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This discussion is intended to provide general information and should not serve as a
substitute for a physician's advice. |
Norplant® is the registered trademark of the Population Council for
a system of six silastic implants filled with levonorgestrel, a synthetic
progestin.
Norplant is an effective, long-acting, reversible contraceptive for women
that protects for up to five years. Six thin, flexible capsules made of a soft, rubberlike
material, filled with a synthetic progestin, are inserted just under the skin of a woman's
upper arm in a minor surgical procedure. The implants do not contain estrogen. Protection
is generally provided within 24 hours after the insertion, and the woman rapidly returns
to her normal fertility when the implants are removed. The most common side effect is
change in menstrual bleeding patterns.
Pregnancy is prevented in Norplant users by a combination of mechanisms. The
most important of these are the inhibition of ovulation and the thickening of the cervical
mucus, which makes it impermeable to sperm. Other mechanisms may add to these
contraceptive effects.
Norplant implants are made with silicone rubber tubing filled with a
synthetic hormone. This contraceptive is not made of new ingredients; the tubing has been
used in surgical applications since the 1950s and the hormone released by the implants,
levonorgestrel, has been used in combined oral contraceptives and in the minipill for more
than 20 years. What is different about the Norplant implant method is the
way it delivers the contraceptive drug to the body.
Each of the six Norplant
capsules is 34 mm (1 3/16 of an inch) long and
2.4 mm in diameter
(about the size of a pocket match) and contains 36 mg of levonorgestrel, which is released
at a low, steady rate.
The Norplant implant method is one of the most effective reversible
contraceptives available. For every 1,000 women who use Norplant implants
for a year, fewer than two will become pregnant. During the first five years
of use, Norplant implants have a lower failure rate than the pill or most
IUDs and the method's efficacy can be compared to surgical sterilization.
The cumulative pregnancy rate for the entire five years is 1.1 per 100
users.
The Population Council
data are based on capsules made from two kinds of tubing, one denser than
the other. The softer tubing, which is now commonly used, is more effective
over a five-year span, because of a higher release rate of levonorgestrel
into the bloodstream. Recently published data show that the softer tubing
has a cumulative five-year failure rate of less than 2.0 percent.
Norplant implants have been approved for contraceptive protection for five
years. All six capsules have to be inserted during the same procedure, even
if the method is to be used for fewer than five years. At the end of the
fifth year, when the implants should be removed, a new set may be inserted
for continued protection.
Norplant implants may be used by almost any woman in her fertile years who
wants to avoid pregnancy. It is suitable for women who are seeking
continuous, yet reversible, contraception; who want to space their children;
who cannot use methods that contain estrogen; who do not want to be
sterilized; and/or who desire a method that is convenient and not related to
sexual intercourse. There have been no differences in reactions to Norplant
implants based on a woman's race, age, or ethnic group.
Norplant implants should not be used by women who have: active thromboembolic
disorders, such as blood clots in the legs, lungs, or eyes; undiagnosed genital bleeding;
acute liver disease; known or suspected carcinoma of the breast; and a history of
idiopathic intracranial hypertension (IIH). Also, women who are pregnant should not use
Norplant implants. Women who have had previous blood clots or other
thromboembolic disorders should consult with their healthcare providers on whether to use
the method.
Yes. Although pregnancy rates are higher in heavier women (over 154 lbs.), even in this group they
are below those of oral contraceptives.
If there are no contraindications, Norplant implants may be used by women
throughout their reproductive years. A young woman can start using the method once her
periods become regular, which is usually about two years after the onset of her menses.
Older women can use Norplant implants as they approach menopause.
Discussions with women using Norplant implants in various countries show they
liked the method's convenience, effectiveness, and reversibility. Other advantages
mentioned were the method's long-term duration, limited side effects compared to other
methods, and the fact that it was placed in the arm. In some societies, women are
reluctant to undergo internal examinations.
Menstrual irregularities, a side effect of Norplant that can be troublesome
for many women, were cited as the least liked aspect of the method. Prior to insertions
and removals, many women were concerned that the procedures might be painful. Some women
also were concerned because they could not insert or remove the method themselves. With a
provider-dependent method such as Norplant implants, it is important that
women be able to request and receive removal on demand from providers instructed in the
procedures.
Continuation rates have been high in clinical studies and field trials of Norplant
use. Published data for the United States show a continuation rate of 88 percent
in the first year. Cumulative continuation rates in seven preintroduction studies averaged
80 percent or more in succeeding years.
The principal reasons women discontinue using Norplant include: medical
reasons and side effects; in order to become pregnant; or for other personal reasons.
