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copper intrauterine device
INTRAUTERINE COPPER CONTRACEPTIVE
ParaGard® T380A Intrauterine Copper Contraceptive
Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
ParaGard® T 380A Intrauterine Copper Contraceptive should be placed and removed only by healthcare professionals who are experienced with these procedures.
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.
The contraceptive effectiveness of ParaGard® is enhanced by copper continuously released into the uterine cavity. Possible mechanism(s) by which copper enhances contraceptive efficacy include interference with sperm transport or fertilization, and prevention of implantation.
INDICATIONS AND USAGE
ParaGard ® is indicated for intrauterine contraception for up to 10 years. The pregnancy rate in clinical studies has been less than 1 pregnancy per 100 women each year.
ParaGard® should not be placed when one or more of the following conditions exist:
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.
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.
Partial penetration or embedment of ParaGard ® in the myometrium can make removal difficult. In some cases, surgical removal may be necessary.
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.
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.
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.
(See INSTRUCTIONS FOR USE.)
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
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
Table 2 shows discontinuation rates from two clinical studies by adverse event and year.
*Rates were calculated by weighting the annual rates by the number of subjects starting each year for each of the Population Council (3,536 subjects) and the World Health Organization (1,396 subjects) trials.
The following adverse events have also been observed. These are listed alphabetically and not by order of frequency or severity.
INSTRUCTIONS FOR USE
The placement technique for ParaGard® is different from that used for other IUDs. Therefore, the clinician should be familiar with the following instructions.
ParaGard® may be placed at any time during the cycle when the clinician is reasonably certain the patient is not pregnant. For information about timing of postpartum and postabortion insertions, see PRECAUTIONS.
A single ParaGard® should be placed at the fundus of the uterine cavity. ParaGard® should be removed on or before 10 years from the date of insertion.
How to Load and Place ParaGard®:
Do not bend the arms of ParaGard® earlier than 5 minutes before it is to be placed in the uterus. Use aseptic technique when handling ParaGard® and the part of the insertion tube that will enter the uterus.
Load ParaGard® into the insertion tube by folding the two horizontal arms of ParaGard®against the stem and push the tips of the arms securely into the inserter tube.
If you do not have sterile gloves, you can do STEPS 1 and 2 while ParaGard® is in the sterile package. First, place the package face up on a clean surface. Next, open at the bottom end (where arrow says OPEN). Pull the solid white rod partially from the package so it will not interfere with assembly. Place thumb and index finger on top of package on ends of the horizontal arms. Use other hand to push insertion tube against arms of ParaGard® (shown by arrow in Fig. 1). This will start bending the T arms.
Bring the thumb and index finger closer together to continue bending the arms until they are alongside the stem. Use the other hand to withdraw the insertion tube just enough so that the insertion tube can be pushed and rotated onto the tips of the arms. Your goal is to secure the tips of the arms inside the tube (Fig. 2). Insert the arms no further than necessary to insure retention. Introduce the solid white rod into the insertion tube from the bottom, alongside the threads, until it touches the bottom of the ParaGard®.
Grasp the insertion tube at the open end of the package; adjust the blue flange so that the distance from the top of the ParaGard ® (where it protrudes from the inserter) to the blue flange is the same as the uterine depth that you measured with the sound. Rotate the insertion tube so that the horizontal arms of the T and the long axis of the blue flange lie in the same horizontal plane (Fig. 3). Now pass the loaded insertion tube through the cervical canal until ParaGard ® just touches the fundus of the uterus. The blue flange should be at the cervix in the horizontal plane.
To release the arms of ParaGard ®, hold the solid white rod steady and withdraw the insertion tube no more than one centimeter This releases the arms of ParaGard ® high in the uterine fundus (Fig. 4).
Gently and carefully move the insertion tube upward toward the top of the uterus, until slight resistance is felt. This will ensure placement of the T at the highest possible position within the uterus (Fig. 5).
Hold the insertion tube steady and withdraw the solid white rod (Fig. 6).
