Download METHODS OF CONTRACEPTION Fertility Awareness Methods

METHODS OF CONTRACEPTION
There are many forms of family planning and contraception available in the United States. They fall
into a number of broad categories, including: fertility awareness, situational, spermicidal, barrier,
long-acting reversible, shorter-term hormonal, permanent (sterilization), and clinical interruption of
pregnancy (medical/surgical abortion). These methods demonstrate differing levels of
effectiveness, side effects, cost, ease of use, and other advantages and disadvantages.
CONTRACEPTION USE IN THE UNITED STATES: 1982–2008
Method
Number of Users
S o u rce : M o sh e r & Jo n e s, 2 0 1 0 .
Oral contraceptives
10.1 million
Female sterilization
10.3 million
Emergency contraception
5.2 million
Intrauterine device (IUD)
2.1 million
Male condom
5.3 million
Male sterilization (vasectomy)
3.7 million
Fertility Awareness Methods
Fertility awareness methods are also called natural family planning. These methods are most
effective for women who have regular menstrual cycles (between 26 and 32 days in length) and a
cooperative, committed partner. These methods also assume monogamy, because they do not
protect against STIs. Effectiveness also depends on extensive counseling and education by a
clinician.
All fertility awareness methods are designed to determine the fertile days in a woman’s menstrual
cycle, either by counting the days and/or observing changes in cervical mucus and basal body
temperature. On fertile days, the couple either abstains from penile-vaginal intercourse, uses
another method of contraception (such as a condom), or engages in non-penile-vaginal forms of
sexual expression.
Correct and consistent use of fertility awareness methods is somewhat effective; the failure rate
varies from 3 to 5%. With typical use, however, the failure rate may be as high as 25% (Arevalo et
al., 2002).
Fertility awareness methods involve no hormones or devices (other than a basal body temperature
thermometer), so they are comparatively low cost and without side effects. Some couples find that
using these methods enhances their relationship. If they want children in the future, fertility
awareness also can be used to time conception.
STANDARD DAYS METHOD (SDM)
Using the Standard Days Method, the woman tracks the days of her menstrual cycle on a
calendar. Day 1 is the first day of menstruation and days 8 through 19 are the fertile days, when
unprotected intercourse is avoided.
CALENDAR DAYS (Rhythm) METHOD
The Calendar Days Method is the least reliable fertility awareness method, and it requires more
advance planning. The woman keeps track of her menstrual cycle for 6 to 12 months and then
subtracts 18 from the number of days in the shortest cycle and 11 from the number of days in the
longest cycle. The two resulting numbers mark the beginning and end of the fertile period. This
method has been largely replaced by methods that rely on observable changes such as
temperature and cervical mucus changes.
BASAL BODY TEMPERATURE (BBT) METHOD
This method also requires 3 to 4 months advance planning. Each morning, as soon as she wakes,
the woman takes her BBT and records the temperature on a graph. The BBT method is based on
the premise that BBT sometimes drops just before ovulation and almost always rises about 0.4 to
0.8° F and remains elevated for several days afterward. After three or four months of recording
temperatures, a woman who has regular menstrual cycles should be able to predict when
ovulation will occur. Because sperm are thought to be viable for 5 days, the couple avoids
unprotected sex for several days before ovulation begins and for several days after.
OVULATION (Cervical Mucus) METHOD
This method involves tracking daily changes in the cervical mucus during a month of abstinence
from vaginal intercourse. Normally, there is little cervical mucus present between the end of
menstruation and just before ovulation. At the time of ovulation, the mucus becomes clear and
slippery like raw egg whites and is more permeable to sperm. Following ovulation and just before
the onset of menstruation, the mucus becomes thick and sticky, blocking the sperm from entering
the uterus.
SYMPTOTHERMAL METHOD
This is the most complex fertility awareness method and includes BBT and cervical mucus
tracking, as well as assessing and recording cycle length, increased libido, abdominal bloating,
and mittelschmerz (midcycle abdominal pain). This method improves the effectiveness of birth
control but necessitates intense commitment by the couple and extensive education and
counseling by an expert in this method.
LACTATIONAL AMENORRHEA METHOD (LAM)
Breastfeeding has many benefits for both mother and infant. The U.S. Department of Health and
Human Services recommends that infants be exclusively breastfed during the first 4 to 6 months of
life. Ideally, breastfeeding should continue through the first year of life (Office on Women’s Health,
2000).
One of the maternal benefits of breastfeeding is a natural contraceptive effect, an essential factor
in family planning in developing countries. However, lactation is an effective contraceptive for the
first 6 months postpartum only if women breastfeed exclusively and at regular intervals, including
nighttime. “The effectiveness of this method is dependent on the intensity and frequency of infant
suckling and the extent to which supplemental food is added to the infant’s diet.” “Regular
intervals” means no intervals of more than 4 hours between feedings during the day or 6 hours at
night. “Exclusive breastfeeding” means that supplemental food not should exceed 5% to 10% of
total feedings (King, 2007).
Women who supplement breastfeeding or do not breastfeed at all need to use another method of
contraception beginning at 3 weeks postpartum. Although research shows that most nonlactating
women will not ovulate until 6 weeks postpartum, a small number may ovulate as early as 3 weeks
postpartum (Jackson & Glasier, 2011).
Ideally, clinicians would discuss lactation and contraceptive options with patients during the third
trimester of pregnancy. Nonhormonal methods are preferred for women who plan to breastfeed
because contraceptives containing estrogen can interfere with lactation and may have negative
effects on the infant. However, the progestin-only pill can be used by breastfeeding mothers. The
copper IUD can be inserted as early as 10 minutes after the placenta is delivered or anytime up to
3–4 weeks postpartum. Barrier methods such as the condom, the diaphragm, or the cervical cap
can also be used. If the woman wants no additional children, tubal ligation can be accomplished at
the time of delivery.
Situational Contraception
ABSTINENCE
Abstinence means not having vaginal, anal, or oral sex at any time. Abstinence is the only
guaranteed method of preventing pregnancy and transmission of STIs. It is safe, effective, free,
and has no negative side effects. According to the CDC (2011b), an increasing number of teens
and young adults are choosing abstinence to avoid pregnancy and STIs, some for religious
reasons. Internet support groups for those who choose abstinence are growing. It should be noted,
however, that the proliferation of Title V abstinence-only sex education programs after 2000 was
followed by an increase in the teen birth rate in 2006 and 2007, reversing a steady decline that
began in 1991.
COITUS INTERRUPTUS (Withdrawal)
This method is ineffective. Because the preejaculation fluid often contains sperm, even when the
male withdraws before ejaculating, sperm may be left in the vagina. Unfortunately, some
population groups, particularly Latinos, rely on this method. Questioned about birth control use,
many Latinas say: “My husband takes care of me.” What she means is that he’s withdrawing and
ejaculating outside her vagina (Branch et al., 2010).
