Middle East Fertility Society Journal, Vol. 12, No. 1, 2007, pp. 8-12
OPINION
Current
state of intrauterine contraceptive devices
Hesham
Al-Inany, M.D,
Ph.D.
Department
of Obstetrics and Gynecology, Cairo University, Egypt
Correspondence: Hesham Al-Inany, M.D., Ph.D., E-mail: Hesham@khosoba.com
Received on February 5, 2007; revised and accepted on March 14, 2007
Code Number: mf07002
ABSTRACT
Background: Intrauterine contraceptive device (IUCD)
is the most commonly used method of contraception in many countries. Despite
the availability of many generations of IUDs with variable shapes and
configurations, side effects and complications are frequent. We hypothesize
that a modified IUD design with a fundal seeking effect will nullify the side
effects and the complications of the currently available IUDs. Such a design
will be at least as effective as the traditional copper devices without their
well-known disadvantages. This simple modification of the IUD shape will add to
the acceptability of this method even in communities with known preferences to
other alternatives.
Keywords: Intrauterine contraceptive device,
contraception, family planning.
Background
and significance
Contraceptive practices: Methods and
Trends
Contraceptive prevalence
is dependant on method availability or woman choice. However, what is called
as a method mix is a documented biosocial phenomenon when one or two methods
predominate in a given country. Contraceptive method skew is operationally defined
as a single method constituting 50% or more of contraceptive use in a given
country. Recently, the Center for Communication Programs, Johns Hopkins
Bloomberg School of Public Health, USA examined this phenomenon in 96 countries
(1). They found that 34 countries have this type of skewed method mix. These
34
countries were categorized in three groups: 1. sixteen countries in which
traditional methods dominate, most of which are in sub-Saharan Africa; 2. four
countries in which female sterilization predominates (India, Brazil, Dominican
Republic and Panama); and 3. fourteen countries that rely on a single reversible
method (the pill in Algeria, Kuwait, Liberia, Morocco, Sudan and Zimbabwe;
the IUD in Cuba, Egypt, Kazakhstan, Kyrgyz Republic, Moldova, Turkmenistan
and Uzbekistan; and the injectable in Malawi). Method skew in some countries
reflects cultural preferences or social norms.
Consequently, in 7 countries 50% or more of women using contraception opt to
use the intrauterine devices (IUDs) (1).
Patterns of fertility in
Egypt were found in 1995 survey to be 3.5 children per woman: 3.0 in urban
areas, 4.2 in rural areas, 4.6 among uneducated women, and 3.0 among women with
at least a secondary education. Fertility was 67/1000 women per year among
women 15-19 years old in the 4 years preceding the survey, 213/1000 women 25-29
years old, and 211/1000 women 20-24 years old. Fertility declined in each age
group over time and with increasing age. Modern contraceptive prevalence was
45.5%. Contraceptive prevalence ranged from a low of 39.1% among the uneducated
to 52.9% among women with at least some secondary education. The highest
contraceptive prevalence was among women living in urban areas. 62.7% of all
methods were obtained from private sources. The most frequently used method was
the IUD with 30% of women users. 10.4% of women used the pill (2).
Worldwide,
IUDs are among the most commonly used reversible methods of contraception.
Outside of the Peoples Republic of China, the most widely used IUDs are the
Multiload and various T-shaped devices that release microgram amounts of copper
over at least 5 years, including the TCu 380A and Nova T. Copper-releasing IUDs
are highly effective in preventing pregnancy with pregnancy rates of less than
0.8 per 100 women per year. The two most frequently occurring events that lead
to IUD discontinuation are expulsion of the device from the uterus (including
partial expulsion that then requires removal of the IUD) and removal because of
bleeding and/or pain. Expulsion rates and removal rates for bleeding and pain
are highest during the first year of IUD use and decline over time.
Clinical aspects of IUDs
The
intrauterine devices are composed of plastic or metal or a combination of both.
They are to be inserted in the uterine cavity via the cervix. Since the
introduction of the IUDs, a wide and extensive variety of shapes, sizes and
combinations of materials have been used with a wide spectrum of indications,
contraindications, acceptability, compliance, contraceptive effectiveness and
worldwide extent of use. Currently, IUDs are used more frequently in the Middle
and the Far East compared to Europe and the USA. Only 3 IUDs are available for
use in the U.S.: the Progestasert, the Copper TCu380A (Paragard), and a
levonorgestrel-releasing system (Mirena). The Progestasert is made of a special
polymer that contains a reservoir of 38 mg of progesterone, which is released
at a rate of 65 micrograms per day. Consequently, it is effective for 1 year
only. The Paragard is wrapped with a copper wire that creates a surface area of
copper of 300 mm2 on the vertical arms and 40 mm2 on each of the transverse
arms. It is effective for up to 10 years.
