Intrauterine device (IUD) with copper, also known as intrauterine coil or copper coil, is a type of

intrauterine device An intrauterine device (IUD), also known as intrauterine contraceptive device (IUCD or ICD) or coil, is a small, often T-shaped birth control device that is inserted into the uterus to prevent pregnancy. IUDs are one form of long-acting revers ...

which contains

copper Copper is a chemical element with the symbol Cu (from la, cuprum) and atomic number 29. It is a soft, malleable, and ductile metal with very high thermal and electrical conductivity. A freshly exposed surface of pure copper has a pink ...

. It is used for

birth control Birth control, also known as contraception, anticonception, and fertility control, is the use of methods or devices to prevent unwanted pregnancy. Birth control has been used since ancient times, but effective and safe methods of birth contr ...

and

emergency contraception Emergency contraception (EC) is a birth control measure, used after sexual intercourse to prevent pregnancy. There are different forms of EC. Emergency contraceptive pills (ECPs), sometimes simply referred to as emergency contraceptives (ECs), o ...

within five days of

unprotected sex Safe sex is sexual activity using methods or contraceptive devices (such as condoms) to reduce the risk of transmitting or acquiring sexually transmitted infections (STIs), especially HIV. "Safe sex" is also sometimes referred to as safer ...

. It is one of the most effective forms of birth control with a one-year failure rate around 0.7%. The device is placed in the

uterus The uterus (from Latin ''uterus'', plural ''uteri'') or womb () is the organ in the reproductive system of most female mammals, including humans that accommodates the embryonic and fetal development of one or more embryos until birth. The ...

and lasts up to twelve years. It may be used by women of all ages regardless of whether or not they have had children. Following removal,

fertility Fertility is the capability to produce offspring through reproduction following the onset of sexual maturity. The fertility rate is the average number of children born by a female during her lifetime and is quantified demographically. Ferti ...

quickly returns. Side effects may be

heavy menstrual periods Heavy menstrual bleeding (HMB), previously known as menorrhagia or hypermenorrhea, is a menstrual period with excessively heavy flow. It is a type of abnormal uterine bleeding (AUB). Abnormal uterine bleeding can be caused by structural abnorm ...

, and/or rarely the device may come out. It is less recommended for people at high risk of

sexually transmitted infections Sexually transmitted infections (STIs), also referred to as sexually transmitted diseases (STDs) and the older term venereal diseases, are infections that are spread by sexual activity, especially vaginal intercourse, anal sex, and oral ...

as it may increase the risk of

pelvic inflammatory disease Pelvic inflammatory disease, also known as pelvic inflammatory disorder (PID), is an infection of the upper part of the female reproductive system, namely the uterus, fallopian tubes, and ovaries, and inside of the pelvis. Often, there may be ...

in the first three weeks after insertion. It is recommended for people who don't tolerate or hardly tolerate hormonal contraceptives. If a woman becomes

pregnant Pregnancy is the time during which one or more offspring develops ( gestates) inside a woman's uterus (womb). A multiple pregnancy involves more than one offspring, such as with twins. Pregnancy usually occurs by sexual intercourse, but ca ...

with an IUD in place removal is recommended. Very rarely,

uterine perforation Uterine perforation is a potential complication of any intrauterine procedure. It may be associated with injury to surrounding blood vessels or viscera such as the bladder or intestine. If not diagnosed at the time of the procedure it can occasion ...

may occur during insertion if not done properly. The copper IUD is a type of

long-acting reversible birth control Long-acting reversible contraceptives (LARC) are methods of birth control that provide effective contraception for an extended period without requiring user action. They include injections, intrauterine devices (IUDs), and subdermal contraceptiv ...

. It primarily works by killing the sperm. The copper IUD came into medical use in the 1970s. It is on the

World Health Organization's List of Essential Medicines The WHO Model List of Essential Medicines (aka Essential Medicines List or EML), published by the World Health Organization (WHO), contains the medications considered to be most effective and safe to meet the most important needs in a health s ...