Gently and slowly withdraw the insertion tube from the cervical canal. Only the threads should be visible protruding from the cervix. (Fig. 7). Trim the threads so that 3 to 4 cm protrude into the vagina. Note the length of the threads in the patient’s records.
If you suspect that ParaGard ® is not in the correct position, check placement (with ultrasound, if necessary). If ParaGard ® is not positioned completely within the uterus, remove it and replace it with a new ParaGard ®. Do not reinsert an expelled or partially expelled ParaGard ®.
Instrumentation of the cervical os may result in vasovagal reactions, including fainting. Have the patient remain supine until she feels well, and have her get up with caution.
Following placement, examine the patient after her first menses to confirm that ParaGard ® is still in place. You should be able to see or feel only the threads. If ParaGard ® has been partially or completely expelled, remove it. You can place a new ParaGard ® if the patient desires and if she is not pregnant. Do not reinsert a used ParaGard ®.
Evaluate the patient promptly if she complains of any of the following:
The length of the visible threads may change with time. However, no action is needed unless you suspect partial expulsion, perforation, or pregnancy.
If you cannot find the threads in the vagina, check that ParaGard ® is still in the uterus. The threads can retract into the uterus or break, or ParaGard ® can break, perforate the uterus, or be expelled. Gentle probing of the cavity, radiography, or sonography may be required to locate the IUD.
If there is evidence of partial expulsion, perforation, or breakage, remove ParaGard ®.
How to Remove ParaGard®
Remove ParaGard ® with forceps, pulling gently on the exposed threads. The arms of ParaGard ® will fold upwards as it is withdrawn from the uterus. You may immediately insert a new ParaGard ® if the patient requests it and has no contraindications.
Embedment or breakage of ParaGard ® in the myometrium can make removal difficult. Analgesia, paracervical anesthesia, and cervical dilation may assist in removing an embedded ParaGard ®. An alligator forceps or other grasping instrument may be helpful. Hysteroscopy may also be helpful.
ParaGard ® is available in cartons of 1 (one) sterile unit (NDC 51285-204-01). Each ParaGard ® is packaged together with an insertion tube and solid white rod in a Tyvek ® polyethylene pouch.
TEVA WOMEN’S HEALTH, INC.
INFORMATION FOR PATIENTS
ParaGard® T 380A
ParaGard® T 380A Intrauterine Copper Contraceptive is used to prevent pregnancy. It does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
It is important for you to understand this brochure and discuss it with your healthcare provider before choosing ParaGard ® T 380A Intrauterine Copper Contraceptive (ParaGard ®). You should also learn about other birth control methods that may be an option for you.
What is ParaGard®?
ParaGard ® is a copper-releasing device that is placed in your uterus to prevent pregnancy for up to 10 years.
ParaGard ® is made of white plastic in the shape of a “T.” Copper is wrapped around the stem and arms of the “T”. Two white threads are attached to the stem of the “T”. The threads are the only part of ParaGard ® that you can feel when ParaGard ® is in your uterus. ParaGard ® and its components do not contain latex.
How long can I keep ParaGard ® in place?
You can keep ParaGard ® in your uterus for up to 10 years. After 10 years, you should have ParaGard ® removed by your healthcare provider. If you wish and if it is still right for you, you may get a new ParaGard ® during the same visit.
What if I change my mind and want to become pregnant?
Your healthcare provider can remove ParaGard ® at any time. After discontinuation of
How does ParaGard® work?
Ideas about how ParaGard ® works include preventing sperm from reaching the egg, preventing sperm from fertilizing the egg, and preventing the egg from attaching (implanting) in the uterus. ParaGard ® does not stop your ovaries from making an egg (ovulating) each month.
How well does ParaGard® work?
Fewer than 1 in 100 women become pregnant each year while using ParaGard ®.
The table below shows the chance of getting pregnant using different types of birth control. The numbers show typical use, which includes people who don't always use birth control correctly.
Who might use ParaGard ®?
You might choose ParaGard ®if you
Who should not use ParaGard ®?
You should not use ParaGard ® if you
How is ParaGard® placed in the uterus?