Studies conducted by the Population Council indicate that the most common side effects
causing women to halt implant use in a five-year period are: menstrual irregularities
(17.4 percent); headache (1.9 percent); weight changes (1.7 percent); mood changes (1.1
percent); and depression (0.9 percent).
It is important for a woman to know all about Norplant implants and how the
method compares with other available contraceptives. Studies have shown that users who
receive good counseling are more satisfied with the method they adopt and are more likely
to continue using it. Before deciding to use Norplant implants, a woman
should understand how the method works, what side effects to expect, and when to have the
implants removed. She should know that insertions and removals are simple procedures when
performed by trained healthcare providers, and are not painful to most women.
Insertion
and Removal
Should a woman considering
Norplant get a physical exam first?
It is recommended that a woman considering Norplant implants undergo a
medical examination. This may include giving a medical history and having a pelvic exam to
ensure that she has no diseases or conditions that would make it unsafe for her to use
Norplant implants.
Can Norplant
implants be inserted at any time?
To make sure the woman is not pregnant, Norplant implants should be inserted
within seven days after the onset of menstrual bleeding, or immediately postabortion.
However, Norplant implants may be inserted at any time during the menstrual
cycle, provided the woman is not pregnant and effectively uses a nonhormonal method for at
least seven days after insertion.
How are the capsules
inserted?
The implants are inserted under the skin of the inner side of the upper arm in a minor
surgical procedure. A local anesthetic is injected and the clinician makes a small
incision—2 mm long. The capsules are placed one at a time in a fan shape using a
special hollow needle called a trocar. The procedure typically takes 10 to 15 minutes.
Because a local anesthetic is used, there should be little or no pain. Usually the
incision is covered with protective gauze and a small adhesive bandage.
Who performs the insertions?
Generally, any specially trained physician, nurse, nurse-midwife, or other healthcare
professional can do the insertion. The prevailing laws will determine who is allowed to
perform the procedures. Women should confirm that their healthcare provider has been
instructed in the procedure before he or she inserts or removes the Norplant
implants.
Will the insertion site hurt?
The needle providing the anesthetic may sting briefly. When the anesthetic wears off,
there may be some tenderness for a day or two, as well as some discoloration, bruising,
and/or swelling in the area for a few days after placement. There have also been reports
of tingling and numbness in the arm after the procedure.
How should the insertion site
be cared for?
The insertion site should not be bumped for a few days and the area should be kept dry.
The protective gauze bandage should be left in place for three days and the small adhesive
bandage should be left on for a day or two longer.
Are Norplant
implants visible?
Since the incision is tiny, Norplant implants do not leave a noticeable scar
on most women. The implants are comfortable and barely visible. When they are visible, the
outline of the implants, resembling colorless veins, may be seen under the skin.
Will the implants move
around?
After Norplant capsules are inserted, they sometimes move from the original
position. Infrequently, movement of a few inches has been reported. Some Norplant
users have reported movement accompanied by pain or discomfort. The woman should contact
her healthcare provider if this occurs.
Can a woman work after the
insertion?
Yes. She can resume her normal work and domestic activities, as long as she does not bump
the site or get the incision site wet for at least three days.
How soon after insertion can
the couple have sexual relations?
Norplant becomes effective within 24 hours after insertion. If the woman has
the implants inserted within seven days of her menses, she can have sexual relations
without a backup method 24 hours later. If the capsules were inserted at another time of
the menstrual cycle, the woman should use a nonhormonal backup method.
When should a woman return to
the clinic after she receives Norplant implants?
The follow-up schedule depends on the practice of the particular clinic or physician's
office in which a woman receives the implants. She may be asked to return for periodic
health checkups or to report on her experience with the implants. She should be encouraged
to return to the same provider or clinic if she has any health problems that worry her; if
she wants a child; or if she is moving away and needs the address of a clinic in her new
area that provides Norplant services.
Annual checkups, besides being good
medical practice, offer an occasion to remind women to have their implants removed at five
years.
How is Norplant
implant protection reversed?
One of the most important characteristics of Norplant implants is their
reversibility. The contraceptive action stops within two to three days after the implants
are removed during a clinical procedure, under a local anesthetic, similar to the
insertion process.
When should Norplant
implants be removed?
Norplant implants must be removed at the end of five years when they become
less effective. Before that time, however, the woman should be able to request and obtain
removal of the implants at any time, for either a personal or medical reason.
What happens if the implants
are not removed after five years?
More than two-thirds of the hormone remains in the capsules after five years of use. After
that time, the implants will gradually become less effective. While the implants should be
removed at five years, there is no cause for panic if removal is delayed for a few
months.