DOUCHING
Douching after intercourse is ineffective and not recommended. It may increase the risk of
pregnancy by forcing sperm upward into the cervix.
Spermicides
Spermicides are available as creams, foams, gels, suppositories, and films that contain a chemical
called nonoxynol-9 (N9) that kills sperm. Used alone, they are somewhat effective in preventing
pregnancy but are more effective when used with a barrier method such as a condom, diaphragm,
or other barrier. Spermicides do not protect against HIV or other STIs.
Creams, foams, and gels are placed high up in the vagina near the cervix with a plastic plungertype applicator. Suppositories and films are inserted into the vagina and take 10–15 minutes to
become effervescent and effective. These products can be applied up to 1 hour before intercourse
and should be reapplied with each act of intercourse. The woman should not rinse the vagina or
douche for at least 6 hours after the final act of intercourse.
Using spermicides twice daily or more increases the risk of vaginal irritation, yeast infection,
bacterial vaginosis, urinary tract infection, and HIV transmission.
In 2007, the FDA issued a warning for nonoxynol-9 over-the-counter contraceptive products,
requiring manufacturers of these products to include labeling with the following information:
•
For vaginal use only
•
Not for rectal (anal) use
•
Sexually transmitted disease alert: This product does not protect against HIV/AIDS or
other STIs and may increase the risk of getting HIV from an infected partner.
•
Do not use if you or your sex partner has HIV/AIDS. If you do not know whether you or
your sex partner are infected, choose another form of birth control.
•
When using this product, you may get vaginal irritation (burning, itching, or a rash). This
irritation may increase the risk of getting HIV/AIDS from an infected partner.
•
Stop use and ask a doctor if you or your partner get burning, itching, a rash, or other
irritation of the vagina or penis.
Barrier Methods
Barrier methods of contraception prevent sperm from entering the uterus. These methods include
the male condom, female condom, diaphragm, cervical cap, and vaginal sponge. Effectiveness of
any of these methods in preventing pregnancy depends on correct and consistent use. The male
latex condom affords the greatest protection against transmission of STIs. Only abstinence from
any sexual activity offers more effective contraception and prevention of STI transmission.
MALE CONDOM
Condoms are inexpensive, convenient to use, widely available, and can be combined with a
spermicide for additional protection against pregnancy and STI transmission. However, some men
may resist using condoms because they reduce sensation and spontaneity. In addition, some
individuals are allergic to latex. Spermicides containing nonoxynol-9 also can irritate genital
tissues, which can heighten the risk of STI transmission. Women whose partners refuse to use
condoms need to choose a method that does not rely on male partner participation, such as
hormonal contraceptives (oral, transdermal, injection, or implant); a diaphragm or cervical cap with
contraceptive jelly or foam; or an intrauterine device (IUD).
To achieve maximum protection from unintended pregnancy and/or STI/HIV transmission by using
condoms, they must be used consistently and correctly (see box). The failure of condoms to
protect against STI/HIV transmission usually results from inconsistent or incorrect use, rather than
product failure.
•
Inconsistent or nonuse can lead to STI acquisition because transmission can occur with
a single sex act with an infected partner.
•
Incorrect use diminishes the protective effect of condoms by leading to condom
breakage, slippage, or leakage. Incorrect use more commonly entails a failure to use
condoms throughout the entire sex act, from start (of actual contact) to finish (after
ejaculation).
(CDC, 2010c)
HOW TO USE A CONDOM
•
Use a new condom for every act of vaginal, anal, and oral sex—throughout the entire
sex act (from start to finish). Before any genital contact, put the condom on the tip of
the erect penis with the rolled side out.
•
If the condom does not have a reservoir tip, pinch the tip enough to leave a half-inch
space for semen to collect. Holding the tip, unroll the condom all the way to the base
of the erect penis.
•
After ejaculation and before the penis gets soft, grip the rim of the condom and
carefully withdraw. Then gently pull the condom off the penis, making sure that semen
doesn’t spill out.
•
Wrap the condom in a tissue and throw it in the trash where others won’t handle it.
•
If you feel the condom break at any point during sexual activity, stop immediately,
withdraw, remove the broken condom, and put on a new condom.
•
Ensure that adequate lubrication is used during vaginal and anal sex, which might
require water-based lubricants. Oil-based lubricants (e.g., petroleum jelly, shortening,
mineral oil, massage oils, body lotions, and cooking oil) should not be used because
they can weaken latex, causing breakage.
•
Do not use a male condom with a female condom. If the two condoms rub together,
the friction between them can cause the male condom to be pulled off or the female
condom to be pushed in.
Source: CDC, 2010c.
FEMALE CONDOM
The female condom (FC2) is a plastic sheath worn inside the woman’s vagina during intercourse.
It helps prevent pregnancy and reduces the risk of STIs. Made of thin plastic (nitrile), the female
condom is inserted in the vagina much like a tampon. The condom has flexible rings at each end
and is lubricated. The ring at the closed end of the condom holds the pouch in place, and the ring
at the open end stays about an inch outside the vaginal opening during intercourse. The female
condom collects preejaculate fluid and semen, thereby preventing sperm from entering the vagina.
Before anal intercourse, the ring at the closed end of the condom is inserted into the anus.
Female condom. (Source: aids.gov.)
Using a spermicide with the female condom increases its effectiveness in preventing pregnancy.
Spermicide or lubricant should be used on the outside of the closed end of the condom before
insertion into the vagina.
Do not use a male condom with a female condom. If the two condoms rub together, the friction
between them can cause the male condom to be pulled off or the female condom to be pushed in.
The female condom is removed by squeezing and twisting the outer ring to retain the semen inside
the pouch and carefully pulling it out before discarding. Used condoms should be put in the trash,
not flushed down the toilet. Female condoms should not be reused.
One randomized trial comparing the effectiveness of male and female condoms found that they
were equally effective as barriers to semen. Effectiveness as barriers was measured by the
concentration of prostate specific antigen (PSA) in vaginal fluid. However, study participants
reported 4 times as many mechanical problems with female condoms as with male condoms
(Macaluso et al., 2007).
DIAPHRAGM
The diaphragm is a shallow latex or silicone cup that fits over the cervix and is generally used with
spermicidal gel or foam. Diaphragms come in different sizes, ranging from 50 to 95 mm in
diameter, and must be fitted by a physician or nurse practitioner. Patients need to be refitted after
pregnancy or weight gain or loss of 10 or more pounds.
Clinicians need to teach the patient how to:
•
Apply spermicide to the diaphragm, insert it, and check for correct placement
•
Remove the diaphragm
•
Inspect the diaphragm for tears and holes before each use
•
Clean and store the device correctly
Diaphragms can be inserted up to 6 hours before intercourse and should remain in place for at
least 6 hours but no more than 24 hours after the last act of intercourse. For additional acts of
intercourse during the 6-hour period, fresh spermicide should be inserted into the vagina without
removing the diaphragm. The patient should not rinse the vagina or douche while wearing the
diaphragm or for at least 6 hours after the last act of intercourse.