. They are used by more than 170 million women globally.

Medical uses

Copper IUDs are a form of

long-acting reversible contraception Long-acting reversible contraceptives (LARC) are methods of birth control that provide effective contraception for an extended period without requiring user action. They include injections, intrauterine devices (IUDs), and subdermal contraceptiv ...

and are one of the most effective forms of birth control available. The type of frame and amount of copper can affect the effectiveness of different copper IUD models. The failure rates for different models vary between 0.1 and 2.2% after 1 year of use. The T-shaped models with a surface area of 380 mm² of copper have the lowest failure rates. The TCu 380A (ParaGard) has a one-year failure rate of 0.8% and a cumulative 12-year failure rate of 2.2%. Over 12 years of use, the models with less surface area of copper have higher failure rates. The TCu 220A has a 12-year failure rate of 5.8%. The frameless GyneFix has a failure rate of less than 1% per year. Worldwide, older IUD models with lower effectiveness rates are no longer produced. Unlike other forms of reversible contraception, the typical use failure rate and the perfect use failure rate for the copper IUDs are the same because the IUD does not depend on user action. A 2008 review of the available T-shaped copper IUDs recommended that the TCu 380A and the TCu 280S be used as the first choice for copper IUDs because those two models have the lowest failure rates and the longest lifespans. The effectiveness of the copper IUD (failure rate of 0.8%) is comparable to tubal sterilization (failure rate of 0.5%) for the first year. However, the effects of the copper IUD are reversible, which can be viewed as either an advantage or a disadvantage, depending on a person's goals for contraception.

Emergency contraception

It was first discovered in 1976 that the copper IUD could be used as a form of

(EC). The copper IUD is the most effective form of emergency contraception. It is more effective than the hormonal EC pills currently available. The pregnancy rate among those using the copper IUD for EC is 0.09%. It can be used for EC up to five days after the act of unprotected sex and does not decrease in effectiveness during the five days. An additional advantage of using the copper IUD for emergency contraception is that it can be used as a form of birth control for 10–12 years after insertion.

Removal and return to fertility

Removal of the copper IUD should also be performed by a qualified medical practitioner. Fertility has been shown to return to previous levels quickly after removal of the device. One study found that the median amount of time from removal to planned pregnancy was three months for those women using the TCu 380Ag.

Side effects

Expulsion: Sometimes, the copper IUD can be spontaneously expelled from the uterus. Expulsion rates can range from 2.2% to 11.4% of users from the first year to the 10th year. The TCu380A may have lower rates of expulsion than other models. Unusual vaginal discharge, cramping or pain, spotting between periods, postcoital (after sex) spotting, dyspareunia, or the absence or lengthening of the strings can be signs of a possible expulsion. If expulsion occurs, the woman is not protected against pregnancy. If an IUD with copper is inserted after an expulsion has occurred, the risk of re-expulsion has been estimated in one study to be approximately one third of cases after one year.

Magnetic resonance imaging Magnetic resonance imaging (MRI) is a medical imaging technique used in radiology to form pictures of the anatomy and the physiological processes of the body. MRI scanners use strong magnetic fields, magnetic field gradients, and radio wave ...

(MRI) may cause dislocation of a copper IUD, and it is therefore recommended to check the location of the IUD both before and after MRI. Perforated IUD

Perforation: Very rarely, the IUD can move through the wall of the uterus. Risk of perforation is mostly determined by the skill of the practitioner performing the insertion. For experienced medical practitioners, the risk of perforation is 1 per 1,000 insertions or less. It is recommended to consult an obstetrician/gynecologist, who has the equipment to properly insert the IUD and check that it does not move during the months following insertion. Infection: The insertion of a copper IUD poses a transient risk of

