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In This Report

•	Highlights
•	Introduction
•	Oral Contraception
•	Implant Contraception
•	Injected Contraception
•	Intrauterine Devices (IUDs)...
•	Spermicidal and Barrier Con...
•	Natural Family Planning Met...
•	Emergency Contraception
•	Female Sterilization
•	Resources
•	References

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Birth Control Options for Women

Highlights

Drug Approvals

• The Today Sponge is returning to the United States market. In April 2005, the FDA granted re-approval for the popular contraceptive. The manufacturer plans to begin national retail distribution later in the year.

Drug Warnings

• The FDA added a “black box” warning to the labeling of Depo-Provera. The label warns that long-term (more than 2 years) use of Depo-Provera can cause loss of bone density. The decline in bone density loss increases with duration of use and may not be completely reversible even after the drug is discontinued. The FDA recommends that Depo-Provera should not be used for longer than 2 years unless other birth control methods are inadequate. A 2005 study found that adolescents who stop taking Depo-Provera do regain bone density.

Research

• Women who receive Depo-Provera injections have three times the risk of acquiring chlamydia and gonorrhea as women who do not use a hormonal contraceptive. The same study found that oral contraceptive use was not associated with increased risk.
• Direct access to emergency contraception does not increase risk-taking behavior, according to a study published in the Journal of the American Medical Association. The study of young women ages 15 to 24 years found no increased rates of unprotected intercourse or sexually transmitted infections compared to control subjects.

Policy and Regulation

• Many US states are considering legislation that would allow pharmacists to refuse to dispense prescriptions on the basis of moral or religious objections. In response to reports of pharmacists refusing to fill prescriptions for birth control pills, members of Congress in April 2005 introduced the Access to Legal Pharmaceuticals Act that would require pharmacies to fill prescriptions. The bill’s sponsors hope that passage of this act will help ensure women’s legal access to contraceptives.

Introduction

Contraceptives are devices or methods for preventing pregnancy, either by preventing the fertilization of the female egg by the male sperm or by preventing implantation of the fertilized egg. Contraceptives are not modern inventions. The first prescription for a contraceptive device described a tampon barrier device and was written on papyrus in 1550 BC.

Contraceptive Options

Choosing the appropriate contraceptive varies from individual to individual. Contraceptive options for American women include:

• Hormonal contraceptives (oral contraceptives, implants, and injections).
• The intrauterine device (IUD).
• Barrier devices with or without spermicides (diaphragm, cervical cap, female condom).
• Natural family planning methods.
• Female sterilization (tubal ligation).

A 1995 survey of several thousand US women found that the most popular contraceptives (female or male) were female surgical sterilization (28% usage) and oral contraceptives (27%). None of the other female contraceptives had secured the allegiance of more than 3% of users. These included the long-acting and reversible IUDs, implants, or injectable contraceptives. Worldwide, however, the IUD is the most popular reversible contraceptive. When American women were asked why they did not use long-acting contraceptives, they responded with three main reasons:

• Lack of knowledge about them.
• Fear of side effects or health hazards.
• Satisfaction with current methods.

Experts believe that with additional information, more women would be open to other contraceptive options.

Hormonal Contraceptives

Hormonal contraceptives use either a combination of estrogen (usually in the form of the compound estradiol) and progestin, or progestin alone. They are used in many forms:

• Pill form.
• Progestin-releasing IUDs.
• Injections (e.g., Depo-Provera, a progestin injection; or Lunelle, a combination of progestin and estrogen).
• Implants (e.g., Norplant system).
• Skin patches (e.g., Ortho Evra).
• Vaginal rings (NuvaRing).

The pill works in several ways to prevent pregnancy. The pill suppresses ovulation so that an egg is not released from the ovaries, and changes the cervical mucus, causing it to become thicker and making it more difficult for sperm to swim into the womb. The pill also does not allow the lining of the womb to develop enough to receive and nurture a fertilized egg. This method of birth control offers no protection against sexually-transmitted diseases.

Determining Effectiveness

Contraceptive effectiveness is characterized by "typical use" and "perfect use":

• Typical use refers to use under real-life conditions, in which mistakes (such as forgetting to take a birth control pill at the right time) sometimes happen.
• Perfect use refers to contraceptives that are used correctly each time intercourse occurs.

Research has shown that the four most effective standard female contraceptives are surgical sterilization, the IUD, Norplant implants, and Depo-Provera injections. They all have an estimated failure rate of less than 1% during the first year of normal (typical) use. Vasectomy (male surgical sterilization) is the only male contraceptive that is equally effective. By comparison, the estimated failure rate of the male latex condom used without spermicide is 14% with typical use and 3% with perfect use. To put these rates into perspective, it is worth noting that a sexually active woman of reproductive age who does not use contraception faces an 85% likelihood of becoming pregnant in the course of a year.

Access to Contraceptives

Birth control is a controversial subject. In recent years, there has been a growing movement in the United States to restrict a woman's access to contraceptives. In addition to the political battles over non-prescription access to emergency contraception (Plan B), a dozen states are considering legislation that would allow pharmacists to refuse to dispense medications due to moral or religious objections. There have been hundreds of reports of pharmacists refusing to fill birth control prescriptions. In response to this trend, several members of Congress introduced in April 2005 the Access to Legal Pharmaceuticals Act, which would override any state legislation. The bill would require that pharmacies fill birth control prescriptions and would protect women’s legal right to purchase such products.

Oral Contraception

Oral contraceptives (OCs) are available only by prescription and come in either a combination of estrogen and progestin or progestin alone. Many brands of each form are available. Although both are equally effective with typical use, the combined pill is more effective with perfect use and most women choose this form.

Some women, however, experience severe headaches or high blood pressure from the estrogen in the combined pill and must take the progestin-only pill. Not all combined pills or progestin-only pills are alike, and brands differ in the amount of estrogen or progestin they contain. Many OC combined brands now use lower estrogen doses than previous brands and are proving to be safe and effective while providing a better quality of life than earlier OCs.

For all OC users, a check-up at least once a year is essential. It is also important for women to have their blood pressure checked three months after beginning the pill. Former pill users who want to bear children usually regain fertility in three to six months, but they may regain it even sooner.

Click the icon to see an image of a blood clot.

Combination Estrogen/Progestin Contraceptive Pills

Oral contraceptives that contain both estrogen and progestin are the more common type. At least 10 million American women and 100 million women worldwide use the combination OCs. When they were first marketed in the early 1960s, OCs contained as much five times the amount of estrogen and up to 10 times the amount of progestins currently used. After reports of severe complications (stroke, heart attack, and pulmonary embolisms) in young women, the hormone amounts were significantly reduced.

Many different progestins are used. The estrogen compound used in most oral contraceptives is ethinylestradiol, and current dose levels range from 20 to 50 micrograms. Fifty micrograms of estradiol are considered in this report to be high dose, 30 to 35 micrograms are considered to be low dose, and 20 microgram are very low-dose. (It should be noted that the high doses found in current OCs are still much lower than in previous forms.) Expert groups recommend using the lowest possible progestin and estrogen doses (no higher than 50 micrograms).

Brands include the following and their effects vary by estradiol dose level and by the progestin used:

• Desogestrel/estradiol: Desogen and Ortho-Cept are low-dose and Mircette is very low dose. Mircette has been associated with reduced menstrual cramps. According to major analyses, however, low-dose desogestrel poses a higher risk for blood clots than levonorgestrel.
• Drospirenone/estradiol: Yasmin is a low-dose contraceptive. Drospirenone has effects similar to natural progesterone. It is derived from a compound found in some diuretics (water pills) and has no male hormone effects. At this time, it may have fewer side effects than older OCs, including weight gain and emotional swings. It also reduces PMS symptoms and severe cramps and may reduce acne.
• Ethynodiol diacetate/estradiol: Demulen, Zovia are high-dose.
• Gestodene/estradiol: Minesse is a low-dose oral contraceptive approved in Europe. Gestodene is associated with a higher risk for blood clots than levonorgestrel.
• Levonorgestrel/estradiol: Levlen, Levora, Nordette, Portia, Triphasil, Seasonale, and Tri-Norinyl are low-dose and Alesse, Aviane, Levlite, and Lessina are very low-dose forms.
• Norethindrone acetate/estradiol: Estrostep, Loestrin, and Microgestin are all available in low to very low dose.
• Norethindrone/estradiol: Brevicon, ModiCon, Necon, Norethin Nortrel, Ortho-Novum are low dose. Ovcon is available in low and high doses.
• Norethindrone/mestrano: Necon, Norinyl, and Ortho-Novum are high-dose.
• Norgestimate/estradiol: Mononessa, Ortho-Cyclen, Ortho Tri-Cyclen, Sprintec are low dose.
• Norgestrel/estradiol: Cryselle is low-dose and Ovral and Ogestrel are available in low-dose and high-dose forms.
• Some of these brands are also available with iron. Of interest are injections and skin patches that are now available that contain both estrogen and progestin. Their side effects are similar to the combination OCs. Investigative progestins such as nestorone are being investigated in implants, gels, vaginal rings, and patches. [See Box Other Methods for Administering Combination Hormones.]

