Levonorgestrel-releasing implant: Difference between revisions

Norplant is a form of birth control developed by Sheldon J. Segal and Horatio B. Croxatto at the Population Council beginning in 1966, with the first clinical trial in Chile in 1974.^[1][2][3] It was first approved in Finland on November 23, 1983, where it was manufactured by Leiras Oy Pharmaceuticals.^[4] The original Norplant consisted of a set of six small (2.4 mm × 34 mm) silicone capsules, each filled with 36 mg of levonorgestrel (a progestin used in many birth control pills) implanted subdermally in the upper arm and effective for five years.^[5] The original (six capsule) Norplant's production has been phased out; USAID's contract ran until December 2006.^[6]

The original (six capsule) Norplant was approved by the U.S. Food and Drug Administration (FDA) on December 10, 1990, and marketed in the United States in 1991 by Wyeth Pharmaceuticals.^[7] 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 Norplant was withdrawn from the UK market in 1999.^[8]

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;^[9] Jadelle is the successor to the original Norplant in USAID's contract beginning January 2007.^[10]

Norplant 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 of Norplant usually takes 15 minutes and the capsules can sometimes be seen under the skin, although usually they look like small veins. They can also be felt under the skin. Once inserted, the contraceptive works within 24 hours and lasts up to five years.

Norplant works by preventing ovulation, which means that no eggs are released for fertilization, by thickening the mucus of the cervix, which prevents sperm from entering; and by thinning the lining of the uterus, which makes implantation of an embryo less likely.

The way in which Norplant causes these effects is by use of hormones. A small amount of the hormone 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. According to studies completed, Norplant has been shown to be 99% – 99.95% effective at preventing pregnancy, and is one of the most reliable, though not the most available, forms of birth control.

Like all hormonal contraception, Norplant does not protect against sexually transmitted infections.

Norplant should not be used in women with liver disease, breast cancer, or blood clots. Women who believe they may already be pregnant or those with vaginal bleeding should first see a physician. However, since Norplant does not contain estrogen like some birth control pills, older women, women who smoke, and women with high blood pressure are not restricted from using the system.

After three months of using Norplant, women will need to schedule a follow-up appointment to monitor blood pressure and discuss any concerns. Side effects may include irregular menstrual periods for the first approximately three months, including periods lasting longer than normal, bleeding or spotting between periods, heavy bleeding, or going with no period for the mentioned period of time. Common side effects include weight gain, nervousness, anxiety, nausea, vomiting, mastalgia, dizziness, dermatitis/rash, hirsutism, scalp-hair loss, headache, depression, and acne. Sometimes, pain, itching or infection at the site of the implant will occur. Ovarian cysts may also occur, but usually do not require treatment, although they can cause pain even if benign.

Norplant can be removed at any time by creating a second incision and withdrawing the capsules. Norplant 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.^[11]

If desired, a new implant can be inserted at the time of removal.

Removal should never be attempted by someone without the appropriate training. If not done correctly, it can lead to all the complications listed above as well as deep scaring or keloids forming around the capsules and severe nerve damage.

This section relies largely or entirely on a single source. Relevant discussion may be found on the talk page. Please help improve this article by introducing citations to additional sources. Find sources: "Levonorgestrel-releasing implant" – news · newspapers · books · scholar · JSTOR (December 2013)

After FDA approval, The Inquirer on December 12, 1990 published an editorial entitled "Poverty and Norplant: Can Contraception Reduce the Underclass?" This article by Donald Kimelman related Norplant to the fact that half of all black children in America live in poverty. It also endorsed giving women incentives to use the contraceptive. These incentives included public aid and financial gain. "Kansas Republican state representative 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."^[12] Although Norplant's creator, Dr. Sheldon J. Segal immediately opposed "the use of Norplant for any coercive purpose,"^[12] the idea became popular all around the United States. The new contraceptive was instantly embraced by policymakers, legislators, and social pundits as a way of curbing the birthrate of poor Black women.^[12]

In Dorothy Roberts' book Killing the Black Body: Race, Reproduction, and the Meaning of Liberty,^[12] she describes how racial politics creates a challenge to reproductive rights and does not create reproductive freedom for everyone. In Chapter 3 entitled "From Norplant to the Contraceptive Vaccine: The New Frontier of Population Control" she describes the introduction of Norplant and the ways in which it could reduce black women's fertility. She also states how Norplant's potential to enhance women's reproductive freedom was quickly overshadowed by its potential for reproductive abuse. reproductive abuse.

