"Paragard T380a Intrauterine Copper Contraceptive Information"

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Rate (4.7 / 5) 65 votes
% of Women Experiencing
% of Women
an Accidental Pregnancy within
Continuing
3
the First Year of Use
Use at One Year
Method (1)
(4)
Typical Use
1
(2) Perfect Use
2
(3)
Sponge
Parous women
40
20
42
Nulliparous women
20
9
56
ParaGard
T 380A
®
7
20
6
56
Diaphragm
INTRAUTERINE COPPER CONTRACEPTIVE
Withdrawal
19
4
Rx only
8
Condom
21
5
56
PRESCRIBING INFORMATION
Female (Reality)
14
3
61
Male
ParaGard
T 380A Intrauterine Copper Contraceptive
®
Pill
5
71
Patients should be counseled that this product does not protect against HIV infection (AIDS) and
Progestin only
0.5
other sexually transmitted diseases.
Combined
0.1
ParaGard
®
T 380A Intrauterine Copper Contraceptive should be placed and removed only by
IUD
healthcare professionals who are experienced with these procedures.
Progesterone T
2.0
1.5
81
Copper T 380A
0.8
0.6
78
DESCRIPTION
LNg 20
0.1
0.1
81
Depo Provera
0.3
0.3
70
Norplant
0.05
0.05
88
and Norplant-2
Female sterilization
0.5
0.5
100
Male sterilization
0.15
0.10
100
Emergency Contraceptive Pills: Treatment initiated within 72 hours after
9
unprotected intercourse reduces the risk of pregnancy by at least 75%.
Lactational Amenorrhea Method: LAM is a highly effective temporary method of
contraception.
10
ParaGard
®
T 380A Intrauterine Copper Contraceptive (ParaGard
®
) is a T-shaped intrauterine device
Footnotes to Table 1
(IUD), measuring 32 mm horizontally and 36 mm vertically, with a 3 mm diameter bulb at the tip of
Source: Trussell J, Contraceptive efficacy. In Hatcher RA, Trussell J, Stewart F, Cates
the vertical stem. A monofilament polyethylene thread is tied through the tip, resulting in two white
W, Stewart GK, Kowal D, Guest F, Contraceptive Technology: Seventeenth Revised
threads, each at least 10.5 cm in length, to aid in detection and removal of the device. The T-frame
Edition. New York NY: Irvington Publishers, 1998.
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.
1. Among typical couples who initiate use of a method (not necessarily for the first time), the
One ParaGard
®
weighs less than one (1) gram. No component of ParaGard
®
or its packaging contains
percentage who experience an accidental pregnancy during the first year if they do not stop use
latex.
for any other reason.
ParaGard
is packaged together with an insertion tube and solid white rod in a Tyvek
polyethylene
2. Among couples who initiate use of a method (not necessarily for the first time) and who use
®
®
pouch that is then sterilized. A moveable flange on the insertion tube aids in gauging the depth of
it perfectly (both consistently and correctly), the percentage who experience an accidental
insertion through the cervical canal and into the uterine cavity.
pregnancy during the first year if they do not stop use for any reason.
3. Among couples attempting to avoid pregnancy, the percentage who continue to use a method
CLINICAL PHARMACOLOGY
for one year.
The contraceptive effectiveness of ParaGard
is enhanced by copper continuously released into the
4. The percents becoming pregnant in columns (2) and (3) are based on data from populations
®
where contraception is not used and from women who cease using contraception in order to
uterine cavity. Mechanism(s) by which copper enhances contraceptive efficacy include interference
become pregnant. Among such populations, about 89% become pregnant within one year.
with sperm transport and fertilization of an egg, and possibly prevention of implantation.
This estimate was lowered slightly (to 85%) to represent the percentage who would become
INDICATIONS AND USAGE
pregnant within one year among women now relying on reversible methods of contraception if
they abandoned contraception altogether.
ParaGard
®
is indicated for intrauterine contraception for up to 10 years. The pregnancy rate in
5. Foams, creams, gels, vaginal suppositories, and vaginal film.
clinical studies has been less than 1 pregnancy per 100 women each year.
6. Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal
Table 1: Percentage of women experiencing an unintended pregnancy during the first year of typical
body temperature in the post-ovulatory phases.
use and first year of perfect use of contraception and the percentage continuing use at the end of
7. With spermicidal cream or jelly.
the first year: United States
8. Without spermicides.
9. The treatment schedule is one dose within 72 hours after unprotected intercourse, and a second
dose 12 hours after the first dose. Preven is the only dedicated product specifically marketed
for emergency contraception. The Food and Drug Administration has also declared the following
brands of oral contraceptive to be safe and effective for emergency contraception: Ovral (1 dose
% of Women Experiencing
% of Women
is 2 white pills), Alesse (1 dose is 5 pink pills), Nordette or Levlen (1 dose is 4 light-orange pills),
an Accidental Pregnancy within
Continuing
Lo/Ovral (1 dose is 4 white pills), Triphasil or Tri-Levlen (1 dose is 4 yellow pills).
the First Year of Use
Use at One Year
3
10. However, to maintain effective protection against pregnancy, another method of contraception
must be used as soon as menstruation resumes, the frequency or duration of breastfeeds is
reduced, bottle feeds are introduced or the baby reaches 6 months of age.
Method (1)
Typical Use
1
(2) Perfect Use
2
(3)
(4)
CONTRAINDICATIONS
4
85
85
Chance
ParaGard
®
should not be placed when one or more of the following conditions exist:
1. Pregnancy or suspicion of pregnancy
5
26
6
40
Spermicides
2. Abnormalities of the uterus resulting in distortion of the uterine cavity
Periodic Abstinence
25
63
3. Acute pelvic inflammatory disease, or current behavior suggesting a high risk for pelvic
Calendar
9
inflammatory disease
Ovulation Method
3
4. Postpartum endometritis or postabortal endometritis in the past 3 months
Sympto-thermal
6
2
5. Known or suspected uterine or cervical malignancy
Post-ovulation
1
6. Genital bleeding of unknown etiology
7. Mucopurulent cervicitis
7
Cap
8. Wilson’s disease
40
26
42
Parous women
9. Allergy to any component of ParaGard
®
20
9
56
Nulliparous women
10. A previously placed IUD that has not been removed
1
% of Women Experiencing
% of Women
an Accidental Pregnancy within
Continuing
3
the First Year of Use
Use at One Year
Method (1)
(4)
Typical Use
1
(2) Perfect Use
2
(3)
Sponge
Parous women
40
20
42
Nulliparous women
20
9
56
ParaGard
T 380A
®
7
20
6
56
Diaphragm
INTRAUTERINE COPPER CONTRACEPTIVE
Withdrawal
19
4
Rx only
8
Condom
21
5
56
PRESCRIBING INFORMATION
Female (Reality)
14
3
61
Male
ParaGard
T 380A Intrauterine Copper Contraceptive
®
Pill
5
71
Patients should be counseled that this product does not protect against HIV infection (AIDS) and
Progestin only
0.5
other sexually transmitted diseases.
Combined
0.1
ParaGard
®
T 380A Intrauterine Copper Contraceptive should be placed and removed only by
IUD
healthcare professionals who are experienced with these procedures.
Progesterone T
2.0
1.5
81
Copper T 380A
0.8
0.6
78
DESCRIPTION
LNg 20
0.1
0.1
81
Depo Provera
0.3
0.3
70
Norplant
0.05
0.05
88
and Norplant-2
Female sterilization
0.5
0.5
100
Male sterilization
0.15
0.10
100
Emergency Contraceptive Pills: Treatment initiated within 72 hours after
9
unprotected intercourse reduces the risk of pregnancy by at least 75%.
Lactational Amenorrhea Method: LAM is a highly effective temporary method of
contraception.
10
ParaGard
®
T 380A Intrauterine Copper Contraceptive (ParaGard
®
) is a T-shaped intrauterine device
Footnotes to Table 1
(IUD), measuring 32 mm horizontally and 36 mm vertically, with a 3 mm diameter bulb at the tip of
Source: Trussell J, Contraceptive efficacy. In Hatcher RA, Trussell J, Stewart F, Cates
the vertical stem. A monofilament polyethylene thread is tied through the tip, resulting in two white
W, Stewart GK, Kowal D, Guest F, Contraceptive Technology: Seventeenth Revised
threads, each at least 10.5 cm in length, to aid in detection and removal of the device. The T-frame
Edition. New York NY: Irvington Publishers, 1998.
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.
1. Among typical couples who initiate use of a method (not necessarily for the first time), the
One ParaGard
®
weighs less than one (1) gram. No component of ParaGard
®
or its packaging contains
percentage who experience an accidental pregnancy during the first year if they do not stop use
latex.
for any other reason.