Types of Regimens. Combination pills are sold in 21-day or 28-day packs:

• Each pill in the 21-day pack contains the necessary estrogen and progestin.
• The 28-day pack adds seven differently colored "reminder" pills; they are inactive and do not contain hormones, but help the user maintain her daily routine during seven days between active pill use.

OCs may be taken in cycles that include pills of the same or different strengths. These are categorized as monophasic (one-phase), biphasic (two-phase), or triphasic (three-phase).

• Monophasic regimen (e.g., Alesse, Brevicon, Demulen, Desogen, Genora, Levlen, Levlite, Loestrin, Lo/Ovral, ModiCon, Necon, Nordette, Norethin, Norinyl, Ortho-Cyclen, Ortho-Novum, Ovcon, Ovral, Yasmin, Zovia.) A 21-day pack uses tablets that are one strength and one color for 21 days. (A 28-day pack adds seven inactive tablets of a different color.)
• Biphasic regimen (e.g., Mircette, Necon, Nelova, Ortho-Novum). A 21-day pack consists of tablets of one strength and color taken for seven or 10 days, then a second tablet with a different strength and color for the next 11 or 14 days. (And a 28-day pack adds seven inactive tablets of a third color.)
• Triphasic regimen (e.g., Cyclessa, Estrostep-21, Ortho-Novum 7/7/7, Ortho Tri-Cyclen, Tri-Levlen, Tri-Norinyl, Triphasil, Trivora). This pack consists of tablets with three different colors and strengths. In the first phase, there are tablets of one color for five to seven days; for phase two, a second color and strength tablet is taken for five to seven days; and for phase three, a third color and strength tablet is taken for five to 10 days. The difference in duration of each phase depends on the brand. (And a 28-day pack includes a fourth color inactive tablet for the last seven days.)

In all cases, women continue to menstruate, but their periods are lighter, shorter, more regular, and less painful than in women who are not on the pill. It is not clear if the biphasic or triphasic regimens offer any advantage over the monophasic in controlling bleeding. The monophasic regimen is the most studied regimen, and a major analysis found no major differences in bleeding control between monophasic and biphasic systems. One analysis found better bleeding control with the triphasic than the biphasic, but this have been due to different progestins used in each regimen (levonorgestrel in the triphasic and norethindrone in the biphasic).

Some researchers are investigating continuous oral contraceptives, either by extending a monophasic regimen or by using specific agents (. e.g., Seasonale, which contains estrogen and levonorgestrel). This approach produces a period only about every three months. Continuous OCs have the potential for helping women with either heavy bleeding, painful periods, or both. Breakthrough bleeding is the most common side effect but decreases over time. This approach is not suitable for women who frequently miss taking their pills. Long-term effects of steady hormone use are not known, and continuous contraceptives are still in trials.

Taking the Pills. Typically, the user takes the first pill either on the Sunday after her period starts or during the first 24 hours of her period. (The first pill can be started at any time during the menstrual without affecting the bleeding patterns. Ovulation can occur that month, however.) The remaining pills are taken once a day, ideally at the same time of day, until the pack is used up. The user, if she has a 21-day pack, waits seven days before starting a new pack. If she is on the 28-day pack, she takes the seven inactive pills.

If a woman misses one or more pills, she should take the following precautions:

• Missing the first pill in a new cycle. Take a tablet as soon as she remembers and the next one at the usual time. Two tablets can be taken in one day. Use barrier contraception for seven days after the missed dose. [See Spermicidal and Barrier Contraception.]
• Missing a pill two days in a row. Take two pills as soon as she remembers and then two more the following day. Also use back-up barrier contraception until the next pill cycle.
• Missing more than two, she should discard the pack, use a back-up birth control method and begin a new cycle on the following Sunday, even if she has started bleeding. One study found that women who miss three pills will probably still not ovulate, but nevertheless, they should take all necessary the precautions to prevent pregnancy.

Progestin-Only Oral Contraceptives

Progestin-only pill brands including the following:

• Levonorgestrel (Plan B).
• Norethindrone (Micronor, Avgestin, Norlutin, Nor-QD). (This progestin is made from male hormones, so may cause more male side effects than others.)
• Norgestrel (Ovrette).

Progestin-only pills, which only contain progestins, are always sold in 28-day packs and all the pills are active. Progestin-only pills must be taken at precisely the same time each day to maintain top effectiveness. If a woman deviates from her pill schedule by even three hours, she should call her doctor about using back-up contraception for the next two days. Progestin-only pill users will experience even lighter periods than those taking combination pills; some may not have periods at all. These agents should not be used by premenopausal women in their 40s, since they pose a higher risk for adverse effects in this group.

Advantages of Oral Contraceptives

Oral contraceptives are the choice of between one-quarter and one-third of American women who use birth control, making them the most popular reversible contraceptives in the US. OCs are among the most effective contraceptives; failure rates are very low and are usually due to noncompliance. Some studies have suggested that women who are overweight may have a higher risk for failure.  The risk for these women is also still very low, however.

OCs also have the following advantages:

• More sexual freedom. OCs do not interfere with intercourse, and in fact, many women report that sex is more pleasurable because they no longer have to worry about pregnancy.
• Reduce menorrhagia (heavy bleeding) and, therefore, reduce the risk for anemia.
• Reduction in dysmenorrhea (severe pain). High-dose OCs have been especially helpful, but they carry risks. Specific newer low-dose OCs that contain certain progestins, such as Yasmin (with drospirenone) and Mircette (with desogestrel), may reduce menstrual pain.
• Possible reduction in premenstrual syndrome with specific OCs, notably Yasmin. This OC may reduce premenstrual depression, water retention, and appetite to a greater degree that other OCs. Some OCs, however, are associated with worse emotional changes. Monophasic OCs may have a more beneficial effect on mood than triphasic OCs. To confuse matters, OCs with high progestin/low estrogen levels may produce worse moods in women without premenstrual syndrome but may be helpful for women with PMS.
• Reduction in endometriosis.

Endometriosis is the condition in which the tissue that normally lines the uterus (endometrium) grows on other areas of the body causing pain and irregular bleeding.

• Reduction of ovarian cancer. OCs may reduce the risk of ovarian cancer by 30% to 50% (even in women with genetic risk factors). Progestin appears to be the protective factor by suppressing ovulation. Protection occurs after five years of use and persists for 10 to 20 years after stopping. (One study indicated that taking birth control pills for only three to six months may confer long-term protection.) Some experts believe that women at particular risk for ovarian cancer might consider oral contraceptives with the highest progestin dose.
• Reduction of endometrial (uterine) cancer. According to some studies, older OCs reduced the risk for endometrial cancer by half. More studies are needed on newer formulations, which have lower doses of estrogen, but it is generally believed that they, too, are protective.
• Possible protection against colon cancer. Duration of use does not seem to be associated with decreased risk, but protection appears stronger for women who have used oral contraceptives more recently.
• Acne improvement with low-dose OCs. (Some low-dose OCs, such as Ortho Tri-Cyclen, have been specifically approved for acne reduction, although most low-dose OCs reduce testosterone levels and so many may help reduce acne. Yasmin, for example, has properties that block male hormones, which are associated with acne. In one study, Yasmin use produced a 63.5% response.)
• Possible protection against bone loss with low-dose OCs in some cases. The effect of OCs on bone density is unclear and may depend on the specific formulas that make up an OC. An important Canadian study that followed a group of young women found that OCs resulted in lower bone density and higher risk for fractures, possibly because taking OCs at younger ages interferes with achieving peak bone mass. Some evidence suggests, however, that OCs may protect against bone loss in women during the perimenopausal period. In addition, specific progestins (such as norethindrone or norgestimate) may be bone protective. More research is needed.

Disadvantages and Complications of Oral Contraceptives

Common Side Effects. Estrogen and progesterone have different side effects and women on the combined pill may experience different effects from those on the progestin-only pill. Symptoms of serious problems include severe abdominal pain, chest pain, unusual headaches, visual disturbances, or severe pain or swelling in the legs. Of note, in spite of some concerns, combination OCs do not cause weight gain.

[For specific side effects of estrogen and progestin, See Box Hormones Used in Contraception.]

Serious Effects on Heart and Circulation. OCs posed some serious risks when they first were introduced and estrogen and progestin levels were high. Such complications include blood clots, heart attack, stroke, and pulmonary embolism.