The latest CDC study on contraceptive use found that use of the diaphragm has declined steadily
since 1982 from 8% to near 0% (Mosher & Jones, 2010).
CERVICAL CAP
The cervical cap (FemCap) is a thimble-shaped silicone cup that fits over the cervix and has a
strap for removal. Like the diaphragm, the cap requires fitting by a physician or nurse practitioner
and is designed to be used with a spermicide. The cervical cap is available in three sizes: 22, 26,
and 30 mm as measured by the inner diameter of the rim. The 22 mm cap is intended for women
who have never been pregnant. The 26 mm cap is designed for women who have been pregnant
even for 2 weeks and did not have a vaginal delivery. The 30 mm cap is intended for women who
have had a vaginal delivery of a full-term infant.
Clinicians need to teach patients how to:
•
Apply spermicide inside the bowl and the groove around the outside of the cap
•
Insert the cap and check for correct placement
•
Remove the cap
•
Clean and store the device correctly
The cap can be inserted ahead of time and should be left in place for at least 6 hours after the last
act of intercourse, but should not be worn for more than 48 hours. Additional acts of intercourse
during the 6-hour period do not require additional spermicide. The patient should not rinse the
vagina or douche while wearing the cervical cap and for at least 6 hours after the last act of
intercourse.
The cap should not be used during menstruation.
VAGINAL SPONGE
The vaginal sponge (Today sponge) is a soft, disk-shaped polyurethane device with a depression
on the side that fits over the cervix and a loop on the other side for removing the device. It contains
the spermicide nonoxynol-9 and is intended for one-time use only. Before insertion, the woman
wets the sponge with tap water, squeezes it once to spread the spermicide, and inserts it into the
vagina with the depression next to the cervix. There is no need to add spermicide for additional
acts of intercourse.
The sponge may be inserted ahead of time and remains effective for 24 hours after insertion. It
should be left in place for at least 6 hours after having sex to prevent pregnancy. The sponge must
be removed within 30 hours after insertion because the risk of toxic shock syndrome increases
after that time. Women should not rinse the vagina or douche while wearing the sponge.
(Toxic shock syndrome is a rare and sometimes fatal syndrome among women of reproductive
age, primarily associated with use of tampons and IUDs. Clinical features include sudden onset of
fever, chills, vomiting, diarrhea, muscle aches, and rash. It can rapidly progress to severe and
intractable hypotension and multisystem dysfunction. Desquamation, particularly on the palms and
soles, can occur 1–2 weeks after onset of the illness (CDC, 2005).)
The vaginal sponge is more effective in preventing pregnancy in nulliparous women. It does not
prevent transmission of STIs.
Long-Acting Reversible Contraception (LARC)
LARC refers to birth control methods that provide effective contraception over a period of 3 to 10
years without requiring any action on the part of the user. “Long-acting reversible methods of
contraception (LARC), which includes IUDs and the subdermal implant Implanon, have been
proven to be the most effective method of reversible contraception, with failure rates of <1% in the
first year of use” (Spain et al., 2010). Despite this fact, use of LARC is much lower in the United
States compared with other countries.
One reason is the lingering distrust of intrauterine devices (IUDs) among women and clinicians,
based on early problematic devices such as the Dalkon Shield. Another reason is the higher initial
cost to both patient and provider, even though LARC methods are very cost-effective over the long
term. Providers may also lack adequate training in IUD and implant insertion. A study in California
found that only 60% felt “very comfortable” inserting the copper T device (ParaGard), and just 40%
felt “very comfortable” inserting Mirena (Harper et al., 2009).
The profit motive may also play a role in the comparatively low usage of LARC methods in the
United States. The devices generate far less revenue and profit for their manufacturers than do
refillable methods. For example, in an earlier study, the one-time sale of a copper IUD yielded only
about $200, whereas the 10-year refillable prescription for OCPs might have generated a profit of
more than $1,000 (Trussel et al., 1995).
For women with conditions that may make unintended pregnancy an unacceptable health risk,
long-acting, highly effective contraceptive (LARC) methods may be the best choice. Women with
these conditions should be advised that sole use of barrier methods for contraception and
behavior-based methods of contraception may not be the most appropriate choice because of their
relatively higher typical-use rates of failure.
INTRAUTERINE DEVICES (IUDs)
Intrauterine contraceptive devices were introduced in the 1970s, an era of little or no regulation of
medical devices. Many of the early IUDs caused serious health problems. The most notorious IUD
was the Dalkon Shield, which caused serious infections, infertility, other injuries, and death.
Women were outraged that devices so widely marketed were not regulated by the U.S. Food &
Drug Administration (FDA). This outrage led to federal legislation in 1976 authorizing the FDA to
require testing and approval of all medical devices, including IUDs. The FDA also required
clinicians to provide unbiased information about IUDs so that women could make an informed
choice.
Today’s IUDs are vastly different and much safer from those available in the 1970s, and their use
is increasing. The latest CDC study on contraceptive use reported that by 2006–2008, 5.5% (2.1
million women) were using IUDs, up from 1% in 1995 (Mosher & Jones, 2010). Current IUDs are
also far more expensive than their predecessors because of the need for premarketing testing and
approval, which makes them inaccessible to many women. For example, for an uninsured woman,
the out-of-pocket costs for an IUD run between $500 and $1,000, including examinations, tests,
the IUD, insertion, and removal (Planned Parenthood, 2010a). If the woman continues to use the
IUD for several years, the cost can be amortized over that period, making it less expensive.
However, such a large up-front cost is a barrier for many women.
In states where Medicaid or other insurance reimbursements fail to cover the cost of IUDs, some
providers either do not offer them or buy IUDs from outside the United States. The latter practice is
illegal because the unapproved devices may be unsafe or ineffective. However, if the devices were
purchased in Canada, they are likely to be as safe as those produced in the United States since
Canada has rigorous approval standards for medical devices.
The cost issue may be resolved by 2010 Patient Protection and Affordable Care Act, which
requires insurance companies to cover preventive health services without imposing costs on
patients. This would guarantee family planning coverage without co-payments and deductibles.
However, as mentioned earlier, the debate continues over whether family planning qualifies as
preventive care since pregnancy is not an illness.
Two Types of IUDs
There are two types of highly effective intrauterine contraceptive devices available in the United
States. Both are long acting and reversible, which means there is a quick return to fertility after
removal of the device. Each IUD has a string, which the clinician cuts to an appropriate length.
Patients need to check the string each month to be sure the IUD is still in place.
Both IUDs are T-shaped devices, but one contains copper (ParaGard, CopperT380A) and the
other releases a small amount of the progestin levonorgestrel (LNG) (Mirena). Both require
insertion by a physician or other specially trained clinician. The copper IUD was approved for use
in 1988; it remains effective for 10 years. The Mirena device was approved for use in 2001 and
remains effective for 5 years.