(PID) in the first 21 days after insertion. However, it is a small risk and is attributable to preexisting

gonorrhea Gonorrhea, colloquially known as the clap, is a sexually transmitted infection (STI) caused by the bacterium ''Neisseria gonorrhoeae''. Infection may involve the genitals, mouth, or rectum. Infected men may experience pain or burning with u ...

chlamydia infection Chlamydia, or more specifically a chlamydia infection, is a sexually transmitted infection caused by the bacterium ''Chlamydia trachomatis''. Most people who are infected have no symptoms. When symptoms do appear they may occur only several we ...

at the time of insertion, and not to the IUD itself. By the United States Agency for International Development (USAID). Retrieved on Feb 14, 2010 Proper

infection prevention Infection prevention and control is the discipline concerned with preventing healthcare-associated infections; a practical rather than academic sub-discipline of epidemiology. In Northern Europe, infection prevention and control is expanded from ...

procedures have little or no effect on the course of gonorrhea or chlamydia infections but are important in helping protect both clients and providers from infection in general. Such infection prevention practices include washing hands and then putting on gloves, cleaning the cervix and vagina, making minimal contact with non-sterile surfaces (using a no-touch insertion technique), and, after the procedure, washing hands again and then processing instruments. The device itself carries no increased risk of PID beyond the time of insertion. Cramping: Some women can feel cramping during the IUD insertion process and immediately after as a result of cervix dilation during insertion. Taking NSAIDs before the procedure often reduces discomfort, as the use of a

local anaesthetic A local anesthetic (LA) is a medication that causes absence of pain sensation. In the context of surgery, a local anesthetic creates an absence of pain in a specific location of the body without a loss of consciousness, as opposed to a general a ...

Misoprostol Misoprostol is a synthetic prostaglandin medication used to prevent and treat stomach and duodenal ulcers, induce labor, cause an abortion, and treat postpartum bleeding due to poor contraction of the uterus. Misoprostol is taken by mouth w ...

6 to 12 hrs before insertion can help with cervical dilation. Some women may have cramps for 1 to 2 weeks following insertion. Heavier periods: The copper IUD may increase the amount of blood flow during a woman's

menstrual periods The menstrual cycle is a series of natural changes in hormone production and the structures of the uterus and ovaries of the female reproductive system that make pregnancy possible. The ovarian cycle controls the production and release of eggs a ...

. On average, menstrual

blood loss Bleeding, hemorrhage, haemorrhage or blood loss, is blood escaping from the circulatory system from damaged blood vessels. Bleeding can occur internally, or externally either through a natural opening such as the mouth, nose, ear, urethra, ...

may increase by 20–50% after insertion of a copper-T IUD; This symptom may clear up for some women after 3 to 6 months. Irregular bleeding and spotting: For some women, the copper IUD may cause spotting between periods during the first 3 to 6 months after insertion. Ultrasonography of IUD with copper

Pregnancy: Although rare, if pregnancy does occur with the copper IUD in place there can be side effects. The risk of

ectopic pregnancy Ectopic pregnancy is a complication of pregnancy in which the embryo attaches outside the uterus. Signs and symptoms classically include abdominal pain and vaginal bleeding, but fewer than 50 percent of affected women have both of these symptom ...

to a woman using an IUD is lower than the risk of ectopic pregnancy to a woman using no form of birth control. However, of pregnancies that do occur during IUD use, a higher than expected percentage (3–4%) are ectopic. If pregnancy occurs with the IUD in place there is a higher risk of

miscarriage Miscarriage, also known in medical terms as a spontaneous abortion and pregnancy loss, is the death of an embryo or fetus before it is able to survive independently. Miscarriage before 6 weeks of gestation is defined by ESHRE as biochemica ...

or early delivery. If this occurs and the IUD strings are visible, the IUD should be removed immediately by a clinician. Although the Dalkon Shield IUD was associated with septic abortions (infections associated with miscarriage), other brands of IUD are not. IUDs are also not associated with

birth defects A birth defect, also known as a congenital disorder, is an abnormal condition that is present at birth regardless of its cause. Birth defects may result in disabilities that may be physical, intellectual, or developmental. The disabilities can ...

