ParaGard

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 intrauterine contraception for up to 10 years. The pregnancy rate in clinical studies has been less than 1 pregnancy per 100 women each year.

Table 1: Percentage of women experiencing an unintended pregnancy during the first year of typical use and first year of perfect use of contraception and the percentage continuing use at the end of the first year: United States

Footnotes to Table 1 Source: Trussel J, Contraceptive efficacy. In Hatcher RA, Trussel J, Stewart F, Cates W, Stewart GK, Kowal D, Guest F, Contraceptive Technology: Seventeenth Revised Edition. New York NY: Irvington Publishers, 1998.
	% of Women Experiencing an Accidental Pregnancy within the First Year of Use		% of Women Continuing Use at One Year3
Method (1)	Typical Use1 (2)	Perfect Use2 (3)	(4)
Chance4	85	85
Spermicides5	26	6	40
Periodic Abstinence Calendar Ovulation Method Sympto-thermal6 Post-ovulation	25	9 3 2 1	63
Cap7 Parous women Nulliparous women	40 20	26 9	42 56
Sponge Parous women Nulliparous women	40 20	20 9	42 56
Diaphragm7	20	6	56
Withdrawal	19	4
Condom8 Female (Reality) Male	21 14	5 3	56 61
Pill Progestin only Combined	5	0.5 0.1	71
IUD Progesterone T Copper T 380A LNg 20	2.0 0.8 0.1	1.5 0.6 0.1	81 78 81
Depo Provera	0.3	0.3	70
Norplant and Norplant-2	0.05	0.05	88
Female sterilization	0.5	0.5	100
Male sterilization	0.15	0.10	100
Emergency Contraceptive Pills: Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%.9
Lactational Amenorrhea Method: LAM is a highly effective temporary method of contraception.10

1. Among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. 2. Among couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly), the percentage who experience an accidental 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 for one year. 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 become pregnant. Among such populations, about 89% become pregnant within one year. This estimate was lowered slightly (to 85%) to represent the percentage who would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether. 5. Foams, creams, gels, vaginal suppositories, and vaginal film. 6. Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases. 7. With spermicidal cream or jelly. 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 is 2 white pills), Alesse (1 dose is 5 pink pills), Nordette or Levlen (1 dose is 4 light-orange pills), Lo/Ovral (1 dose is 4 white pills), Triphasil or Tri-Levlen (1 dose is 4 yellow pills). 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.

ParaGard® should not be placed when one or more of the following conditions exist:

1. Pregnancy or suspicion of pregnancy 2. Abnormalities of the uterus resulting in distortion of the uterine cavity 3. Acute pelvic inflammatory disease, or current behavior suggesting a high risk for pelvic inflammatory disease 4. Postpartum endometritis or postabortal endometritis in the past 3 months 5. Known or suspected uterine or cervical malignancy 6. Genital bleeding of unknown etiology 7. Mucopurulent cervicitis 8. Wilson’s disease 9. Allergy to any component of ParaGard® 10. A previously placed IUD that has not been removed

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.

Continuing Care:

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:

• Abdominal or pelvic pain, cramping, or tenderness; malodorous discharge; bleeding; fever • A missed period

(See WARNINGS, Pelvic Infection, Intrauterine Pregnancy and Ectopic Pregnancy.)

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.

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