ParaGard (left) and Mirena (right) intrauterine devices.
The ParaGard IUD is made of polyethylene with copper along the vertical stem and horizontal
arms. Once inserted, it releases a small of copper into the uterus, which blocks the sperm from
reaching and fertilizing the egg (ovum). If fertilization does occur, the IUD prevents the fertilized
egg from implanting in the endometrium. There is a risk of ectopic pregnancy if an egg is fertilized
outside the uterus. Paragard can also be used as emergency contraception. If inserted within 5
days after unprotected intercourse, it reduces the risk of pregnancy by more than 99%.
The Mirena hormonal IUD is sometimes called an intrauterine system (IUS).It releases progestin
(LNG) into the uterus, which prevents ovulation and causes the cervical mucus to thicken so
sperm can’t reach the egg. It also prevents implantation. Initially, the Mirena releases 20 mg of
LNG per day; over time the dose decreases to 10 mcg per day after 5 years. The high levels of
LNG cause the endometrium to atrophy, diminishing the menstrual flow and, in some women,
ending periods altogether. Women with uterine fibroids or adenomyosis may find that the LNG
reduces menstrual symptoms. Some women may experience side effects of LNG such as mood
changes, acne, headache, breast tenderness, and follicular ovarian cysts in the first few months
after insertion.
In women for whom estrogen is contraindicated (smokers older than age 35, postpartum
breastfeeding women, those with breast cancer), LNG offers an effective alternative to prevent
pregnancy.
For the first 7 days after insertion of Mirena, women should use a non-hormonal backup method of
contraception. Neither ParaGard nor Mirena protects against transmission of STIs.
These devices can be inserted any time during the menstrual cycle when pregnancy can be
excluded, usually within a week after the woman’s period has started. They can also be inserted
immediately after delivery of the placenta or after complete postpartum uterine involution or postabortion.
Patients should be screened for gonorrhea and chlamydia (cultures) when an IUD is inserted. If
the results are positive, antibiotic treatment should begin but removal of the IUD is usually
unnecessary.
Neither ParaGard nor Mirena protects against transmission of STIs.
Complications and Contraindications
Complications of IUD insertion include uterine perforation at the time of insertion (rare), expulsion
of the device, and slight increased risk of infection during the first month of use if bacteria enter the
uterus during insertion. Expulsion occurs in no more than 5% of users and is more common in
nulliparous women.
Some women who use the copper IUD may experience bleeding and cramping, but menstrual
cycles are generally unaffected. Those who use Mirena may have frequent light bleeding for the
first three months after insertion, but by 6 months, most women experience reduced bleeding.
About 20% of women experience amenorrhea after 12 months of use of Mirena.
Contraindications to use of either IUD include:
•
Current pelvic inflammatory disease (PID) or endometritis after delivery, spontaneous or
elective abortion. Insertion of the IUD should be delayed at least 3 months after
successful treatment of the inflammation. If a woman develops PID while using the IUD,
it is not necessary to remove the device.
•
Unexplained vaginal bleeding prior to evaluation
•
Malignant gestational trophoblastic disease
•
Cervical or endometrial cancer
•
Fibroids or uterine anomalies that distort the uterine cavity
•
Current purulent cervicitis or chlamydial or gonorrheal infection
•
Known pelvic tuberculosis
•
Current breast cancer (for Mirena only)
SUBDERMAL ETONOGESTREL IMPLANT (Implanon)
The subdermal contraceptive Implanon is the only subdermal contraceptive implant available in the
United States since Norplant was taken off the market in 2006. Implanon is a single matchsticksized rod made of ethylene vinyl acetate that contains the progestin etonogestrel. This implant
provides 3 years of very effective contraceptive protection by inhibiting ovulation.
Insertion and removal of the implant must be performed by a physician, nurse practitioner, or other
trained clinician. The implant is inserted under the skin on the inside of the upper non-dominant
arm. Insertion is done thru a needle, so no incision is required. The procedure takes less than 1
minute and is normally relatively painless. The implant must be removed at the end of 3 years, and
this procedure generally takes about 3 minutes.
Nonhormonal backup contraception (abstinence or a condom) is needed for the first 7 days after
insertion of Implanon.
Implanon may be less effective in overweight women (more than 130% of their ideal body weight),
particularly any woman taking drugs that induce liver enzymes to treat active liver disease.
Complications and Contraindications
Implanon is not visible but it is palpable if inserted correctly. The clinician should palpate the arm
immediately after insertion of the device to ensure that it is properly placed. The FDA warns that
“deep insertions may lead to difficult or impossible removals. Failure to remove Implanon may
result in infertility, ectopic pregnancy, or inability to stop a drug-related adverse event. Undetected
failure to insert Implanon may lead to an unintended pregnancy.”
Risks and side effects of Implanon are similar to other progestin-only contraceptive methods, the
most common of which is irregular bleeding patterns, including:
•
Spotting
•
Prolonged bleeding
•
Frequent irregular bleeding
•
Unpredictable bleeding over time
•
Amenorrhea
Implanon is contraindicated in women who have:
•
Known or suspected pregnancy
•
Current or past history of thrombosis or thromboembolic disorders
•
Hepatic tumors (benign or malignant), active liver disease
•
Undiagnosed abnormal genital bleeding
•
Known or suspected breast cancer or history of breast cancer
Clinicians should be alert to the possibility of ectopic pregnancy among patients using Implanon
who become pregnant or complain of lower abdominal pain. Although pregnancy is uncommon
among users of this implant, a pregnancy that does occur is more likely to be ectopic than
pregnancy occurring in a patient using no contraception.
Implanon does not prevent transmission of STIs.
Shorter-Acting Hormonal Contraceptives
Hormonal methods of contraception prevent pregnancy by interfering with ovulation, fertilization,
and/or implantation of the fertilized egg (Office on Women’s Health, 2010). (The long-acting
reversible contraception mentioned above also prevents pregnancy through these same means,
although for much longer periods of time.)
Hormonal contraception in the United States began with FDA approval of the “Pill” in 1960. Since
then, the range of hormonal contraceptives has expanded beyond pills to include intrauterine and
intravaginal devices, a transdermal patch, an implantable rod, and an injectable contraceptive.
Some of these methods deliver both estrogen and progestin, referred to as combined hormonal
contraception; others deliver only progestin. Each method and each medication have unique risks
and benefits.
None of the hormonal methods prevent STIs.
COMBINATION ESTROGEN-PROGESTIN APPROACHES
Combined hormonal contraception is now available as oral contraceptive pills as well as the
vaginal ring (NuvaRing) and the transdermal patch (Ortho Evra). Combined oral contraceptives
(COCs) are the most widely used type of oral contraceptive pill (OCP).
