used Skyla for a while, the number of bleeding and spotting days is likely to lessen. For some women, periods will stop altogether. When Skyla is removed, your menstrual periods should return.

    Learn how to check with your insurance company.

    Skyla does not protect against HIV infection (AIDS) and other sexually transmitted infections (STIs). If you think that you or your partner may be at risk of getting an STI, you should use condoms and call your healthcare professional.

    Do not use Skyla if you:
    • are or might be pregnant; Skyla cannot be used as emergency contraceptive
    • have a serious pelvic infection called pelvic inflammatory disease (PID) or have had PID in the past unless you have had a normal pregnancy after the infection went away
    • have an untreated genital infection now
    • have had a serious pelvic infection in the past 3 months after a pregnancy
    • can get infections easily. For example, if you:
      • have multiple sexual partners or your partner has multiple sexual partners
      • have problems with your immune system
      • use or abuse intravenous drugs
    • have or suspect you might have cancer of the uterus or cervix
    • have bleeding from the vagina that has not been explained
    • have liver disease or a liver tumor
    • have breast cancer or any other cancer that is sensitive to progestin (a female hormone), now or in the past
    • have an intrauterine device in your uterus already
    • have a condition of the uterus that changes the shape of the uterine cavity, such as large fibroid tumors
    • are allergic to levonorgestrel, silicone, polyethylene, silver, silica, barium sulfate or iron oxide

    Call your healthcare professional right away if you think you may be pregnant. If possible, also do a urine pregnancy test. If you get pregnant while using Skyla, you may have an ectopic pregnancy. This means that the pregnancy is not in the uterus. Unusual vaginal bleeding or abdominal pain may be a sign of ectopic pregnancy.

    Ectopic pregnancy is a medical emergency that often requires surgery. Ectopic pregnancy can cause internal bleeding, infertility, and even death.

    There are also risks if you get pregnant while using Skyla and the pregnancy is in the uterus. Severe infection, miscarriage, premature delivery, and even death can occur with pregnancies that continue with an intrauterine device (IUD). Because of this, your healthcare professional may try to remove Skyla, even though removing it may cause a miscarriage. If Skyla cannot be removed, talk with your healthcare professional about the benefits and risks of continuing the pregnancy and possible effects of the hormone on your unborn baby. 

    If you continue your pregnancy, see your healthcare professional regularly. Call your healthcare professional right away if you get flu-like symptoms, fever, chills, cramping, pain, bleeding, vaginal discharge, or fluid leaking from your vagina. These may be signs of infection.

    Skyla can cause serious side effects, including:
    • Ectopic pregnancy and intrauterine pregnancy risks. There are risks if you become pregnant while using Skyla. Call your healthcare professional right away if you think you may be pregnant. If possible, also do a urine pregnancy test. If you get pregnant while using Skyla, you may have an ectopic pregnancy. This means that the pregnancy is not in the uterus. Unusual vaginal bleeding or abdominal pain may be a sign of ectopic pregnancy. Ectopic pregnancy is a medical emergency that often requires surgery. Ectopic pregnancy can cause internal bleeding, infertility, and even death. There are also risks if you get pregnant while using Skyla and the pregnancy is in the uterus. Severe infection, miscarriage, premature delivery, and even death can occur with pregnancies that continue with an intrauterine device (IUD). Because of this, your healthcare professional may try to remove Skyla, even though removing it may cause a miscarriage. If Skyla cannot be removed, talk with your healthcare professional about the benefits and risks of continuing the pregnancy and possible effects of the hormone on your unborn baby. If you continue your pregnancy, see your healthcare professional regularly. Call your healthcare professional right away if you get flu-like symptoms, fever, chills, cramping, pain, bleeding, vaginal discharge, or fluid leaking from your vagina. These may be signs of infection.
    • Life-threatening infection. Life-threatening infection can occur within the first few days after Skyla is placed. Call your healthcare professional immediately if you develop severe pain or fever shortly after Skyla is placed.
    • Pelvic inflammatory disease (PID). Some IUD users get a serious pelvic infection called pelvic inflammatory disease. PID is usually sexually transmitted. You have a higher chance of getting PID if you or your partner has sex with other partners. PID can cause serious problems such as infertility, ectopic pregnancy or pelvic pain that does not go away. PID is usually treated with antibiotics. More serious cases of PID may require surgery including removal of the uterus (hysterectomy). In rare cases, infections that start as PID can even cause death.

      Tell your healthcare professional right away if you have any of these signs of PID: long-lasting or heavy bleeding, unusual vaginal discharge, low abdominal (stomach area) pain, painful sex, chills, fever, genital lesions or sores.  
    • Perforation. Skyla may go into the wall of the uterus (become embedded) or go through the wall of the uterus. This is called perforation. If this occurs, Skyla may no longer prevent pregnancy. If perforation occurs, Skyla may move outside the uterus and can cause internal scarring, infection, or damage to other organs, and you may need surgery to have Skyla removed. Excessive pain or vaginal bleeding during placement of Skyla, pain or bleeding that gets worse after placement, or not being able to feel the threads may happen with perforation. The risk of perforation is increased if Skyla is inserted while you are breastfeeding.
    • Expulsion. Skyla may come out by itself. This is called expulsion. Expulsion occurs in about 3 out of 100 women. Excessive pain or vaginal bleeding during placement of Skyla, pain or bleeding that gets worse after placement, or not being able to feel the threads may happen with expulsion. You may become pregnant if Skyla comes out. If you think that Skyla has come out, avoid intercourse or use a non-hormonal backup birth control (such as condoms or spermicide) and call your healthcare professional.
    Common side effects of Skyla include:
    • Pain, bleeding, or dizziness during and after placement. If these symptoms do not stop 30 minutes after placement, Skyla may not have been placed correctly. Your healthcare professional will examine you to see if Skyla needs to be removed or replaced.
    • Changes in bleeding. You may have bleeding and spotting between menstrual periods, especially during the first 3–6 months. Sometimes the bleeding is heavier than usual at first. However, the bleeding usually becomes lighter than usual and may be irregular. Call your healthcare professional if the bleeding remains heavier than usual or increases after it has been light for a while.
    • Missed menstrual periods. About 1 out of 16 women stop having periods after 1 year of Skyla use. If you have any concerns that you may be pregnant while using Skyla, do a urine pregnancy test and call your healthcare professional. If you do not have a period for 6 weeks during Skyla use, call your healthcare professional. When Skyla is removed, your menstrual periods should return.
    • Cysts on the ovary. About 14 out of 100 women using Skyla develop a cyst on the ovary. These cysts usually disappear on their own in two to three months. However, cysts can cause pain and sometimes cysts will need surgery.
    Other common side effects include:
    • abdominal or pelvic pain
    • acne or greasy skin
    • headache or migraine
    • inflammation or infection of the outer part of your vagina (vulvovaginitis)
    • painful periods

    These are not all the possible side effects with Skyla. For more information, ask your healthcare professional.
    Call your healthcare professional for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Bayer Healthcare Pharmaceuticals at 1-888-842-2937.  

    Skyla can be safely scanned with MRI only under specific conditions. Before you have an MRI, tell your healthcare professional that you have Skyla, an intrauterine device (IUD), in place.

    You may use Skyla when you are breastfeeding if more than 6 weeks have passed since you had your baby. If you are breastfeeding, Skyla is not likely to affect the quality or amount of your breast milk or the health of your nursing baby. However, isolated cases of decreased milk production have been reported. The risk of Skyla going into the wall of the uterus (becoming embedded) or going through the wall of the uterus is increased if Skyla is inserted while you are breastfeeding.