IUD with progestogen | |
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Background | |
Type | Intrauterine |
First use | 1990 (Mirena—currently available) 1976 (Progestasert—discontinued in 2001) |
Synonyms | intrauterine system (IUS), levonorgestrel intrauterine system |
Trade names | Mirena, Skyla, Liletta, others |
AHFS/Drugs.com | Professional Drug Facts |
Failure rates (first year) | |
Perfect use | 0.1–0.2% [1] |
Typical use | 0.1–0.2% [1] |
Usage | |
Duration effect | 3–8 years |
Reversibility | 2–6 months |
User reminders | Check thread position monthly |
Clinic review | One month after insertion, then annually |
Advantages and disadvantages | |
STI protection | No |
Periods | Menstrual irregularity, periods usually lighter or none at all |
Weight | Potential side effect |
Benefits | No need to remember to take daily action |
Risks | benign ovarian cysts, transient risk of PID, uterine perforation (rare) |
A hormonal intrauterine device (IUD), also known as an 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 into the uterus. [2] It is used for birth control, heavy menstrual periods, and to prevent excessive build of the lining of the uterus in those on estrogen replacement therapy. [2] It is one of the most effective forms of birth control with a one-year failure rate around 0.2%. [1] The device is placed in the uterus and lasts three to eight years. [3] [4] Fertility often returns quickly following removal. [2]
Side effects include irregular periods, benign ovarian cysts, pelvic pain, and depression. [2] Rarely uterine perforation may occur. [2] Use is not recommended during pregnancy but is safe with breastfeeding. [2] The IUD with progestogen is a type of long-acting reversible birth control. [5] It works by thickening the mucus at the opening of the cervix, stopping the buildup of the lining of the uterus, and occasionally preventing ovulation. [2]
The IUD with levonorgestrel was first approved for medical use in 1990 in Finland and in the United States in 2000. [6] It is on the World Health Organization's List of Essential Medicines. [7] [8]
Clinical data | |
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Pregnancy category |
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ATC code |
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Legal status | |
Legal status |
The hormonal IUD is an extremely effective method of birth control, and a 2021 study demonstrated that it may be used for emergency contraception. [15] In addition to birth control, the hormonal IUD is used for prevention and treatment of:
Advantages:
Disadvantages:
After insertion, Mirena is effective at preventing pregnancy for up to eight years. [29] Kyleena is approved for five years and Skyla is approved for three years. [30] [31]
The hormonal IUD is a long-acting reversible contraceptive, and is considered one of the most effective forms of birth control. The first year failure rate for the hormonal IUD is 0.1-0.2% and the five-year failure rate is 0.7-0.9%. [32] [29] [33] These rates are comparable to tubal sterilization, but unlike sterilization the effects of the hormonal IUD are reversible.
The hormonal IUD is considered to be more effective than other common forms of reversible contraception, such as the birth control pill, because it requires little action by the user after insertion. [23] The effectiveness of other forms of birth control is mitigated (decreased) by the users themselves. If medication regimens for contraception are not followed precisely, the method becomes less effective. IUDs require no daily, weekly, or monthly regimen, so their typical use failure rate is therefore the same as their perfect use failure rate. [23]
In a 10-year study, the levonorgestrel coil was found to be as effective as oral medicines (tranexamic acid, mefenamic acid, combined oestrogen–progestogen or progesterone alone) for heavy periods; the same proportion of women had not had surgery for heavy bleeding and had similar improvements in their quality of life. [34] [35]
In women with bicornuate uterus and in need of contraception, two IUDs are generally applied (one in each horn) due to lack of evidence of efficacy with only one IUD. [36] Evidence is lacking regarding progestogen IUD usage for menorrhagia in bicornuate uterus, but a case report showed good effect with a single IUD for this purpose. [37]
Progestogen-only contraceptives such as an IUD are not believed to affect milk supply or infant growth. [38] However, a study in the Mirena application for FDA approval found a lower continuation of breastfeeding at 75 days in hormonal IUD users (44%) versus copper IUD users (79%). [39] : 37
When using Mirena, about 0.1% of the maternal dose of levonorgestrel can be transferred via milk to the nursed infant. [40] A six-year study of breastfed infants whose mothers used a levonorgestrel-only method of birth control found the infants had increased risk of respiratory infections and eye infections, though a lower risk of neurological conditions, compared to infants whose mothers used a copper IUD. [41] No longer-term studies have been performed to assess the long-term effects on infants of levonorgestrel in breast milk.