ParaGard
is packaged together with an insertion tube and solid white rod in a Tyvek
polyethylene
2. Among couples who initiate use of a method (not necessarily for the first time) and who use
®
®
pouch that is then sterilized. A moveable flange on the insertion tube aids in gauging the depth of
it perfectly (both consistently and correctly), the percentage who experience an accidental
insertion through the cervical canal and into the uterine cavity.
pregnancy during the first year if they do not stop use for any reason.
3. Among couples attempting to avoid pregnancy, the percentage who continue to use a method
CLINICAL PHARMACOLOGY
for one year.
The contraceptive effectiveness of ParaGard
is enhanced by copper continuously released into the
4. The percents becoming pregnant in columns (2) and (3) are based on data from populations
®
where contraception is not used and from women who cease using contraception in order to
uterine cavity. Mechanism(s) by which copper enhances contraceptive efficacy include interference
become pregnant. Among such populations, about 89% become pregnant within one year.
with sperm transport and fertilization of an egg, and possibly prevention of implantation.
This estimate was lowered slightly (to 85%) to represent the percentage who would become
INDICATIONS AND USAGE
pregnant within one year among women now relying on reversible methods of contraception if
they abandoned contraception altogether.
ParaGard
®
is indicated for intrauterine contraception for up to 10 years. The pregnancy rate in
5. Foams, creams, gels, vaginal suppositories, and vaginal film.
clinical studies has been less than 1 pregnancy per 100 women each year.
6. Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal
Table 1: Percentage of women experiencing an unintended pregnancy during the first year of typical
body temperature in the post-ovulatory phases.
use and first year of perfect use of contraception and the percentage continuing use at the end of
7. With spermicidal cream or jelly.
the first year: United States
8. Without spermicides.
9. The treatment schedule is one dose within 72 hours after unprotected intercourse, and a second
dose 12 hours after the first dose. Preven is the only dedicated product specifically marketed
for emergency contraception. The Food and Drug Administration has also declared the following
brands of oral contraceptive to be safe and effective for emergency contraception: Ovral (1 dose
% of Women Experiencing
% of Women
is 2 white pills), Alesse (1 dose is 5 pink pills), Nordette or Levlen (1 dose is 4 light-orange pills),
an Accidental Pregnancy within
Continuing
Lo/Ovral (1 dose is 4 white pills), Triphasil or Tri-Levlen (1 dose is 4 yellow pills).
the First Year of Use
Use at One Year
3
10. However, to maintain effective protection against pregnancy, another method of contraception
must be used as soon as menstruation resumes, the frequency or duration of breastfeeds is
reduced, bottle feeds are introduced or the baby reaches 6 months of age.
Method (1)
Typical Use
1
(2) Perfect Use
2
(3)
(4)
CONTRAINDICATIONS
4
85
85
Chance
ParaGard
®
should not be placed when one or more of the following conditions exist:
1. Pregnancy or suspicion of pregnancy
5
26
6
40
Spermicides
2. Abnormalities of the uterus resulting in distortion of the uterine cavity
Periodic Abstinence
25
63
3. Acute pelvic inflammatory disease, or current behavior suggesting a high risk for pelvic
Calendar
9
inflammatory disease
Ovulation Method
3
4. Postpartum endometritis or postabortal endometritis in the past 3 months
Sympto-thermal
6
2
5. Known or suspected uterine or cervical malignancy
Post-ovulation
1
6. Genital bleeding of unknown etiology
7. Mucopurulent cervicitis
7
Cap
8. Wilson’s disease
40
26
42
Parous women
9. Allergy to any component of ParaGard
®
20
9
56
Nulliparous women
10. A previously placed IUD that has not been removed
1
WARNINGS
3. Vaginal bleeding
(See ADVERSE REACTIONS, Table 2), menstrual
1. Intrauterine Pregnancy
In the 2 largest clinical trials with ParaGard
®
changes were the most common medical reason for discontinuation of ParaGard
. Discontinuation
®
If intrauterine pregnancy occurs with ParaGard
in place and the string is visible, ParaGard
should
®
®
rates for pain and bleeding combined are highest in the first year of use and diminish thereafter. The
be removed because of the risk of spontaneous abortion, premature delivery, sepsis, septic shock,
percentage of women who discontinued ParaGard
because of bleeding problems or pain during
®
and, rarely, death. Removal may be followed by pregnancy loss.
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
If the string is not visible, and the woman decides to continue her pregnancy, check if the ParaGard
®
®
ADVERSE REACTIONS.)
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
4. Vasovagal reactions, including fainting
risk of premature labor and delivery is increased.
