Norplant
Encyclopedia
Norplant is a form of birth control
developed by the Population Council
that was first approved in 1983 in Finland
, where it was manufactured by Leiras Oy Pharmaceuticals. 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. The original (six capsule) Norplant's production has been phased out; USAID's contract ran until December 2006.
The original (six capsule) Norplant was approved by the U.S. Food and Drug Administration (FDA) in 1990 and marketed in the United States in 1991 by Wyeth Pharmaceuticals having been developed by Sheldon Segal
. 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 Norplant was withdrawn from the UK market in 1999.
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.
s. They can also be felt under the skin. Once inserted, the contraceptive works within 24 hours and lasts up to five years.
, 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 disease
s.
, 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.
and discuss any concerns. Side effects
may include irregular menstrual period
s 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 cyst
s may also occur, but usually do not require treatment, although they can cause pain even if benign
.
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.
On August 26, 1999, after winning 3 jury verdicts, 20 pretrial summary judgment
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.
.
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.
Birth control
Birth control is an umbrella term for several techniques and methods used to prevent fertilization or to interrupt pregnancy at various stages. Birth control techniques and methods include contraception , contragestion and abortion...
developed by the Population Council
Population Council
The Population Council is an international, nonprofit, non-governmental organization. The Council conducts biomedical, social science, and public health research and helps build research capacities in developing countries. One-third of its research relates to HIV and AIDS; its other major program...
that was first approved in 1983 in Finland
Finland
Finland , officially the Republic of Finland, is a Nordic country situated in the Fennoscandian region of Northern Europe. It is bordered by Sweden in the west, Norway in the north and Russia in the east, while Estonia lies to its south across the Gulf of Finland.Around 5.4 million people reside...
, where it was manufactured by Leiras Oy Pharmaceuticals. The original Norplant consisted of a set of six small (2.4 mm × 34 mm) silicone
Silicone
Silicones are inert, synthetic compounds with a variety of forms and uses. Typically heat-resistant and rubber-like, they are used in sealants, adhesives, lubricants, medical applications , cookware, and insulation....
capsules, each filled with 36 mg of levonorgestrel
Levonorgestrel
Levonorgestrel is a second generation synthetic progestogen used as an active ingredient in some hormonal contraceptives.-Chemistry:...
(a progestin
Progestin
A progestin is a synthetic progestogen that has progestinic effects similar to progesterone. The two most common uses of progestins are for hormonal contraception , and to prevent endometrial hyperplasia from unopposed estrogen in hormone replacement therapy...
used in many birth control pills) implanted subdermally in the upper arm and effective for five years. The original (six capsule) Norplant's production has been phased out; USAID's contract ran until December 2006.
The original (six capsule) Norplant was approved by the U.S. Food and Drug Administration (FDA) in 1990 and marketed in the United States in 1991 by Wyeth Pharmaceuticals having been developed by Sheldon Segal
Sheldon Segal
Sheldon Jerome Segal was an American embryologist and biochemist who spent his entire career working on contraception and made major innovations in the field of long-lasting alternatives, including in the creation of Norplant, the first major development advance in birth control since the birth...
. 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.
Norplant II (Norplant-2, Jadelle), also developed by the Population Council and manufactured by Schering Oy
Schering
Schering AG was a research-centered German pharmaceutical company. It was founded in 1851 by Ernst Christian Friedrich Schering and merged with Bayer's pharma sector in December 2006. The company's headquarters was in Berlin-Wedding, Germany...
, 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.
Insertion
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 veinVein
In the circulatory system, veins are blood vessels 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 blood to the heart...
s. They can also be felt under the skin. Once inserted, the contraceptive works within 24 hours and lasts up to five years.
Function and effectiveness
Norplant works by preventing ovulationOvulation
Ovulation is the process in a female's menstrual cycle by which a mature ovarian follicle ruptures and discharges an ovum . Ovulation also occurs in the estrous cycle of other female mammals, which differs in many fundamental ways from the menstrual cycle...