. Some barrier contraceptives protect against STIs.

Hormonal contraceptives Hormonal contraception refers to birth control methods that act on the endocrine system. Almost all methods are composed of steroid hormones, although in India one selective estrogen receptor modulator is marketed as a contraceptive. The origina ...

reduce the risk of developing

(PID), a serious complication of certain STIs. IUDs, by contrast, do ''not'' protect against STIs or PID.
Copper Toxicity: There exists anecdotal evidence linking copper IUDs to cases of

copper toxicity Copper toxicity (or Copperiedus) is a type of metal poisoning caused by an excess of copper in the body. Copperiedus could occur from consuming excess copper salts, but most commonly it is the result of the genetic condition Wilson's disease and ...

Contraindications

A category 3 condition indicates conditions where the theoretical or proven risks usually outweigh the advantages of inserting a copper IUD. A category 4 condition indicates conditions that represent an unacceptable health risk if a copper IUD is inserted. Women should not use a copper IUD if they: (Category 4) *Are pregnant or think they may be pregnant *Have certain uterine abnormalities *Have

malignant Malignancy () is the tendency of a medical condition to become progressively worse. Malignancy is most familiar as a characterization of cancer. A ''malignant'' tumor contrasts with a non-cancerous ''benign'' tumor in that a malignancy is not s ...

gestational trophoblastic disease *Have or may have an STI *Have or may have had a pelvic infection within the past three months *Have pelvic tuberculosis *Have unexplained abnormal vaginal bleeding *Have untreated cervical cancer *Have uterine cancer *Having a septic pregnancy or abortion (Category 3) *Are

postpartum The postpartum (or postnatal) period begins after childbirth and is typically considered to end within 6 weeks as the mother's body, including hormone levels and uterus size, returns to a non-pregnant state. The terms puerperium, puerperal pe ...

between 48 hours and 4 weeks (increased IUD expulsion rate with delayed postpartum insertion). The CDC and WHO criteria differ in their recommendation for women postpartum between 48 hours and 4 weeks. The CDC does not list this as a contraindication. *Have

AIDS Human immunodeficiency virus infection and acquired immunodeficiency syndrome (HIV/AIDS) is a spectrum of conditions caused by infection with the human immunodeficiency virus (HIV), a retrovirus. Following initial infection an individual ma ...

(unless clinically well on

anti-retroviral therapy The management of HIV/AIDS normally includes the use of multiple antiretroviral drugs as a strategy to control HIV infection. There are several classes of antiretroviral agents that act on different stages of the HIV life-cycle. The use of multiple ...

) *Have

benign Malignancy () is the tendency of a medical condition to become progressively worse. Malignancy is most familiar as a characterization of cancer. A ''malignant'' tumor contrasts with a non-cancerous ''benign'' tumor in that a malignancy is not s ...

gestational trophoblastic disease *Have

ovarian cancer Ovarian cancer is a cancerous tumor of an ovary. It may originate from the ovary itself or more commonly from communicating nearby structures such as fallopian tubes or the inner lining of the abdomen. The ovary is made up of three different ...

*Have very high individual likelihood of exposure to

or chlamydial STIs A full list of contraindications can be found in the

World Health Organization The World Health Organization (WHO) is a specialized agency of the United Nations responsible for international public health. The WHO Constitution states its main objective as "the attainment by all peoples of the highest possible level o ...

(WHO) ''Medical Eligibility Criteria for Contraceptive Use'' and the

Centers for Disease Control and Prevention The Centers for Disease Control and Prevention (CDC) is the national public health agency of the United States. It is a United States federal agency, under the Department of Health and Human Services, and is headquartered in Atlanta, Georg ...