Most of the current low-dose OCs have reduced the risk significantly, although a risk for one or more of these complications still exists in women with certain risk factors (e.g., genetic factors, smoking, severe diabetes, and high blood pressure). Even among high-risk young women the additional risk for heart attack and stroke is still low. For example, low-dose OCs add only 9 complications per 100,000 women who smoke and have high blood pressure (which is still lower than the risk of death from pregnancy itself). Newer formulations have also reduced these risks.

The following are some observations on these complications.

• Blood clots (thromboses). Oral contraceptive use increases the risk for blood clots, particularly in women with inherited clotting defects. (Unfortunately, tests for genetic abnormalities that increase the risk for blood clots are expensive and not routinely available.) The risk is highest in the first few months. The danger, however, is very slight, particularly in women with no other risk factors.
• Hypertension. High blood pressure that occurs after a woman begins taking OCs can usually be corrected by discontinuing the medication, and women who use OCs should not be unduly alarmed. Of some concern was a study suggesting that OCs may cause a small but persistent increase in diastolic blood pressure (the second number in a blood pressure reading), which in turn may increase the risk for heart disease years later.
• Stroke. Evidence has consistently reported a higher than normal risk for stroke in women taking OCs even if women have no other stroke risk factors. The current low-dose OCs have significantly reduced the danger. Women with high blood pressure, however, still face a higher risk for stroke, particularly in the presence of smoking and migraines. The risk for stroke, however, is still very low in absolute terms, even for these women.

Click the icon to see an image of stroke.

• Heart attacks. Studies suggest a higher risk for heart attacks in certain women taking OCs, regardless of their risk for blood clots. OCs can also adversely affect cholesterol, lipids, and blood sugar levels, depending on the balance of estrogen and progestins. Smoking is the significant risk factor. In fact, some studies have found no higher risk for heart attack in healthy women who do not smoke. The chance for a heart attack is higher in OC users who have high blood pressure, unhealthy cholesterol levels, or both.

Different progestins may affect risk for one or more of these complications. For example, the newer-generation progestins desogestrel (e.g., Desogen, Ortho-Cept) and gestodene (Minesse) may pose a higher risk for blood clots than those containing levonorgestrel. However, some evidence suggests that they pose a lower risk for heart attacks.

Breast Cancer. Studies have been conflicting about whether estrogen in oral contraception increases the chances for breast cancer, and if it does, which women are at risk. Some research supported a higher risk in women with a family history of breast cancer and who also used OCs before 1975, which contained high-dose estrogens and progestins. A reassuring 2002 study supported an earlier major study, with both finding no evidence that current OC use increases the risk for breast cancer. It also reported no higher risk in women who had taken OCs for 15 years of more or had taken them at young ages. Some issues remain unresolved. For example, the risk for women currently taking OCs around menopause (ages 45 to 64) is still unclear. OCs users with a family history of breast cancer or who carry the BRCA1 genetic mutation (although possibly not those with the BRCA2) may be at higher risk. Such women are at higher risk for breast cancer in any case.

Cervical Cancer. A number of studies, including a major analysis, has reported a strong association between cervical cancer and long-term use of oral contraception (OC). The risk is highest (up to four times the risk of nonusers) in women infected with human papillomavirus (HPV) who have taken OCs for ten years or more. (Women who are not infected with HPV have no significantly higher risk.) The reasons for this risk from OC use are not entirely clear. Some experts have suggested that the hormones in OCs might facilitate entry of the HPV virus into the genetic material of cervical cells. Certainly, women who use OCs are less likely to use a diaphragm, condoms, or other methods that offer some protection against sexually transmitted diseases, including HPV.

Click the icon to see an image of cervical cancer.

Other Complications. Other complications have been associated with the use of oral contraceptives:

• Taking oral contraceptives containing certain progestins (desogestrel in one study) also increased the risk for periodontal disease. Other progestins do not pose a risk for gum disease.
• There has been some debate over whether the progestin-only pill increases the risk for permanent type 2 diabetes in women who develop a temporary form of diabetes during pregnancy (called gestational diabetes). In any case, the low-dose combination pill does not to pose such a risk. Women with a history of gestational diabetes should discuss this controversy with their physician.
• Some evidence suggests that oral contraceptives may reduce lung capacity during exercise. In fact, there have been a few reports of exacerbation of asthma with OCs, but this is an uncommon effect.
• The pill can affect the liver and, in rare cases, has been associated with liver tumors, gallstones, or jaundice. Women with a history of liver disease, such as hepatitis, should consider other contraceptive options.

Interactions with Other Medications. Oral contraceptives can interact with a number of other medications and herbs.

Implant Contraception

Progestin implant contraception uses rods that are inserted under the skin and continuously release tiny amounts of progestin into the bloodstream.

The standard implant has been the Norplant system, which uses the hormone levonorgestrel. This implant contraception consists of six flexible plastic rods, each about the size of a cardboard match. The Norplant system can generally remain in the arm for five years or be removed earlier if the recipient wishes. It is currently off the market.

Newer systems (Norplant II, Jadelle, Implanon) use fewer implants. The Norplant II and Jadelle system uses two rods and Implanon uses only one. All are proving to be safe and effective. A 2000 study on Implanon, which uses the progestin ketodesogestrel, reported that it was less costly than oral contraceptives, injected progestins (Depo-Provera), and Norplant. It was also more effective than Depo-Provera in preventing pregnancy.

Insertion of Implants. To ensure that a potential Norplant recipient is not pregnant at the time of insertion, the implants are usually inserted during the first seven days of her period. The typical procedure is as follows:

• The rods are inserted by a specially trained health care provider under the skin of the upper inside part of the non-dominant arm.
• After injecting the insertion site with a local anesthetic, the health care provider makes a small incision in the arm and places the implants under the skin with a trocar, a sharp-tipped instrument that resembles a large ballpoint pen. There are no stitches.
• A bandage is then placed over the wound and remains there for a few days to allow the site to heal.
• The entire procedure takes about 10 minutes and is painless, except for any discomfort caused by the anesthetic injection.
• For a few days afterward the recipient may also experience bruising, swelling, and discomfort at the insertion site.
• The implants begin to work within eight to 24 hours of the procedure, but the woman should use additional contraceptive protection for a week or two, depending on the physician's recommendation.

Implants do not require maintenance of any kind and do not affect the use of the arm once the insertion site has healed. They can be felt if the insertion site is touched, and their outline may be visible in thin arms. A return visit to the health care provider within three months of insertion, followed by yearly check-ups, allows the recipient's progress to be monitored.

Removing the Implant. When the time comes to remove the implants, the insertion site is again anesthetized and a small incision is made in the arm. Removal can be uncomfortable and is more difficult than the original procedure if scar tissue has formed over the implants. Removal usually takes 15 to 20 minutes, but may require more than one visit. (New implants with fewer rods appear to be much easier and faster to remove.) The implants' contraceptive action wears off a few hours after removal. Fertility is restored within a couple of weeks. If the user wishes, new implants can be inserted as soon as the old ones are removed.

Candidacy for Levonorgestrel Implants

Levonorgestrel implants are comparable to tubal ligation in effectiveness. They are good choices for women who want to delay pregnancy for several years but hope to bear children later on. Although failure is rare, pregnancies do occur and are more likely in heavier and younger women.

Women should absolutely not use Norplant if they are pregnant or have the following conditions, or history of them:

• Breast cancer.
• Acute liver disease or tumors.
• Blood clots.
• Undiagnosed vaginal bleeding.

Those who should consider other methods first include the following:

• Women who are breastfeeding. They should wait for six weeks after delivery to receive the implants. (One study suggested the newer Implanon system has no adverse affect on breast milk and so may be a safe option for breast-feeding mothers.)
• Women at risk for breast cancer, blood clots, heart disease, diabetes, high blood pressure, liver disease, or stroke.
• Women at risk for osteoporosis because of a link between bone calcium loss and progestin-contraceptives. (One study, however, reported that young girls who used the Norplant implants experienced increased bone density.)

Implants do not provide protection against sexually transmitted diseases, so women at risk for infection should also use a barrier contraceptive, or as an alternative to the implants.

Advantages of Levonorgestrel Implants

A study of women attending four family planning clinics reported that 92% of users of the implants were satisfied with the Norplant system. Another reported that the continuation rate after a year was better than that of combined oral contraceptive use. In general, studies indicate that at the end of five years, between 40% and 70% of recipients still used implants.

The advantages of the implants are as follows:

• Levonorgestrel implants prevent pregnancy for up to five years.
• They are easily reversible.
• Like the IUD, the implants allow users to enjoy sex without worrying about taking a birth control pill every day, or inserting a diaphragm or cervical cap before sex begins.
• Progestins may protect against uterine and ovarian cancer.