1
Some women have vasovagal reactions immediately after insertion. Hence, patients should remain
Human data about risk of birth defects from copper exposure are limited. However, studies have not
supine until feeling well and should be cautious when getting up.
detected a pattern of abnormalities, and published reports do not suggest a risk that is higher than
the baseline risk for birth defects.
5. Expulsion following placement after a birth or abortion
2. Ectopic Pregnancy
ParaGard
has been placed immediately after delivery, although risk of expulsion may be higher
®
than when ParaGard
is placed at times unrelated to delivery.
However, unless done immediately
®
7
Women who become pregnant while using ParaGard
should be evaluated for ectopic pregnancy.
®
postpartum, insertion should be delayed to the second postpartum month because insertion
A pregnancy that occurs with ParaGard
in place is more likely to be ectopic than a pregnancy in
®
during the first postpartum month (except for immediately after delivery) has been associated with
the general population. However, because ParaGard
prevents most pregnancies, women who use
®
increased risk of perforation.
8
ParaGard
have a lower risk of an ectopic pregnancy than sexually active women who do not use
®
any contraception.
2-3
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
3. Pelvic Infection
associated with a higher risk of expulsion than placement after the first trimester abortion.
9
Although pelvic inflammatory disease (PID) in women using IUDs is uncommon, IUDs may be
6. Magnetic resonance imaging (MRI)
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,
Limited data suggest that MRI at the level of 1.5 Tesla is acceptable in women using ParaGard
. One
®
the visit following the first post-insertion menstrual period is an opportunity to assess the patient
study examined the effect of MRI on the CU-7
Intrauterine Copper Contraceptive and Lippes Loop
®
for infection, as well as to check that the IUD is in place. (See INSTRUCTIONS FOR USE, Continuing
intrauterine devices. Neither device moved under the influence of the magnetic field or heated during
Care.) Since pelvic infection is most frequently associated with sexually transmitted organisms, IUDs
the spin-echo sequences usually employed for pelvic imaging.
An in vitro study did not detect
10
are not recommended for women at high risk for sexual infection. Prophylactic antibiotics at the time
movement or temperature change when ParaGard
®
was subjected to MRI.
11
of insertion do not appear to lower the incidence of PID.
4
7. Medical diathermy
PID can have serious consequences, such as tubal damage (leading to ectopic pregnancy or
Theoretically, medical (non-surgical) diathermy (short-wave and microwave heat therapy) in a
infertility), hysterectomy , sepsis, and, rarely, death. It is therefore important to promptly assess and
patient with a metal-containing IUD may cause heat injury to the surrounding tissue. However, a
treat any woman who develops signs or symptoms of PID.
small study of eight women did not detect a significant elevation of intrauterine temperature when
Guidelines for treatment of PID are available from the Centers for Disease Control and Prevention
diathermy was performed in the presence of a copper IUD.
12
(CDC), Atlanta, Georgia at www.cdc.gov or 1-800-311-3435. Antibiotics are the mainstay of therapy.
8. Pregnancy
Most healthcare professionals also remove the IUD.
is contraindicated during pregnancy. (See CONTRAINDICATIONS and WARNINGS.)
ParaGard
®
The significance of actinomyces-like organisms on Papanicolaou smear in an asymptomatic IUD
user is unknown,
and so this finding alone does not always require IUD removal and treatment.
5-6
9. Nursing mothers
However, because pelvic actinomycosis is a serious infection, a woman who has symptoms of pelvic
Nursing mothers may use ParaGard
®
. No difference has been detected in concentration of copper in
infection possibly due to actinomyces should be treated and have her IUD removed.
human milk before and after insertion of copper IUDs. The literature is conflicting, but limited data
4. Immunocompromise
suggest that there may be an increased risk of perforation and expulsion if a woman is lactating.
13
Women with AIDS should not have IUDs inserted unless they are clinically stable on antiretroviral
10. Pediatric use
therapy. Limited data suggest that asymptomatic women infected with human immunodeficiency
ParaGard
is not indicated before menarche. Safety and efficacy have been established in women
®
virus may use intrauterine devices. Little is known about the use of IUDs in women who have
over 16 years old.
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
ADVERSE REACTIONS
against the theoretical risk of infection.
The most serious adverse events associated with intrauterine contraception are discussed in
5. Embedment
WARNINGS and PRECAUTIONS. These include:
Partial penetration or embedment of ParaGard
in the myometrium can make removal difficult. In
®
some cases, surgical removal may be necessary.