, which means that no eggs
Ovum
An ovum is a haploid female reproductive cell or gamete. Both animals and embryophytes have ova. The term ovule is used for the young ovum of an animal, as well as the plant structure that carries the female gametophyte and egg cell and develops into a seed after fertilization...
are released for fertilization by thickening the mucus
Mucus
In vertebrates, mucus is a slippery secretion produced by, and covering, mucous membranes. Mucous fluid is typically produced from mucous cells found in mucous glands. Mucous cells secrete products that are rich in glycoproteins and water. Mucous fluid may also originate from mixed glands, which...
of the cervix
Cervix
The cervix is the lower, narrow portion of the uterus where it joins with the top end of the vagina. It is cylindrical or conical in shape and protrudes through the upper anterior vaginal wall...
, which prevents sperm
Spermatozoon
A spermatozoon is a motile sperm cell, or moving form of the haploid cell that is the male gamete. A spermatozoon joins an ovum to form a zygote...
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
Hormone
A hormone is a chemical released by a cell or a gland in one part of the body that sends out messages that affect cells in other parts of the organism. Only a small amount of hormone is required to alter cell metabolism. In essence, it is a chemical messenger that transports a signal from one...
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
Pregnancy
Pregnancy refers to the fertilization and development of one or more offspring, known as a fetus or embryo, in a woman's uterus. In a pregnancy, there can be multiple gestations, as in the case of twins or triplets...
, 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 disease
Sexually transmitted disease
Sexually transmitted disease , also known as a sexually transmitted infection or venereal disease , is an illness that has a significant probability of transmission between humans by means of human sexual behavior, including vaginal intercourse, oral sex, and anal sex...
s.
Contraindications
Norplant should not be used in women with liver diseaseLiver
The liver is a vital organ present in vertebrates and some other animals. It has a wide range of functions, including detoxification, protein synthesis, and production of biochemicals necessary for digestion...
, breast cancer
Breast cancer
Breast cancer is cancer originating from breast tissue, most commonly from the inner lining of milk ducts or the lobules that supply the ducts with milk. Cancers originating from ducts are known as ductal carcinomas; those originating from lobules are known as lobular carcinomas...
, 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
Estrogen
Estrogens , oestrogens , or œstrogens, are a group of compounds named for their importance in the estrous cycle of humans and other animals. They are the primary female sex hormones. Natural estrogens are steroid hormones, while some synthetic ones are non-steroidal...
like some birth control pills, older women, women who smoke, and women with high blood pressure are not restricted from using the system.
Side effects
After three months of using Norplant, women will need to schedule a follow-up appointment to monitor blood pressureBlood pressure
Blood pressure is the pressure exerted by circulating blood upon the walls of blood vessels, and is one of the principal vital signs. When used without further specification, "blood pressure" usually refers to the arterial pressure of the systemic circulation. During each heartbeat, BP varies...
and discuss any concerns. Side effects
Adverse effect (medicine)
In medicine, an adverse effect is a harmful and undesired effect resulting from a medication or other intervention such as surgery.An adverse effect may be termed a "side effect", when judged to be secondary to a main or therapeutic effect. If it results from an unsuitable or incorrect dosage or...
may include irregular menstrual period
Menstrual cycle
The menstrual cycle is the scientific term for the physiological changes that can occur in fertile women for the purpose of sexual reproduction. This article focuses on the human menstrual cycle....
s for the first approximately three months, including periods lasting longer than normal, bleeding
Bleeding
Bleeding, technically known as hemorrhaging or haemorrhaging is the loss of blood or blood escape from the circulatory system...
or spotting between periods, heavy bleeding, or going with no period for the mentioned period of time. Common side effects include weight gain
Weight gain
Weight gain is an increase in body weight. This can be either an increase in muscle mass, fat deposits, or excess fluids such as water.-Description:...
,
nervousness
Anxiety
Anxiety is a psychological and physiological state characterized by somatic, emotional, cognitive, and behavioral components. The root meaning of the word anxiety is 'to vex or trouble'; in either presence or absence of psychological stress, anxiety can create feelings of fear, worry, uneasiness,...
, anxiety
Anxiety
Anxiety is a psychological and physiological state characterized by somatic, emotional, cognitive, and behavioral components. The root meaning of the word anxiety is 'to vex or trouble'; in either presence or absence of psychological stress, anxiety can create feelings of fear, worry, uneasiness,...
, nausea
Nausea
Nausea , is a sensation of unease and discomfort in the upper stomach with an involuntary urge to vomit. It often, but not always, precedes vomiting...
, vomiting
Vomiting
Vomiting is the forceful expulsion of the contents of one's stomach through the mouth and sometimes the nose...