Who should remove the
implants?
The implants can be removed at the same clinic or office where they were inserted or at
another health facility that offers Norplant implants. As with insertion, a
woman should confirm that her clinician has been instructed in the removal procedure prior
to removing the implants.
Is removal painful?
Just as when the capsules were inserted, the health professional will apply a local
anesthetic so the woman should not feel pain. It is not necessary to use general
anesthesia for this procedure. Clinicians should feel the site to be sure they can locate
all six capsules prior to removing them. If they cannot be felt, the implants can be
located through x-ray or ultrasound, which are painless procedures.
A small incision—not longer
than 4 mm—will be made, through which all the implants are removed. When the
anesthetic wears off, there may be some tenderness, discoloration, bruising, and swelling
in the area for a few days.
Are removals more difficult
than insertions? How long does removal take?
Although most removals are not difficult, the removal procedure usually takes longer than
insertion. Some implants may be harder than others to locate and remove if they were
inserted too deeply or if temporary swelling of the arm occurs during removal. There have
been reports of nerve injury, most commonly associated with deep placement and removal. If
the clinician is unable to remove all the capsules at one time, the woman should return at
another time after her arm heals. Women should be informed of the possibility of needing a
subsequent visit for removal and should not be alarmed if this is necessary.
How should women care for the
site after removal?
As with insertion, it is important to avoid rough contact with the removal site for a few
days. The area should be kept clean, dry, and bandaged until healed (3 to 5 days) so that
the site does not become infected.
How soon afterwards can a
woman become pregnant?
The reversibility of Norplant implants is one of the important advantages of
the method. Once the implants are removed, the contraceptive effect wears off quickly
(within two to three days). The woman can become pregnant as rapidly as she would have if
she had used another reversible method or if she had used no method during the time Norplant
was inserted in her arm.
Can another set of implants
be inserted when the old set is removed?
Yes. If a woman wants to continue using Norplant, a new set of implants can
be inserted when the old set is removed. The second set can be placed through the incision
from which the earlier set was removed, in the same or opposite direction, or in the other
arm. If a woman does not want to continue with Norplant implants and does not
want to become pregnant, she should be offered another contraceptive method before she
leaves the clinic.
What are the side effects of
Norplant?
The most common side effect of Norplant use is irregular menstrual bleeding.
Irregularities vary from woman to woman and may include: prolonged menstrual bleeding
during the first months of use (rarely heavy bleeding); untimely bleeding or spotting
between periods; no bleeding at all for several months and, in some cases, for a year or
longer; or a combination of these patterns.
Other side effects experienced with
Norplant are frequently associated with use of hormonal methods. Side effects
reported by users that are probably related to Norplant implants include:
headache (the most frequent complaint after menstrual irregularities); dizziness;
nervousness; anxiety; nausea, and vomiting; adnexal enlargement; itching/rashes; acne;
change of appetite; weight gain; breast tenderness; excessive hair growth; hair loss; and
discoloration of the skin at the insertion site.
Preexisting conditions of acne or
excessive growth of body or facial hair could worsen. Occasionally, an infection may occur
at the implant site (which can be treated with an antibiotic), or there may be a brief
incidence of pain, itching, numbness, or tingling in the arm of insertion.
How frequently do Norplant
side effects occur?
Bleeding irregularities (including spotting, longer or heavier periods, or no bleeding)
are reported by 70 to 80 percent of Norplant users. Both increased and
reduced bleeding tend to diminish with time.
Percentages of users reporting the
other more common side effects during the first year of use are: headache (18 percent);
skin problems including dermatitis and acne (15 percent); and nausea (8 percent). Appetite
changes, weight changes, and nervousness are each reported by 6 percent of users.
Are the bleeding
irregularities associated with Norplant implants serious?
Most bleeding irregularities associated with Norplant® use are not serious,
although they may be troublesome for some users. Change in the menstrual bleeding
pattern—the most frequently reported side effect—is to be expected with hormonal
methods that do not contain estrogen. If a woman experiences heavy bleeding, she should
make a follow-up visit to her physician or healthcare provider.
What kind of bleeding pattern
can be expected?
It is not possible to predict the kind of bleeding pattern a woman will have while using
Norplant implants. There is some evidence of a correlation between a woman's
weight and the kind of bleeding irregularities she will have. Some studies indicate that
very thin women are more likely to be amenorrheic, while heavier women have more bleeding
and spotting days, but accurate predictions of how she will react to the method cannot be
made. Both increased and reduced bleeding tend to diminish with time. Many women can
expect an altered menstrual bleeding pattern to become more regular after six to nine
months.