Disadvantages and Complications of Levonorgestrel Implants

The disadvantages of the implants are as follows:

• They have the same side effects as any device containing progestins. In many cases these problems subside as time passes, or can be substantially reduced using other therapies.
• Some studies have reported an association between depression and Norplant use. One study revealed that after two years, many Norplant users who reported severe depression at the beginning showed improvement.
• About 3% of users suffer a reaction to the local anesthetic, experience tissue or nerve damage due to poorly placed implants, or experience problems in removal.
• Certain medications interfere with Norplant, including antiseizure drugs and rifampin (rifampicin), an antibiotic used to treat tuberculosis. A physician must always be informed of any medications the patient is taking, even if they are unrelated to gynecologic problems.

There have been some reports of strokes, unexpected pressure in the brain, and clotting abnormalities in women using implants, but a major 2001 five-year study reported that there were no major health complications and that the implant was an effective, safe method of contraception.

Injected Contraception

Injected contraceptives help fill the needs of women who are able to take hormonal contraceptives but have difficulty complying with daily pills. Injected progestins have been the standard form, but they can have severe effects on the menstrual cycle. More recently, combination injections of estrogen and progestins have been developed that are effective, have fewer side effects than progestin injections, and may even have health benefits.

Injected Progestins

Injected progestins, particularly depo-medroxyprogesterone acetate or DMPA (Depo-Provera), are currently the standard injected contraceptive and are very effective. Depo-Provera uses a progestin called medroxyprogesterone. Like other progestin contraceptives, Depo-Provera prevents pregnancy by halting ovulation, thickening the cervical mucus, and stopping the implantation of fertilized eggs in the uterine lining.

Administering Injections. The typical procedures for progestin injections are as follows:

• A physical examination is necessary before beginning the injections.
• It is injected into a muscle in the patient's arm or buttock, and during months between injections, the hormone slowly diffuses out of the muscle into the bloodstream.
• Depo-Provera requires an injection by the physician every three months. Another injected progesterone (Noristerat) needs to be injected every two months.
• If more than two weeks pass beyond the regular injection schedules, the woman should have a pregnancy test before taking the next one.

Candidacy for Injected Progestins

Depo-Provera is a good choice for many women who want to delay pregnancy for several years but hope to bear children later on. It is safe for many women who are not candidates for OCs, including smokers over 35, and for those who have the following conditions:

• Risk for blood clots or stroke.
• Migraines.
• Diabetes.
• Systemic lupus.

Systemic lupus erythematosus is a chronic inflammatory autoimmune disorder which may affect many organ systems including the skin, joints and internal organs. The disease may be mild or severe and life-threatening. African-Americans and Asians are disproportionately affected.

• Coronary artery disease.

Click the icon to see an image of atherosclerosis.

It may actually reduce the frequency of crises in sickle cell patients, and reduce seizures in women with epilepsy.

Depo-Provera is not given to women with the following conditions:

• Liver disease.
• Unexplained vaginal bleeding.
• Pregnancy.
• Women who are breastfeeding for the first six weeks after delivery.
• Women at risk for osteoporosis.

Because of the long lag time between ending treatments and restoration of fertility, Depo-Provera is not recommended for women who are thinking of becoming pregnant within two years.

Advantages of Injected Progestins

The advantages of Depo-Provera are as follows:

• Progesterone injections provide highly effective reversible protection against pregnancy without placing heavy demands on the user's time or memory.
• They also may protect against uterine and ovarian cancer and do not pose any risk for breast cancer.
• DMPA is also useful for painful periods, heavy bleeding (including heavy bleeding caused by fibroids), premenstrual syndrome, and endometriosis.
• Depo-Provera does not appear to cause weight gain as other hormonal agents may.

Disadvantages and Complications of Injected Progestins

Disadvantages are as follows:

• Side effects of any progestin-containing contraceptive. For example, about 60% of users gain weight during long-term use. For these and other reasons, 70% of users stop the injections within a year.
• Most users of Depo-Provera stop menstruating altogether after a year. Women who eventually want to have children should be aware that Depo-Provera can cause persistent infertility for up to 22 months after the last injection, although the average is 10 months. This is significantly longer than restoration of fertility after the removal of the Norplant implant.
• Long-term (more than 2 years) use of Depo-Provera can cause loss of bone density. In November 2004, the FDA added a “black box” warning to the Depo-Provera label advising of this risk. The warning notes that the decline in bone density increases with duration of use and may not be completely reversible even after the drug is discontinued. Based on this information, the FDA recommends that Depo-Provera should not be used for longer than two years unless other birth control methods are inadequate. A 2005 study of young women (age 14 to 18 years) found that adolescents who stop taking Depo-Provera do regain bone density.
• The injections do not provide protection against sexually transmitted diseases. According to a 2004 study, women who take Depo-Provera have three times the risk of acquiring chlamydia and gonorrhea as women who do not use a hormonal contraceptive. The reason for this increased risk is unclear. The same study found that oral contraceptive use, in comparison to non-hormonal contraceptives, was not associated with increased risk.
• Depo-Provera has been associated with a higher incidence of depression, although it is unclear whether the contraception was really the cause.
• Of some concern was a 2002 study that found changes in the arteries of long-time users, suggesting a risk for future heart disease. More research is warranted.

Intrauterine Devices (IUDs)

The intrauterine device (IUD) is a small plastic device that is inserted into the uterus. An IUD's contraceptive action begins as soon as the device is placed in the uterus and stops as soon as it is removed. Precisely how the IUD prevents pregnancy is a mystery. Some experts believe that the presence of the IUD alters the fluids in the fallopian tubes and uterus, which reduces the chances for fertilization.

The intrauterine device shown uses copper as the active contraceptive, others use progesterone in a plastic device. IUDs are very effective at preventing pregnancy (less than 2% chance per year for the progesterone IUD, less than 1% chance per year for the copper IUD). IUDs come with increased risk of ectopic pregnancy and perforation of the uterus and do not protect against sexually transmitted disease. IUDs are prescribed and placed by health care providers.

IUD Forms

The two standard IUDs are copper-releasing or progestin-releasing IUDs. Both are effective and have specific advantages and disadvantages:

Copper-Releasing IUDs. Copper-releasing IUDs (ParaGard, Nova T) are partly wrapped in copper and can remain in the uterus for 10 years. So-called frameless copper IUDs (Gynefix, FlexiGard, or CuFix) consist of nylon thread that holds the copper sleeves. They are equal to standard copper IUDs in effectiveness and may have fewer side effects. They are difficult to implant and not yet available in the US. A number of other new designs are also under investigation.

Progestin-Releasing IUDs.These IUDs continuously release progestin into the uterus in small amounts. They may be specifically beneficial for women with menstrual disorders. The levonorgestrel-releasing intrauterine system, or LNG-IUS (Mirena), releases progestin for up to five years. To date, of all the IUDs, the LNG-IUS appears to solve more problems than the other versions. It is long acting, safe, is very effective in preventing heavy bleeding, and helps reduce cramps. In fact, one expert described the LNG-IUS as a nearly ideal contraceptive.With short-term IUDs (Progesterone T, Progestatsert) the progestin supply runs out after a year and a new IUD must be inserted.

FibroPlant is a unique "frameless" LNG-IUS device that is very small and secretes a very low dose of progestin. It appears to have very few hormonal effects, although comparison studies are needed to prove any significant advantages over the Mirena.

Inserting the IUD

With some exceptions, an IUD can be inserted at any time, except during pregnancy. It is typically inserted in the following manner by a trained health professional:

• A plastic tube containing the IUD (the inserter) is slid through the cervical canal into the uterus.
• A plunger in the tube pushes the IUD into the uterus.
• Attached to the base of the IUD are two thin but strong plastic strings. After the instruments are removed, the health care provider cuts the strings so that about an inch of each dangles outside the cervix within the vagina.

The strings have two purposes:

• They enable the user or health care provider to check that the IUD is properly positioned. (Because the IUD has a higher rate of expulsion during menstruation, the woman user should also check for the strings after each period.)
• They are used for pulling the IUD out of the uterus when removal is warranted.

Candidacy for the IUD

The IUD is often an excellent choice for women who do not anticipate future pregnancies, but who do not wish to be sterilized. Women who are unable to use hormonal contraceptives (for example, those with heart disease, epilepsy, migraines, hypertension, or liver disease) may be good candidates for the copper IUD.