Oral Contraceptive Pills (OCP)
When the first birth control pill was approved by the FDA half a century ago, it changed women’s
lives around the world. For the first time, women could control their fertility on their own with a daily
pill. Preventing pregnancy did not require a condom or a diaphragm or the cooperation of a
partner—only the “Pill.” This new freedom helped fuel the women’s movement and the surge of
women into the American workforce. However, not all women were free to use the Pill in 1960:
“Contraceptives were not available to married women in all states until Griswold v. Connecticut in
1965 and were not available to unmarried women in all states until Eisenstadt v. Baird in 1972”
(QuickOverview.com, 2010).
As one physician wrote, “Today there are over 60 formulations of the Pill, containing varying
amounts of estrogen and progesterone, and taken on varying cycles. In the last 50 years OCPs
have become the number-one contraceptive for women in the United States” (Hathaway, 2010).
The early pills contained 3 times as much estrogen as today’s formulation, as well as lower doses
of different, more potent progestins.
OCPs prevent pregnancy by preventing ovulation. They also cause changes in the endometrium
and thicken the cervical mucus to prevent the sperm from reaching the egg. Taken correctly,
OCPs are very effective at preventing pregnancy. However, correct use means remembering to
take the Pill at the same time every day. It also means having access to a clinician for a
prescription and having insurance or sufficient income to pay for the drug over time. These factors
create barriers for many women.
As mentioned earlier, there are more than 60 formulations of the Pill, which vary in dosage, the
forms of estrogen and progestin they contain, and usage. There are four basic types of COCs as
described in the following table.
TYPES OF COMBINED ORAL CONTRACEPTIVES
21-day
Taken for 21 days each month, followed by a 7-day period without pills
during which menstruation occurs.
28-day
Taken for 28 days. Depending on the type, the last 7 pills in the packet
may be hormone-free pills or estrogen pills, either of which allows
menstruation to occur.
Extended use
(Seasonale,
Seasonique)
Packaged for 3-month use (84 days). Depending on the brand, the final 7
pills are either hormone-free or contain estrogen, which allows
menstruation to occur.
Continuous use
(Lybrel)
Taken daily for 1 year, during which menstruation will be infrequent and
may even stop.
In December 2010, the FDA approved the first low-dose oral contraceptive to combine 0.8 mg
norethindrone and 0.025 ethinyl estradiol in chewable form, with four 75 mg ferrous fumarate (iron)
placebo tablets. The 24-day active hormone regimen is intended to provide users with a low level
of breakthrough bleeding and short, light, predictable periods (PR newswire, 2010).
OCPs should be taken at the same time each day. COCs can be started on the first day of the
menstrual cycle or on the Sunday after menstruation begins. This method requires a backup
method of contraception for the next 7 days of the first cycle. Whatever day a woman starts
taking the pill, she should always start the next pack on the same day of the week she started the
first pack. Clinicians recommend that patients keep an extra pack of pills and a backup method
such as condoms available in case she misses some pills or loses her initial pack.
OCPs, like all drugs, also have side effects and, for some women, serious risks. CDC scientists
found that nearly one third of women who had ever used the pill discontinued use of the pill
because they were dissatisfied with it, either because of side effects, changes in their menstrual
cycle, or the difficulties in remembering to take the pill (Mosher & Jones, 2010).
Side effects of OCPs include:
•
Breakthrough bleeding (may be prolonged with continuous dose pills) or irregular
periods
•
Breast tenderness
•
Nausea
•
Bloating
•
Headache
Many of the side effects disappear after the first few cycles of use.
More serious risks include:
•
Increased risk of venous thromboembolism (VTE) in the legs
•
Heart attacks and stroke in women over 35 (greatly increased risk by smoking)
•
Gallbladder disease
•
Liver tumors
CONTRAINDICATIONS FOR COMBINED ORAL CONTRACEPTIVES (COCs)
•
Hypertension
•
Less than 21 days postpartum
•
Lactating
•
On medication that may compromise efficacy of contraceptive (St. John’s wort, some
antibiotics, some anti-seizure medications)
•
History of or current coronary or ischemic heart disease
•
History of stroke
•
History of deep vein thrombosis
•
Multiple risk factors for heart disease (older age, smoking, diabetes, and hypertension)
•
History of or current breast cancer
•
Migraines with aura; migraines without aura in women 35 years and older
•
Systemic lupus erythematosus
•
Diabetes with complications
•
Liver tumors
•
Severe cirrhosis
•
Complicated organ transplant
Source: ARHP, 2009; ACOG, 2010.
There is less risk of serious side effects and complications with progestin-only
contraceptives, which are discussed later in this course.
According to the American College of Obstetricians and Gynecologists (2010), OCPs offer women
many benefits beyond effective contraception, which include:
•
Regulating the menstrual cycle
•
Decreased menstrual bleeding
•
Decreased pain and mood swings during menses
•
Decreased risk of several cancers (uterine, ovarian, colorectal)
•
Improved acne symptoms
Vaginal Contraceptive Ring (NuvaRing)
NuvaRing.
The vaginal contraceptive ring, called NuvaRing (Organon), is a latex-free, flexible transparent
vaginal ring made of ethylene vinyl acetate copolymers and magnesium stearate. It contains low
doses of both estrogen and progesterone. Once placed in the vagina, it releases an average daily
dose of 15 mcg ethinyl estradiol (EE) and 120 mcg of etonogestrel into the systemic circulation
over a 3-week time period. The ring is removed and discarded at the end of 3 weeks, and 7 days
later a new ring is inserted. Backup non-hormonal contraception should be used for the first
7 days after insertion of the ring.
The NuvaRing was approved by the FDA in 2001. Used correctly, it is comparable to the
effectiveness of COCs and the patch. It comes in one size that fits most women and does not have
to be fitted by a health professional. However, it does require a prescription.
As with other combined oral contraceptives (COCs), the ring prevents pregnancy by inhibiting
gonadotropins and preventing ovulation. In addition to contraceptive benefits, the ring helps
regulate irregular menstruation cycles, decreases menorrhagia and dysmenorrhea, and reduces
the frequency of bacterial vaginosis.
User acceptability of this device is high among both younger and older reproductive-age women
regardless of parity. A large international study showed that, compared with COCs, the vaginal ring
was preferred by 8 out of 10 women (Novak et al., 2003). Another study comparing the NuvaRing
and the transdermal patch found that 7 out of 10 women preferred the ring (Creinin et al., 2008).
Side effects and contraindications are similar to COCs and the patch. Expulsion of the device,
interference with intercourse, or leukorrhea are uncommon (less than 3% of users discontinue use
because of these events).
Close clinical surveillance is also needed for users with significant pelvic relaxation (uterovaginal
prolapse), those with a history of vaginal irritation or toxic shock syndrome, those who experience
severe constipation or vaginal obstruction, or those who are uncomfortable touching their genitalia
(Wieder & Pattimakiel, 2010).
The NuvaRing does not protect against STIs.