Mirena is releasing
levonorgestrel at 20 ug/day. It is effective for up to 5 years. It is as
effective as copper TCu380A and Norplant but also more likely to cause
amenorrhea. This function could actually be beneficial in some patients
particularly those with menorrahgia. However, side effects of progesterone as
depression, acne, headache, and weight change may also occur (3).
The exact mechanism of
IUDs action is not well understood. The most accepted explanation for IUDs
contraceptive effect is the initiation of a hostile environment to the
fertilized ovum. The most widely observed phenomenon is the mobilization of
leukocytes in response to the presence of the IUD. Supporting this hypothesis
is the widely observed leukocytes aggregate around the IUD in the endometrial
fluids and mucosa and, to a lesser extent, in the stroma and underlying
myometrium. Alteration of the endometrial maturation with the
progesterone-releasing device, tubal cilial action, and possible disruption of
normal oocyte maturation are all proposed mechanisms for the copper devices. In
additional a possible spermicidal activity is postulated (4).
The TCu380A is probably
the most effective currently available IUD with a failure rate of less than 1%
per year while the Progestasert failure rate is 1-1.5% (5). However, 25% of the
pregnancies are ectopic. Consequently the latter device does not protect
against ectopic pregnancy (6).
In
a recent meta-analysis, 34 trials were included to compare different copper
IUDs for their effectiveness and side effects. They found that TCu380A was more
effective than MLCu375, MLCu250, TCu220 and TCu200. Changing the position of
the copper on the arm of the IUD for TCu380S did not improve the efficacy of
TCu380A. MLCu375 was no more effective than TCu220, at 1 year, MLCu250 to 3
years or Nova-T to 3 years Compared to TCu380A, none of the IUDs showed any
benefits in terms of bleeding or pain, or any of the other reasons for early
discontinuation. This meta-analysis showed that TCu380A is more effective
compared to other IUDs. There is no data available comparing different IUDs in
special subgroups, such as nulliparous women (7).
Indications an IUD
Ideally, IUDs are to be
used in parous women in a mutually monogamous relationship who do not have a
current or prior history of STDs or PID. Women desiring a method of high
efficacy that is free of daily or sex related activity and women who cannot use
hormonal contraception due to side effects or medical conditions are suitable
candidates. Several surveys demonstrated that IUD users are highly satisfied
with their method.
Contraindications to the Use of IUDs
Current
pregnancy; undiagnosed abnormal vaginal bleeding; acute cervical, uterine, or
salpingeal infection; past salpingitis; and suspected gynecologic malignancy
are all absolute contraindications for IUDs. Relative contraindications include
nulliparity or high priority attached to future childbearing; prior ectopic
pregnancy; history of STDs; multiple sexual partners; moderate or severe
dysmenorrhea; congenital anomalies of the uterus or other abnormalities such as
leiomyomas; iron deficiency anemia; valvular heart disease; frequent expulsions
or problems with prior IUD use; age younger than 25 years (due to higher
prevalence of Chlamydia infections); and Wilson's disease (if a copper IUD is
to be used). If the client is in a monogamous relationship, age younger than 25
years is not a contraindication.
Complications of Insertion
Mild to
moderate discomfort or pain is often encountered at sounding or insertion. The
degree of discomfort and pain is proportional to the size of the IUD. This also
could be related to the dilatation of the cervical canal and distention of the
endometrial cavity which may lead to syncopal attacks as well. It was suggested
that paracervical anesthesia could reduce pain and syncope. It is also possible
that analgesics may be helpful for several hours following IUD insertion.
Partial or complete perforation of the uterus is a rare avoidable complication
of IUD insertion. Accurate determination of the position and size of the uterus
and strict adherence to the recommended insertion procedure could prevent
perforation.
Disadvantages and Side Effects
A. Pregnancy
The management of
intrauterine pregnancy with an IUD is mainly dependant on the patient wishes.
If the patient wishes it to continue, the IUD may be removed by traction on the
plastic tail. However, if this attempt is failed, it is advisable to leave the
device in place. Should the pregnancy continue, the incidence of spontaneous
miscarriage is around 50%, compared to only 12% in the general population. Such
a high incidence of spontaneous miscarriage could be reduced to only 20-25% if
the IUD is removed. In addition it nullifies the risk of septic abortion.
Concerning ectopic pregnancy, copper IUDs, reduces the risk twofold or more
relative to patients using no contraception.
