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ParaGard® T 380A Intrauterine Copper Contraceptive (ParaGard®) is a T-shaped intrauterine device (IUD), measuring 32 mm horizontally and 36 mm vertically, with a 3 mm diameter bulb at the tip of the vertical stem. A monofilament polyethylene thread is tied through the tip, resulting in two white threads, each at least 10.5 cm in length, to aid in detection and removal of the device. The T-frame is made of polyethylene with barium sulfate to aid in detecting the device under x-ray. ParaGard® also contains copper: approximately 176 mg of wire coiled along the vertical stem and a 68.7 mg collar on each side of the horizontal arm. The total exposed copper surface area is 380 ± 23 mm². One ParaGard® weighs less than one (1) gram. No component of ParaGard® or its packaging contains latex.
ParaGard® is packaged together with an insertion tube and solid white rod in a Tyvek® polyethylene pouch that is then sterilized. A moveable flange on the insertion tube aids in gauging the depth of insertion through the cervical canal and into the uterine cavity.
Paragard is indicated for prevention of pregnancy in females of reproductive potential for up to 10 years.
Refer to Table 1 for recommended timing of Paragard insertion.
Table 1: Recommended Timing of Paragard Insertion
| Clinical Situation | Recommended Timing of Paragard Insertion |
| 1. Start Paragard in females not currentlyusing contraception | At any time during the menstrual cycle. |
| 2. Switch to Paragard from an oral,transdermal, or vaginal form ofhormonal contraception or an injectableprogestin contraceptive | At any time during the menstrual cycle; discontinue the previous method. |
| 3. Switch to Paragard from a contraceptiveimplant or other intrauterine system | Same day the implant or IUS is removed (insert at any time during the menstrual cycle). |
| 4. Insert Paragard after abortion ormiscarriage | Immediately after abortion, although immediate placement has a slightly higher risk of expulsion than placement at other times. Insertion after second trimester abortion is associated with a higher risk of expulsion than insertion after a first trimester abortion. |
| 5. Insert Paragard after Childbirth |
May insert immediately postpartum. |
| Note: The inserter provided with Paragard (see Figure 1) and the Insertion Procedure described in subsection 2.4 are not applicable for immediate insertion after childbirth. For immediate insertion post childbirth, remove the inserter and Paragard from the tray, move the button forward and then completely back to release the Paragard unit from the inserter and insert Paragard. | |
Read the Preparation Instructions and Insertion Procedure before initiating Paragard insertion.
Before insertion:
Follow the insertion instructions exactly as described to ensure proper placement and avoid early release of Paragard from the inserter.
Step 1: Opening the Sterile Paragard Package
Figure 1: Inserter
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Figure 2: Paragard Intrauterine System (IUS)
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Do not slide the button on the handle before folding the arms in the tray.
Do not repeatedly slide the button forward and back as this may cause slack in the threads and may result in an unsuccessful placement.
Step 2: Loading Paragard into the Inserter
Figure 3: Folding Tips of T-Arms of Paragard using Loading Tip
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IMPORTANT: Do not leave the T-Arms of Paragard bent for more than 5 minutes, as the arms may not open properly.
Figure 4: Inserting Tips of T-Arms into Insertion Tube
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Step 3: Adjusting the Flange
Figure 5: Adjusting the Blue Flange to sound depth
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Step 4: Removing Inserter from Tray
Figure 6: Removal of Inserter from Tray
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Step 5: Inserting Paragard to the Fundus
Figure 7: Inserter with Paragard at Uterine Fundus
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Step 6: Releasing Paragard and Withdrawing Inserter
Figure 8: Release T-Arms of Paragard at Uterine Fundus
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Figure 9: Appropriate Paragard Placement in Uterus
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Following placement:
Paragard is a T-frame copper-containing intrauterine system (IUS) consisting of a polyethylene frame with barium sulfate measuring 32 mm horizontally and 36 mm vertically, with approximately 176 mg of copper wire wrapped around the vertical stem and an approximately 68.7 mg copper wire collar placed on each side of the horizontal arm with a total exposed copper surface area is 380 ± 23 mm², packaged with a sterile pre-assembled inserter as a single-use, disposable device in a tray. A monofilament polyethylene thread is tied through the tip of the vertical stem resulting in two white threads, each approximately 36.5 cm in length. Figure 1 displays the contents of the package [see DOSAGE AND ADMINISTRATION].
Paragard (intrauterine copper contraceptive) is available in cartons of 1 (one) sterile unit (NDC 59365-5129-1).
