Paragard

ParaGard

Photo of a common IUD (ParaGard T 380A)
Background
Birth control type Intrauterine
First use 1984
Failure rates (first year)
Perfect use 0.6%[1]
Typical use 0.8%[1]
Usage
Duration effect 10 years
Reversibility yes
User reminders Check thread position after each period. Have removed shortly after menopause, if not before.
Advantages and disadvantages
STD protection No
Weight No effect
Benefits Unnecessary to take any daily action.
Emergency contraception if inserted within 5 days

The ParaGard T-380A is an IUD with copper, manufactured and marketed in the United States by Duramed Pharmaceuticals. It is the only copper-containing intrauterine device approved for use in the U.S. (two hormonal uterine devices, Mirena and Skyla, are also approved). The ParaGard consists of a T-shaped polyethylene frame wound with copper wire, along with two monofilament threads to aid in removal of the IUD. The ParaGard is typically inserted and removed in a gynecologist's office, occasionally with the use of local anesthesia. Most often, patients are advised to take a dose of ibuprofen approximately one hour prior to insertion in order to control pain. The ParaGard is currently approved for 10 years use, however the newest data show it actually remains effective for at least 12 years, and perhaps beyond, after which it should be removed and replaced if desired. The ParaGard can be used as a form of emergency contraception if inserted within three to five days after unprotected intercourse, and it can be inserted 8 weeks after childbirth.

Like all (non-hormonal) IUDs, the ParaGard prompts the release of leukocytes and prostaglandins by the endometrium. These immune mediators provide an environment not preferable to sperm and eggs; the presence of copper increases this spermicidal effect. An IUD causes cervical mucus to be thicker in consistency, thereby altering sperm migration. This is similar to the way oral contraceptive pills work. Uterotubal fluid and motility changes inhibit sperm migration.

The ParaGard's perfect and typical use effectiveness rate is 99.4%. First year expulsion rate is 5.7%, with expulsion rates dropping off sharply after the first year. There is a higher risk of expulsion for women who have never given birth. Side effects can include heavier or longer periods, worsening cramps and may include a slightly increased risk of pelvic inflammatory disease.

The ParaGard T 380A was developed in the 1970's by the Population Council and Finishing Enterprises Inc. (FEI). The Population Council's ParaGard new drug application (NDA) was approved by the U.S. Food and Drug Administration (FDA) and FEI began manufacturing it for distribution outside the United States in 1984. GynoPharma (originally GynoMed) began marketing it in the U.S. in May 1988. On August 2, 1995, Ortho-McNeil acquired GynoPharma and began marketing ParaGard in the U.S. On January 1, 2004, FEI Women's Health acquired the patent from the Population Council and U.S. marketing rights from Ortho-McNeil. On November 10, 2005, Duramed Pharmaceuticals, a subsidiary of Barr Pharmaceuticals, acquired FEI Women's Health and ParaGard. On July 18, 2008, it was announced that Teva Pharmaceutical Industries Ltd. would acquire Barr Pharmaceuticals.

The original FDA approval of ParaGard in 1984 was for 4 years continuous use, this was later extended to 6 years in 1989, then 8 years in 1991, then 10 years in 1994. (ATC code G02BA02)

References

  1. ↑ 1.0 1.1 Trussell, James (2011). "Contraceptive efficacy". In Hatcher, Robert A.; Trussell, James; Nelson, Anita L.; Cates, Willard Jr.; Kowal, Deborah; Policar, Michael S. (eds.). Contraceptive technology (20th revised ed.). New York: Ardent Media. pp. 779–863. ISBN 978-1-59708-004-0. ISSN 0091-9721. OCLC 781956734. Table 26–1 = Table 3–2 Percentage of women experiencing an unintended pregnancy during the first year of typical use and the first year of perfect use of contraception, and the percentage continuing use at the end of the first year. United States.

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