TRANSDERMAL PATCH (Ortho Evra)
The transdermal contraceptive patch (Ortho Evra) is a thin, flexible beige adhesive patch that is
applied to the upper arm, buttock, stomach, or chest (but not the breast) once a week for 3 weeks.
The patch releases progesterone (150 mcg of norelgestromin) and estrogen (20 mcg of ethinyl
estradiol) daily to prevent ovulation. Each patch contains 9 days of medication so if the patient
forgets to change the patch at the end of 7 days, it retains its contraceptive effectiveness for 2
more days. Three consecutive 7-day patches are applied, followed by 1 week without a patch per
cycle.
A prescription is required for the patch. Clinicians also need to provide an extra prescription for
patients in the event of detachment. Any patch that becomes detached must be replaced by a new
patch because the medication is in the adhesive. The patch is water-resistant and can be worn
during exercise, showers, bathing, and swimming. Heat, humidity, and exercise do not affect
adhesion.
The patch is comparable in effectiveness to COCs but may be slightly less effective in women who
weigh more than 198 pounds. However, the patch can still be effective for these women (Zieman
et al., 2002).
The side effects of the patch are similar to those of COCs. However, side effects generally lessen
during the first 2 or 3 months of use. Skin irritation may occur at the site of application. According
to CDC scientists (Mosher & Jones, 2010), one half of the women who had ever used the patch
had discontinued it either because of side effects or because they didn’t like the changes in their
menstrual cycles.
Since 2005, the FDA has required a “black box warning” on the Ortho Evra label, cautioning
clinicians about the increased risk of venous thromboembolism in some women using the patch
compared with the risk of COCs. This increased risk is apparently due to the higher sustained
concentration of ethinyl estradiol (EE) delivered by the patch compared with the EE in COCs,
which quickly drops to lower concentrations following administration.
The black box warning also highlights the risk of smoking while using the patch as follows:
Cigarette smoking increases the risk of serious cardiovascular side
effects from hormonal contraceptive use. This risk increases with age and
with heavy smoking (15 or more cigarettes per day) and is quite marked
in women over 35 years of age. Women who use oral contraceptives,
including Ortho Evra®, should be strongly advised not to smoke.
CONTRAINDICATIONS FOR ORTHO EVRA CONTRACEPTIVE PATCH
Ortho Evra should not be used in women who currently have the following conditions:
•
Thrombophlebitis, thromboembolic disorders
•
Past history of deep vein thrombophlebitis or thromboembolic disorders
•
Known thrombophilic conditions
•
Cerebrovascular or coronary artery disease (current or past history)
•
Valvular heart disease with complications
•
Persistent blood pressure values of ≥160 mm Hg systolic or ≥100 mg Hg diastolic
•
Diabetes with vascular involvement
•
Headaches with focal neurological symptoms
•
Major surgery with prolonged immobilization
•
Known or suspected carcinoma of the breast or personal history of breast cancer
•
Carcinoma of the endometrium or other known or suspected estrogen-dependent
neoplasia
•
Undiagnosed abnormal genital bleeding
•
Cholestatic jaundice of pregnancy or jaundice with prior hormonal contraceptive use
•
Acute or chronic hepatocellular disease with abnormal liver function
•
Hepatic adenomas or carcinomas
•
Known or suspected pregnancy
•
Hypersensitivity to any component of this product
Source: Food & Drug Adm inistration, 2010.
Progestin-Only Contraceptives
Progestin-only contraceptives include the oral contraceptive “Mini-pill,” the subdermal implant
Implanon (discussed above under long-acting reversible contraception), and the injectable DepoProvera. An earlier implant called Norplant was removed from the U.S. market in 2000 because of
side effects.
PROGESTIN-ONLY OCP (“Mini-Pill”)
The progestin-only pill contains no estrogen and is an option for those women for whom estrogen
is contraindicated, such as those who are breastfeeding, over 35, or at risk for thromboembolism.
However, women with liver tumors or lupus erythematosus should not take progestin-only pills.
Taken daily, the mini-pill thickens cervical mucus, which prevents fertilization. Less often, it stops
ovulation.
The mini-pill must be taken at the same time each day. If a woman is more than 3 hours late in
taking the pill, she needs to use a backup method of birth control for at least the next 48 hours.
Clinicians recommend that women taking the mini-pill have emergency contraception (EC) on
hand. Patients under the age of 17 must have a prescription for EC (see discussion later in this
course). Antibiotics may interfere with efficacy of the mini-pill.
Side effects of the mini-pill include:
•
Initial irregular bleeding (frequent, prolonged, unpredictable, or amenorrhea)
•
Weight gain
•
Anxiety or depression
•
Decreased libido
•
Fatigue
•
Ovarian cysts
•
Headache
•
Breast tenderness
•
Dizziness
•
Excessive body hair growth
•
Acne
Irregular bleeding normally decreases after several months.
The mini-pill is contraindicated in women with a history of or current breast cancer.
The mini-pill does not prevent transmission of STIs.
DEPOT-MEDROXYPROGESTERONE ACETATE (DMPA) (Depo-Provera) (“The
Shot”)
Injectable Depo-Provera (DMPA) provides 3 months of highly effective contraception to inhibit
ovulation. The shot (either intramuscular or subcutaneous) delivers 150 mg of
medroxyprogesterone acetate and must be administered by a trained clinician. Nonhormonal
backup contraception is needed for the first 7 days after the initial injection of DMPA.
The efficacy and convenience of DMPA have made it very popular with sexually active
adolescents, although one large study showed that the copper-T IUD was more effective in
preventing pregnancy (Hofmeyr et al., 2010). DMPA side effects are similar to other progestinonly contraceptives and include initial irregular bleeding, weight gain, and delayed return to fertility
after stopping the shots.
A Dutch study of more than 400 premenopausal women ages 18–50 years found that DMPA more
than tripled the risk of deep vein thrombosis (DVT) in users. They did not find a similar effect in
users of the Merina intrauterine system containing levonorgestrel (LNG) (van Hylckama Vlieg et
al., 2010).
Another U.S. study of 1,000 women ages 20–44 years found that recent DMPA use (within 5
years) for 12 months or longer was associated with a 2.2-fold increased risk of invasive breast
cancer. The risk appeared to dissipate shortly after DMPA use was discontinued, and there was no
increased risk for women who used it for less than a year. The researchers also found that women
who used the contraceptive for less than a year or who had stopped using it more than a year
earlier did not have an increased risk of breast cancer (Li et al., 2012).
Women who are overweight when beginning to use DMPA may find that the shots increase their
appetite, raising their risk of further weight gain. However, the shots may decrease the risk of
dysfunctional bleeding in overweight women. Being overweight seems to mitigate the loss of bone
density common in women who use DMPA (discussed in more detail below). Some women also
experience anxiety or depression, headache, and breast tenderness. It takes 6 to 10 months after
the final shot for DMPA to leave the body, and side effects persist until clearance occurs.