(CDC) ''United States Medical Eligibility Criteria for Contraceptive Use''. Being a

nulliparous In biology and human medicine, gravidity and parity are the number of times a woman is or has been pregnant (gravidity) and carried the pregnancies to a viable gestational age (parity). These terms are usually coupled, sometimes with additional te ...

women (women who have never given birth) is not a contraindication for IUD use. IUDs are safe and acceptable even in young nulliparous women. The same is likely the case for

virgin Virginity is the state of a person who has never engaged in sexual intercourse. The term ''virgin'' originally only referred to sexually inexperienced women, but has evolved to encompass a range of definitions, as found in traditional, modern ...

women, unless there is a microperforate hymen that obstructs any insertion of the IUD.

Device description

There are a number of models of copper IUDs available around the world. Most copper devices consist of a plastic core that is wrapped in a copper wire. Many of the devices have a T-shape similar to the

hormonal IUD A hormonal intrauterine device (IUD), also known as a intrauterine system (IUS) with progestogen and sold under the brand name Mirena among others, is an intrauterine device that releases a progestogenic hormonal agent such as levonorgestrel int ...

. However, there are "frameless" copper IUDs available as well.ParaGard is the only model currently available in the United States. At least three copper IUD models are available in Canada, two of which are slimmer T-shape versions used for women who have not had children. Early copper IUDs had copper around only the vertical stem, but more recent models have copper sleeves wrapped around the horizontal arms as well, increasing effectiveness. Some newer models also contain a silver core instead of a plastic core to delay copper fragmentation as well as increase the lifespan of the device. The lifespan of the devices range from 3 years to 10 years; however, some studies have demonstrated that the TCu 380A may be effective through 12 years. Its ATC code is .

Insertion

The copper IUD must be inserted by a qualified medical practitioner. It is recommended to consult an obstetrician/gynecologist, who has the equipment to properly insert the IUD and check that it does not move during the months following insertion. A copper IUD can be inserted at any phase of the menstrual cycle, but the optimal time is right after the menstrual period when the cervix is softest and the woman is least likely to be pregnant. The insertion process generally takes five minutes or less. The procedure can cause cramping or be painful for some women. Before placement of an IUD, a

medical history The medical history, case history, or anamnesis (from Greek: ἀνά, ''aná'', "open", and μνήσις, ''mnesis'', "memory") of a patient is information gained by a physician by asking specific questions, either to the patient or to other peo ...

and

physical examination In a physical examination, medical examination, or clinical examination, a medical practitioner examines a patient for any possible medical signs or symptoms of a medical condition. It generally consists of a series of questions about the pati ...

by a medical professional is useful to check for any contraindications or concerns. Author: Omnia M Samra. Last Editorial Review: 5/18/2006 It is also recommended by some clinicians that patients be tested for

and

chlamydia Chlamydia, or more specifically a chlamydia infection, is a sexually transmitted infection caused by the bacterium '' Chlamydia trachomatis''. Most people who are infected have no symptoms. When symptoms do appear they may occur only several we ...

, as these two infections increase the risk of contracting pelvic inflammatory disease shortly after insertion. Immediately prior to insertion, the clinician will perform a pelvic exam to determine the position of the uterus. p.150: After the pelvic exam, the vagina is held open with a speculum. A

tenaculum A tenaculum is a surgical instrument, usually classified as a type of forceps. It consists of a slender sharp-pointed hook attached to a handle and is used mainly in surgery for seizing and holding parts, such as blood vessels.Merriam-Webster Onl ...

is used to steady the cervix and uterus. Uterine sounding may be used to measure the length and direction of the cervical canal and uterus in order to decrease the risk of

. The IUD is placed using a narrow tube, which is inserted through the cervix into the uterus. Short monofilament plastic/nylon strings hang down from the uterus into the vagina. The clinician will trim the threads so that they only protrude 3 to 4 cm out of the cervix and remain in the upper vagina. The strings allow the patient or clinician to periodically check to ensure the IUD is still in place and to enable easy removal of the device. The copper IUD can be inserted at any time in a woman's menstrual cycle as long as the woman is not pregnant. An IUD can also be inserted immediately postpartum and post-abortion as long as no infection has occurred. Breastfeeding is not a contraindication for the use of the copper IUD. The IUD can be inserted in women with HIV or AIDS as it does not increase the risk of transmission. Although previously not recommended for nulliparous women (women who have not had children), the IUD is now recommended for most women who are past menarche (their first period), including adolescents. After the insertion is finished, normal activities such as sex, exercise, and swimming can be performed as soon as it feels comfortable. Strenuous physical activity does not affect the position of the IUD.

