Here’s A Birth Control Option To Consider If You’re Rethinking Your Long-Term Family Planning Goals

Brought to you by the maker of LILETTA® (levonorgestrel-releasing intrauterine system) 52 mg.

“Which type of birth control should I use?” It seems like a question that’s on many people’s minds lately. Whether you’re brand new to using birth control, or you’ve been using a specific method for a while, sometimes life’s curveballs may cause you to rethink your long-term family planning goals. Since the contraception decision is unique to each individual, it’s important to do the research and consider your personal history, lifestyle, and health profile. If getting pregnant isn’t in your plans now, among the most effective birth control methods to consider is an intrauterine system or IUS (also known as an intrauterine device or IUD). One example of an IUD is LILETTA. Below, we take you through some IUD 101 to help you make the most informed choice for yourself, so you and your healthcare provider can determine if an IUD may be an option for you.

What is an IUD and how does it work?

An IUD is a long-term, yet reversible contraceptive method that can be used to prevent pregnancy for several years. It’s a plastic, T-shaped device that is placed inside the uterus by a healthcare provider. Different IUDs vary slightly in size, but they’re typically about the size of a quarter. IUDs have two threads at the stem (or lower end) that are about one or two inches long. The threads are the only part you can feel when the IUD is in your uterus; however, unlike a tampon string, the threads do not extend outside your body.

There are two types of IUDs: non-hormonal (copper) IUDs and IUDs that release the hormone progestin. The way that IUDs work to prevent pregnancy is not exactly known. However, both types of IUDs are believed to prevent sperm from reaching an egg to avoid pregnancy. In the case of non-hormonal IUDs, sperm isn’t compatible with copper, so a copper IUD makes it difficult for sperm to reach an egg. Hormone-based IUDs may also work by either thickening mucus in the cervix to block sperm or by reducing sperm survival, and thinning the lining of your uterus. Your doctor can help you determine what type makes sense for you.

Despite the popularity and efficacy of IUDs, a few myths about them still exist.

Myth #1: An IUD can only be used by women who already have kids.

IUDs can be used by women who have or have not given birth to a child. So, whether you already have children, or are looking to delay motherhood, talk to your healthcare provider about whether an IUD could be a fit for your family planning goals. Your healthcare provider can determine if an IUD is appropriate for you, since not every woman is a candidate. In fact, your healthcare provider will not prescribe an IUD, like LILETTA, if you are or may be pregnant, have a pelvic infection (eg, pelvic inflammatory disease (PID) or endometritis), untreated genital infection, certain cancers, unexplained vaginal bleeding, fibroids, or short-term liver disease, get infections easily, or are allergic to any of its ingredients.

Myth #2: IUDs can’t be reversed.

An important fact about IUDs is that they are a reversible form of birth control. Current IUDs can be used for up to 3 to 10 years (depending on the specific IUD) and must be removed after the approved timeframe. However, there’s no minimum requirement for how long it has to stay in —and if you decide you want to have it removed, you can speak with your doctor. IUD removal involves a trip to your doctor. Just remember, once the IUD is out, you could become pregnant as soon as it is removed. If you do not want to become pregnant, you should discuss this with your healthcare provider who can help you determine another method of birth control to use. In fact, some methods may need to be started 7 days before the IUD is removed to prevent pregnancy.

Myth #3: Your partner will always feel your IUD during sex.

An IUD is placed in the uterus, not in the vagina, so your partner shouldn’t feel your IUD. In some instances, your partner may feel the threads. If this occurs, or if you or your partner experience pain during sex, talk with your healthcare provider to check whether your IUD has moved or needs to be replaced.

Myth #4: There is a high chance it could come out of the uterus (expulsion).

Partial or complete expulsion of an IUD may occur, resulting in the loss of contraceptive protection. There is a higher risk of expulsion in certain people, like those who recently gave birth, which is why insertion of the IUD in such cases may need to be delayed a minimum of four to six weeks or until your uterus goes back to its pre-pregnancy form depending on the product. In general, the risk of your IUD coming out is estimated to be between two to 10 percent in the first year across all IUDs on the market. For LILETTA, expulsion occurs in about 4 out of 100 women, most often in the first year of use. Most doctors will ask you to come back about a month after insertion, and then at least once a year or more depending on your situation, just to check that the IUD hasn't moved. Your doctor will also show you how to perform a monthly self-examination of the threads to make sure your IUD is properly in place (more on that below). If the IUD comes out, you could become pregnant. You should use another birth control method like condoms and spermicide or not have sex until you are seen by your healthcare provider.