A quote from Chapter 3 states that "Norplant was the ideal contraceptive."^[12] While Norplant is thought of as a science at the time, the "ideal" in Norplant is socially constructed. Based on the construction of society in the 18th century, Norplant belonged to the objectivity, which is the period of encyclopedia. Since the people who contribute to this knowledge are wealthy white men, the controversy in Norplant begins with the stereotypical population in the society. While scientists are in authority to give Norplant to their patients, the population is controlled by government. This leads to the controversy in different ethnic groups based on the hierarchy in the society.

All around the United States, programs and laws were implemented to make Norplant more available to poor women and poor teenage girls as a form of birth control. Every state made Norplant available to women for free through Medicaid or other forms of public assistance and to teenage girls through school programs that presented Norplant as the most reasonable option. In many states, judges even gave women who were convicted with child abuse or drug use while pregnant the choice between getting Norplant implanted or serving jail time.^[13] "Within two years, thirteen state legislatures had proposed some twenty measures to implant poor women with Norplant."^[12] Because of this availability, at least half the women that used Norplant were Medicaid recipients. Louisiana state representative David Duke went as far as to propose paying women to use Norplant, and a bill in North Carolina would have required all women who got a state-funded abortion to get Norplant as well. Likewise, some states considered making Norplant mandatory for women on welfare in order to keep receiving benefits. On top of marketing mainly to poor women, it was also proposed that women be asked to apply for a license in order to get it removed. However, none of the proposed measures were passed or applied.^[12][13]

Norplant was promoted to the public as the solution to teen pregnancy. Rates of contraceptive failure are significantly higher among teens than adults because of teens’ failure to comply with methods of protection. Teenagers were targeted to use Norplant because of financial issues that the mothers would have. Black teenagers were targeted the most because of the idea that "children were raising children," as stated by Dorothy Roberts in Killing the Black Body: Race, Reproduction, and the Meaning of Liberty.^[12] They were also more associated with having children out of wedlock and a child for these teens was seen as kind of a financial escape because almost of them did not aspired to get a higher education. Most young mothers resorted to welfare to support their child before the child was five years old.^[12] Policymakers argued that Norplant would allow teenagers to get an education and pursue a career. Also, policymakers that pushed for Norplant to be used stated that it would prevent more children from being born into poverty. The policymakers stated that the government aid dependence would decrease if Norplant was given to teens. The first big city to aggressively enforce the use of Norplant was Baltimore.^[12] The mayor at the time, Kurt Schmoke, 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 school. Laurence G. Paquin Middle School became the first school to provide Norplant to their students.^[12] 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 in Los Angeles and Crane High School in Chicago’s West Side adopted the program of providing Norplant to their students. Because Norplant was enforced in predominantly Black school, questions of racism arose amongst Black community leaders.

Although Norplant is used to prevent teenage pregnancy and poor women, it also affects other issues. It is stated that Norplant does not protect from AIDS and STDs. Researchers claimed that "almost one-quarter of the implant acceptors in our sample may be at increased risk of contracting an STD." ^[12] Douglas Besharov, a scholar of the Social Welfare Studies at the American Enterprise Institute, believed that since Norplant prevented pregnancy, this created an increase in teen sex which also leads to an increase in STDs. ^[12] Norplant has positive and negative effects. The idea of Norplant is to reduce pregnancy and sexual activities in the society, but the increase of sexual activities after inserting Norplant created a risk in STDs. As a result, Norplant can reduce abortions in the society, but it can also increase health risks.

By 1996, more than 50,000 women had filed lawsuits, including 70 class actions, against Wyeth and/or its subsidiaries, or doctors who prescribed Norplant.^[14] Wyeth never lost a Norplant lawsuit, even in cases which came before a jury.^[15]

On August 26, 1999, after winning 3 jury verdicts, 20 pretrial summary judgments 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."^[16][17]

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.^[18]

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.^[19]

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.^[20]

Jadelle will be subsidized for use in New Zealand by government medical body PHARMAC from 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.^[21] The consultation process is not public and it is unclear if this addresses the concerns raised. Medical professionals also suggested follow up. PHARMAC will 'suggest' this to the manufacturer.

Despite its discontinuation in the US and the West, Norplant is still used in the developing world. According to one study 6.2 out of 100 rural women interviewed in one region in Bangladesh use the device, according to the United Nations Population Fund.^[22] The Bangladesh Fertility Research Program (BFRP) also used Norplant in an attempt for population control.^[23]

Indonesia, the country with one of the largest populations in the world, was one of the first countries to use Norplant. The Indonesian government dispensed Norplant at a high rate to decrease population growth. However, this led to a decrease in citizen's rights. For example, in Bogor, only employees who use Norplant as a method of contraceptive received their paychecks on time while other jobs required proof of Norplant use.

Norplant and other 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.

• Sylvia (2011). "Norplant implant procedure". Vancouver, B.C.: www.birthcontrolimplant.org (Sylvia's personal webpage). Retrieved November 25, 2011.