ParaGard ® is placed in your uterus during an office visit. Your healthcare provider first examines you to find the position of your uterus. Next, he or she will cleanse your vagina and cervix, measure your uterus, and then slide a plastic tube containing ParaGard ® into your uterus. The tube is removed, leaving ParaGard ® inside your uterus. Two white threads 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. Some women feel faint, nauseated, or dizzy for a few minutes afterwards. Your healthcare provider may ask you to lie down for a while and to get up slowly.
How do I check that ParaGard® is in my uterus?
Visit your healthcare provider for a check-up about one month after placement to make sure ParaGard ® is still in your uterus.
You can also check to make sure that ParaGard ® is still in your uterus by reaching up to the top of your vagina with clean fingers to feel the two threads. Do not pull on the threads. If you cannot feel the threads, ask your healthcare provider to check if ParaGard ® is in the right place. If you can feel more of ParaGard ® than just the threads, ParaGard ® is not in the right place. If you can’t see your healthcare provider right away, use an additional birth control method. If ParaGard ® is in the wrong place, your chances of getting pregnant are increased. It is a good habit for you to check that ParaGard ® is in place once a month.
You may use tampons when you are using ParaGard ®.
What if I become pregnant while using ParaGard®?
If you think you are pregnant, contact your healthcare professional right away. If you are pregnant and ParaGard ® is in your uterus, you may get a severe infection or shock, have a miscarriage or premature labor and delivery, or even die. Because of these risks, your healthcare provider will recommend that you have ParaGard ® removed, even though removal may cause miscarriage.
If you continue a pregnancy with ParaGard ® in place, see your healthcare provider regularly. Contact your healthcare provider right away if you get fever, chills, cramping, pain, bleeding, flu-like symptoms, or an unusual, bad smelling vaginal discharge.
A pregnancy with ParaGard ® in place has a greater than usual chance of being ectopic (outside your uterus). Ectopic pregnancy is an emergency that may require surgery. An ectopic pregnancy can cause internal bleeding, infertility, and death. Unusual vaginal bleeding or abdominal pain may be signs of an ectopic pregnancy.
Copper in ParaGard® does not seem to cause birth defects.
What side effects can I expect with ParaGard®?
The most common side effects of ParaGard ® are heavier, longer periods and spotting between periods; most of these side effects diminish after 2-3 months. However, if your menstrual flow continues to be heavy or long, or spotting continues, contact your healthcare provider.
Infrequently, serious side effects may occur:
You may have other side effects with ParaGard ®. For example, you may have anemia (low blood count), backache, pain during sex, menstrual cramps, allergic reaction, vaginal infection, vaginal discharge, faintness, or pain. This is not a complete list of possible side effects. If you have questions about a side effect, check with your healthcare provider.
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 advice about prescription medicines
This brochure summarizes the most important information about ParaGard ®. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider for information about ParaGard ® that is written for healthcare professionals.
This checklist will help you and your healthcare provider discuss the pros and cons of ParaGard ® for you. Do you have any of the following conditions?
TEVA WOMEN’S HEALTH, INC.
Subsidiary of TEVA PHARMACEUTICALS USA, Inc.
Sellersville, PA 18960
PRINCIPAL DISPLAY PANEL - 1 UNIT
ParaGard ® T 380A
intrauterine copper contraceptive
Each unit wound with approximately 176 mg of copper wire. In addition, a single copper sleeve is swaged on each of the two transverse arms. Each sleeve contains approximately 68.7 mg of copper. The total surface area of copper on the device is 380 ± 23mm2. IMPORTANT: To be inserted in the uterus only by a licensed clinician or under the supervision of a physician. See detailed instructions for use. NOTE: A Patient Package Insert is provided with each unit. Please ensure that this package insert is provided to the patient. Review patient brochure with each patient before insertion.
Store at controlled room temperature: 59º to 86ºF (15º to 30ºC).
Revised: 01/2011 Teva Women's Health, Inc.
Reproduced with permission of U.S. National Library of Medicine
Copyright © 2018
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