There are conflicting recommendations about use of Mirena while breastfeeding. The U.S. CDC does not recommend any hormonal method as a first choice of contraceptive for nursing mothers, although progestin-only methods, such as Mirena, may be used with close follow-up or when the benefits outweigh the risks. [42] The World Health Organization recommends against immediate postpartum insertion, citing increased expulsion rates. It also reports concerns about potential effects on the infant's liver and brain development in the first six weeks postpartum. However, it recommends offering Mirena as a contraceptive option beginning at six weeks postpartum even to nursing women. [43] [44] Planned Parenthood offers Mirena as a contraceptive option for breastfeeding women beginning at four weeks postpartum. [45]
A hormonal IUD should not be used by people who:
Insertion of an IUD is acceptable after a dilation and evacuation (D&E) abortion (second-trimester abortion), but may be associated with a higher expulsion rate. [48] To reduce the risk of infection, insertion of an IUD is not recommended for women that have had a medical abortion but have not yet had an ultrasound to confirm that the abortion was complete, or that have not yet had their first menstruation following the medical abortion. [45]
A full list of contraindications can be found in the WHO Medical Eligibility Criteria for Contraceptive Use and the CDC United States Medical Eligibility Criteria for Contraceptive Use. [24] [49]
According to a 1999 evaluation of the studies performed on progestin-only birth control by the International Agency for Research on Cancer, there is some evidence that progestin-only birth control reduces the risk of endometrial cancer. The IARC in 1999 concluded that there is no evidence progestin-only birth control increases the risk of any cancer, though the available studies were too small to be definitively conclusive. [66]
Progesterone is a hormone in the endometrium that counteracts estrogen driven growth. [67] Very low levels of progesterone will cause estrogen to act more, leading to endometrial hyperplasia and adenocarcinoma. [67] These effects can be minimized if treated with progestin, but not in very many cases.
Estrogen and progesterone have an antagonistic relationship. Estrogen promotes the growing of endometrial lining, while progesterone limits it. [67] In the case of endometrial cancer, progesterone can negatively regulate estrogen driven growth. Tumors formed are correlated with insufficient progesterone and excess estrogen. [67] In patients with endometrial cancer who use progestin releasing IUDs concluded mixed results.
A 2020 meta-analysis by Livia Conz et al. estimated that users of levonorgestrel-releasing systems had an increased breast cancer risk in general (with an odds ratio of 1.16) and higher risk for those over age 50 (odds ratio 1.52), and suggested balancing this risk against the known benefits of long-term use. [68] Researchers cautioned against causal interpretation from this study, citing confounding effects, methodological concerns and a 2020 meta-analysis of randomized controlled trials which showed no increased risk. [69] [70] [71]
No evidence has been identified to suggest Mirena affects bone mineral density (BMD). [72] Two small studies, limited to studying BMD in the forearm, show no decrease in BMD. [73] [74] One of the studies showed at seven years of use, similar BMD at the midshaft of the ulna and at the distal radius as nonusers matched by age and BMI. [73] In addition, BMD measurements were similar to the expected values for women in the same age group as the participants. The authors of the study said their results were predictable, since it is well established that the main factor responsible for bone loss in women is hypoestrogenism, and, in agreement with previous reports, they found estradiol levels in Mirena users to be normal. [73]
The hormonal IUD is a small T-shaped piece of plastic, which contains levonorgestrel, a type of progestin. [29] The cylinder of the device is coated with a membrane that regulates the release of the drug. [75] Bayer markets Skyla as Jaydess in the United Kingdom. [76] Jaydess releases six micrograms per day and lasts for three years. [77] In comparison, oral contraceptives can contain 150 micrograms of levonorgestrel. [53] The hormonal IUD releases the levonorgestrel directly into the uterus, as such its effects are mostly paracrine rather than systemic. Most of the drug stays inside the uterus, and only a small amount is absorbed into the rest of the body. [53]
