How is
LILETTA inserted?

Once you and your healthcare provider have decided that LILETTA is appropriate for you, it can be placed during an in-office visit. Placement is done by your healthcare provider, usually takes a few minutes, and can be done at your gynecologist’s office.

Insertion Process

The insertion process includes:

An examination of your pelvis to find the position of your uterus
Preparation of your uterus and vagina for LILETTA placement
Placement of LILETTA into your uterus
Trimming of the LILETTA threads to the right length

Will insertion be painful?

You may experience pain, bleeding, or dizziness during and after placement. If your symptoms do not pass within 30 minutes after placement, LILETTA may not have been placed correctly. Your healthcare provider will examine you to see if LILETTA needs to be removed or replaced.

Should I check that LILETTA is in place?

Yes, you should check that LILETTA is in proper position by feeling the threads. It is a good habit to do this 1 time a month.

Your healthcare provider should teach you how to check that LILETTA 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 threads.
Do not pull on the threads.

If you feel more than just the threads or if you cannot feel the threads, LILETTA may not be in the right position and may not prevent pregnancy. Use non-hormonal back-up birth control (such as condoms and spermicide) and ask your healthcare provider to check that LILETTA is still in the right place.

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

What I Need To Know About Insertion:

Before During After

LILETTA^® (levonorgestrel-releasing intrauterine system) 52 mg is a hormone-releasing system placed in your uterus to prevent pregnancy for as long as you want for up to 4 years.

IMPORTANT RISK INFORMATION ABOUT LILETTA

Do not use LILETTA if you:
- Are or might be pregnant; LILETTA cannot be used as an emergency contraceptive
- Have a serious pelvic infection called pelvic inflammatory disease (PID) or endometritis unless you have had a normal pregnancy after the infection went away (PID occurs in less than 1% of users)
- Have an untreated lower genital infection now
- Have had an infection from an abortion within the last 3 months
- Can get infections easily; for example, if you:
  - Have problems with your immune system
  - Have multiple sexual partners or your partner has multiple sexual partners
  - 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 short-term (acute) liver disease or 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 system (IUS) 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, or barium sulfate
Call your healthcare provider right away if you think you are pregnant. If you get pregnant while using LILETTA, you may have an ectopic pregnancy, which means the pregnancy is not in the uterus. Unusual vaginal bleeding or abdominal pain especially with missed periods may be a sign of ectopic pregnancy. Ectopic pregnancy can cause internal bleeding. There are also risks if you get pregnant while using LILETTA and the pregnancy is in the uterus. Severe infection and premature delivery can occur with pregnancies that continue with an IUS
Although uncommon, pregnancy while using LILETTA can be life threatening and may result in loss of pregnancy or fertility
Bleeding and spotting may increase in the first 3 to 6 months and remain irregular. Periods over time usually become shorter, lighter or may stop
Life-threatening infection can occur within the first few days after LILETTA is placed. Call your healthcare provider immediately if you develop severe pain or fever shortly after LILETTA is placed
Some IUS users get a serious pelvic infection called pelvic inflammatory disease (PID) or endometritis. These are usually sexually transmitted. You have a higher chance of getting PID or endometritis if you or your partner has sex with other partners. PID or endometritis can cause serious problems such as infertility, ectopic pregnancy or pelvic pain that does not go away. More serious cases of PID or endometritis may require surgery. Removal of the uterus (hysterectomy) is sometimes needed. In rare cases, infections that start as PID or endometritis can even cause death. Tell your healthcare provider right away if you have any of these signs of PID or endometritis: long-lasting or heavy bleeding, unusual vaginal discharge, low abdominal pain, painful sex, chills, or fever
LILETTA may become attached to (embedded) or go through the uterus (perforation). If perforation occurs, LILETTA may move outside the uterus and can cause internal scarring, infection, or damage to other organs and you may need surgery to have LILETTA removed. Risk of perforation is increased in breastfeeding women
LILETTA may come out of your uterus (expulsion). Expulsion occurs in about 4 out of 100 women, most often in the first year of use. You may become pregnant if LILETTA comes out. If you think that LILETTA has come out, use another birth control method like condoms and spermicide or do not have sex (vaginal intercourse) until you are seen by a healthcare provider
Ovarian cysts may occur but usually disappear

LILETTA does not protect against HIV or STDs.

Available by prescription only.

Please also see full Prescribing Information.

Liletta Important Risk Information