Women with risk factors that preclude hormonal contraceptives should probably avoid progestin-releasing IUDs, although the progestin doses are much lower with LNG-IUS and probably do not pose the same risks. Other women who may be poor candidates for the IUD are those with the following history or conditions:

• Current or recent history of pelvic infection.
• Risk factors for sexually transmitted diseases (such as having multiple sexual partners).
• History of menstrual disorders. (Progestin-releasing IUDs may be an option for women with heavy or painful bleeding. They should avoid the copper-releasing IUDs, however.)
• Current pregnancy.
• Abnormal Pap tests.
• Cervical or uterine cancer.
• Anatomical abnormalities of the uterus.
• A very large or very small uterus.

Advantages of the Intrauterine Device

The IUD is one of the safest, least expensive, and most effective contraceptive devices available. In spite of its clear advantages and current safety record, only 1% of American women currently use the IUD. (Over 10% of European women have chosen the IUD.) This low use in America is mainly due to persisting and now unwarranted fears of serious infection. [See Infection below.] In fact, increasing its use would most likely reduce both the number of abortions and sterilizations in the US, without producing unwanted infertility.

IUDs in general have the following advantages:

• The IUD is more effective than OCs at preventing pregnancy and it is reversible. Once it is removed, fertility returns. (In spite of outdated concerns, studies have found no adverse effects on fertility with the current IUDs.)
• Unlike the pill, there is no daily routine to follow.
• Unlike the barrier methods (spermicides, diaphragm, cervical cap, and the male or female condom), there is no insertion procedure to cope with before or during sex.
• Intercourse can resume at any time, and as long as the IUD is properly positioned, neither the user nor her partner typically feels the IUD or its strings during sexual activity.
• It is the least expensive form of contraception over the long term.

There also additional advantages, depending on the specific IUD:

• The progestin-releasing LNG-IUS (Mirena) is now considered to be one of the best options for treating menorrhagia (heavy menstrual bleeding). Some studies suggest it might help avoid hysterectomy in 80% of cases. Note: irregular break-through bleeding can occur for the first six months. It may even be appropriate and protective for women with uterine fibroids.
• The copper-releasing IUDs do not have hormonal side effects and may help protect against endometrial (uterine) cancer.

Disadvantages and Complications of Specific Intrauterine Devices

The insertion procedure can be painful and sometimes causes cramps, but for many women it is painless or only slightly uncomfortable. Patients are often advised to take an over-the-counter painkiller ahead of time. They can also ask for a local anesthetic to be applied to the cervix if they are sensitive to pain in that area. Occasionally a woman will feel dizzy or light-headed during insertion. Some women may have cramps and backaches for a day or two after insertion, and others may suffer cramps and backaches for weeks or months. Over-the-counter painkillers can usually moderate this discomfort.

Menstrual Bleeding with the Copper T IUD. Both IUD forms have effects on menstruation, although they differ significantly by type:

• Copper releasing IUDs can cause cramps, longer and heavier menstrual periods, and spotting between periods. Prescription medications are available to control the bleeding and pain, which, in any event, usually subside after a few months.
• Progestin-releasing IUDs produce irregular bleeding and spotting during the first few months. Bleeding may disappear altogether. (This characteristic, particularly with the LNG-IUS is a major advantage for women who suffer from heavy menstrual bleeding but may be perceived as a problem for others.)

Menstrual difficulties can be so troublesome with either IUD that, according to one study, they were responsible for a removal rate of 5% to 15% within a year of insertion.

Infection. The current versions of IUD pose a slightly higher risk for pelvic inflammatory disease in the first month following insertion. The risk of PID in women without any symptoms of sexually transmitted infections, however, is the same in both IUD users and nonusers. Some physicians employ preventive antibiotics before inserting the IUD, but a major analysis did not find that this was helpful. (An early IUD, the Dalkon Shield, which sported a braided tail, was banned after reports of several deaths and a very high rate of infection.)

Ovarian Cysts. The LNG-IUS may increase the risk for ovarian cysts, but such cysts usually do not cause symptoms and resolve on their own.

Expulsion. An estimated 2% to 8% of IUDs are expelled from the uterus within the first year. Expulsion is most likely to occur during the first three months after insertion. Expulsion rates may be higher than average if the IUD is inserted immediately after delivery of a child. In one out of five cases, the user fails to notice that the device is gone, and thus faces the risk of unintended pregnancy. The risk for expulsion is highest during menstruation, so users are strongly advised to examine their sanitary napkins for the IUD every day during the period and to regularly check for the IUD strings throughout the month.

Effects on Pregnancy. None of the current IUDs increase the risk for infertility. In the very unlikely event that a woman conceives with an IUD in place, however, there is a higher risk of an ectopic pregnancy or miscarriage.

Click the icon to see an image of an ectopic pregnancy.

If the IUD is removed right after conception, than the risk for miscarriage is close to average (about 20%). There is no evidence that the IUD in a pregnant woman increases the risk for birth defects in the infant.

Perforation. A potentially serious complication of the IUD is the accidental perforation of the uterus during insertion or later perforation if the IUD shifts position. Such an occurrence is very rare and the risk is higher or lower depending on the skill of the inserter.

Spermicidal and Barrier Contraception

Barrier contraceptives are devices that provide a mechanical barrier between the sperm and the egg. Examples of barrier contraceptives include the male condom, female condom, and the diaphragm. [For a description of the male condom, see Box Male Condom.] Barrier devices are the only contraceptive methods that can help prevent sexually transmitted diseases (STDs).

Spermicides

Spermicides are sperm-killing substances available as foams, creams, or gels, and are often used in female contraception with barrier and other devices. Spermicides are usually available without a prescription or medical examination.

The active ingredient in US-made spermicides is usually nonoxynol-9, which attacks the surface of the sperm cell. Nonoxynol-9, however, does not provide any additional protection against sexually-transmitted diseases. In fact, research now suggests that frequent use may cause vaginal injuries and actually increase the risk for HIV transmission in women. In addition, use of a spermicide with a barrier device also poses a two- to three-fold risk for a urinary tract infection in women, regardless of whether the device is a condom or diaphragm. Spermicides are no longer recommended with male condoms. Some experts question their use with the diaphragm, suggesting that they may not even add much protection against pregnancies. A major analysis of current research found only one study that reported enhanced protection, but it had limitations.

In general, spermicides may be an appropriate choice for women who have intercourse only once in a while, or need backup protection against pregnancy (for instance, if they forget to take their birth control pills). Spermicides should not be used alone as the primary method of birth control. Nor should they be used to prevent sexually transmitted diseases.

Diaphragm

The diaphragm, which is generally used with a spermicidal cream, foam, or gel, is a small dome-shaped latex cup with a flexible ring that fits over the cervix. The cup acts as a physical barrier against the entry of sperm into the uterus. The spermicide provides added chemical protection. (Of note: some evidence suggests that spermicide does not add any additional protection, but more studies are needed to confirm this. Current spermicides, in any case, do not protect against sexually transmitted infections.)

The diaphragm is a flexible rubber cup that is filled with spermicide and self-inserted over the cervix prior to intercourse. The device is left in place several hours after intercourse. The diaphragm is a prescribed device fitted by a health care professonal and is more expensive than other barrier methods such as condoms.

There are three basic rim designs.

• The Arcing Spring diaphragm applies strong pressure and easily flips into place. It is useful for women with weak vaginal muscles and for new users who are worried about incorrect placement.
• The Coil Spring Rim is useful for women with strong vaginal muscles.
• The Flat Spring Rim has a delicate rim and a gentle spring, and may be appropriate for women who have not had children.

Diaphragms come in different sizes and require a fitting by a trained health care provider. The health care provider also advises and prescribes the correct size of diaphragm for the user. Some women will need to be refitted with a different-sized diaphragm after pregnancy, abdominal or pelvic surgery, or weight loss or gain of 10 pounds or more. As a general rule, diaphragms should be replaced every one to two years.

Although the diaphragm has a relatively high failure rate, even with perfect use, it is considered a good choice for women whose health or lifestyle prevents them from using more effective hormonal contraceptives. Certain conditions of the vagina and uterus, a history of toxic shock syndrome, or a history of recurrent urinary tract infections, may disqualify a woman from using the device. The diaphragm should not be used if either partner is allergic to latex or spermicides.

Using and Inserting the Diaphragm. The diaphragm can be placed in the vagina up to one hour before intercourse and can be used even when a woman is menstruating. The following are general guidelines for insertion:

• Before or after each use, the woman should hold the diaphragm up to the light and fill it with water to check for holes, tears, or leaks.
• A small amount of spermicide (about one tablespoon) is usually placed inside the cup and some is smeared around the lip of the cup. Important Note: The use of spermicides with a diaphragm is under debate. It may not offer additional protection against pregnancy. It can increase the risk for urinary tract infections and does not protect against sexually transmitted diseases. Be sure to read the discussion of spermicides above.
• The device is then folded in half and inserted into the vagina by hand or with the assistance of a plastic inserter.
• The diaphragm should fit over the cervix, blocking entry to the womb.
• If more than six hours pass before repeat intercourse occurs, the diaphragm is left in place and extra spermicide is inserted into the vagina using an applicator.
• The diaphragm must remain in the vagina for six to eight hours after the final act of intercourse, and can safely stay there up to 24 hours after insertion.
• The diaphragm should be washed with soap and warm water after each use and then stored in its original container, which should be kept in a cool dry place.