Although about 5% of the
pregnancies that occur with a copper IUD in situ are ectopic, the overall
contraceptive action of copper IUDs reduces the risk of all pregnancies and the
absolute risk of an ectopic pregnancy. On the other side, Progestasert does not
over any protection against ectopic pregnancy. It has been demonstrated that
the risk may be 50% or greater in comparison with that of no contraception. Lastly
with Mirena use, half of all pregnancies were ectopic. However the of ectopic
with Mirena was not significantly different than the rate for sexually active
women not using contraception. There is no increased incidence of congenital
abnormalities in babies who are conceived with the IUD in utero.
B. Expulsion
Expulsions of IUDs are mostly spontaneous and occur in the
immediate post-insertion period during menses. The quality and the
configuration of the device is probably the most important detrimental factor
controlling the incidence of expulsion. In addition the stiffness, size, and
shape of the device are contributing factors. In general, the expulsion rate is
roughly proportional to the degree of distortion of the endometrial cavity
brought about by the presence of the IUD. Consequently, devices that fit the
uterine cavity configuration the best are probably associated with the least
incidence of expulsion.
Confirming that the
device is in place is ascertained by periodic self examination to be assured
that the tail of the device is still present. Expulsion of the IUD may not be
noticeable. Common reasons for missed threads of the IUD may be due to that
fact that the filament may have been drawn back into the cervix or endometrial
cavity. Less commonly, the device may have perforated the uterine wall at
insertion and passed into the peritoneal cavity which occurs in < 1 out of
1000 insertions. Sometimes the tail may have separated from the device and been
expelled unnoticed. Ascertainment of the location of the IUD could be performed
by careful inspection or exploration of the endometrial cavity with an
ultrasound examination or, if necessary, by an x-ray examination that includes
an anteroposterior as well as a lateral film and use of a sound to localize the
uterine cavity.
C. Bleeding or Pain
Bleeding or pain or both
are common reasons for removal of an IUD and discontinuation of this method of
contraception. The incidence of these symptoms is more or less related to the
degree of endometrial compression and myometrial distention brought about by
the IUD configuration. Thus, an IUD that conforms to the natural size and shape
of the endometrial cavity is likely to cause less pain or bleeding than one
that distorts the cavity and the uterine wall. The adaptability and the
conformational yielding of the device are of paramount importance for the
success of the device.
D. Pelvic Infection
The
association between IUD use and pelvic inflammatory disease or salpingitis has
been demonstrated by several studies. However, on controlling for other risk
factors associated with PID, the extent of the infection risk was reduced (8).
The infection risk is the highest around the time of insertion with 3- to
4-fold increase suggesting that contamination is of essence. This was
confirmed by the lack of evidence of an increased risk of PID after 3-4 months
after insertion or thereafter after controlling for the known risks of PID as
those with multiple sexual partners or prior STDs. The anaerobic, gram-positive
bacteria, Actinomyces Israeli, the main pathogen associated with association
with IUD induced infection (9). Ampicillin, 250 mg four times a day for 14 days
is the recommended treatment upon diagnosis. If the repeat PAP smear is
positive for A Israeli, the IUD should be removed (10).
Discontinuation of IUD
Desire for pregnancy is
the primary reason for discontinuation. Partial expulsion, persistent cramping,
bleeding, or anemia, accounting for about 20% of IUD discontinuation in the
first 3 months; acute PID or Antinomies infection on Pap smear; pregnancy;
perforation; and significant post-insertion pain, which may indicate improper
placement or partial perforation are all indications for the removal of the
device.
In a study cohort of 371
women who had an IUD, the cause of discontinuation was evaluated. The incidence
of IUD discontinuation in the first year following insertion was 17.5%.
Approximately 32% of the study sample continued using their devices after 5
years. The average duration of IUD use was 36 months. Of the 371 women, 39.6%
discontinued IUD use because of a desire to conceive, 18.6% because of side
effects, 4.9% because they were sexually inactive and 1.6% because of
opposition from the woman's family. The most common side effects reported as
reasons for discontinuation were bleeding, infection and pain. They found that
discontinuation was inversely related to current age, marital age and number of
living children. They suggested a strategy to minimize discontinuation through
effective educational strategies on the process of fertility and contraception.
They also suggested that improved counseling and good selection of candidates
before IUD insertion is required (11). Similar results were reported in other
countries as well (12).
Device Design
Research on developing
new IUD devices was mainly focused to improve IUD performance by developing
better insertion mechanisms that permit better retention of the IUD in the
uterus and the use of smaller and more flexible IUDs to minimize the insertion
related complications. It is generally agreed that smaller and more flexible
IUDs cause less pain and bleeding.
REFERENCES