Types

Many different types of copper IUDs are currently manufactured worldwide, but availability varies by country. In the United States, only one type of copper IUD is approved for use, while in the United Kingdom, over ten varieties are available. One company,

Mona Lisa N.V. Mona may refer to: People *Mona (name), a female given name, nickname and surname * Mona (Angolan footballer) (born 1997) *Mona, ring name of American wrestler Nora Greenwald Museums * Museum of Nebraska Art, Kearney, Nebraska, US *Museum of Neo ...

, offers generic versions of many existing IUDs., a manufacturer of generic IUDs

Frameless IUDs

The frameless IUD eliminates the use of the frame that gives conventional IUDs their signature T-shape. This change in design was made to reduce discomfort and expulsion associated with prior IUDs; without a solid frame, the frameless IUD should mold to the shape of the uterus. It may reduce expulsion and discontinuation rates compared to framed copper IUDs. Gynefix is the only frameless IUD brand currently available. It consists of hollow copper tubes on a

polypropylene Polypropylene (PP), also known as polypropene, is a thermoplastic polymer used in a wide variety of applications. It is produced via chain-growth polymerization from the monomer propylene. Polypropylene belongs to the group of polyolefins a ...

thread. It is inserted through the

cervix The cervix or cervix uteri (Latin, 'neck of the uterus') is the lower part of the uterus (womb) in the human female reproductive system. The cervix is usually 2 to 3 cm long (~1 inch) and roughly cylindrical in shape, which changes during ...

with a special applicator that sutures the thread to the fundus (top) of the

; the thread is then cut with a tail hanging outside of the cervix, similar to frame IUDs. When this tail is pulled, the suture comes undone and the device can be removed. This requires more force than removing a T-shaped IUD and results in comparable discomfort during removal. Gynefix is not approved for use in the United States.

Mechanism of action

The copper IUD's primary mechanism of action is to prevent fertilization. p. S28: p. 246: p. 259: Copper acts as a spermicide within the uterus. The presence of copper increases the levels of copper ions,

prostaglandin The prostaglandins (PG) are a group of physiologically active lipid compounds called eicosanoids having diverse hormone-like effects in animals. Prostaglandins have been found in almost every tissue in humans and other animals. They are deriv ...

s, and

white blood cell White blood cells, also called leukocytes or leucocytes, are the cells of the immune system that are involved in protecting the body against both infectious disease and foreign invaders. All white blood cells are produced and derived from mult ...

s within the uterine and tubal fluids. Although not a primary mechanism of action, some experts in human reproduction believe there is sufficient evidence to suggest that IUDs with copper can disrupt implantation, p. 199: especially when used for

. p. 157: p. 121: Despite this, there has been no definitive evidence that IUD users have higher rates of embryonic loss than women not using contraception. Therefore, the copper IUD is considered to be a true contraceptive and not an abortifacient.

Usage

Globally, the IUD is the most widely used method of reversible birth control. The most recent data indicates that there are 169 million IUD users around the world. This includes both the nonhormonal and hormonal IUDs. IUDs are most popular in Asia, where the prevalence is almost 30%. In Africa and Europe, the prevalence is around 20%. As of 2009, levels of IUD use in the United States are estimated to be 5.5%. Data in the United States does not distinguish between hormonal and non-hormonal IUDs. In Europe, copper IUD prevalence ranges from under 5% in the United Kingdom to over 10% in Denmark in 2006.