The hormonal IUD is inserted in a similar procedure to the nonhormonal copper IUD, and can only be inserted by a qualified medical practitioner. [53] Before insertion, a pelvic exam is performed to examine the shape and position of the uterus. A current STI at the time of insertion can increase the risk of pelvic infection. [78] However, routine screening for gonorrhea and chlamydia prior to insertion is not recommended. [79] If a person needs screening and there is no evidence of infection on examination or has been previously screened, insertion of the IUD does not need to be delayed. [80]
During the insertion, the vagina is held open with a speculum, the same device used during a pap smear. [53] A grasping instrument is used to steady the cervix, the length of the uterus is measured for proper insertion with a uterine sound for decreasing chance of uterine perforation with the IUD, and the IUD is placed using a narrow tube through the opening of the cervix into the uterus. [53] A short length of monofilament plastic/nylon string hangs down from the cervix into the vagina. The string allows physicians and patients to check to ensure the IUD is still in place and enables easy removal of the device. [53] Moderate to severe cramping can occur during the procedure, which generally takes five minutes or less. Insertion can be performed immediately postpartum and post-abortion if no infection has occurred. [24]
Misoprostol is not effective in reducing pain in IUD insertion. [81]
Removal of the device should also be performed by a qualified medical practitioner. After removal, fertility will return to previous levels relatively quickly. [82] One study found that the majority of participants returned to fertility within three months. [83]
Levonorgestrel is a progestogen, i.e. a progesterone receptor agonist. The hormonal IUD's primary mechanism of action is to prevent fertilization. [53] [84] [85] [86] [87] The levonorgestrel intrauterine system has several contraceptive effects, although thickening of the cervical mucus appears to be the primary effect. [88] Other effects include making the inside of the uterus become fatal to sperm [86] [89] and thinning of the endometrial lining, but this is not the usual function. [90] [91]
Ovulation is not inhibited in all cases. [86] [92]
Numerous studies have demonstrated that IUDs primarily prevent fertilization, not implantation. [53] In one experiment involving tubal flushing, fertilized eggs were found in half of women not using contraception, but no fertilized eggs were found in women using IUDs. [93] IUDs also decrease the risk of ectopic pregnancy, which further implies that IUDs prevent fertilization. [53]
Hormonal IUDs were developed in the 1970s following the development of the copper IUD in the 1960s and 1970s. [94] Dr. Antonio Scommenga, working at the Michael Reese Hospital in Chicago, discovered that administering progesterone inside the uterus could have contraceptive benefits. [94] With knowledge of Scommegna's work, a Finnish doctor, Jouni Valter Tapani Luukkainen, created the T-shaped IUD that released progesterone, marketed as the Progestasert System in 1976. This IUD had a short, 1-year lifespan and never achieved widespread popularity. Following this relative lack of success, Dr. Luukkainen replaced the progesterone with the hormone levonorgestrel to be released over a five-year period, creating what is now Mirena. [95]
The Mirena IUD was studied for safety and efficacy in two clinical trials in Finland and Sweden involving 1,169 women who were all between 18 and 35 years of age at the beginning of the trials. The trials included predominantly Caucasian women who had been previously pregnant with no history of ectopic pregnancy or pelvic inflammatory disease within the previous year. Over 70% of the participants had previously used IUDs. [11]
In 2013 Skyla, a lower dose levonorgestrel IUD effective for up to three years, was approved by the FDA. [96] Skyla has a different bleeding pattern than Mirena, with only 6% of women in clinical trials becoming amenorrheic (compared to approximately 20% with Mirena).