What is LILETTA (levonorgestrel-releasing intrauterine system)?

If you’re considering an intrauterine system, or IUS, also known as an IUD, one option is LILETTA. It contains 52 milligrams of a progestin hormone called levonorgestrel. LILETTA is small and flexible and slowly releases this hormone into your uterus, so only a small amount of levonorgestrel enters your bloodstream. It doesn’t contain any estrogen. In a clinical study among U.S. women, 16-35 years of age, who had and had not given birth, LILETTA was found to be more than 99% effective at preventing pregnancy for up to six years. While it can be removed at any time by a healthcare provider, you’ll have to get a new one at the six-year mark if you choose to continue to use this IUD past that point. A new LILETTA can even be placed in the uterus during the same office visit.

It’s important to discuss with your healthcare provider if LILETTA could be an option for you, and to learn about the benefits, as well as the potential risks. For example, while pregnancy with LILETTA is uncommon (less than 1 in 100), it can be life-threatening and result in loss of pregnancy or fertility. Serious infections can also occur after LILETTA is placed, so it's important to call your healthcare provider immediately if you have symptoms, like severe pain or fever shortly after insertion. See additional Important Risk Information about LILETTA below.

If you are interested in using LILETTA, what do you need to do?

Before choosing LILETTA, or any birth control method, you will need to talk with your healthcare provider about your health status and other personal considerations. They’ll obtain a complete medical and social history to determine conditions that might influence the selection of LILETTA for contraception. If you are a candidate, they’ll perform a physical examination and appropriate tests for genital or sexually transmitted infections.

LILETTA insertion can be done during a routine office visit. The insertion process includes several steps, such as:

• 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

During and after insertion, some people experience side effects such as pain, bleeding, or dizziness. If your side effects become severe or don't go away within 30 minutes after insertion, LILETTA may not have been placed correctly, or these may be symptoms of perforation or expulsion. Your healthcare provider will examine you to see if LILETTA needs to be removed or replaced.

Most doctors will ask you to come back about a month after insertion, and then at least once a year or more depending on your situation, just to check that the IUD hasn't moved. The IUD may be an option for people who are seeking birth control without a daily regimen, however, you are advised to feel the threads at least once a month to see if they are reachable and that your IUD is still in position.

Your doctor will walk you through the following steps to make sure your IUD is properly in place:

• First, wash your hands with soap and water.
• Then, you can check by reaching up to the top of your vagina with clean fingers to feel the threads.
• Make sure you do not pull on the threads.

If you feel more than just the threads or don’t feel them at all, it doesn’t necessarily mean there’s an issue, but you should check in with your doctor to make sure. There’s a chance that your IUD may not be in the right position, so it may not prevent pregnancy. If you think your IUD has come out, you could become pregnant, so use a non-hormonal method of birth control like condoms and spermicide, or do not have sex until you are seen by a healthcare provider.

For the first three to six months, your period may become a little unpredictable and you may bleed more than usual. You may also have frequent spotting or light bleeding and cramping. Some people have heavy bleeding during this time. After you have used LILETTA for a while, the number of bleeding or spotting days is likely to lessen. Call your doctor if the bleeding remains heavier than usual or increases after it has been light for a while. For some, menstrual periods will stop altogether. But once LILETTA is removed, your menstrual periods will likely return to their former pattern.

So, is LILETTA an option for me?

If you’re reconsidering your family planning goals and looking to prevent pregnancy, a big part of an IUD’s appeal may be not having to remember a daily pill schedule (though an IUD will require you to self-check for proper positioning by feeling the threads monthly). Once LILETTA is inserted, it can be used to prevent pregnancy for as long as you want for up to six years.

Remember: LILETTA does not protect against HIV infection (AIDS) and other sexually transmitted infections, so be sure to always practice safe sex. Make sure to keep reading for more Important Risk Information about LILETTA below.

Contraception is a personal decision. If you are considering getting an IUD, do a bit of research to learn more, then talk to your doctor to see if it could be right for you.

IMPORTANT RISK INFORMATION

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 labor or 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 partially go into (become embedded) or go completely through (perforate) the wall of the uterus. If perforation occurs, LILETTA may move outside the uterus and can cause internal scarring, infection, or damage to other organs. You may need surgery to have LILETTA removed if it is embedded or perforation occurs. 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.

INDICATION

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 6 years.

Available by prescription only.

Please also see full Prescribing Information and Patient Information for LILETTA: https://media.allergan.com/actavis/actavis/media/allergan-pdf-documents/product-prescribing/liletta_pi.pdf