Each Paragard is white, T-shaped, and measures 32 mm horizontally and 36 mm vertically, with approximately 176 mg of copper wire wrapped around the vertical stem and an approximately 68.7 mg copper wire collar placed on each side of the horizontal arms, and with a monofilament polyethylene thread tied through the tip of the vertical stem [see DOSAGE AND ADMINISTRATION]. The T-frame is made of polyethylene with barium sulfate. Each Paragard is packaged with a sterile pre-assembled inserter as a single-use, disposable device in a tray and in a Tyvek® polyethylene pouch.
Store at controlled room temperature: 59° to 86°F (15° to 30°C).
Manufactured by: CooperSurgical, Inc. Trumbull, CT 06611. Revised: Jun 2024.
The following serious adverse reactions are discussed elsewhere in the labeling:
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
The data described below reflect exposure in two trials [see Clinical Studies].
Table 2 shows discontinuation rates from the two clinical studies by adverse reaction and year.
Table 2: Summary of Rates* (No. per 100 Subjects) by Year for Adverse Reactions Causing Discontinuation
| Year | ||||||||||
| 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | |
| Number of Women at Start of Year | 4,932 | 3,149 | 2,018 | 1,121 | 872 | 621 | 563 | 483 | 423 | 325 |
| Expulsion | 5.7 | 2.5 | 1.6 | 1.2 | 0.3 | 0.0 | 0.6 | 1.7 | 0.2 | 0.4 |
| Bleeding/Pain | 11.9 | 9.8 | 7.0 | 3.5 | 3.7 | 2.7 | 3.0 | 2.5 | 2.2 | 3.7 |
| Other Medical Event | 2.5 | 2.1 | 1.6 | 1.7 | 0.1 | 0.3 | 1.0 | 0.4 | 0.7 | 0.3 |
| *Rates were calculated by weighting the annual rates by the number of subjects starting each year for each of the U.S. Composite Study (3536 subjects) and the World Health Organization (1396 subjects) trials. | ||||||||||
The following adverse reactions have also been observed: anemia, backache, dysmenorrhea, dyspareunia, complete or partial expulsion, prolonged menstrual flow, menstrual spotting, pain and cramping, and vaginitis.
The Paragard inserter that enables single-hand insertion was evaluated in Study CSIPD-001. A total of 117 females of reproductive potential aged 18 to 49 years, underwent Paragard insertion and were followed for up to 12 weeks of Paragard use. Subjects were predominantly white (76%), 45% were parous, and 35% were obese. Successful placement of Paragard with first attempt occurred in 91% of the subjects and 99% with two insertion attempts. Adverse reactions of special interest occurring during the study were IUS expulsion (2.6%), vasovagal reaction (2.6%), IUS malposition (1.7%), partial uterine perforation (0.9%), and IUS embedment (0.9%).
The following adverse reactions have been identified during post-approval use of Paragard. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Gastrointestinal Disorders: abdominal distension, nausea
General Disorders and Administration Site Conditions: device breakage, pyrexia; copper wire breakage
Immune System Disorders: allergy to metals, hypersensitivity
Infections and Infestations: endometritis/uterine infection
Musculoskeletal and Connective Tissue Disorders: muscle spasms
Nervous System Disorders: dizziness
Reproductive System and Breast Disorders: amenorrhea
Skin and Subcutaneous Tissue Disorders: Stevens-Johnson syndrome
No drug-drug interaction or drug-herbal supplement interaction studies have been conducted with Paragard.
Included as part of the "PRECAUTIONS" Section
Evaluate for possible ectopic pregnancy in any female who becomes pregnant while using Paragard because a pregnancy that occurs with Paragard in place is more likely to be ectopic than a pregnancy in the general population. However, because Paragard prevents most pregnancies, females who use Paragard have a lower risk of an ectopic pregnancy than sexually active females who do not use any contraception.
The incidence of ectopic pregnancy in the clinical trials with Paragard (which excluded females with a previous history of ectopic pregnancy) was approximately 0.06%. Ectopic pregnancy may require surgery and may result in loss of fertility.
If intrauterine pregnancy occurs with Paragard in place and the strings are visible or can be retrieved from the cervical canal, remove Paragard because leaving it in place may increase the risk of spontaneous abortion and preterm labor. Removal of Paragard may also result in spontaneous abortion. In the event of an intrauterine pregnancy with Paragard, consider the following:
In females becoming pregnant with an intrauterine system (IUS), including Paragard in place, septic abortion, with septicemia, septic shock, and death, may occur [see Sepsis]. Septic abortion typically requires hospitalization and treatment with intravenous antibiotics. Septic abortion may result in spontaneous abortion or a medical indication for pregnancy termination. A hysterectomy may be required if severe infection of the uterus occurs, which will result in permanent infertility.