CDC scientists (Mosher & Jones, 2010) found that more than 40% of women who had ever used
DMPA discontinued it because of side effects or because they didn’t like the changes to their
menstrual cycle.
DEPO-PROVERA AND BONE LOSS
Research indicates that women using DMPA experience significant loss of bone mineral density
(BMD). A recent large study in Switzerland found that DMPA users ages 20–44 years had a “slightly
increased risk of fractures” compared with nonusers. Fracture rates were highest among women
using DMPA more than 2–3 years (Meier et al., 2010).
This risk raises concerns about the long-term effects of DMPA use during adolescence because this
is normally a period of peak BMD development. Studies show that some BMD loss is recovered after
DMPA use is stopped. However, recovery rates vary, and women ages 18–21 experience greater
loss and reduced acquisition of BMD than older women (Walsh et al., 2008; Practice Committee of
the ASRM, 2008).
Research also indicates that DMPA has different effects on BMD in different bones; the femoral head
(the top of the thigh bone) is most vulnerable to BMD loss among women using DMPA. This finding is
worrisome since the femoral head is the most common fracture site among post-menopausal women.
Concern about the loss of BMD among users of DMPA prompted the Food & Drug Administration to
require a black box warning on DMPA in 2004 recommending that DMPA use be limited to two years
or less. The warning cautions that “bone loss is greater with increasing duration of use and may not
be completely reversible. Depo-Provera Contraceptive should be used as a long-term birth control
method (e.g., longer than 2 years) only if other birth control methods are inadequate” (FDA, 2004).
Some professional organizations have questioned the need for this warning, citing studies that BMD
is recovered after DMPA is stopped. However, women’s health advocacy organizations remain
concerned. As Susan K. Flinn wrote, “The length of time it takes a woman’s bone mineral density to
recover after using the shot makes it important to weigh the method’s use carefully, particularly for
young women (whose BMD is still developing) and women approaching menopause (who are at
greater risk for osteoporosis and fractures)” (Flinn, 2010).
DMPA is contraindicated in women with:
•
A history of or current breast cancer
•
Anorexia
•
Chronic use of steroids
Clinicians should encourage women who use DMPA to:
•
Engage in weight-bearing exercise
•
Increase their intake of calcium and vitamin D
•
Avoid smoking
•
Limit or eliminate alcohol consumption
DMPA does not prevent transmission of STIs.
Emergency Contraception (EC)
Emergency contraception can prevent most pregnancies when taken
after intercourse. It provides an important back-up in cases of
unprotected intercourse or contraceptive accident (such as forgotten
pills or torn condoms) and is especially valuable after rape or coerced
sex.
—World Health Organization (2010b)
Emergency contraception is used after unprotected sex in order to prevent pregnancy. EC is most
effective the sooner it is taken after unprotected sex. All women at risk for unintended pregnancy
should be encouraged to have EC on hand in the event of contraceptive failure, forgotten pills,
rape, or coerced sexual intercourse.
Five methods of emergency contraception are available in the United States, as described in the
table below.
TYPES OF EMERGENCY CONTRACEPTION
Name
Description
Availability
Plan B One-Step
A single 1.5 mg levonorgestrel pill, also known
incorrectly as the “morning-after” pill. In fact, Plan B
should be taken within 72 hours of unprotected sex.
Only by prescription for
women younger than 17
years; over the counter
for women 17 years and
older.
Next Choice
(Generic)
Comprises two 0.75 mg levonorgestrel pills. The
first pill should be taken orally as soon as possible
within 72 hours after unprotected intercourse, and
the second should be taken 12 hours after the first
pill. However, both pills can be taken at the same
time without increasing side effects or decreasing
efficacy.
Only by prescription for
women younger than 17
years; over the counter
for women 17 years and
older.
Yuzpe Method
Consists of taking COCs containing levonorgestrel
in higher doses.
Only by prescription for
women younger than 17
years; over the counter
for women 17 years and
older.
Copper T IUD
(ParaGard)
Can be inserted within 72 hours after unprotected
sex and is more than 99% effective in reducing
pregnancy risk. (The Mirena IUD cannot be used for
EC.)
Must be inserted by a
health professional.
Ella
The newest emergency contraceptive tablet
approved for the U.S. market. It contains ulipristal
acetate and acts to inhibit or delay ovulation. Ella
should be taken within 120 hours (5 days) after
unprotected sex.
Only by prescription for
all ages.
A team of experts from around the globe has reviewed the scientific evidence on levonorgestrel
EC pills and concluded that they are very safe (WHO, 2010a). “They do not cause abortion or
harm future fertility. Side-effects are uncommon and generally mild.” The most common side
effect from taking levonorgestrel EC pills is irregular menses. In addition, some women may
experience short-term side effects similar to PMS symptoms, such as nausea, cramps, diarrhea,
and fatigue.
BARRIERS TO USE
Emergency contraception (EC) appears to be one of medicine’s best-kept secrets. Myths and
misinformation EC abound not only among teens and young women but among physicians and
pharmacists. Ignorance, prejudice, and religious beliefs are barriers to prescribing and obtaining
EC.
A survey of 1,800 U.S. obstetricians and gynecologists found that gender, religion, and divergent
beliefs about the effects of EC shaped physicians’ beliefs and practices. Only half of the physicians
surveyed offer EC to all women of childbearing age, while 6% never offer it, and another 6% offer it
only after sexual assault. Male physicians and those who were religious were more likely to never
offer EC or only after sexual assault (Lawrence et al., 2010). State health policies can also
interfere with a woman’s access to EC (see Table 00).
Although EC pills are available in many countries, many adolescents and adult women are
uninformed or misinformed about this method. The World Health Organization (2010b) attributes
this to “the very poor basic understanding of fertility, contraception, and pregnancy risk that seems
widespread in both developing and developed countries.” A 2007 study of adolescents in New
York City schools found that less than half of them had heard of EC pills (New York City
Department of Health, 2007). Other studies in California have found that knowledge about EC is
highest among college-educated white women and lowest among poor women and women of
color.
Widespread, sensationalist, and often inaccurate media coverage of EC have created fear of these
and other hormonal birth control methods. However, according to WHO (2010a), “In the case of
levonorgestrel-alone emergency contraceptives, safety has been clearly demonstrated through
countless studies and many decades of use: no new research needs to be conducted. The urgent
question is how we can explain and disseminate the science in simple terms.”
To counter the inaccurate messages about EC, the National Institute for Reproductive Health
initiated a national public awareness campaign called Back Up Your Birth Control, committed to
raising awareness of and expanding access to EC. (Information on obtaining free informational
materials is listed below under “Resources.”) Begun over 10 years ago, this campaign targets high
school and college women and encourages participation through social media networks.
EMERGENCY CONTRACEPTION AND MEDICAL ABORTION
Some pro-life/anti-choice organizations have misrepresented emergency contraception as “medical
abortion.” This creates confusion not only among patients but also among healthcare providers.