Intrauterine pregnancy
Pelvic infection
Septic abortion
Perforation
6. Perforation
Ectopic pregnancy
Embedment
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
Table 2 shows discontinuation rates from two clinical studies by adverse event and year.
the peritoneal cavity. Pre-operative imaging followed by laparoscopy or laparotomy is often required
Table 2. Summary of Rates (No. per 100 Subjects) by Year for
to remove an IUD from the peritoneal cavity.
Adverse Events Causing Discontinuation
7. Expulsion
Expulsion can occur, usually during the menses and usually in the first few months after insertion.
Adverse Event
Year
There is an increased risk of expulsion in the nulliparous patient. If unnoticed, an unintended
1
2
3
4
5
6
7
8
9
10
pregnancy could occur.
Pregnancy
0.7
0.3
0.6
0.2
0.3
0.2
0.0
0.4
0.0
0.0
8. Wilson’s Disease
Expulsion
5.7
2.5
1.6
1.2
0.3
0.0
0.6
1.7
0.2
0.4
Theoretically, ParaGard
®
can exacerbate Wilson’s disease, a rare genetic disease affecting copper
excretion.
Bleeding/Pain
11.9
9.8
7.0
3.5
3.7
2.7
3.0
2.5
2.2
3.7
PRECAUTIONS
Other Medical
2.5
2.1
1.6
1.7
0.1
0.3
1.0
0.4
0.7
0.3
Event
Patients should be counseled that this product does not protect against HIV infection (AIDS)
No. of Women at
and other sexually transmitted diseases.
4932
3149
2018
1121
872
621
563
483
423
325
Start of Year
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.)
2
STEP 3
*Rates were calculated by weighting the annual rates by the number of subjects starting
Fig. 3
Grasp the insertion tube at the open end of the package; adjust
each year for each of the Population Council (3,536 subjects) and the World Health Orga-
the blue flange so that the distance from the top of the ParaGard
nization (1,396 subjects) trials.
®
(where it protrudes from the inserter) to the blue flange is the
The following adverse events have also been observed. These are listed alphabetically and
same as the uterine depth that you measured with the sound.
not by order of frequency or severity.
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
Anemia
Menstrual flow, prolonged
(Fig. 3). Now pass the loaded insertion tube through the cervical
Backache
Menstrual spotting
canal until ParaGard
just touches the fundus of the uterus. The
®
Dysmenorrhea
Pain and cramping
blue flange should be at the cervix in the horizontal plane.
Dyspareunia
Urticarial allergic skin reaction
Expulsion, complete or partial
Vaginitis
Leukorrhea
INSTRUCTIONS FOR USE
STEP 4
To release the arms of ParaGard
, hold the solid white rod
®
The placement technique for ParaGard
is different from that used for other IUDs. Therefore, the
®
Fig. 4
steady and withdraw the insertion tube no more than one
clinician should be familiar with the following instructions.
centimeter. This releases the arms of ParaGard
high in the
®
ParaGard
®
may be placed at any time during the cycle when the clinician is reasonably certain the
uterine fundus (Fig. 4).
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.
Before Placement:
STEP 5
1. Make sure that the patient is an appropriate candidate for ParaGard
®
and that she has read the
Gently and carefully move the insertion tube upward toward the
Fig. 5
Patient Package Insert.
top of the uterus, until slight resistance is felt. This will ensure
2. Use of an analgesic before insertion is at the discretion of the patient and the clinician.
placement of the T at the highest possible position within the
3. Establish the size and position of the uterus by pelvic examination.
uterus (Fig. 5).
4. Insert a speculum and cleanse the vagina and cervix with an antiseptic solution.
5. Apply a tenaculum to the cervix and use gentle traction to align the cervical canal with the uterine
cavity.
6. Gently insert a sterile sound to measure the depth of the uterine cavity.
HOLD
PUSH
7. The uterus should sound to a depth of 6 to 9 cm except when inserting ParaGard
immediately
SOLID
®
TUBE
WHITE
post-abortion or post-partum. Insertion of ParaGard
®
into a uterine cavity measuring less than
UP
ROD
6 cm may increase the incidence of expulsion, bleeding, pain, and perforation. If you encounter
cervical stenosis, avoid undue force. Dilators may be helpful in this situation.
STEP 6
Hold the insertion tube steady and withdraw the solid white rod
Fig. 6
How to Load and Place ParaGard
:
®
(Fig. 6).
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.
STEP 1
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.
