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Paragard T380a (Copper Intrauterine) - Warnings and Precautions



1.  Intrauterine Pregnancy

If intrauterine pregnancy occurs with ParaGard® in place and the string is visible, ParaGard® should be removed because of the risk of spontaneous abortion, premature delivery, sepsis, septic shock, and, rarely, death. Removal may be followed by pregnancy loss.

If the string is not visible, and the woman decides to continue her pregnancy, check if the ParaGard® is in her uterus (for example, by ultrasound). If ParaGard® is in her uterus, warn her that there is an increased risk of spontaneous abortion and sepsis, septic shock, and rarely, death.1 In addition, the risk of premature labor and delivery is increased.1

Human data about risk of birth defects from copper exposure are limited. However, studies have not detected a pattern of abnormalities, and published reports do not suggest a risk that is higher than the baseline risk for birth defects.

2. Ectopic Pregnancy

Women who become pregnant while using ParaGard ® should be evaluated for ectopic pregnancy. 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, women who use ParaGard ® have a lower risk of an ectopic pregnancy than sexually active women who do not use any contraception.2-3

3. Pelvic Infection

Although pelvic inflammatory disease (PID) in women using IUDs is uncommon, IUDs may be associated with an increased relative risk of PID compared to other forms of contraception and to no contraception. The highest incidence of PID occurs within 20 days following insertion. Therefore, the visit following the first post-insertion menstrual period is an opportunity to assess the patient for infection, as well as to check that the IUD is in place. (See INSTRUCTIONS FOR USE, Continuing Care.) Since pelvic infection is most frequently associated with sexually transmitted organisms, IUDs are not recommended for women at high risk for sexual infection. Prophylactic antibiotics at the time of insertion do not appear to lower the incidence of PID.4

PID can have serious consequences, such as tubal damage (leading to ectopic pregnancy or infertility), hysterectomy, sepsis, and, rarely, death. It is therefore important to promptly assess and treat any woman who develops signs or symptoms of PID.

Guidelines for treatment of PID are available from the Centers for Disease Control and Prevention (CDC), Atlanta, Georgia at www.cdc.gov or 1-800-311-3435. Antibiotics are the mainstay of therapy. Most healthcare professionals also remove the IUD.

The significance of actinomyces-like organisms on Papanicolaou smear in an asymptomatic IUD user is unknown,5-6 and so this finding alone does not always require IUD removal and treatment. However, because pelvic actinomycosis is a serious infection, a woman who has symptoms of pelvic infection possibly due to actinomyces should be treated and have her IUD removed.

4. Immunocompromise

Women with AIDS should not have IUDs inserted unless they are clinically stable on antiretroviral therapy. Limited data suggest that asymptomatic women infected with human immunodeficiency virus may use intrauterine devices. Little is known about the use of IUDs in women who have illnesses causing serious immunocompromise. Therefore these women should be carefully monitored for infection if they choose to use an IUD. The risk of pregnancy should be weighed against the theoretical risk of infection.

5. Embedment

Partial penetration or embedment of ParaGard ® in the myometrium can make removal difficult. In some cases, surgical removal may be necessary.

6. Perforation

Partial or total perforation of the uterine wall or cervix may occur rarely during placement, although it may not be detected until later. Spontaneous migration has also been reported. If perforation does occur, remove ParaGard ® promptly, since the copper can lead to intraperitoneal adhesions. Intestinal penetration, intestinal obstruction, and/or damage to adjacent organs may result if an IUD is left in the peritoneal cavity. Pre-operative imaging followed by laparoscopy or laparotomy is often required to remove an IUD from the peritoneal cavity.

7. Expulsion

Expulsion can occur, usually during the menses and usually in the first few months after insertion. There is an increased risk of expulsion in the nulliparous patient. If unnoticed, an unintended pregnancy could occur.

8. Wilson’s Disease

Theoretically, ParaGard ® can exacerbate Wilson’s disease, a rare genetic disease affecting copper excretion.


Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

1. Information for patients

Before inserting ParaGard ® discuss the Patient Package Insert with the patient, and give her time to read the information. Discuss any questions she may have concerning ParaGard ® as well as other methods of contraception. Instruct her to promptly report symptoms of infection, pregnancy, or missing strings.

2. Insertion precautions, continuing care, and removal.


3. Vaginal bleeding

In the 2 largest clinical trials with ParaGard ® (see ADVERSE REACTIONS, Table 2), menstrual changes were the most common medical reason for discontinuation of ParaGard ®. Discontinuation rates for pain and bleeding combined are highest in the first year of use and diminish thereafter. The percentage of women who discontinued ParaGard ® because of bleeding problems or pain during these studies ranged from 11.9% in the first year to 2.2 % in year 9. Women complaining of heavy vaginal bleeding should be evaluated and treated, and may need to discontinue ParaGard ®. (See ADVERSE REACTIONS.)

4. Vasovagal reactions, including fainting

Some women have vasovagal reactions immediately after insertion. Hence, patients should remain supine until feeling well and should be cautious when getting up.

5. Expulsion following placement after a birth or abortion

ParaGard ® has been placed immediately after delivery, although risk of expulsion may be higher than when ParaGard ® is placed at times unrelated to delivery.7 However, unless done immediately postpartum, insertion should be delayed to the second postpartum month because insertion during the first postpartum month (except for immediately after delivery) has been associated with increased risk of perforation.8

ParaGard ® can be placed immediately after abortion, although immediate placement has a slightly higher risk of expulsion than placement at other times.9 Placement after second trimester abortion is associated with a higher risk of expulsion than placement after the first trimester abortion.9

6. Magnetic resonance imaging (MRI)

Limited data suggest that MRI at the level of 1.5 Tesla is acceptable in women using ParaGard ®. One study examined the effect of MRI on the CU-7 ® Intrauterine Copper Contraceptive and Lippes Loop™ intrauterine devices. Neither device moved under the influence of the magnetic field or heated during the spin-echo sequences usually employed for pelvic imaging.10 An in vitro study did not detect movement or temperature change when ParaGard ® was subjected to MRI.11

7. Medical diathermy

Theoretically, medical (non-surgical) diathermy (short-wave and microwave heat therapy) in a patient with a metal-containing IUD may cause heat injury to the surrounding tissue. However, a small study of eight women did not detect a significant elevation of intrauterine temperature when diathermy was performed in the presence of a copper IUD.12

8. Pregnancy

ParaGard ® is contraindicated during pregnancy. (See CONTRAINDICATIONS and WARNINGS.)

9. Nursing mothers

Nursing mothers may use ParaGard ®. No difference has been detected in concentration of copper in human milk before and after insertion of copper IUDs. The literature is conflicting, but limited data suggest that there may be an increased risk of perforation and expulsion if a woman is lactating. 13

10. Pediatric use

ParaGard ® is not indicated before menarche. Safety and efficacy have been established in women over 16 years old.

Page last updated: 2008-01-24

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