If a female becomes pregnant with Paragard in place and if Paragard cannot be removed or the female chooses not to have it removed, warn her that failure to remove Paragard increases the risk of miscarriage, sepsis, premature labor, and premature delivery. Prenatal care should include counseling about these risks and that she should report immediately any flu-like symptoms, fever, chills, cramping, pain, bleeding, vaginal discharge or leakage of fluid, or any other symptom that suggests complications of the pregnancy.
Severe infection or sepsis, including Group A streptococcal sepsis (GAS), have been reported following insertion of IUSs, including Paragard. In some cases, severe pain occurred within hours of insertion followed by sepsis within days. Because death from GAS is more likely if treatment is delayed, it is important to be aware of these rare but serious infections. Aseptic technique during insertion of Paragard is essential in order to minimize serious infections such as GAS [see DOSAGE AND ADMINISTRATION].
Insertion of Paragard is contraindicated in the presence of known or suspected Pelvic Inflammatory Disease (PID) or endometritis [see CONTRAINDICATIONS]. IUSs, including Paragard, have been associated with an increased risk of PID, most likely due to organisms being introduced into the uterus during insertion. In the clinical trials with Paragard, the incidence of PID that resulted in the removal of Paragard was approximately 0.1% [see Clinical Studies].
Counsel women who receive Paragard to notify a healthcare provider if they have complaints of lower abdominal or pelvic pain, odorous discharge, unexplained bleeding, fever, or genital lesions or sores. In such circumstances, perform a pelvic examination promptly to evaluate for possible pelvic infection. Remove Paragard in cases of recurrent PID or endometritis, or if an acute pelvic infection is severe or does not respond to treatment.
PID can have serious consequences, such as tubal damage (leading to ectopic pregnancy or infertility), hysterectomy, sepsis, and death.
PID or endometritis are often associated with a sexually transmitted infection (STI) and Paragard does not protect against STIs. The risk of PID or endometritis is greater for females who have multiple sexual partners, and also for females whose sexual partner(s) have multiple sexual partners. Females who have had PID or endometritis are at increased risk for a recurrence or re-infection. In particular, ascertain whether a female is at increased risk of infection (for example, leukemia, acquired immune deficiency syndrome (AIDS), intravenous drug abuse).
PID or endometritis may be asymptomatic but still result in tubal damage and its sequelae.
Remove Paragard in cases of recurrent endometritis or PID, or if an acute pelvic infection is severe or does not respond to treatment. Prophylactic antibiotics administered at the time of insertion do not appear to lower the incidence of PID.
Promptly assess and treat any female who develops signs or symptoms of PID. Perform appropriate testing for sexually transmitted infection and initiate antibiotic therapy promptly. Paragard does not need to be removed immediately. Reassess the patient in 48-72 hours. If no clinical improvement occurs, continue antibiotics and consider removal of Paragard. If the decision is to remove Paragard, start antibiotics prior to removal to avoid the potential risk for bacterial spread resulting from the removal procedure.
Actinomycosis has been associated with IUS use, including Paragard. Symptomatic women with known actinomycosis infection should have Paragard removed and receive antibiotics. Actinomycetes can be found in the genital tract cultures in healthy women without IUSs. The significance of actinomyces-like organisms on a Papanicolaou (PAP) smear in an asymptomatic IUS user is unknown, and this finding alone does not always require IUS removal and treatment. When possible, confirm a PAP smear diagnosis with cultures.
Partial penetration or embedment of Paragard in the myometrium can make removal difficult. In some cases, surgical removal may be necessary. Breakage of an embedded Paragard during non-surgical removal has been reported [see DOSAGE AND ADMINISTRATION].
Partial or total perforation of the uterine wall or cervix may occur during insertions, although the perforation may not be detected until sometime later. Perforation may reduce contraceptive efficacy and result in pregnancy. The incidence of perforation during or following Paragard insertion in clinical trials was 0.2% (13 out of 5344).
Delayed detection or removal of Paragard in cases of perforation may result in migration outside the uterine cavity, adhesions, peritonitis, intestinal penetration, intestinal obstruction, abscesses and/or damage to adjacent organs.
A postmarketing safety study conducted in Europe (EURAS IUD) with IUSs, including copper IUSs, demonstrated an increased risk of perforation in lactating women. The risk of perforation may be increased if an IUS, such as Paragard, is inserted when the uterus is fixed, retroverted or not completely involuted during the postpartum period.
If perforation does occur, locate and remove Paragard promptly. Surgery may be required. Preoperative imaging followed by laparoscopy or laparotomy is often required to remove Paragard from the peritoneal cavity.