, mastalgia
Mastalgia
Mastodynia, mastalgia or mammalgia are names for a medical symptom that means breast pain .Pain can range from minor discomfort to severely incapacitating pain...
, dizziness
Dizziness
Dizziness refers to an impairment in spatial perception and stability. The term is somewhat imprecise. It can be used to mean vertigo, presyncope, disequilibrium, or a non-specific feeling such as giddiness or foolishness....
, dermatitis
Dermatitis
-Etymology:Dermatitis derives from Greek derma "skin" + -itis "inflammation" and genetic disorder.-Terminology:There are several different types of dermatitis. The different kinds usually have in common an allergic reaction to specific allergens. The term may describe eczema, which is also called...
/rash
Rash
A rash is a change of the skin which affects its color, appearance or texture. A rash may be localized in one part of the body, or affect all the skin. Rashes may cause the skin to change color, itch, become warm, bumpy, chapped, dry, cracked or blistered, swell and may be painful. The causes, and...
, hirsutism
Hirsutism
Hirsutism or frazonism is the excessive hairiness on women in those parts of the body where terminal hair does not normally occur or is minimal - for example, a beard or chest hair. It refers to a male pattern of body hair and it is therefore primarily of cosmetic and psychological concern...
, scalp-hair loss
Baldness
Baldness implies partial or complete lack of hair and can be understood as part of the wider topic of "hair thinning". The degree and pattern of baldness can vary greatly, but its most common cause is male and female pattern baldness, also known as androgenic alopecia, alopecia androgenetica or...
, headache
Headache
A headache or cephalalgia is pain anywhere in the region of the head or neck. It can be a symptom of a number of different conditions of the head and neck. The brain tissue itself is not sensitive to pain because it lacks pain receptors. Rather, the pain is caused by disturbance of the...
, depression
Depression (mood)
Depression is a state of low mood and aversion to activity that can affect a person's thoughts, behaviour, feelings and physical well-being. Depressed people may feel sad, anxious, empty, hopeless, helpless, worthless, guilty, irritable, or restless...
, and acne
Acne vulgaris
Acne vulgaris is a common human skin disease, characterized by areas of skin with seborrhea , comedones , papules , pustules , Nodules and possibly scarring...
. Sometimes, pain
Pain
Pain is an unpleasant sensation often caused by intense or damaging stimuli such as stubbing a toe, burning a finger, putting iodine on a cut, and bumping the "funny bone."...
, itching or infection at the site of the implant will occur. Ovarian cyst
Ovarian cyst
An ovarian cyst is any collection of fluid, surrounded by a very thin wall, within an ovary. Any ovarian follicle that is larger than about two centimeters is termed an ovarian cyst. An ovarian cyst can be as small as a pea, or larger than an orange....
s may also occur, but usually do not require treatment, although they can cause pain even if benign
Benign
A benign tumor is a tumor that lacks the ability to metastasize. Common examples of benign tumors include moles and uterine fibroids.The term "benign" implies a mild and nonprogressive disease. Indeed, many kinds of benign tumors are harmless to human health...
.
Removal
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.
If desired, a new implant can be inserted at the time of removal.
Norplant discontinued in the United States
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. 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
Summary judgment
In law, a summary judgment is a determination made by a court without a full trial. Such a judgment may be issued as to the merits of an entire case, or of specific issues in that case....
s and the dismissal
Involuntary dismissal
Involuntary dismissal is the termination of a court case despite the plaintiff's objection.In United States Federal courts, involuntary dismissal is governed by Federal Rules of Civil Procedure Rule 41....
of 14,000 claims, Wyeth offered out-of-court cash settlements
Settlement (law)
In law, a settlement is a resolution between disputing parties about a legal case, reached either before or after court action begins. The term "settlement" also has other meanings in the context of law.-Basis:...
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 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. Reference: http://www.pharmac.govt.nz/2010/07/01/Notification%20of%20approved%20Jadelle%20funding%20proposal.pdf/text. 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.Use in the developing world
Despite its discontinuation in the USA 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 FundUnited Nations Population Fund
The United Nations Population Fund is a UN organization. The work of the UNFPA involves promotion of the right of every woman, man and child to enjoy a life of health and equal opportunity. This is done through major national and demographic surveys and with population censuses...
.
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.