STEP 7
Next, open at the bottom end (where arrow says OPEN). Pull the solid white rod partially from the
Gently and slowly withdraw the insertion tube from the cervical
Fig. 7
package so it will not interfere with assembly. Place thumb and index finger on top of package on
canal. Only the threads should be visible protruding from the
ends of the horizontal arms. Use other hand to push insertion tube against arms of ParaGard
(shown
®
cervix. (Fig. 7). Trim the threads so that 3 to 4 cm protrude
by arrow in Fig. 1). This will start bending the T arms.
into the vagina. Note the length of the threads in the patient’s
records.
Fig. 1
PUSH
TUBE
STEP 2
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
.
®
ROTATE AND
Fig. 2
PUSH TUBE
3
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
.
®
®
INFORMATION FOR PATIENTS
CAUTION
ParaGard
T 380A
®
Instrumentation of the cervical os may result in vasovagal reactions, including fainting. Have the
Intrauterine Copper Contraceptive
patient remain supine until she feels well, and have her get up with caution.
Continuing Care:
ParaGard
T 380A Intrauterine Copper Contraceptive is used to prevent
®
Following placement, examine the patient after her first menses to confirm that ParaGard
is still
®
pregnancy. It does not protect against HIV infection (AIDS) and other
in place. You should be able to see or feel only the threads. If ParaGard
has been partially or
®
sexually transmitted diseases.
completely expelled, remove it. You can place a new ParaGard
if the patient desires and if she is not
®
It is important for you to understand this
pregnant. Do not reinsert a used ParaGard
.
®
brochure and discuss it with your healthcare
Evaluate the patient promptly if she complains of any of the following:
provider before choosing ParaGard
®
T
• Abdominal or pelvic pain, cramping, or tenderness; malodorous discharge; bleeding; fever
380A Intrauterine Copper Contraceptive
• A missed period
(ParaGard
). You should also learn about other
®
birth control methods that may be
(See WARNINGS, Pelvic Infection, Intrauterine Pregnancy and Ectopic Pregnancy.)
an option for you.
The length of the visible threads may change with time. However, no action is needed unless you
suspect partial expulsion, perforation, or pregnancy.
What is ParaGard
?
®
If you cannot find the threads in the vagina, check that ParaGard
®
is still in the uterus. The
ParaGard
®
is a copper releasing device that
threads can retract into the uterus or break, or ParaGard
®
can break, perforate the uterus, or be
is placed in your uterus to prevent pregnancy
expelled. Gentle probing of the cavity, radiography, or sonography may be required to locate the IUD.
for up to 10 years. ParaGard
is made of white
®
If there is evidence of partial expulsion, perforation, or breakage, remove ParaGard
.
®
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
®
How to Remove ParaGard
®
can feel when ParaGard
is in your uterus. ParaGard
and its components do not contain latex.
®
®
Remove ParaGard
®
with forceps, pulling gently on the exposed threads. The arms of ParaGard
®
will
How long can I keep ParaGard
in place?
®
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.
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
Embedment or breakage of ParaGard
®
in the myometrium can make removal difficult. Analgesia,
get a new ParaGard
during the same visit.
®
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.
What if I change my mind and want to become pregnant?
HOW SUPPLIED
Your healthcare provider can remove ParaGard
at any time. After discontinuation of ParaGard
, its
®
®
contraceptive effect is reversed.
ParaGard
is available in cartons of 1 (one) sterile unit (NDC 59365-5128-1).
®
Each ParaGard
is packaged together with an insertion tube and solid white rod in a Tyvek
®
®
How does ParaGard
work?
®
polyethylene pouch.
Ideas about how ParaGard
®
works include preventing sperm from reaching the egg, preventing
sperm from fertilizing the egg, and possibly preventing the egg from attaching (implanting) in the
REFERENCES
uterus. ParaGard
does not stop your ovaries from making an egg (ovulating) each month.
®
1. Tatum HJ, Schmidt FH, Jain AK. Management and out come of pregnancies associated with the
How well does ParaGard
work?
®
Copper T intrauterine contraceptive device. Am J Obstet Gyneco l. 1976;126:869-879.
Fewer than 1 in 100 women become pregnant each year while using ParaGard
.
®
2. Sivin I. Dose- and age-dependent ectopic pregnancy risks with intrauterine contraception. Obstet
Gyneco l. 1991;78:291-298.
The table below shows the chance of getting pregnant using different types of birth control. The
3. Franks AL, Beral V, Cates W Jr, Hogue CJR. Contraception and ectopic pregnancy risk. Am J
numbers show typical use, which includes people who don’t always use birth control correctly.
Obstet Gyneco l. 1990;163:1120-1123.
