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Levonorgestrel-releasing implant, sold under the brand name Jadelle among others, are devices that release
levonorgestrel 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 name Plan B One-Step among ...
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 ...
. It is one of the most effective forms of birth control with a one-year failure rate around 0.05%. The device is placed under the skin and lasts for up to five years. It may be used by women who have a history 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 n ...
and therefore cannot use an
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 reversi ...
. Following removal fertility quickly returns. It is generally well tolerated with few significant side effects. Side effects may include irregular
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 ...
, no periods, headaches, and breast pain. Use is not recommended in people with significant
liver disease Liver disease, or hepatic disease, is any of many diseases of the liver. If long-lasting it is termed chronic liver disease. Although the diseases differ in detail, liver diseases often have features in common. Signs and symptoms Some of the sig ...
. The levonorgestrel implant 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 contracepti ...
. It primarily works by stopping
ovulation Ovulation is the release of eggs from the ovaries. In women, this event occurs when the ovarian follicles rupture and release the secondary oocyte ovarian cells. After ovulation, during the luteal phase, the egg will be available to be fertilize ...
and by thickening the
mucus Mucus ( ) is a slippery aqueous secretion produced by, and covering, mucous membranes. It is typically produced from cells found in mucous glands, although it may also originate from mixed glands, which contain both serous and mucous cells. It is ...
around 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 ...
. A levonorgestrel-releasing implant was approved for medical use in 1983 in Finland and in the United States in 1990. 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 ...
. Levonorgestrel implants are approved in more than 60 countries and used by more than seven million women. As of 2015 it is approved but not available in the United States.


Medical uses

Levonorgestrel-releasing implant is 99–99.95% effective at preventing
pregnancy 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 can ...
, and is one of the most reliable, though not the most available, forms of birth control. Levonorgestrel-releasing implant prevents pregnancy through multiple methods: by preventing
ovulation Ovulation is the release of eggs from the ovaries. In women, this event occurs when the ovarian follicles rupture and release the secondary oocyte ovarian cells. After ovulation, during the luteal phase, the egg will be available to be fertilize ...
, which means that no
eggs Humans and human ancestors have scavenged and eaten animal eggs for millions of years. Humans in Southeast Asia had domesticated chickens and harvested their eggs for food by 1,500 BCE. The most widely consumed eggs are those of fowl, especial ...
are released for
fertilization Fertilisation or fertilization (see spelling differences), also known as generative fertilisation, syngamy and impregnation, is the fusion of gametes to give rise to a new individual organism or offspring and initiate its development. Proce ...
; by thickening the
mucus Mucus ( ) is a slippery aqueous secretion produced by, and covering, mucous membranes. It is typically produced from cells found in mucous glands, although it may also originate from mixed glands, which contain both serous and mucous cells. It is ...
of 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 ...
, which prevents
sperm Sperm is the male reproductive cell, or gamete, in anisogamous forms of sexual reproduction (forms in which there is a larger, female reproductive cell and a smaller, male one). Animals produce motile sperm with a tail known as a flagellum, wh ...
from entering; and by thinning the lining of the uterus, which makes implantation of an embryo less likely. The way in which levonorgestrel-releasing implant causes these effects is by use of hormones. A small amount of the
hormone A hormone (from the Greek participle , "setting in motion") is a class of signaling molecules in multicellular organisms that are sent to distant organs by complex biological processes to regulate physiology and behavior. Hormones are required fo ...
progestin is released through the capsules continuously, more during the first year and a half, but then at a level similar to most contraceptive pills afterward. Like all hormonal contraception, levonorgestrel-releasing implant does not protect against
sexually transmitted infection 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 s ...
s. Implantable contraceptives are especially effective in the developing world, as they do not require daily administration or access to a hospital to be effective. In addition, no continual contraceptive supplies (pills, condoms, etc.) are necessary, and it is a highly effective, low cost contraceptive over the long term.


