Paragard
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The ParaGard T-380A is a copper-T IUD 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. (a hormonal uterine device, the Mirena, 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 under local anesthesia in a gynecologist's office. The ParaGard is currently approved for 10 years use, however the newest data shows 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 directly after childbirth or abortion.
Like all (non-hormonal) IUDs, the ParaGard prompts the release of leukocytes and prostaglandins by the endometrium. These substances are hostile to both sperm and eggs; the presence of copper increases this spermicidal effect. Although the only experimentally demonstrated effect is spermicidal/ovicidal, it is possible the IUD may rarely prevent the development of embryos.[1][2]
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 PID.
The ParaGard T 380A was developed in the 1970s by the Population Council and Finishing Enterprises Inc. (FEI). The Population Council's ParaGard NDA was approved by the FDA and FEI began manufacturing it for distribution outside the United States in 1984. GynoPharma (original name 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, Durmaed Pharmaceuticals, a subsidiary of Barr Pharmaceuticals, acquired FEI Women's Health and ParaGard.
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.
[edit] External links
- ParaGard T 380A Intrauterine Copper Contraceptive]
- ParaGard T 380A Patient Package Insert
- FEI Women's Health ParaGard T 380A Timeline
[edit] References
- ^ Mechanisms of the Contraceptive Action of Hormonal Methods and Intrauterine Devices (IUDs). Family Health International (2006). Retrieved on 2006-07-05.
- ^ Keller, Sarah (Winter 1996, Vol. 16, No. 2). IUDs Block Fertilization. Network. Family Health International. Retrieved on 2006-07-05.
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