Advantages of the Diaphragm. The diaphragm can be carried in a purse, can be inserted up to an hour before intercourse begins, and usually cannot be felt by either partner. It appears to protect against cervical gonorrhea, Chlamydia, and trichomoniasis, although more research is needed to confirm this. It does not provide protection against sexually-transmitted infections in areas other than the cervix.

Disadvantages and Complications of the Diaphragm. Some disadvantages or complications are as follows:

• Failure rates are high, about 20% with typical use.
• Some women dislike having to insert the device every time intercourse occurs or have trouble mastering the insertion and removal process.
• One potential worry is that the device may slip out of place when the woman is on top during intercourse.
• Frequent urinary tract infections are a problem for some users. This difficulty can sometimes be resolved by a refitting, by urinating before inserting the device, or by urinating after intercourse.
• Cases of toxic shock syndrome have been reported among diaphragm users, but it is very rare. To be safe, the diaphragm should not stay in place for more than 24 hours. (It is still important for pregnancy protection, however, to retain the diaphragm for six to eight hours after intercourse.)
• Of note: it provides protection against sexually transmitted disease only in the cervix and women should not rely on it for protection against HIV.

Cervical Cap

The cervical cap (Prentif, FemCap) is a thimble-shaped latex cup that fits over the cervix and is always used with a spermicidal cream or gel. It is like the diaphragm, but smaller, and is available in only four sizes. The cap is sold by prescription and requires a pelvic examination, Pap test, and fitting by a health care provider.

Insertion and Use of the Cervical Cap. After a small amount of spermicide is placed in the cap, the device is inserted by hand. As in diaphragm use, instruction and practice is required. The cap must be kept in the vagina for eight hours after the final act of intercourse. Caps wear out and should be replaced every one to two years. A refitting may also be needed when a woman experiences certain changes in her health or physical status.

Click the icon to see an image of a cervical cap.

Candidacy for the Cervical Cap. Because of the restricted range of available sizes, about one woman in five will not be able to be fitted for the cap. The cap is not widely used, and some women, particularly those who live in sparsely populated areas, may not have access to health care professionals who are trained in fitting this device. Other conditions that can preclude cap use include the following:

• An abnormal Pap test.
• A history of toxic shock syndrome.
• A sexually transmitted or reproductive tract infection.
• Inflammation of the cervix.
• The cap has little value for women who have had children, because the stretching of the vagina and cervix makes obtaining a proper fit more difficult and failure rates are high.

Advantages of the Cervical Cap. Among women who have never given birth, the cap's failure rate, at least with Prentif cervical cap, is similar to that of the diaphragm. (The FemCap appears to have a higher failure rate.) The cap in general is also similar to the diaphragm in terms of cost, ease of use, protection against STDs, and also the potential for latex or spermicidal allergies. But unlike the diaphragm, the cap can safely remain in the vagina for up to 48 hours (twice the time limit for a diaphragm), so it can be inserted well in advance of intercourse. The cap is rarely associated with urinary tract infections, and no documented cases of toxic shock syndrome have been reported.

Disadvantages of the Cervical Cap. The following are disadvantages of the cervical cap.

• Failure rate with any cap is high in women who have given birth (40%). In general, the FemCap has a higher risk for failure than either the diaphragm or the Prentif cap.
• Unlike the diaphragm, the cap cannot be used during menstruation.
• Use of the cervical cap -- particularly the Prentif cap -- poses a higher risk for abnormal cervical cell growth than with the diaphragm.

Female Condom

The female condom (e.g., Reality, Femidom) is a lubricated, loose-fitting pouch that lines the vagina. It is designed to create a physical barrier against sperm and sexually transmitted diseases by surrounding the penis during intercourse. The failure rate for the female condom is about the same as for the diaphragm and cervical cap. It is available without a prescription but may be hard to find.

Use and Insertion of the Female Condom. The female condom is about three inches wide and six to seven inches long (larger than a male condom), with a flexible ring at both ends. Current products are made of polyurethane.

• The ring at the closed end is used to insert the device into the vagina and hold it in place over the cervix.
• The ring at the open end remains outside the vagina and partly covers the labia (lips).

The insertion process may seem daunting at first but becomes much easier with practice:

• The female condom is inserted by hand into the vagina up to eight hours before intercourse. (It should never be used in combination with a male condom.)
• Although the female condom is prelubricated, extra lubricant is sometimes needed while inserting the device or during intercourse. (It is not made of latex, so oil lubricants will not harm it.)
• During intercourse, the woman checks to be sure that the outer ring is lying flat against her labia and then guides her partner's penis into the ring.

The female condom should be removed in the following circumstances:

• If it tears during insertion or use.
• If the outer ring is pushed inside.
• If it bunches up inside the vagina.

The female condom may be the best option for women at risk for sexually transmitted diseases and who are not certain that their male partner will use a condom. There are virtually no obstacles against its use except a negative psychological perception. It is not completely fail-proof against pregnancy or sexually transmitted diseases.

Advantages of the Female Condom. In one study, 75% of the women preferred the female to the male condom. Many men also find it more appealing than the latex male condom. The female condom has a number of advantages over the male condom:

• The female condom is an effective barrier to viruses, including HIV, and other sexually transmitted organism, particularly since it covers a large area, including external genitals. However, there are few clinical studies at this time to determine its protection against sexually transmitted diseases. No contraceptive device is fool proof.
• The standard female condom is made of polyurethane, which is thin and soft but at the same time 40% stronger than the latex male condoms. Polyurethane is not damaged by lubricating oils, as latex is and is also less likely to cause an allergic reaction. It transmits body heat better than latex, providing a more "natural" sensation, and possibly enhancing the pleasure of the sexual act.
• The man does not have to withdraw his penis immediately after ejaculation, as is the case with the male condom, but can, if he wishes, withdraw after he has lost his erection.

Disadvantages and Complications of the Female Condom. Compliance rates are low for many reasons. About 25% of women have difficulty on the first attempt at self-insertion. Some women are distressed by self-insertion. The inner ring may be uncomfortable for some women (in which case it can be removed). Some couples complain that the female condom is unpleasant to look at and can be noisy during intercourse. Without sufficient lubrication, it can also be pushed out of place by the penis. Using more lubricant can help keep the female condom in place and reduce the noise. Female condoms are also expensive (about $3.00 each) and some women wash them out and reuse them to save money. (In such cases, they should be disinfected first and then washed carefully.) Repeated washings can increase the risk for damage and holes. It is not known how many rewashings are safe.

The Sponge

The sponge (Today, Protectaid) is a disposable form of barrier contraception. It is made of soft polyurethane, is round in shape, and fits over the cervix like a diaphragm, but is smaller and easily portable. In 1994, the popular OTC contraceptive was taken off the U.S. market because of problems at the company's manufacturing facility. A new company has since acquired the rights to manufacture the sponge, and has been selling it in Canada and online since 2003. In April 2005, the FDA granted re-approval for the Today sponge to return to the U.S. market.

Use and Insertion. To use the sponge, the woman first wets it with water, then inserts it into the vagina with a finger, using a cord loop attachment. It can be inserted up to six hours before intercourse and should be left in place for at least six hours following intercourse. The sponge provides protection for up to 12 hours. It should not be left in for more than 30 hours from time of insertion.

The sponge should not be used during menstruation, after childbirth, miscarriage, or termination of pregnancy, or by women with a history of toxic shock syndrome.

Advantages. Because the sponge is not felt during intercourse and can be inserted up to six hours before intercourse, it encourages spontaneity. It appears to protect against cervical gonorrhea and Chlamydia.

Disadvantages. Failure rates (about 10%) are higher than with the diaphragm. There is a very small risk for toxic shock using the sponge, as there is for other barrier methods of contraception. The sponge may increase the risk for candidiasis (yeast infection). People who are allergic to spermicides should not use the sponge. The sponge does not protect against HIV or sexually transmitted diseases outside the cervix. The Today sponge contains ten times the amount of the spermicide, nonoxynol-9, than other products, and there is some evidence that this spermicide may increase the risk for HIV. The Protectaid sponge, available in Canada, contains a mix of three spermicides (nonoxynol-9, sodium cholate and benzal konium chloride).

Lea Shield

The Lea shield is made of silicone and its cup-shaped bowl completely surrounds the cervix without resting on it. The shield, therefore, does not need to be fitted, and manufacturers showed results equal to the diaphragm and cap when used with spermicide. Its advantages are as follows:

• One size fits all.
• Can be left for 48 hours after intercourse.
• Reusable for six months.