4. Grimes DA, Schulz KF. Prophylactic antibiotics for intrauterine device insertion: a meta-analysis
Number of women out of 100 women who are likely to get pregnant over one year
of the randomized controlled trials. Contraception. 1999;60:57-63.
5. Lippes J. Pelvic actinomycosis: a review and preliminary look at prevalence. Am J Obstet Gyneco
Method of Birth Control
Pregnancies per 100 women over
l. 1999;180:265-269.
one year
6. Petitti DB, Yamamoto D, Morgenstern N. Factors associated with actinomyces-like organisms
No Method
85
on Papanicolaou smear in users of intrauterine contraceptive devices. Am J Obstet Gyneco l.
1983;145:338-341.
Spermicides
26
7. Grimes D, Schulz K, van Vliet H, Stanwood N. Immediate post-partum insertion of intrauterine
devices: a Cochrane review. Hum Reprod. 2002;17:549-554.
Periodic abstinence
25
8. Cole LP, Edelman DA, Potts DM, Wheeler RG, Laufe LE. Postpartum insertion of modified
intrauterine devices. J Reprod Med. 1984;29:677-682.
Cap with Spermicides
20
9. Grimes DA, Schulz KF, Stanwood N. Immediate post-abortal insertion of intrauterine devices.
Vaginal Sponge
20 to 40
(Cochrane Review). In: The Cochrane Library , Issue 2, 2003. Oxford: Update Software.
10. Hess T, Stepanow B, Knopp MV. Magnetic resonance imaging: safety of intrauterine contraceptive
Diaphragm with Spermicides
20
devices during MR imaging. Eur Radiol. 1996;6:66-68.
11. Mark AS, Hricak H. Intrauterine devices. MR imaging. Radiology. 1987;162:311-314.
Withdrawal
19
12. Heick A., Espersen T., Pedersen HL, Raahauge J: Is diathermy safe in women with copper-
Condom without spermicides (female)
21
bearing IUDs? Acta Obstet Gynecol Scand. 1991;70(2):153-5.
13. Rodrigues da Cunha AC, Dorea JG, Cantuaria AA. Intrauterine device and maternal copper
Condom without spermicides (male)
14
metabolism during lactation. Contraception 2001;63:37-9.
Oral Contraceptives
5
IUDs, Depo-Provera, implants, sterilization
less than 1
Who might use ParaGard
?
®
You might choose ParaGard
if you
®
• need birth control that is very effective
• need birth control that stops working when you stop using it
• need birth control that is easy to use
Who should not use ParaGard
?
®
You should not use ParaGard
®
if you
• Might be pregnant
• Have a uterus that is abnormally shaped inside
• Have a pelvic infection called pelvic inflammatory disease (PID) or have current behavior that
puts you at high risk of PID (for example, because you are having sex with several men, or your
partner is having sex with other women)
4
• Have had an infection in your uterus after a pregnancy or abortion in the past 3 months
have been pregnant before. If you think that ParaGard
has partly or completely fallen out, use an
®
• Have cancer of the uterus or cervix
additional birth control method, such as a condom and call your healthcare provider.
• Have unexplained bleeding from your vagina
You may have other side effects with ParaGard
®
. For example, you may have anemia (low blood
• Have an infection in your cervix
count), backache, pain during sex, menstrual cramps, allergic reaction, vaginal infection, vaginal
• Have Wilson’s disease (a disorder in how the body handles copper)
discharge, faintness, or pain. This is not a complete list of possible side effects. If you have
• Are allergic to anything in ParaGard
®
questions about a side effect, check with your healthcare provider.
• Already have an intrauterine contraceptive in your uterus
When should I call my healthcare provider?
How is ParaGard
placed in the uterus?
®
Call your healthcare provider if you have any concerns about ParaGard
. Be sure to call if you
®
ParaGard
®
is placed in your uterus during an office
• Think you are pregnant
visit. Your healthcare provider first examines you
• Have pelvic pain or pain during sex
to find the position of your uterus. Next, he or she
• Have unusual vaginal discharge or genital sores
will cleanse your vagina and cervix, measure your
• Have unexplained fever
uterus, and then slide a plastic tube containing
• Might be exposed to sexually transmitted diseases (STDs)
ParaGard
into your uterus. The tube is removed,
®
• Cannot feel ParaGard
®
threads or can feel the threads are much longer
leaving ParaGard
inside your uterus. Two white
®
• Can feel any other part of the ParaGard
besides the threads
®
threads extend into your vagina. The threads are
• Become HIV positive or your partner becomes HIV positive
trimmed so they are just long enough for you to
• Have severe or prolonged vaginal bleeding
feel with your fingers when doing a self-check.