The city of Turku, Finland, is currently the only production site for the Mirena contraceptive family. [97]
In 2009, Bayer, the maker of Mirena, was issued an FDA Warning Letter by the United States Food and Drug Administration for overstating the efficacy, minimizing the risks of use, and making "false or misleading presentations" about the device. [98] [99] From 2000 to 2013, the federal agency received over 70,072 complaints about the device and related adverse effects. [100] [101] As of April 2014, over 1,200 lawsuits have been filed in the United States. [99] [102] [103] [104]
A copper intrauterine device (IUD), also known as an intrauterine coil or copper coil or non-hormonal IUD, is a type of intrauterine device which contains copper. It is used for birth control and emergency contraception within five days of unprotected sex. 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 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 quickly returns.
Emergency contraception (EC) is a birth control measure, used after sexual intercourse to prevent pregnancy.
The combined oral contraceptive pill (COCP), often referred to as the birth control pill or colloquially as "the pill", is a type of birth control that is designed to be taken orally by women. It is the oral form of combined hormonal contraception. The pill contains two important hormones: a progestin and estrogen. When taken correctly, it alters the menstrual cycle to eliminate ovulation and prevent pregnancy.
A progestogen, also referred to as a progestagen, gestagen, or gestogen, is a type of medication which produces effects similar to those of the natural female sex hormone progesterone in the body. A progestin is a synthetic progestogen. Progestogens are used most commonly in hormonal birth control and menopausal hormone therapy. They can also be used in the treatment of gynecological conditions, to support fertility and pregnancy, to lower sex hormone levels for various purposes, and for other indications. Progestogens are used alone or in combination with estrogens. They are available in a wide variety of formulations and for use by many different routes of administration. Examples of progestogens include natural or bioidentical progesterone as well as progestins such as medroxyprogesterone acetate and norethisterone.
Heavy menstrual bleeding (HMB), previously known as menorrhagia or hematomunia, is a menstrual period with excessively heavy flow. It is a type of abnormal uterine bleeding (AUB).
Levonorgestrel is a hormonal medication which is used in a number of birth control methods. It is combined with an estrogen to make combination birth control pills. As an emergency birth control, sold under the brand names Plan B One-Step and Julie, among others, it is useful within 72 hours of unprotected sex. The more time that has passed since sex, the less effective the medication becomes, and it does not work after pregnancy (implantation) has occurred. Levonorgestrel works by preventing ovulation or fertilization from occurring. It decreases the chances of pregnancy by 57–93%. In an intrauterine device (IUD), such as Mirena among others, it is effective for the long-term prevention of pregnancy. A levonorgestrel-releasing implant is also available in some countries.
Progestogen-only pills (POPs), colloquially known as "mini pills", are a type of oral contraceptive that contain synthetic progestogens (progestins) and do not contain estrogens. They are primarily used for the prevention of undesired pregnancy, although additional medical uses also exist.
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 original hormonal method—the combined oral contraceptive pill—was first marketed as a contraceptive in 1960. In the ensuing decades, many other delivery methods have been developed, although the oral and injectable methods are by far the most popular. Hormonal contraception is highly effective: when taken on the prescribed schedule, users of steroid hormone methods experience pregnancy rates of less than 1% per year. Perfect-use pregnancy rates for most hormonal contraceptives are usually around the 0.3% rate or less. Currently available methods can only be used by women; the development of a male hormonal contraceptive is an active research area.
Etonogestrel is a medication which is used as a means of birth control for women. It is available as an implant placed under the skin of the upper arm under the brand names Nexplanon and Implanon. It is a progestin that is also used in combination with ethinylestradiol, an estrogen, as a vaginal ring under the brand names NuvaRing and Circlet. Etonogestrel is effective as a means of birth control and lasts at least three or four years with some data showing effectiveness for five years. Following removal, fertility quickly returns.
Controversy over the beginning of pregnancy occurs in different contexts, particularly as it is discussed within the debate of abortion in the United States. Because an abortion is defined as ending an established pregnancy, rather than as destroying a fertilized egg, depending on when pregnancy is considered to begin, some methods of birth control as well as some methods of infertility treatment might be classified as causing abortions.
There are many methods of birth control that vary in requirements, side effects, and effectiveness. As the technology, education, and awareness about contraception has evolved, new contraception methods have been theorized and put in application. Although no method of birth control is ideal for every user, some methods remain more effective, affordable or intrusive than others. Outlined here are the different types of barrier methods, hormonal methods, various methods including spermicides, emergency contraceptives, and surgical methods and a comparison between them.