Contraindications

Levonorgestrel-releasing implant should not be used in women with
liver disease Liver disease, or hepatic disease, is any of many diseases of the liver. If long-lasting it is termed chronic liver disease. Although the diseases differ in detail, liver diseases often have features in common. Signs and symptoms Some of the sig ...
,
breast cancer Breast cancer is cancer that develops from breast tissue. Signs of breast cancer may include a lump in the breast, a change in breast shape, dimpling of the skin, milk rejection, fluid coming from the nipple, a newly inverted nipple, or a r ...
, or
blood clot A thrombus (plural thrombi), colloquially called a blood clot, is the final product of the blood coagulation step in hemostasis. There are two components to a thrombus: aggregated platelets and red blood cells that form a plug, and a mesh of ...
s. Women who believe they may already be pregnant or those with vaginal bleeding should first see a physician. However, since it does not contain
estrogen Estrogen or oestrogen is a category of sex hormone responsible for the development and regulation of the female reproductive system and secondary sex characteristics. There are three major endogenous estrogens that have estrogenic hormonal activ ...
like some birth control pills, older women, women who smoke, and women with
high blood pressure Hypertension (HTN or HT), also known as high blood pressure (HBP), is a long-term medical condition in which the blood pressure in the arteries is persistently elevated. High blood pressure usually does not cause symptoms. Long-term high b ...
are not restricted from using the system.


Side effects

After three months of using, women may need to schedule a follow-up appointment to monitor blood pressure and discuss any concerns.
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, consequence ...
may include irregular
menstrual period 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 ...
s for the first approximately three months, including periods lasting longer than normal,
bleeding 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, v ...
or spotting between periods, heavy bleeding, or going with no period for the mentioned period of time. Sometimes,
pain Pain is a distressing feeling often caused by intense or damaging stimuli. The International Association for the Study of Pain defines pain as "an unpleasant sensory and emotional experience associated with, or resembling that associated with, ...
,
itching Itch (also known as pruritus) is a sensation that causes the desire or reflex to scratch. Itch has resisted many attempts to be classified as any one type of sensory experience. Itch has many similarities to pain, and while both are unpleasant ...
or infection at the site of the implant will occur.
Ovarian cyst An ovarian cyst is a fluid-filled sac within the ovary. Often they cause no symptoms. Occasionally they may produce bloating, lower abdominal pain, or lower back pain. The majority of cysts are harmless. If the cyst either breaks open or causes ...
s may also occur, but usually do not require treatment, although they can cause pain even if
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 ...
.


Technique


Insertion

Levonorgestrel-releasing implant is implanted under the skin in the upper arm of a woman, by creating a small incision and inserting the capsules in a fanlike shape. Insertion usually takes 15 minutes and the capsules can sometimes be seen under the skin, although usually they look like small
vein Veins are blood vessels in humans and most other animals that carry blood towards the heart. Most veins carry deoxygenated blood from the tissues back to the heart; exceptions are the pulmonary and umbilical veins, both of which carry oxygenated ...
s. They can also be felt under the skin. Once inserted, the contraceptive works within 24 hours and lasts up to five years.


Removal

Levonorgestrel-releasing implant can be removed by creating a second incision and withdrawing the capsules. It is normally removed when the five-year period is over, or if: * Pregnancy is desired * Different birth control is preferred * Complications arise Normally removal is not complicated; removal difficulties have been reported with a frequency of 6.2%, based on 849 removals. Removal difficulties include: multiple incisions, capsule fragments remaining, pain, multiple visits, deep placement, lengthy removal procedure, or other. If desired, a new implant can be inserted at the time of removal.


History

It was developed by Sheldon J. Segal and Horacio Croxatto at 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 ...
beginning in 1966, with the first clinical trial in
Chile Chile, officially the Republic of Chile, is a country in the western part of South America. It is the southernmost country in the world, and the closest to Antarctica, occupying a long and narrow strip of land between the Andes to the east a ...
in 1974. It was first approved in
Finland Finland ( fi, Suomi ; sv, Finland ), officially the Republic of Finland (; ), is a Nordic country in Northern Europe. It shares land borders with Sweden to the northwest, Norway to the north, and Russia to the east, with the Gulf of Both ...
on November 23, 1983, where it was manufactured by Leiras Oy Pharmaceuticals. The original Norplant consisted of a set of six small (2.4 mm × 34 mm)
silicone A silicone or polysiloxane is a polymer made up of siloxane (−R2Si−O−SiR2−, where R = organic group). They are typically colorless oils or rubber-like substances. Silicones are used in sealants, adhesives, lubricants, medicine, cooking ...
capsules, each filled with 36 mg of
levonorgestrel 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 name Plan B One-Step among ...
implanted under the skin in the upper arm and effective for five years. The original (six-capsule) Norplant production has been phased out;
USAID The United States Agency for International Development (USAID) is an independent agency of the U.S. federal government that is primarily responsible for administering civilian foreign aid and development assistance. With a budget of over $27 ...
's contract ran until December 2006. The original (six capsule) Norplant 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 s ...
(FDA) on December 10, 1990, and marketed in the United States in 1991 by Wyeth Pharmaceuticals. Norplant distribution in the United States ended in 2002; limited supplies still remained in the U.S. until 2004. Norplant was withdrawn from the UK market in 1999. Production of Norplant was discontinued globally in 2008.