Is the lack of bleeding
harmful?
Sometimes a woman is concerned about amenorrhea—no monthly bleeding at all. A woman's
health or future fertility will not be harmed if she does not have her period while using
Norplant; there is no blood "buildup." If a woman wants to make
sure she is not pregnant, she can return to the clinic for a pregnancy test. She is
probably not pregnant, but the test might reassure her.
Does the use of Norplant
implants make women anemic?
Despite the increased frequency of menstrual bleeding in some women using Norplant,
the amount of total blood loss is usually less than normal menses. In some studies, in
fact, hemoglobin values of Norplant implant users have been shown to
increase. There have been a few rare exceptions of severe blood loss.
Should women be given
estrogen to control bleeding and spotting?
Norplant implants are estrogen-free and many women and their healthcare
providers choose the method for exactly this reason. Research is being conducted to test
the effectiveness of a few treatments for bleeding irregularities, but it is still too
early to tell whether any will be successful. As of now, the best way to handle irregular
bleeding is through sensitive and thorough counseling of women who want the method.
Research has shown that women who have been well counseled about what to expect with
implants are more likely to find the method acceptable and to continue with it.
How do Norplant
implants affect the body's chemistry?
Extensive clinical pharmacology research has shown no adverse effects of progestin implant
use on endocrine patterns, the endometrium, lipoproteins, adrenal function, thyroid
function, and a variety of other physiological indicators in healthy women. These studies
also have given no indication of cardiovascular, respiratory, central nervous system, or
other serious problems, nor is there any evidence of carcinogenicity or teratogenicity
associated with Norplant implant use in healthy women.
Certain conditions present before
implant use, such as diabetes, may be affected by Norplant use; women with
these conditions should be carefully monitored. (See additional questions in this section
for specific conditions.)
What are warning signs of
possible problems?
A woman using Norplant implants should return to her healthcare provider or
clinic right away if she has: severe lower abdominal pain (possible ectopic pregnancy);
heavy vaginal bleeding; arm pain; pus or bleeding at the insertion site (an indication of
infection); expulsion of an implant (this rarely occurs with proper placement); episodes
of migraine or repeated severe headaches; blurred vision; or delayed menstrual cycles
after a long interval of regular cycles.
Failure to have periods after
regular cycles may be a sign of pregnancy. If the woman is not bleeding at her expected
time and has lower abdominal pain or symptoms of pregnancy, she should visit the clinic
without delay.
Are there other health
considerations with Norplant use?
Women with certain health conditions can use Norplant implants, provided they
have regular checkups. If a woman has any of the following conditions, she should discuss
them with her healthcare provider before using the method: breast nodules, fibro-cystic
disease of the breast, an abnormal breast x-ray or mammogram; diabetes; elevated
cholesterol or triglycerides; high blood pressure; migraine or other headaches; epilepsy;
mental depression; gallbladder, heart, or kidney disease; a history of blood clots, heart
attack, or stroke; or a history of scanty or irregular menses.
Does Norplant
cause heart or vascular problems?
Although there have been postmarketing reports of stroke, myocardial infarction, and
certain vascular problems such as thromboembolic disorders (all of which occur among the
general population) among Norplant users; no cause-and-effect relationship
between Norplant use and these conditions has been shown.
Thrombophlebitis and superficial
phlebitis have also been reported among Norplant users, most commonly
occurring in the arm of insertion. (See below for more information on stroke and heart
attacks among smokers.)
Does Norplant
cause autoimmune diseases?
Autoimmune diseases such as scleroderma, systemic lupus, and rheumatoid arthritis occur in
the general population and more frequently among women of childbearing age. There have
been rare reports of various autoimmune diseases, including those listed above, in
Norplant users; however, the rate is significantly less than the rate among
the general population of women of reproductive age. While it is believed that the
occurrence of autoimmune diseases among Norplant users is coincidental,
healthcare providers should be alert to the earliest manifestations of these diseases.
Does Norplant
cause birth defects?
Although there have been rare reports of birth defects in offspring of women who were
using Norplant inadvertently during early pregnancy, these conditions are not
believed to be caused by Norplant use. However, if a woman becomes pregnant
while using the implants, they must be removed immediately.
Can a smoker use Norplant
implants?
Cigarette smoking increases the risk of heart attacks and strokes in users of combined
(estrogen-progestin) oral contraceptives. This risk increases with age and with heavy
smoking (15 or more cigarettes a day) and is quite marked in women over 35 years old.
While this is believed to be an estrogen-related effect, it is not known whether a similar
risk exists with progestin-only methods such as Norplant implants. Therefore,
a woman who chooses to use Norplant implants is advised not to smoke.
