Paragard
Encyclopedia
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. (a hormonal uterine device, the Mirena
, is 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 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 directly after childbirth
.
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.
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
. There is anecdotal evidence that although the first few periods after insertion may be heavier and more uncomfortable than usual, this appears to abate in most users.
The ParaGard T 380A was developed in the 1970s 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.
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 )
United States
The United States of America is a federal constitutional republic comprising fifty states and a federal district...
by Duramed Pharmaceuticals
Barr Pharmaceuticals
Barr Pharmaceuticals was a global specialty pharmaceutical company that operated in more than 30 countries worldwide. Barr were engaged in the development, manufacture and marketing of generic and proprietary pharmaceuticals, biopharmaceuticals and active pharmaceutical ingredients.-History:Barr...
. It is the only copper-containing intrauterine device approved for use in the U.S. (a hormonal uterine device, the Mirena
IntraUterine System
The IUD with progestogen, intrauterine system , or IntraUterine Contraceptive is a long-acting reversible hormonal contraceptive device that is placed in the uterus. An IUS has a hormone cylinder that releases a progestin called levonorgestrel...
, is also approved). The ParaGard consists of a T-shaped polyethylene
Polyethylene
Polyethylene or polythene is the most widely used plastic, with an annual production of approximately 80 million metric tons...
frame wound with copper wire, along with two monofilament
Monofilament line
Monofilament fishing line is fishing line made from a single fiber of plastic. Most fishing lines are now monofilament because monofilament fibers are cheap to produce and are produced in a range of diameters which have different tensile strengths...
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 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
Emergency contraception
Emergency contraception , or emergency postcoital contraception, refers to birth control measures that, if taken after sexual intercourse, may prevent pregnancy.Forms of EC include:...
if inserted within three to five days after unprotected intercourse
Sexual intercourse
Sexual intercourse, also known as copulation or coitus, commonly refers to the act in which a male's penis enters a female's vagina for the purposes of sexual pleasure or reproduction. The entities may be of opposite sexes, or they may be hermaphroditic, as is the case with snails...
, and it can be inserted directly after childbirth
Childbirth
Childbirth is the culmination of a human pregnancy or gestation period with the birth of one or more newborn infants from a woman's uterus...
.
Like all (non-hormonal) IUDs, the ParaGard prompts the release of leukocytes and prostaglandins by the endometrium
Endometrium
-Function:The endometrium is the innermost glandular layer and functions as a lining for the uterus, preventing adhesions between the opposed walls of the myometrium, thereby maintaining the patency of the uterine cavity. During the menstrual cycle or estrous cycle, the endometrium grows to a...
. These substances are hostile to both sperm and eggs; the presence of copper increases this spermicidal
Spermicide
Spermicide is a contraceptive substance that eradicates sperm, inserted vaginally prior to intercourse to prevent pregnancy. As a contraceptive, spermicide may be used alone. However, the pregnancy rate experienced by couples using only spermicide is higher than that of couples using other methods...
effect. Although the only experimentally demonstrated effect is spermicidal/ovicidal, it is possible the IUD may rarely prevent the development of embryos.
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
Pelvic inflammatory disease
Pelvic inflammatory disease is a generic term for inflammation of the uterus, fallopian tubes, and/or ovaries as it progresses to scar formation with adhesions to nearby tissues and organs. This may lead to infections. PID is a vague term and can refer to viral, fungal, parasitic, though most...
. There is anecdotal evidence that although the first few periods after insertion may be heavier and more uncomfortable than usual, this appears to abate in most users.
The ParaGard T 380A was developed in the 1970s by the Population Council
Population Council
The Population Council is an international, nonprofit, non-governmental organization. The Council conducts biomedical, social science, and public health research and helps build research capacities in developing countries. One-third of its research relates to HIV and AIDS; its other major program...
and Finishing Enterprises Inc. (FEI). The Population Council's ParaGard new drug application
New drug application
The New Drug Application is the vehicle in the United States through which drug sponsors formally propose that the Food and Drug Administration approve a new pharmaceutical for sale and marketing...
(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
Ortho-McNeil Pharmaceutical
The company was formed from the merger of Ortho Pharmaceutical and McNeil Pharmaceutical in 1993. Both of these pharmaceutical companies are pioneers and leaders in areas such as pain management, acid reflux disease, and infectious diseases...
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
Barr Pharmaceuticals
Barr Pharmaceuticals was a global specialty pharmaceutical company that operated in more than 30 countries worldwide. Barr were engaged in the development, manufacture and marketing of generic and proprietary pharmaceuticals, biopharmaceuticals and active pharmaceutical ingredients.-History:Barr...
, 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. (ATC
Anatomical Therapeutic Chemical Classification System
The Anatomical Therapeutic Chemical Classification System is used for the classification of drugs. It is controlled by the WHO Collaborating Centre for Drug Statistics Methodology , and was first published in 1976....
code )