Norplant II (Norplant-2, Jadelle), also developed by the Population Council and manufactured by Schering Oy, consists of two small (2.5 mm × 43 mm) silicone rods each containing 75 mg of levonorgestrel in a polymer matrix, instead of six capsules. It was approved May 31, 1996 by the FDA as being effective for three years; it was subsequently approved November 22, 2002 by the FDA as being effective for five years. Jadelle has not been marketed in the United States; Jadelle is the successor to the original Norplant in USAID's contract beginning January 2007.


Society and culture


United States

By 1996, more than 50,000 women had filed lawsuits, including 70 class actions, against Wyeth or its subsidiaries, or doctors who prescribed Norplant. Wyeth never lost a Norplant lawsuit, even in cases which came before a jury. On August 26, 1999, after winning 3 jury verdicts, 20 pretrial
summary judgment In law, a summary judgment (also judgment as a matter of law or summary disposition) is a judgment entered by a court for one party and against another party summarily, i.e., without a full trial. Summary judgments may be issued on the merits of a ...
s and the dismissal of 14,000 claims, Wyeth offered out-of-court cash settlements of $1,500 each to about 36,000 women who contended that they had not been adequately warned about possible side effects of Norplant such as irregular menstrual bleeding, headaches, nausea and depression. Wyeth said that most of the plaintiffs experienced routine side effects described in Norplant's labeling information. Wyeth did not admit to any wrongdoing, saying the settlement offer "was purely a business decision," noting "our legal success has come at a steep price because lawsuits are time-consuming, expensive, and have a chilling effect on research," and that it would continue to offer Norplant and would contest "any and all new lawsuits aggressively." About 32,000 women accepted the out-of-court $1,500 settlements. On August 14, 2002, Wyeth won partial summary judgment and dismissal of the claims of the 2,960 remaining plaintiffs who had not accepted Wyeth's out-of-court settlement offer. In August 2000, Wyeth suspended shipments of Norplant in the United States because during regular quality assurance monitoring, representative samples of seven lots distributed beginning October 20, 1999 tested within product specifications, but at the lower end of the release rate specification for shelf life stability, raising concerns about those lots' contraceptive effectiveness. Wyeth recommended that women who had Norplant capsules from those lots implanted use backup contraception until they determined the clinical relevance of the atypically low levels of levonorgestrel release. On July 26, 2002, Wyeth announced that data from investigations conducted in women with Norplant capsules from the suspect lots did not suggest less contraceptive effectiveness than that reported in clinical trials, and that therefore backup contraception could be safely discontinued. Wyeth also announced that due to limitations in product component supplies, they did not plan to resume marketing the six-capsule Norplant system in the United States.


New Zealand

Jadelle was added to the Pharmaceutical Management Agency's (Pharmac) schedule and subsequently subsidized in August 2010. Medical professionals raised concerns during a consultation process indicating preference for a product which is easier to insert. The agreement between Bayer New Zealand and Pharmac was conditional on Bayer New Zealand providing adequate training to ensure doctors are comfortable in the insertion and removal technique.