Do Norplant
implants protect against sexually transmitted infections?
No. This form of contraception does not protect against sexually transmitted
infections (STIs). If a woman thinks she might be at risk for STIs, she and her partner should use a
condom in addition to the implants.
Can a woman use Norplant
implants if she is breastfeeding?
Hormonal methods are not considered the most appropriate contraceptives for breastfeeding
women. However, studies have shown no significant effects on the growth or health of
infants whose mothers used levonorgestrel implants beginning six weeks after childbirth.
There is no experience to support the use of Norplant implants earlier than
six weeks after childbirth.
Is sickle cell anemia a
contraindication?
Sickle cell anemia is not considered a contraindication for the use of Norplant
implants. However, the Council does not have data from clinical trials, since women who
were anemic were not included in the Council's studies with Norplant
implants.
Do other drugs interact with
Norplant implants?
Certain drugs may interact with the hormone
delivered by Norplant implants to make them less effective in preventing pregnancy.
These include drugs used for epilepsy such as phenytoin (like Dilantin), and drugs for
rheumatoid conditions such as phenylbutazone (Butazolidin is one brand). A woman using
Norplant implants should tell her healthcare provider if she is taking any of
these medications.
Is there a risk of ectopic
pregnancy?
The risk of ectopic pregnancy (a fetus developing outside the uterus) is very low, because
of the high effectiveness of the method. Ectopic pregnancies have occurred among women
using Norplant implants at an average rate of 1.3 per 1,000 woman-years, less
than the overall ectopic rate of women in the United States during the 1980s. The risk may
increase with the duration of Norplant implant use or with increased weight
of the user. It is important, therefore, that the implants be removed at the end of five
years when they become less effective.
Are ovarian cysts a problem
for the users of Norplant implants?
Functional ovarian cysts or enlarged follicles sometimes occur in Norplant
users, as they do in women who do not use Norplant implants. These enlarged
follicles may produce discomfort in some women, although most users would not be aware of
them unless they were found during a physical exam. In the majority of women, enlarged
follicles will disappear on their own and should not require surgery. Rarely, they may
twist or rupture so that surgery is required.
Are long-term side effects
known?
Long-term side effects of Norplant use are not yet known. However, the
drug contained in Norplant, levonorgestrel, has been used in oral
contraceptives for over 20 years.
To learn more about any possible
rare, medium-term health effects related to the method, the World Health Organization, the
Population Council, and Family Health International are conducting an international
postmarketing surveillance of Norplant implant use. Some 8,000 method users
and discontinuers, and an equal number of controls, in eight developing countries have
been followed for five years.
Research
and Development
Why
were Norplant implants developed?
The Population Council developed Norplant implants to expand contraceptive
options for women, by offering a method that was convenient, long-acting, and reversible.
In addition, the implants deliver a very low dose of progestin and contain no estrogen.
Why are additional
contraceptives needed?
There is currently no reversible contraceptive that all women like and are able to use. A
woman may try several methods until she finds the one that best suits her. Furthermore, a
woman may switch methods several times during her reproductive lifetime because of changes
in her age, health, economic security, marital status, lifestyle, and concept of ideal
family size. All of these factors can have an impact on her decisions about contraception:
when to use or stop using it, what kind to use, and when to switch to another method.
Even with Norplant
implants as an option, there is a need for new contraceptives for groups of women whose
needs are not met by existing methods.
Norplant implants were tested in four developing and four developed
countries, including the United States. In addition, many countries have conducted
preintroduction studies to obtain data on local experience with the method and to train
providers in insertion, removal, and counseling techniques. By 1991, when the method
became available in the United States, Norplant implants had been studied in
clinical trials and preintroduction studies involving over 55,000 volunteers in more than
40 countries.
By July 1995, the method was approved in 44 countries, including Sweden, France, the
United Kingdom, and the United States. The US Food and Drug
Administration approved Norplant for marketing in December 1990.
Is there a risk of Norplant
being used coercively?
Yes. There is a risk of any provider-controlled method being used coercively. The
Population Council advocates solely the voluntary use of any contraceptive.
Women have the right to balanced and accurate information, trained and capable
healthcare providers, aseptic conditions, and the ability to discontinue the
method whenever they choose to do so. When a method is provider-dependent, informed consent should always be obtained
at the time the method is adopted, and Norplant users should have ready
access to removal of the implants by capable health care providers.
The Council has worked
since 1983 to encourage introduction of implants with concern for user
satisfaction and emphasis on the quality of care in the provision of family
planning services.