Natural Family Planning Methods

Natural family planning contraceptive methods include those that do not require medication, physical devices, or surgery to prevent pregnancy.

Cycle-based fertility awareness methods rely on tracking the changes in the body that signal fertility. A woman is only fertile during part of the menstrual cycle. By monitoring certain changes in her body, a woman can more or less predict the fertile phase and abstain at that time. She can also use barrier methods if she isn't prohibited by religious beliefs. The Catholic Church, for example, generally approves most natural family planning methods.

Monitoring Basal Body Temperature. To determine the most likely time of ovulation and therefore the time of fertility, a woman is instructed to take her body temperature, called her basal body temperature. This is the body's temperature as it rises and falls in accord with hormonal fluctuations.

• Each morning before rising, the woman takes her temperature with a specialized basal body thermometer and marks the result on a graph-paper chart. (Of interest is a wrist watch-like device under investigation that measures skin changes to predict ovulation.)
• The woman also notes the days of menstruation and sexual activity.
• The so-called "fertile window" is six days long and starts five days before ovulation and ends the day of ovulation.
• The chances for fertility are considered to be highest between days 10 and 17 in the menstrual cycle (with day 1 being the first day of the period and ovulation occurring about two weeks later). It should be noted, however, that a 2000 study reported that only 30% of women were fertile within that period of time. In the study, women had a 10% chance of ovulating on each day between day 6 and 21. Researchers who conducted the study suggested that each woman track the length of her cycle, which in the general population of women actually runs between 19 and 60 days. A long cycle, for example, suggests a delayed ovulation date.
• Immediately after ovulation, the body temperature increases sharply in about 80% of cases. (Some women can be ovulating normally yet not show this temperature pattern.)

By studying the temperature patterns after a few months, couples can begin to anticipate ovulation and plan their sexual activity accordingly. Couples must try to avoid becoming fixated on the chart, however, in scheduling their sexual activity. Spontaneity can be lost, and the stress on the relationship can be quite severe, possibly impeding fertility.

Home Monitoring System. A number of home test kits may help couples determine times of fertility. Not all are available in the US.

• Some test kits monitor reproductive hormone levels in the urine (e.g., Persona, Clear Plan).
• Other devices (e.g., Lady Comp, Bioself) measure basal body temperature.
• Yet another approach (PFT 1-2-3 Kit, Maybe Baby, Fertility Tracker, and Ovu-Tech) employs a pocket microscope to examine crystals of dried saliva, which would indicate the presence of hormones associated with fertile days.

No comparative studies are available on these tests and there is little evidence to determine their reliability. None are reliable enough to be used for complete contraception. Manufacturers of Persona, for example, claim failure rates of 6%.

Cervical Mucus Method. A much more reliable method (also called the ovulation method) requires a woman to take a sample (by hand) of her cervical mucus every day for a least a month and to record its quantity, appearance, feel, and to note other physical signs connected with the reproductive system. Cervical mucus changes in predictable ways over the course of each menstrual cycle:

• Six days before ovulation, mucus is affected by estrogen and becomes clear and elastic. Ovulation is likely to occur the last day that mucus has these properties.
• Right after ovulation, mucus is affected by progesterone and is thick, sticky, and opaque.

Once a woman's individual pattern is understood, analyzing cervical mucus can provide a highly accurate guide to fertility.

Creighton Model. The Creighton Model is a variation of the cervical mucus method. When used precisely, pregnancy rates have been reported to be less than 1%, although given the likelihood of errors, the annual failure rate is about 3% to 4%. It is an intensive program involving both the couple and a trainer. Having a regular cycle is not necessary for success. The woman learns when she is most likely to be ovulating, when she is likely to conceive, and to determine if her reproductive system is functioning normally or abnormally. It requires a trained instructor, however, and the program is not yet available everywhere.

Prolonged Breastfeeding (The Lactational Amenorrhea Method). Breastfeeding often delays the onset of ovulation and menstruation for about six months. A technique called the Lactational Amenorrhea Method (LAM) has been devised to allow women to rely on breastfeeding for natural family planning. New mothers are candidates for LAM if their periods have not returned after delivery. They must be breastfeeding the baby on demand, day and night, without regularly substituting other liquids or foods in the baby's diet.

The risk for pregnancy with this method is less than 2% in the early months, although by six months after birth it increases to over 5%. The return of menstruation indicates the return of fertility. Bleeding or spotting during the first 56 days is not considered menstruation. After that, two or more consecutive days of bleeding are usually an indicator that periods have returned. Ovulation can occur before menstruation resumes, although it is less likely within six months of delivery (particularly if the mother is intensively breastfeeding).

Candidacy for Natural Family Planning

Because of the high risk for pregnancy, natural family planning methods are recommended only for those whose strong religious beliefs prohibit standard contraceptive methods. Couples who are not guided by religious authority, but who simply want a more natural sexual life, should use a barrier contraceptive during the fertile phase and no contraception during the rest of the cycle. To be effective against pregnancy, cycle-based methods require not only training, commitment, discipline, and perseverance, but also the cooperation of the male partner. Cycle-based methods are not recommended for women unless they are in a stable, monogamous relationship, and can count on their partner's willing participation.

Advantages of Natural Family Planning

Many couples, especially older ones, who have used these methods for a while and are strongly motivated, are able to successfully incorporate fertility awareness into their lives. For those with strong religious beliefs, natural family planning allows them to have a fulfilling sexual life yet still adhere to the rules of their church.

Disadvantages and Complications of Natural Family Planning

Couples who adopt a cycle-based approach to pregnancy avoidance must often abstain from sex or substitute other kinds of sexual intimacy for vaginal intercourse. Some couples find this self-denial and the need for vigilant tracking of the cycle difficult and stressful for the relationship. Failure rates are high with natural family planning, although newer methods, such as the Creighton Model, are reporting very effective results. The risk for sexually transmitted diseases is also of particular concern, because such methods offer no protection against infection and religious beliefs usually preclude barrier protection.

Emergency Contraception

Emergency contraception is available to prevent pregnancy:

• After sexual assault.
• After consensual intercourse in which contraception is not used.
• When contraception is used but fails (for instance, when a condom breaks or a diaphragm dislodges).

Basics of Emergency Contraception

Emergency contraception uses hormonal or IUD approaches to prevent either fertilization or the implantation of a fertilized egg in the uterine lining. This is not the same thing as the "abortion pill" [See Mifepristone, below ]. Emergency contraception is available from private health care providers, Planned Parenthood and other family planning clinics, and community and student health centers. Emergency contraception is available at hospital emergency departments, except when the hospital is affiliated with a religion that opposes birth control.

Experts argue that it should be more readily available to women, particularly in light of a study that found no increased usage of emergency contraception when women had easy access to it. A 2005 study published in the Journal of the American Medical Association found that among women ages 15 to 24 years, direct access to emergency contraception did not increase risk-taking behavior. Women in the study were given direct access to emergency contraception either through a pharmacy or having the pills on hand in advance. They did not have increased rates of unprotected intercourse or sexually transmitted infections compared to controls.

Non-prescription access to emergency contraception has been tied up in a political battle. In 2003, the manufacturer of the levonorgestrel emergency oral contraceptive Plan B filed an application for the drug to be sold over-the-counter (OTC). Later that year, an FDA advisory committee found the product safe and effective, and overwhelmingly recommended approval. However, in 2004 the FDA delayed granting OTC status, citing safety concerns regarding adolescent use. This action was strongly condemned by the American College of Obstetricians and Gynecologists, Planned Parenthood, and other medical organizations.

In January 2005, the FDA again delayed a decision. Opponents contend that the FDA is being influenced by political, not scientific, considerations. At the time of this report, no final federal decision regarding non-prescription availability had been made. Plan B is available without a doctor’s prescription in some American states. Several states have approved legislation that gives pharmacists permission to write a prescription for Plan B. The drug is available without a prescription in other countries, including Canada.

Specific Methods

Emergency Oral Contraception. There are two forms of emergency oral contraception:

• The Yuzpe method is the most common method. It simply employs two doses of combined oral contraceptives containing estrogen and the progestin levonorgestrel. (Some evidence suggests that combinations with other progestins, such as norethindrone, may also be useful). In general, this approach is effective in preventing pregnancies 75% of the time (although some studies report lower success rates).
• The other standard approach uses two doses of the progestin levonorgestrel, which includes Plan B (approved in the US), Ovrette, and Levonelle (in the UK). Studies indicate that this method causes less stomach distress and is more effective than the Yuzpe method. In one large study, levonorgestrel prevented pregnancy in 85% of women requiring emergency contraception.