Hypomenorrhea or hypomenorrhoea, also known as short or scanty periods, is extremely light menstrual blood flow. It is the opposite of heavy periods or hypermenorrhea which is more properly called menorrhagia.
Long-acting reversible contraceptives (LARC) are methods of birth control that provide effective contraception for an extended period without requiring user action. They include hormonal and non-hormonal intrauterine devices (IUDs) and subdermal hormonal contraceptive implants. They are the most effective reversible methods of contraception because their efficacy is not reliant on patient compliance. The failure rates of IUDs and implants is less than 1% per year.
Progestogen-only contraception relies on progestogens alone to achieve contraception. It is one of the two major types of hormonal contraception, with the other major type being combined hormonal contraceptive methods. There are several progestogen only contraceptive methods:
A contraceptive implant is an implantable medical device used for the purpose of birth control. The implant may depend on the timed release of hormones to hinder ovulation or sperm development, the ability of copper to act as a natural spermicide within the uterus, or it may work using a non-hormonal, physical blocking mechanism. As with other contraceptives, a contraceptive implant is designed to prevent pregnancy, but it does not protect against sexually transmitted infections.
Birth control, also known as contraception, anticonception, and fertility control, is the use of methods or devices to prevent unintended pregnancy. Birth control has been used since ancient times, but effective and safe methods of birth control only became available in the 20th century. Planning, making available, and using human birth control is called family planning. Some cultures limit or discourage access to birth control because they consider it to be morally, religiously, or politically undesirable.
An intrauterine device (IUD), also known as intrauterine contraceptive device or coil, is a small, often T-shaped birth control device that is inserted into the uterus to prevent pregnancy. IUDs are a form of long-acting reversible birth control (LARC).
Women's reproductive health in the United States refers to the set of physical, mental, and social issues related to the health of women in the United States. It includes the rights of women in the United States to adequate sexual health, available contraception methods, and treatment for sexually transmitted diseases. The prevalence of women's health issues in American culture is inspired by second-wave feminism in the United States. As a result of this movement, women of the United States began to question the largely male-dominated health care system and demanded a right to information on issues regarding their physiology and anatomy. The U.S. government has made significant strides to propose solutions, like creating the Women's Health Initiative through the Office of Research on Women's Health in 1991. However, many issues still exist related to the accessibility of reproductive healthcare as well as the stigma and controversy attached to sexual health, contraception, and sexually transmitted diseases.
There are many types of contraceptive methods available in France. All contraceptives are obtained by medical prescription after a visit to a family planning specialist, a gynecologist or a midwife. An exception to this is emergency contraception, which does not require a prescription and can be obtained directly in a pharmacy.
Menstrual suppression refers to the practice of using hormonal management to stop or reduce menstrual bleeding. In contrast to surgical options for this purpose, such as hysterectomy or endometrial ablation, hormonal methods to manipulate menstruation are reversible.
Mechanism of action
Although the precise mechanism of action is not known, currently available IUCs work primarily by preventing sperm from fertilizing ova.26 IUCs are not abortifacients: they do not interrupt an implanted pregnancy.27 Pregnancy is prevented by a combination of the "foreign body effect" of the plastic or metal frame and the specific action of the medication (copper or levonorgestrel) that is released. Exposure to a foreign body causes a sterile inflammatory reaction in the intrauterine environment that is toxic to sperm and ova and impairs implantation.28,29 The production of cytotoxic peptides and activation of enzymes lead to inhibition of sperm motility, reduced sperm capacite journal and survival, and increased phagocytosis of sperm.30,31… The progestin in the LNg IUC enhances the contraceptive action of the device by thickening cervical mucus, suppressing the endometrium, and impairing sperm function. In addition, ovulation is often impaired as a result of systemic absorption of levonorgestrel.23
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Table 7-1. Myths and misconceptions about IUCs
Myth: IUCs are abortifacients. Fact: IUCs prevent fertilization and are true contraceptives.
