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Skyla Warnings and Precautions

Specific Precautions and Warnings With Skyla

Some warnings and precautions to be aware of prior to using this drug include the following:
  • You should know that Skyla does not protect against HIV, AIDS, or other sexually transmitted infections (STI). Let your healthcare provider know if you believe you may have been exposed to an STI during Skyla treatment.
  • Although it's unlikely you'll become pregnant while using Skyla, if a pregnancy does occur, there is an increased risk it will occur outside the womb. This is known as an ectopic pregnancy. Ectopic pregnancies are unable to proceed as normal. They can be life-threatening to a woman, and may cause damage that results in infertility.

    Let your healthcare provider know right away if you develop signs of an ectopic pregnancy, such as lower abdominal (stomach) pain and unusual vaginal bleeding. Women who have had an ectopic pregnancy or pelvic infection in the past have a higher risk for this complication.
  • If a normal pregnancy occurs during Skyla use, Skyla should be removed. Leaving it in place increases the risk for miscarriage, premature birth, and infections. In addition, the developing infant will be exposed to levonorgestrel (the hormone in Skyla). Removing the device may also cause miscarriage, but generally appears to be safer than leaving it in place.
  • Like other IUDs, Skyla can increase the risk for serious pelvic infections, including pelvic inflammatory disease (PID). This disease can cause infertility, an ectopic pregnancy, and even death. The condition is usually treated with antibiotics. In serious cases, surgery to remove the uterus (a hysterectomy) may be necessary. Let your healthcare provider know immediately if you have signs of pelvic inflammatory disease, such as:
    • Prolonged or heavy vaginal bleeding
    • Unusual vaginal discharge
    • Lower abdominal (stomach) or pelvic pain or tenderness
    • Pain during sex
    • Fever or chills.
  • Women who use Skyla may have irregular periods, bleeding, spotting, and cramps during the first three to six months of use. After this time, the number of bleeding and spotting days usually decreases; however, irregular periods can persist. Let your healthcare provider know if you continue to have abnormal bleeding, spotting, or cramping, or if the symptoms are particularly severe.
  • Up to 12 percent of women stop having monthly periods altogether with Skyla use. Let your healthcare provider know the first time you do not have a monthly period for six weeks. He or she may want to make sure you're not pregnant.
  • Although rare, you could develop a potentially life-threatening infection shortly after Skyla is inserted. Contact your healthcare provider if you have signs of infections, such as severe pain or fever, in the first few days after the device has been placed in your uterus.
  • In some instances, the device may attach to or perforate (go through) the wall of the uterus. If this happens, it may no longer work to prevent pregnancy and will need to be removed. Surgery may be needed to remove the device. If Skyla perforates the uterus, it could cause scarring, infections, and damage to other internal body parts.
  • Skyla can come out by itself, which could cause pain and bleeding but can also go unnoticed. An increase in menstrual bleeding can be a sign that the device has come out. If you believe Skyla has come out, contact your healthcare provider right away. You will need to use a backup method of birth control to prevent pregnancy until Skyla is replaced.
  • Skyla can cause cysts on your ovaries. For most women, the cysts are painless, and disappear on their own within two to three months. In rare cases, they cause pain and need to be removed with surgery.
  • Women who have had or currently have breast cancer should not use this medication because some breast cancers are hormone-sensitive. This means hormones can cause the cancer cells to grow. It is unknown whether Skyla increases the risk for breast cancer. 

Make sure your healthcare provider knows if any of these conditions apply to you before Skyla treatment, or if you develop them while Skyla is in place.
  • Let your healthcare provider know if you develop cancer of the uterus or cervix or yellowing of the skin or whites of the eyes (jaundice) during Skyla treatment. He or she may recommend removing Skyla.
  • It is a good idea to check the placement of Skyla once a month. You can do this by washing your hands with soap and water and then feeling for the threads at the top of your vagina. If you do not feel the threads, or feel more than the threads, let your healthcare provider know right away. Skyla may not be properly placed, and may not prevent pregnancy.
  • Let your healthcare provider know you are using Skyla before you have an MRI (magnetic resonance imaging. Skyla can only be safely scanned under certain conditions.
  • Skyla should not be used by women who are pregnant or may be pregnant (see Skyla and Pregnancy).
  • Levonorgestrel, the hormone in Skyla, passes through breast milk. Therefore, if you are breastfeeding or plan to start, discuss this with your healthcare provider prior to using the device (see Skyla and Breastfeeding). Skyla is considered to be compatible with breastfeeding.
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