With both methods, the woman takes her first pill or pills within 72 hours of intercourse and a second dose 12 hours later. The earlier they are taken, the more effective they are in preventing pregnancy. Some evidence suggests they may be effective up to five days after sex, although effectiveness is greater if used within 72 hours. Although these regimens are popularly called morning-after pills, they are actually the same oral contraceptives that users of OCs take regularly.

Side effects of emergency oral contraception methods include:

• Nausea and vomiting are common in both approaches, but particularly with the Yuzpe method.
• Fatigue.
• Headaches.
• Dizziness.
• Diarrhea.
• Breast tenderness.
• Fluid retention.
• Changes in the timing or flow of the woman's next menstrual period.

Immediate side effects typically subside within a day or two of taking the second dose. Family planning experts warn that emergency pill use should not be treated as a substitute for regular contraception.

Copper-Releasing IUD. An alternative emergency contraception relies on insertion of a copper-releasing IUD within five days of intercourse. It can be removed after the woman's next period, or left in place to provide ongoing contraception. The copper IUD reduces the risk of pregnancy by 99.9%.

Mifepristone. Mifepristone, also called RU486, Mifeprex, and the "abortion pill," blocks progesterone action so that the lining thins and deters implantation of the egg. Unlike emergency oral contraception, this agent can abort an existing pregnancy. A single dose used within 72 hours of unprotected sex can prevent pregnancy. Some researchers believe mifepristone may have the potential to be given in low-doses for on-going contraception, much like the combined pill.

When used after pregnancy occurs, mifepristone is taken within forty-nine days of a woman's last period. The woman is given three pills by her doctor during her first visit, and then a second drug (misoprostol) two days later. The second drug, misoprostol, causes uterine contractions that will expel the embryo. A third visit is needed to ensure the abortion is successful. Women who have ectopic or tubal pregnancies cannot take mifepristone. Side effects include pain, and use of the pills may also cause nausea and bleeding. In four out of 2,100 American women tested, bleeding was heavy enough to require transfusion.

Female Sterilization

Female surgical sterilization (also called tubal sterilization, tubal ligation, and tubal occlusion) is a low-risk, highly effective one-time procedure that offers lifelong protection against pregnancy. About 700,000 women undergo this procedure each year in the US, where it is the most popular form of contraception.

Basics of Female Sterilization

Female surgical sterilization procedures block the fallopian tubes and thereby prevents sperm from reaching and fertilizing the eggs. The ovaries continue to function normally, but the eggs they release break up and are harmlessly absorbed by the body. Tubal sterilization is performed in a hospital or outpatient clinic under local or general anesthesia.

The uterus is a hollow muscular organ located in the female pelvis between the bladder and rectum. The ovaries produce the eggs that travel through the fallopian tubes. Once the egg has left the ovary it can be fertilized and implant itself in the lining of the uterus. The main function of the uterus is to nourish the developing fetus prior to birth.

Sterilization does not cause menopause. Menstruation continues as before, with usually very little difference in length, regularity, flow, or cramping. (One study suggested that women with a history of Cesarean section may experience slightly heavier bleeding.) Sterilization does not offer protection against STDs.

Click the icon to see an image of tubal ligation.

Specific Tubal Sterilization Techniques

Laparoscopy. Laparoscopy is the most common surgical approach for tubal sterilization:

• The procedure begins with a tiny incision in the abdomen in or near the navel. The surgeon inserts a narrow viewing scope called a laparoscope through the incision.
• A second small incision is made just above the pubic hairline and a probe is inserted.
• Once the tubes are found, the surgeon closes them using different methods: clips, tubal rings, or electrocoagulation (using an electric current to cauterize and destroy a portion of the tube).
• Laparoscopy usually takes 20 to 30 minutes and causes minimal scarring. The patient is often able to go home the same day and can resume intercourse as soon as she feels ready.

Click the icon to see an illustrated series detailing tubal ligation.

Minilaparotomy. Minilaparotomy does not employ a viewing instrument and requires an abdominal incision, but they are small -- about two inches long. The tubes are tied and cut. Generally speaking, minilaparotomy is preferred for women who choose to be sterilized right after childbirth, while laparoscopy is preferred at other times. Minilaparotomy usually takes approximately half an hour to perform. Women who undergo minilaparotomy typically need a few days to recover and can resume intercourse after consulting their doctor.

Laparotomy. Laparotomy, a less common approach, requires an extensive two- to five-inch incision in the abdomen. It is considered major surgery and can require a hospital stay of a few days followed by recovery at home for several weeks. Resumption of intercourse depends on how quickly one is able to recover.

Culdoscopy. Culdoscopy involves inserting a scope through the vagina and into the pelvic cavity. Although it is less invasive than laparoscopy, a major 2002 analysis reported that at this time it carries a higher complication rate than either laparoscopy or minilaparotomy.

Candidacy for Female Surgical Sterilization

Before undergoing sterilization, a woman must be sure that she no longer wants to bear children and will not want to bear children in the future, even if the circumstances of her life change drastically. She must also be aware of the many effective contraceptive choices available. Possible reasons for choosing female sterilization procedures over reversible forms of contraception include the following:

• Not wanting children and being unable to use other methods of contraception.
• Health problems that make pregnancy unsafe.
• Genetic disorders.

If married, both partners should completely agree that they no longer want to have children and should also have ruled out vasectomy for the man. Vasectomy is a simple procedure that has a lower failure rate than female surgical sterilization, carries fewer risks, and is less expensive. [ See In-Depth Report #27, Vasectomy.]

Even if all these factors are present, a woman must consider her options carefully before proceeding. Studies report that over time, between 14% and 25% of women eventually regret this choice. Studies suggest that women at highest risk for regretting sterilization are the following:

• Women who are younger at the time of sterilization. In one long-term study, over 40% of women who had had tubal ligation between the ages of 18 and 24 regretted their choice. (Only about 4% of women over 35 had these regrets.)
• Women who had the procedure immediately after a vaginal delivery.
• Women who had the procedure within seven years of her youngest child.
• Women in lower income groups.

If a woman changes her mind and wants to become pregnant, a reversal procedure is available, but it is very difficult to perform and requires an experienced surgeon. Subsequent pregnancy rates after reversal are between 20% and 84%, depending on the surgical skill, the age of the woman, and, to a lesser degree, her weight and the length of time between the tubal ligation and the reversal procedure. Not all insurance carriers cover the cost of reversal.

Advantages of Female Surgical Sterilization

Women who choose sterilization no longer need to worry about pregnancy or cope with the distractions and possible side effects of contraceptives. Sterilization does not impair sexual desire or pleasure, and many people say that it actually enhances sex by removing the fear of unwanted pregnancy. There is some evidence it may help reduce the risk for ovarian cancer.

Disadvantages and Complications of Female Surgical Sterilization

The following are disadvantages of sterilization:

• Failure is rare, but about one woman in 200 becomes pregnant during the first year after sterilization, and failure rate can rise to 5% after 10 years. About a third of these pregnancies are ectopic, which require surgical treatment.
• After any of the procedures, a woman may feel tired, dizzy, nauseous, bloated, or gassy, and may have minor abdominal and shoulder pain. In general, there is more postoperative pain with the tubal ring than with electrocoagulation.
• Serious complications from female surgical sterilization are rare and are most likely to occur with abdominal procedures. They include bleeding, infection, or reaction to the anesthetic. On rare occasions the bowels or blood vessels are injured and require major surgical repair. The use of electrocoagulation poses a risk for burns in the small intestine and may increase the risk for menstrual disorders afterward.

Resources

• www.nichd.nih.gov -- National Institute of Child Health and Human Development
• www.plannedparenthood.org -- Planned Parenthood
• www.engenderhealth.org -- EngenderHealth
• www.asrm.com -- American Society for Reproductive Medicine
• www.not-2-late.com -- Emergency Contraception Website
• www.acog.org -- American College of Obstetricians and Gynecologists
• www.agi-usa.org -- The Alan Guttmacher Institute

References

Morrison CS, Bright P, Wong EL, Kwok C, Yacobson I, Gaydos CA, et al. Hormonal contraceptive use, cervical ectopy, and the acquisition of cervical infections. Sex Transm Dis. 2004;31(9):561-567.

Raine TR, Harper CC, Rocca CH, Fischer R, Padian N, Klausner JD, et al. Direct access to emergency contraception through pharmacies and effect on unintended pregnancy and STIs: a randomized controlled trial. JAMA. 2005;293(1):54-62.

Scholes D, LaCroix AZ, Ichikawa LE, Barlow WE, Ott SM. Change in bone mineral density among adolescent women using and discontinuing depot medroxyprogesterone acetate contraception. Arch Pediatr Adolesc Med. 2005;159(2):139-144.

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