Conclusions
Active substances released from the IUD or IUS, together with products derived from the inflammatory reaction present in the luminal fluids of the genital tract, are toxic for spermatozoa and oocytes, preventing the encounter of healthy gametes and the formation of viable embryos. The current data do not indicate that embryos are formed in IUD users at a rate comparable to that of nonusers. The common belief that the usual mechanism of action of IUDs in women is destruction of embryos in the uterus is not supported by empirical evidence. The bulk of the data indicate that interference with the reproductive process after fertilization has taken place is exceptional in the presence of a T-Cu or LNG-IUD and that the usual mechanism by which they prevent pregnancy in women is by preventing fertilization.
Mechanisms of action
Thus, both clinical and experimental evidence suggests that IUDs can prevent and disrupt implantation. It is unlikely, however, that this is the main IUD mode of action, … The best evidence indicates that in IUD users it is unusual for embryos to reach the uterus.
In conclusion, IUDs may exert their contraceptive action at different levels. Potentially, they interfere with sperm function and transport within the uterus and tubes. It is difficult to determine whether fertilization of the oocyte is impaired by these compromised sperm. There is sufficient evidence to suggest that IUDs can prevent and disrupt implantation. The extent to which this interference contributes to its contraceptive action is unknown. The data are scanty and the political consequences of resolving this issue interfere with comprehensive research.
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Summary
IUDs that release copper or levonorgestrel are extremely effective contraceptives... Both copper IUDs and levonorgestrel releasing IUSs may interfere with implantation, although this may not be the primary mechanism of action. The devices also create barriers to sperm transport and fertilization, and sensitive assays detect hCG in less than 1% of cycles, indicating that significant prevention must occur before the stage of implantation.
Mechanism of action
The contraceptive action of all IUDs is mainly in the intrauterine cavity. Ovulation is not affected, and the IUD is not an abortifacient.58–60 It is currently believed that the mechanism of action for IUDs is the production of an intrauterine environment that is spermicidal.
Nonmedicated IUDs depend for contraception on the general reaction of the uterus to a foreign body. It is believed that this reaction, a sterile inflammatory response, produces tissue injury of a minor degree but sufficient to be spermicidal. Very few, if any, sperm reach the ovum in the fallopian tube.
The progestin-releasing IUD adds the endometrial action of the progestin to the foreign body reaction. The endometrium becomes decidualized with atrophy of the glands.65 The progestin IUD probably has two mechanisms of action: inhibition of implantation and inhibition of sperm capacite journal, penetration, and survival.
Intrauterine devices
Mechanisms of action
The common belief that the usual mechanism of action of IUDs in women is destruction of embryos in the uterus is not supported by empirical evidence... Because concern over mechanism of action represents a barrier to acceptance of this important and highly effective method for some women and some clinicians, it is important to point out that there is no evidence to suggest that the mechanism of action of IUDs is abortifacient.
The LNG-IUS, like the copper device, has a very low ectopic pregnancy rate. Therefore, fertilization does not occur and its main mechanism of action is also preconceptual. Less inflammation occurs within the uterus of LNG-IUS users, but the potent progestin effect thickens cervical mucus to impede sperm penetration and access to the upper genital track.
Both copper IUDs and levonorgestrel releasing IUSs may interfere with implantation
Although the precise mechanism of action is not known, currently available IUCs work primarily by preventing sperm from fertilizing ova.26 IUCs are not abortifacients: they do not interrupt an implanted pregnancy.27 Pregnancy is prevented by a combination of the "foreign body effect" of the plastic or metal frame and the specific action of the medication (copper or levonorgestrel) that is released. Exposure to a foreign body causes a sterile inflammatory reaction in the intrauterine environment that is toxic to sperm and ova and impairs implantation.28,29 The production of cytotoxic peptides and activation of enzymes lead to inhibition of sperm motility, reduced sperm capacite journal and survival, and increased phagocytosis of sperm.30,31… The progestin in the LNg IUC enhances the contraceptive action of the device by thickening cervical mucus, suppressing the endometrium, and impairing sperm function. In addition, ovulation is often impaired as a result of systemic absorption of levonorgestrel