Partial or complete expulsion of Paragard has been reported, resulting in the loss of contraceptive protection. The incidence of expulsion in the clinical trials with Paragard was approximately 2.3%. Consider further diagnostic imaging, such as x-ray, to confirm expulsion if the IUS is not found in the uterus.
Paragard has been placed immediately after delivery, although the risk of expulsion may be increased when the uterus is not completely involuted at the time of insertion. Remove a partially expelled Paragard.
Paragard may exacerbate Wilson’s disease, a rare genetic disease affecting copper excretion; therefore, the use of Paragard is contraindicated in females of reproductive potential with Wilson’s disease [see CONTRAINDICATIONS].
Paragard can alter the bleeding pattern and result in heavier and longer menstrual cycles with intermenstrual spotting.
In two clinical trials with Paragard, there were reports of oligomenorrhea and amenorrhea; however, a causal relationship between Paragard and these events could not be established. Menstrual changes were the most common medical reason for discontinuation of Paragard. Discontinuation rates for pain and bleeding combined were highest in the first year of use and diminished thereafter. The percentage of females who discontinued Paragard because of bleeding problems or pain during these studies ranged from 12% in the first year to 2% in Year 9. Females complaining of heavy vaginal bleeding should be evaluated and treated, and may need to discontinue Paragard [see ADVERSE REACTIONS].
Non-clinical testing has demonstrated that Paragard is MR Conditional. A patient with Paragard can be safely scanned in an MR system meeting the following conditions:
Under the scan conditions defined above, Paragard is expected to produce a maximum temperature rise of less than 0.5° C after 15 minutes of continuous scanning.
In non-clinical testing, the image artifact caused by the system extended less than 5 mm from the implant when imaged with a gradient echo pulse sequence and a 3.0 T MRI system.
Medical equipment that contain high levels of Radiofrequency (RF) energy such as diathermy may cause health effects (by heating tissue) in females with a metal-containing IUD including Paragard. Avoid using high medical RF transmitter devices in females with Paragard.
Advise the patient to read the FDA-approved patient labeling (PATIENT INFORMATION).
Before inserting Paragard, counsel patients on the following:
Advise patients that Paragard does not protect against HIV infection and other sexually transmitted diseases.
Advise patients to report pregnancies and be evaluated immediately, as a pregnancy with Paragard in place is more likely to be an ectopic pregnancy, and the risks of ectopic pregnancy include the loss of fertility [see WARNINGS AND PRECAUTIONS].
Advise patients to report pregnancies and be evaluated immediately, as an intrauterine pregnancy with Paragard in place, may result in septic abortion, with septicemia, septic shock, and possible death. Septic abortion typically requires hospitalization and treatment with intravenous antibiotics. Septic abortion may result in spontaneous abortion or a medical indication for pregnancy termination. A hysterectomy may be required if severe infection of the uterus occurs, which will result in permanent infertility. If Paragard remains in the uterus during a pregnancy, there is an increased risk of miscarriage, sepsis, premature labor and premature delivery. Advise patients that a pregnancy must be followed closely and advise patients to report immediately any symptom, such as flu- like symptoms, fever, chills, cramping, pain, bleeding, vaginal discharge or leaking of fluid, or any other symptom that suggests complications of the pregnancy [see WARNINGS AND PRECAUTIONS].
Advise patients that sepsis may occur after insertion of Paragard and to seek immediate treatment for fever and pelvic pain that occurs soon after insertion, as untreated sepsis can result in death [see WARNINGS AND PRECAUTIONS].
Advise patients that pelvic inflammatory disease (PID) may occur after insertion of Paragard and that PID can cause tubal damage leading to ectopic pregnancy or infertility, or can necessitate hysterectomy, or cause death. Advise patients to recognize and report promptly any symptoms of PID including development of menstrual disorders (prolonged or heavy bleeding), unusual vaginal discharge, abdominal or pelvic pain or tenderness, dyspareunia, chills, and fever [see WARNINGS AND PRECAUTIONS].
Advise patients regarding the risks of embedment, perforation, and expulsion and inform patients that in some cases, removal of Paragard may be difficult and surgical removal may be necessary. Inform patients that perforation can cause infection, scarring, damage to other organs, pain, or infertility. Inform patients that excessive pain or vaginal bleeding during IUS placement, worsening pain or bleeding after placement, or the inability to feel the IUS strings may occur with IUS perforation and expulsion. There is no protection from pregnancy if Paragard is displaced or expelled [see WARNINGS AND PRECAUTIONS].