Controversy

Some American legislators have unsuccessfully attempted to provide financial incentives to women on
welfare Welfare, or commonly social welfare, is a type of government support intended to ensure that members of a society can meet basic human needs such as food and shelter. Social security may either be synonymous with welfare, or refer specifical ...
who agree to use Norplant. For example, in Kansas, Republican Kerry Patrick introduced legislation that would grant welfare recipients a one-time payment of $500 to use Norplant, followed by a $50 bonus each year the implants remained in place." Some judges have offered Norplant implants as a voluntary alternative to jail time for certain women convicted of child abuse or drug abuse during pregnancy. Two days after the 1990 FDA approval of Norplant, an editorial in ''
The Philadelphia Inquirer ''The Philadelphia Inquirer'' is a daily newspaper headquartered in Philadelphia, Pennsylvania. The newspaper's circulation is the largest in both the U.S. state of Pennsylvania and the Delaware Valley metropolitan region of Southeastern Pennsy ...
'' suggested reducing the size of the black underclass by offering welfare mothers increased benefits if they agreed to use Norplant. Eleven days later the ''Inquirer'' apologized for their "misguided and wrongheaded" editorial and for their suggestion of offering incentives for Norplant use. Critics such as the
ACLU The American Civil Liberties Union (ACLU) is a nonprofit organization founded in 1920 "to defend and preserve the individual rights and liberties guaranteed to every person in this country by the Constitution and laws of the United States". T ...
argued that such uses are coercive and discriminatory, and compared such uses to early 20th-century American eugenics. In '' Killing the Black Body'', black feminist Dorothy Roberts links such uses of Norplant to a "white mainstream" that is allegedly determined to "demonize, even criminalize" poor black women's lives and reproductive choices. Within two years of Norplant's FDA approval, legislators in thirteen U.S. states had proposed nearly two dozen bills offering incentives for, or requiring use of Norplant by welfare mothers; none of these proposals passed.
The first big city to aggressively promote the use of Norplant was
Baltimore Baltimore ( , locally: or ) is the most populous city in the U.S. state of Maryland, fourth most populous city in the Mid-Atlantic, and the 30th most populous city in the United States with a population of 585,708 in 2020. Baltimore was ...
. Baltimore targeted
teenagers Adolescence () is a transitional stage of physical and psychological development that generally occurs during the period from puberty to adulthood (typically corresponding to the age of majority). Adolescence is usually associated with the t ...
because the birthrate was three times higher than other states. In Baltimore, about ten percent of girls between ages 15 and 17 gave birth during 1990. Young mothers would often drop out of school and struggle to raise the child in poverty. The mayor at the time,
Kurt Schmoke Kurt Lidell Schmoke (born December 1, 1949) is an American politician and lawyer who was the 47th mayor of Baltimore, Maryland, from 1987 to 1999, the first African American to be elected to the post. He is the current president of the University ...
, pushed for laws that would give teen girls more access to Norplant. Norplant was eventually given to teen girls at schools without parental consent. Programs were designed for, and performed in, predominantly black schools. Laurence G. Paquin Middle School became the first school to provide Norplant to their students. Paquin Middle School had 355 female students but only 5 of them were not black. Their program started off as a pilot program and soon other urban high schools like
San Fernando High School San Fernando High School (SFHS) is a high school of the Los Angeles Unified School District. It is located in the Pacoima neighborhood of Los Angeles, in the northeastern San Fernando Valley, California. It is near and also serves the City of San ...
in
Los Angeles Los Angeles ( ; es, Los Ángeles, link=no , ), often referred to by its initials L.A., is the largest city in the state of California and the second most populous city in the United States after New York City, as well as one of the world' ...
and Crane High School in Chicago's
West Side West Side or Westside may refer to: Places Canada * West Side, a neighbourhood of Windsor, Ontario * West Side, a neighbourhood of Vancouver, British Columbia United Kingdom * West Side, Lewis, Outer Hebrides, Scotland * Westside, Birmingham ...
adopted the program of providing Norplant to their students. Because of a focus on predominantly black schools, questions of
racism Racism is the belief that groups of humans possess different behavioral traits corresponding to inherited attributes and can be divided based on the superiority of one Race (human categorization), race over another. It may also mean prejudice, d ...
arose among black community leaders.


See also

*
Contraceptive patch A contraceptive patch, also known as "the patch", is a transdermal patch applied to the skin that releases synthetic oestrogen and progestogen hormones to prevent pregnancy. They have been shown to be as effective as the combined oral contr ...
* Nexplanon, another subdermal contraceptive implant


References


External links

{{portal bar, Medicine Hormonal contraception Implants (medicine) Wikipedia medicine articles ready to translate World Health Organization essential medicines