History

According to popular legend, Arab traders inserted small stones into the uteruses of their camels to prevent pregnancy during long desert treks. The story was originally a tall tale to entertain delegates at a scientific conference on

family planning Family planning is the consideration of the number of children a person wishes to have, including the choice to have no children, and the age at which they wish to have them. Things that may play a role on family planning decisions include marita ...

; although it was later repeated as truth, it has no known historical basis. Precursors to IUDs were first marketed in 1902. Developed from stem

pessaries A pessary is a prosthetic device inserted into the vagina for structural and pharmaceutical purposes. It is most commonly used to treat Stress incontinence, stress urinary incontinence to stop urinary leakage and to treat pelvic organ prolapse to ...

(where the stem held the pessary in place over the cervix), the 'stem' on these devices actually extended into the uterus itself. Because they occupied both the vagina and the uterus, this type of stem pessary was also known as an ''intrauterine device''. The use of ''intrauterine'' devices was associated with high rates of infection; for this reason, they were condemned by the medical community. The first intrauterine device (contained entirely in the uterus) was described in a

German German(s) may refer to: * Germany (of or related to) **Germania (historical use) * Germans, citizens of Germany, people of German ancestry, or native speakers of the German language ** For citizens of Germany, see also German nationality law **Ge ...

publication in 1909, although the author appears to have never marketed his product. In 1929,

Ernst Gräfenberg Ernst Gräfenberg (26 September 1881 – 28 October 1957) was a German-born physician and scientist. He is known for developing the intra-uterine device (IUD), and for his studies of the role of the woman's urethra in orgasm. The G-spot is name ...

of Germany published a report on an IUD made of silk sutures. He had found a 3% pregnancy rate among 1,100 women using his ring. In 1930, Gräfenberg reported a lower pregnancy rate of 1.6% among 600 women using an improved ring wrapped in silver wire. Unbeknownst to Gräfenberg, the silver wire was contaminated with 26% copper.

Copper Copper is a chemical element with the symbol Cu (from la, cuprum) and atomic number 29. It is a soft, malleable, and ductile metal with very high thermal and electrical conductivity. A freshly exposed surface of pure copper has a pink ...

's role in increasing IUD efficacy would not be recognized until nearly 40 years later. In 1934, Japanese physician Tenrei Ota developed a variation of Gräfenberg's ring that contained a supportive structure in the center. The addition of this central disc lowered the IUD's expulsion rate. These devices still had high rates of infection, and their use and development were further stifled by World War II politics: contraception was forbidden in both Nazi Germany and Axis-allied Japan. The Allies did not learn of the work by Gräfenberg and Ota until well after the war ended. The first plastic IUD, the ''Margulies Coil'' or ''Margulies Spiral'', was introduced in 1958. This device was somewhat large, causing discomfort to a large proportion of women users, and had a hard plastic tail, causing discomfort to their male partners. The modern colloquialism "coil" is based on the coil-shaped design of early IUDs. The ''Lippes Loop'', a slightly smaller device with a monofilament tail, was introduced in 1962 and gained in popularity over the Margulies device. The

stainless steel Stainless steel is an alloy of iron that is resistant to rusting and corrosion. It contains at least 11% chromium and may contain elements such as carbon, other nonmetals and metals to obtain other desired properties. Stainless steel's r ...

single-ring IUD was developed in the 1970s and widely used in China because of low manufacturing costs. The Chinese government banned production of steel IUDs in 1993 due to high failure rates (up to 10% per year). Howard Tatum, in the US, conceived the plastic T-shaped IUD in 1968. Shortly thereafter Jaime Zipper, in Chile, introduced the idea of adding copper to the devices to improve their contraceptive effectiveness. It was found that copper-containing devices could be made in smaller sizes without compromising effectiveness, resulting in fewer

side effects In medicine, a side effect is an effect, whether therapeutic or adverse, that is secondary to the one intended; although the term is predominantly employed to describe adverse effects, it can also apply to beneficial, but unintended, consequenc ...