Emergency contraception prevents pregnancy, whereas medical abortion terminates pregnancy.
“According to general medical definitions of pregnancy that have been endorsed by AHRP, the
American College of Obstetricians and Gynecologists, and the U.S. Department of Health and Human
Services, pregnancy begins when a pre-embryo completes implantation into the lining of the uterus”
(ARHP, 2008).
Medical abortion involves the use of different medications that can induce abortion. Three such drug
regimens are available in the United States: mifepristone (RU-486) and misoprostol, methotrexate
with misoprostol, and misoprostol alone. These drugs require a prescription and careful clinical
monitoring of patients.
Permanent Contraception (Sterilization)
Women and couples who choose to remain childless or who decide they have as many children as
they want or can support may choose some form of permanent contraception for one or both
partners. Female sterilization can be performed either through surgery (tubal ligation) or
nonsurgical insertion of microinserts (Essure, Adiana) to block the fallopian tubes. The cost of
female sterilization ranges from $1,500 to $6,000. Male sterilization (vasectomy) is surgically
performed and is much less expensive. Costs range from $350 to $1,000 (Planned Parenthood,
2010b,c).
Patients considering sterilization need to know that these are essentially irreversible procedures.
They need to consider how their lives might change in the future, for example, the death of a child
or partner, or divorce and remarriage. Attempts to restore fertility are often unsuccessful as well as
expensive.
Researchers in the United Kingdom found that women chose sterilization for three principal
reasons: (1) to avoid the possible side effects of hormones; (2) to avoid the continuing need to
make decisions about child-bearing; and/or (3) lack of information about long-acting reversible
methods of contraception. Some of the women who had chosen sterilization had regrets later
about their choice even though they had received counseling before deciding (Kane et al., 2009).
Permanent contraception may be most appropriate for women who:
•
Do not want to have children in the future, no matter how their lives may change
•
Have a partner who also does not want children but does not want to have a vasectomy
•
Have considered other methods of birth control and want to avoid the side effects, risks,
or costs of those methods
•
Have health problems that pregnancy would exacerbate
•
Have a hereditary condition that they do not want to pass on (e.g., HIV, hemophilia,
Tay-Sachs disease)
•
Do not have any health issues that would make surgery dangerous
(Healthwise, Inc., 2010)
SURGICAL TUBAL OCCLUSION
Female surgical sterilization to occlude (block), cut, band, cauterize, or tie the fallopian tubes is a
low-risk procedure that achieves immediate contraceptive effectiveness. The surgery may be a
laparoscopic procedure, a mini-laparotomy, or a laparotomy. All of these procedures can be
performed on an outpatient basis, although the mini-laparotomy and laparotomy are generally
used for postpartum sterilization or during abdominal surgery for another reason (cesarean section
or removal of adhesions from pelvic inflammatory disease [PID] or endometriosis). Laparoscopy
usually involves general anesthesia. A mini-laparotomy or laparotomy may involve general
anesthesia or regional anesthesia (an epidural).
The only risks of surgical sterilization include only those related to general anesthesia and any
surgery. Patients should be counseled concerning the following possible short-term effects:
•
Slight vaginal bleeding
•
Possible distension of the abdomen and/or back or shoulder pain (after laparoscopy)
caused by gas used to expand the abdominal cavity for better visibility by the surgeon
Sexual intercourse can be resumed as soon as it does not cause pain, usually 1 week after
surgery. The menstrual cycle is not affected by surgical sterilization. Although no backup method
of birth control is necessary after surgery, patients who are not in a monogamous relationship with
an HIV-negative partner should be counseled to use condoms to protect against STIs.
NONSURGICAL TUBAL OCCLUSION
There are two types of microinserts available for nonsurgical occlusion of the fallopian tubes:
Essure and Adiana. These inserts are placed in the fallopian tubes near where they join the uterus
using a hysteroscopic procedure. Patients are screened for vaginal infection and STIs before
implants are inserted. Usually performed under local anesthesia or sedation, the procedure takes
about 15 minutes.Backup birth control is needed for 3 months until scar tissue forms around
the inserts, thereby blocking the tubes. At the end of three months, a hysterosalpingogram is
performed to confirm that the tubes are occluded.
The Essure device consists of two small concentric metal (containing nickel) coils around a mesh
of polyethylene terephthalate (PET) fibers. After insertion, the outer coils expand to hold the device
in place, and the PET fibers cause a moderate inflammatory reaction, leading to the formation of
scar tissue from the surrounding tubal walls. Over the next 3 to 6 months, the lining of the tubes
grows into the microinserts to occlude the tubes.
(Recent research suggests that PET may leach endocrine-disrupting chemicals from packaging
made with this plastic [Sax, 2010]. However, there is currently insufficient research to conclude
that such leaching will occur with all PET products when exposed to human tissue.)
The Adiana device uses radiofrequency (RF) radiation as part of the microinsert procedure. After
exposing the wall of each tube to a low level of RF, creating a superficial lesion, a soft silicone
polymer microinsert is placed at the lesion sites. Over the next 3 months, the lining of the tubes
grows into the microinserts, occluding the tubes.
These microinserts are new, so the long-term effects are unknown. Risks of the procedure include
perforation of the uterus and/or tube during insertion and improper placement of the inserts.
Short-term effects include cramping, pain, and bleeding or spotting on the day of the procedure.
Contraindications for either Essure or Adiana include:
•
Patient’s uncertainty about choice of permanent contraception
•
Pregnancy (actual or suspected)
•
Taking immunosuppressive medication
•
Previous delivery, miscarriage, or abortion within past 6 weeks (Essure) or 3 months
(Adiana)
•
Current pelvic infection
•
Inaccessible or malformed uterus and fallopian tubes
•
Allergy to contrast medium used for hysterosalpingogram
•
Hypersensitivity or allergy to nickel confirmed by a skin test (for Essure only)
•
Unwilling to use backup birth control for the first 3 months
•
Unwilling to return 3 months later to check for tubal occlusion
•
Previous tubal ligation
VASECTOMY (Male Sterilization)
Vasectomy is a decades-old method of male sterilization. Safe, swift, and highly effective,
vasectomy is an outpatient procedure performed on approximately 13% of American men each
year. The no-scalpel vasectomy (NSV) is the standard of care and involves 10 minutes for prep
and administration of local anesthesia and 10 minutes for the procedure itself. The surgeon makes
a small opening (a few millimeters) in the skin of the scrotal sac to expose the vas deferens. The
vas are then ligated or cauterized; no sutures are necessary. Sexual activity can be resumed as
soon as local discomfort (short-term tenderness and possible bruising) has ended.
Backup contraception (a condom) is needed for the first 15 to 20 ejaculations (or about 12
weeks) after the procedure because sperm may remain in the vas beyond the point of occlusion.
It is important for the patient to return for a sperm check before stopping the backup contraception.
Men who are not in a monogamous relationship with an HIV-negative partner should continue
condom use to protect against STIs.