• Miss a menstrual period
As ParaGard
goes in, you may feel cramping or
®
pinching. Some women feel faint, nauseated, or
General advice about prescription medicines
dizzy for a few minutes afterwards. Your healthcare
This brochure summarizes the most important information about ParaGard
®
. If you would like
provider may ask you to lie down for a while and to
more information, talk with your healthcare provider. You can ask your healthcare provider for
get up slowly.
information about ParaGard
®
that is written for healthcare professionals.
How do I check that ParaGard
is in my uterus ?
®
Checklist
Visit your healthcare provider for a check-up
This checklist will help you and your healthcare provider discuss the pros and cons of ParaGard
®
about one month after placement to make sure
for you. Do you have any of the following conditions?
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
Yes
No
Don’t know
feel the two threads. Do not pull on the threads.
Abnormal Pap smear
If you cannot feel the threads, ask your
healthcare provider to check if ParaGard
®
Abnormalities of the uterus
is in the right place. If you can feel more of
Allergy to copper
ParaGard
than just the threads, ParaGard
®
®
is not in the right place. If you can’t see
Anemia or blood clotting problems
your healthcare provider right away, use an
Bleeding between periods
additional birth control method. If ParaGard
®
is in the wrong place, your chances of getting
Cancer of the uterus or cervix
pregnant are increased. It is a good habit for
Fainting attacks
you to check that ParaGard
is in place once a
®
month.
Genital sores
Heavy menstrual flow
You may use tampons when you are using ParaGard
®
.
HIV or AIDS
What if I become pregnant while using ParaGard
?
®
Infection of the uterus or cervix
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
®
IUD in place now or in the past
premature labor and delivery, or even die. Because of these risks, your healthcare provider will
More than one sexual partner
recommend that you have ParaGard
removed, even though removal may cause miscarriage.
®
Pelvic infection (PID)
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-
Possible pregnancy
like symptoms, or an unusual, bad smelling vaginal discharge.
Repeated episodes of pelvic infection (PID)
A pregnancy with ParaGard
in place has a greater than usual chance of being ectopic (outside
®
Serious infection following a pregnancy or
your uterus). Ectopic pregnancy is an emergency that may require surgery. An ectopic pregnancy
abortion in the past 3 months
can cause internal bleeding, infertility, and death. Unusual vaginal bleeding or abdominal pain may
be signs of an ectopic pregnancy.
Severe menstrual cramps
Copper in ParaGard
does not seem to cause birth defects.
®
Sexual partner who has more than one sexual
partner
What side effects can I expect with ParaGard
?
®
Sexually transmitted disease (STD) such as
The most common side effects of ParaGard
®
are heavier, longer periods and spotting between
gonorrhea or chlamydia
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,
Wilson’s disease
serious side effects may occur:
• Pelvic inflammatory disease (PID): Uncommonly, ParaGard
and other IUDs are associated with
®
PID. PID is an infection of the uterus, tubes, and nearby organs. PID is most likely to occur in
the first 20 days after placement. You have a higher chance of getting PID if you or your partner
have sex with more than one person. PID is treated with antibiotics. However, PID can cause
serious problems such as infertility, ectopic pregnancy, and chronic pelvic pain. Rarely, PID
may even cause death. More serious cases of PID require surgery or a hysterectomy (removal
of the uterus). Contact your healthcare provider right away if you have any of the signs of PID:
abdominal or pelvic pain, painful sex, unusual or bad smelling vaginal discharge, chills, heavy
bleeding, or fever.
Cooper Surgical, Inc.
• Difficult removals: Occasionally ParaGard
®
may be hard to remove because it is stuck in the
95 Corporate Drive
uterus. Surgery may sometimes be needed to remove ParaGard
.
®
Trumbull, CT 06611
• Perforation: Rarely, ParaGard
®
goes through the wall of the uterus, especially during placement.
USA
This is called perforation. If ParaGard
perforates the uterus, it should be removed. Surgery may
®
Rev. 01/2018
be needed. Perforation can cause infection, scarring, or damage to other organs. If ParaGard
®
perforates the uterus, you are not protected from pregnancy.
Based on labeling:
• Expulsion: ParaGard
may partially or completely fall out of the uterus. This is called expulsion.
®
P/N 1017006
Women who have never been pregnant may be more likely to expel ParaGard
®
than women who
PAR-41312
5