Paragard

Generic Name: intrauterine copper contraceptive

• Paragard is a copper-releasing system that is placed in your uterus by your healthcare provider to prevent pregnancy for up to 10 years.
• Paragard can be removed by your healthcare provider at any time.
• Paragard does not contain any hormones.
• Paragard can be used whether or not you have given birth to a child.

Paragard is a small, flexible plastic “T” shaped intrauterine system with copper wrapped around the stem and placed on arms of the “T”. Two thin white threads are attached to the stem (lower end) of Paragard. The threads are the only part of Paragard you can feel when Paragard is in your uterus; however, unlike a tampon string, the threads do not extend outside of your body.

Paragard does not protect against HIV infection (AIDS) or other sexually transmitted infections (STIs).

What if I need birth control for more than 10 years?

Paragard must be removed on or before 10 years from the date of insertion. Your healthcare provider can place a new Paragard during the same office visit if you choose to continue using Paragard.

What if I want to stop using Paragard?

Paragard is intended for use up to 10 years, but you can stop using Paragard at any time by asking your healthcare provider to remove it. You could become pregnant as soon as Paragard is removed; however, if you do not want to become pregnant you should use another method of birth control. Talk to your healthcare provider about the best birth control methods for you.

What if I change my mind about birth control and want to become pregnant in less than 10 years?

Your healthcare provider can remove Paragard at any time before the 10 years after placement. You may become pregnant as soon as Paragard is removed.

How does Paragard work?

Paragard works by preventing sperm from reaching the egg, preventing sperm from fertilizing the egg, or possibly preventing attachment (implantation) in the uterus. Paragard does not stop your ovaries from making an egg (ovulating) each month. 

Who might use Paragard?

You might choose Paragard if you:

• want long-term birth control that provides a low chance of getting pregnant (less than 1 in 100)
• want birth control that works continuously for up to 10 years
• want birth control that is reversible
• want a birth control method that you do not need to take daily
• are willing to use a birth control method that is inserted in the uterus
• want birth control that does not contain hormones

Who should not use Paragard?

Do not use Paragard if you:

• are or might be pregnant
• have a condition of the uterus that changes the shape of the uterine cavity, such as large fibroid tumors
• have an untreated pelvic infection called pelvic inflammatory disease (PID) now
• have had an infection in your uterus after a pregnancy or abortion in the past 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 unexplained bleeding from your vagina
• have an untreated lower genital infection now in your cervix
• have Wilson’s disease (a disorder in how the body handles copper)
• are allergic to copper, polyethylene, or barium sulfate
• have an intrauterine system in your uterus already

Before having Paragard placed

Before having Paragard placed, tell your healthcare provider if you have:

• any of the conditions listed above
• slow heart beat (bradycardia)
• dizziness (syncope)
• seizures
• recently had a baby or if you are breastfeeding
• have AIDS, HIV, or any other sexually transmitted infection

Using Paragard

How is Paragard placed?

Paragard is placed in your uterus during an in-office visit.

First, your healthcare provider will examine your pelvis to find the exact position of your uterus. Your healthcare provider will then cleanse your vagina and cervix with an antiseptic solution and then, measure your uterus. Your healthcare provider will then slide a plastic tube containing Paragard into your uterus. The tube is removed, leaving Paragard inside your uterus. Two white threads will extend into your vagina. The threads are trimmed so they are just long enough for you to feel with your fingers when doing a self-check.

As Paragard goes in, you may feel cramping or pinching. You may have some bleeding. Some women feel faint, nauseated, or dizzy for a few minutes afterwards. Your healthcare provider may ask you to lie down until you are feeling better, and to get up slowly.

Should I check that Paragard is in place?

Yes, you should check that Paragard 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 Paragard 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 2 threads. Do not pull on the threads.
If you feel changes in the length of the 2 threads, you cannot feel the threads, or you can feel any other part of Paragard other than the threads, Paragard may not be in the right position and may not prevent pregnancy. Use back-up birth control (such as condoms or spermicide) and ask your healthcare provider to check that Paragard is still in the right place.

If Paragard is accidentally removed, you may be at risk of pregnancy, and should talk to a healthcare provider.

How soon after placement of Paragard should I return to my healthcare provider?

Call your healthcare provider if you have any questions or concerns (see “When should I call my healthcare provider?”). Otherwise you should return to your healthcare provider for a follow-up visit after your first menses after Paragard is placed to make sure that Paragard is in the right position.

What if I become pregnant while using Paragard?

Call your healthcare provider right away if you think you may be pregnant. If you get pregnant while using Paragard, you may have an ectopic pregnancy. This means the pregnancy is not in your uterus. Unusual vaginal bleeding or abdominal pain especially with missed periods 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 Paragard 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 provider may try to remove Paragard, even though removing it may cause a miscarriage. If Paragard cannot be removed, talk with your healthcare provider about the benefits and risks of continuing the pregnancy.