Advise patients that heavier or longer periods and spotting between periods may occur. Instruct patients to report continued or severe symptoms to their healthcare provider [see WARNINGS AND PRECAUTIONS].
Advise patients to check that Paragard is still in the uterus by reaching up to the top of the vagina with clean fingers to feel the two threads. Inform patients not to pull on the threads, which could displace Paragard. Advise patients to promptly report if there are changes in the length of the two threads, if they cannot locate the threads, or they can feel any other part of Paragard besides the threads.
Inform patients that Paragard can be safely scanned with MRI only under specific conditions. Instruct patients who will have an MRI to tell their healthcare provider that they have Paragard [see WARNINGS AND PRECAUTIONS].
Instruct patients to tell their healthcare provider that they have Paragard prior to undergoing medical diathermy [see WARNINGS AND PRECAUTIONS].
Adequate long-term studies in animals to assess the carcinogenic potential of a copper-containing IUS have not been performed.
The genotoxic potential of a copper-containing IUS has not been evaluated.
Use of Paragard is contraindicated for use in pregnant females because there is no need for pregnancy prevention in a female who is already pregnant and Paragard may cause adverse pregnancy outcomes. If a female becomes pregnant with Paragard in place, there is an increased risk of miscarriage, sepsis, premature labor, and premature delivery [see CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS]. Advise the female of the potential risks if pregnancy occurs with Paragard in place.
Published studies on pregnancy outcomes exposed to copper IUSs report up to 27% miscarriage when the IUS was removed compared to 77% miscarriage when the IUS remained in the uterus. Studies on Paragard and birth defects have not been conducted.
No difference has been detected in concentration of copper in human milk before and after insertion of copper IUSs, including Paragard. There is no information on the effect of copper in a breastfed child or the effect on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Paragard and any potential adverse effects on the breastfed child from Paragard.
The safety and effectiveness of Paragard have been established in females of reproductive potential. Efficacy is expected to be the same for postmenarcheal females regardless of age.
Paragard is not indicated in females before menarche.
Paragard has not been studied in women over 65 years of age and is not indicated in this population.
No Information Provided
The use of Paragard is contraindicated when one or more of the following conditions exist:
Copper continuously released into the uterine cavity contributes to the contraceptive effectiveness of Paragard. Mechanism(s) by which copper enhances contraceptive efficacy include interference with sperm transport and fertilization of an egg, and possibly prevention of implantation.
The efficacy of Paragard for use in females of reproductive potential for prevention of pregnancy for up to 10 years was demonstrated in two trials:
The pregnancy rate in the two clinical studies with Paragard was less than 1 pregnancy per 100 women each year (see Table 3).
Table 3: Pregnancy Rates* (Number of Pregnancies per 100 Women) by Year in the WHO and U.S. Studies
| Year | ||||||||||
| 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | |
| Pregnancy | 0.7 | 0.3 | 0.6 | 0.2 | 0.3 | 0.2 | 0.0 | 0.4 | 0.0 | 0.0 |
| Number of Women at Start of Year | 4,932 | 3,149 | 2,018 | 1,121 | 872 | 621 | 563 | 483 | 423 | 325 |
| *Rates were calculated by weighting the annual rates by the number of subjects starting each year for each of the U.S. Composite Study (3536 subjects) and the World Health Organization (1396 subjects) trials. | ||||||||||
PARAGARD®
('par-uh-gahrd)
(intrauterine copper contraceptive)
Paragard does not protect against HIV infection (AIDS) or other sexually transmitted infections (STIs).
Read this Patient Information carefully before you decide if Paragard is right for you. This information does not take the place of talking with your gynecologist or other healthcare provider who specializes in women’s health. If you have any questions about Paragard, ask your healthcare provider. You should also learn about other birth control methods to choose the one that is best for you.
What is Paragard?
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.
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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.
How well does Paragard work for contraception?
The following chart shows the chance of getting pregnant for women who use different methods of birth control. Each box on the chart contains a list of birth control methods that are similar in effectiveness. The most effective methods are at the top of the chart. The box on the bottom of the chart shows the chance of getting pregnant for women who do not use birth control and are trying to get pregnant. Paragard, an intrauterine system (IUS), is in the box at the top of the chart.
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Who might use Paragard?
You might choose Paragard if you:
Do not use Paragard if you:
Before having Paragard placed, tell your healthcare provider if you have:
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.
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You should be ab1le to feell the short threads attached to IPARAGARD with your fin,ger.
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.
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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.
What are the possible side effects of Paragard?
Paragard can cause serious side effects, including:
Common side effects of Paragard include:
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:
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.
This Patient Information has been approved by the U.S. Food and Drug Administration