such as pain and bleeding. T-shaped devices had lower rates of expulsion due to their greater similarity to the shape of the uterus. The poorly designed Dalkon Shield plastic IUD (which had a multifilament tail) was manufactured by the A. H. Robins Company and sold by Robins in the United States for three and a half years from January 1971 through June 1974, before sales were suspended by Robins on June 28, 1974, at the request of the FDA because of safety concerns following reports of 110 septic spontaneous abortions in women with the Dalkon Shield in place, seven of whom had died. Robins stopped international sales of the Dalkon Shield in April 1975. Tatum developed many different models of the copper IUD. He created the TCu220 C, which had copper collars as opposed to a copper filament, which prevented metal loss and increased the lifespan of the device. Second-generation copper-T IUDs were also introduced in the 1970s. These devices had higher surface areas of copper, and for the first time consistently achieved effectiveness rates of greater than 99%. The last model Tatum developed was the TCu380A, the model that is most recommended today. In addition to T-shaped IUDs, there are also U-shaped IUDs (such as the Multiload) and 7-shaped Gravigard Copper 7 (with a mini version for nulliparous women introduced in the 1980s). More recently, a frameless IUD called Gynefix was introduced.

Brands

The ParaGard T-380A is an IUD with copper, manufactured and marketed in the

United States The United States of America (U.S.A. or USA), commonly known as the United States (U.S. or US) or America, is a country Continental United States, primarily located in North America. It consists of 50 U.S. state, states, a Washington, D.C., ...

The Cooper Companies The Cooper Companies, Inc., branded as CooperCompanies, is a global medical device company, publicly traded on the NYSE (NYSE:COO). With its headquarters in San Ramon, California, it has a workforce of more than 12,000 employees worldwide and ...

. It is the only copper-containing intrauterine device approved for use in the U.S. (three hormonal uterine devices,

Mirena A hormonal intrauterine device (IUD), also known as a intrauterine system (IUS) with progestogen and sold under the brand name Mirena among others, is an intrauterine device that releases a progestogenic hormonal agent such as levonorgestrel int ...

, Skyla and Liletta are also approved). The ParaGard consists of a T-shaped

polyethylene Polyethylene or polythene (abbreviated PE; IUPAC name polyethene or poly(methylene)) is the most commonly produced plastic. It is a polymer, primarily used for packaging ( plastic bags, plastic films, geomembranes and containers including b ...

frame wound with copper wire, along with two monofilament threads to aid in the removal of the IUD. The ParaGard T 380A was developed in the 1970s by the

Population Council The Population Council is an international, nonprofit, non-governmental organization. The Council conducts research in biomedicine, social science, and public health and helps build research capacities in developing countries. One-third of its res ...

and Finishing Enterprises Inc. (FEI). The Population Council's ParaGard new drug application (NDA) was approved by the

U.S. Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food ...

(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 Barr Pharmaceuticals was a global specialty and generic drug manufacturer with operations in 30 countries. Approximately 75% of the company's revenues were from the sale of generic drugs, including 18% of sales which were from the sale of oral co ...

, acquired FEI Women's Health and ParaGard. On July 18, 2008, it was announced that Teva Pharmaceutical Industries Ltd. would acquire Barr Pharmaceuticals. On November 1, 2017,

acquired Paragard from

Teva Pharmaceutical Industries Teva Pharmaceutical Industries Ltd. (also known as Teva Pharmaceuticals) is an Israeli multinational pharmaceutical company with headquarters in Tel Aviv, Israel. It specializes primarily in generic drugs, but other business interests include ...

for approximately $1.1 billion. 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 )

References

External links

Association of Reproductive Health Professionals' Clinical Proceedings: New Developments in Intrauterine Contraception
{{DEFAULTSORT:Intrauterine Device World Health Organization essential medicines Wikipedia medicine articles ready to translate