If you continue your pregnancy see your healthcare provider regularly. Call your healthcare provider 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.

It is not known if Paragard can cause long-term effects on the fetus if it stays in place during a pregnancy.

How will Paragard change my periods?

Your period may become heavier and longer. You may also have frequent spotting between periods.

Is it safe to breastfeed while using Paragard?

You may use Paragard when you are breastfeeding. The risk of Paragard becoming attached to (embedded) or going through the wall of the uterus is increased if Paragard is placed while you are breastfeeding.

Will Paragard interfere with sexual intercourse?

You and your partner should not feel Paragard during intercourse. Paragard 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 provider.

Can I have an MRI with Paragard in place?

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

Before you have a medical procedure using heat therapy tell your healthcare provider that you have Paragard in place.

Paragard side effects

Paragard can cause serious side effects, including:

• ectopic pregnancy and intrauterine pregnancy risks: There are risks if you become pregnant while using Paragard (see “What if I become pregnant while using Paragard?”).
• life-threatening infection: Life-threatening infection can occur within the first few days after Paragard is placed. Call your healthcare provider immediately if you develop severe pain or fever shortly after Paragard is placed.
• pelvic inflammatory disease (PID) or endometritis: Some IUS users get a serious pelvic infection called pelvic inflammatory disease (PID) or endometritis. PID and endometritis are usually sexually transmitted. You have a higher chance of getting PID and endometritis if you or your partner has sex with other partners. PID and endometritis can cause serious problems such as infertility, ectopic pregnancy, and pelvic pain that does not go away. PID and endometritis are usually treated with antibiotics. More serious cases of PID or endometritis may require surgery. A hysterectomy (removal of the uterus) is sometimes needed. In rare cases, infections that start as PID can even cause death.
  
  Tell your healthcare provider right away if you have any of these signs of PID or endometritis: low abdominal (stomach area) or pelvic pain, pelvic tenderness, painful sex, unusual or bad smelling vaginal discharge, chills, long-lasting or heavy bleeding, fever, genital lesions or sores.
• embedment: Paragard may become attached to (embedded) the wall of the uterus. This may make it hard to remove Paragard. Surgery may sometimes be needed to remove Paragard.
• perforation: Paragard may go through the wall of the uterus. This is called perforation. If this occurs, Paragard may no longer prevent pregnancy. If perforation occurs, Paragard may move outside the uterus and cause internal scarring, infection, damage to other organs, pain, or infertility and you may need surgery to have Paragard removed. Excessive pain or vaginal bleeding during placement of Paragard, pain or bleeding that gets worse after placement, or not being able to feel the threads may happen with perforation. You are not protected from pregnancy if Paragard moves outside the wall of the uterus. The risk of perforation is increased in breastfeeding women.
• expulsion: Paragard may partially or completely fall out of the uterus by itself. This is called expulsion. Expulsion occurs in about 2 out of 100 women. Excessive pain, vaginal bleeding during placement of Paragard, pain that gets worse, bleeding after placement, or not being able to feel the threads may happen with expulsion. You are not protected from pregnancy if Paragard is expelled.
• changes in bleeding: You may have heavier and longer periods with spotting in between. Sometimes the bleeding is heavier than usual at first. Call your healthcare provider if the bleeding remains heavier or longer and spotting continues.
• reactions after placement or removal: Some women have had reactions such as dizziness (syncope), slowed heart rate (bradycardia), or seizures, immediately after Paragard was placed or removed. This happened especially in women who have had these conditions before.

Common side effects of Paragard include:

• anemia (low red blood cell count)
• backache
• painful periods
• pain during sex
• expulsion (complete or partial)
• vaginal discharge
• prolonged periods
• spotting
• pain and cramping
• vaginal irritation

This is not a complete list of possible side effects with Paragard. For more information, ask your healthcare provider. Tell your healthcare provider about any side effect that bothers you or does not go away.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800­ FDA-1088.

After Paragard has been placed, when should I call my healthcare provider?

Call your healthcare provider if you have any concerns about Paragard. Be sure to call if you:

• think you are pregnant
• have pelvic 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 Paragard may have been expelled (came out)
• cannot feel Paragard’s threads or can feel the threads are much longer
• can feel any other part of the Paragard besides the threads
• become HIV positive or your partner becomes HIV positive
• have severe, bleeding that lasts a long time, or bleeding that concerns you
• miss a menstrual period

General information about the safe and effective use of Paragard.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. You can ask your healthcare provider for information about Paragard that is written for health professionals.

Paragard and its components are not made with natural rubber latex.