Health Square: IUD, intrauterine devices

f intrauterine devices were automobiles, the Dalkon Shield would have been a Pinto,” according to a 1992 news article in USA Today . The faulty design of both products warranted a massive recall and served to smudge the reputation of their manufacturers. Unlike the big­three Pinto manufacturer Ford Motor Company, IUD makers didn't fare so well; Dalkon's A.H. Robins Company declared bankruptcy due to lawsuits costing the company over $480 million, and other IUD manufacturers pulled out of the business because they could no longer afford liability insurance.

But IUDs didn't just fade into the sunset. Scientists improved them, making a second generation of the devices safer and more appealing. Now, American women are once again turning to IUDs for effective long­term birth control.

As you can imagine, researchers conducted numerous studies once women started experiencing problems with the Dalkon Shield. There were two kinds of problem: miscarriages and pelvic inflammatory disease (PID), an infection that can cause infertility. Earlier clinical studies indicated no association with either of these problems, but once the court battles started, researchers found astonishingly high rates of complications with the Dalkon Shield and an unexpected link between all types of intrauterine devices and PID.

Modern researchers have criticized both the conclusions of these older studies and the way they were conducted. After re­examining the data, they feel that other factors, such as life-style, may play a crucial role in the development of complications among women using an IUD.

Although there is no general consensus on the research findings, most experts agree that IUDs are an excellent contraceptive choice for most women as long as the devices are inserted under sterile conditions. Women at risk for sexually transmitted disease, however, should probably select another form of birth control.

What Was the Dalkon Shield?

Throughout this century, IUDs have been manufactured in many different shapes and sizes. The first devices came on the market in 1909. These simple nickel, bronze, and catgut rings later gave way to FDA­approved plastic devices that looked like squiggly S's (Lippes Loop, 1964­1985), ram's horns (Saf­T­Coil, 1967­1983), the number 7 (Copper­7, 1973­1986), and the letter T (Copper­T 380A, 1984­ , Progestasert, 1976­, Copper­T, 1976­1986). A string (tail) attached to the bottom of each device protruded from the cervical opening. If you could feel the string with your finger, you could be sure your IUD was still in place. This tail also made removal easier.

The Dalkon Shield, introduced in 1970 and recalled in 1975, was a plastic device which looked like a round bug with one large eye and five legs on each side. It had a unique tail: not a single filament, but many fibers wound together and enclosed in a sheath. It was this string that led to its demise.

Some scientists now believe that the string had nothing to do with the increased rates of infection seen with the Dalkon Shield. It had been suggested that the string was a breeding ground for bacteria, and that it acted as a wick for bacteria, drawing them from the vagina up into the uterus and on into the fallopian tubes, thus causing dangerous infections. However, the theory did not hold up in subsequent testing, and another factor cast additional doubt: Although the Dalkon Shield came in two sizes—a large one for women who had given birth, and a smaller one for those who had never had children—and both sizes had a multifilament string, only the larger size was associated with pregnancy­related deaths.

THE NOTORIOUS DALKON SHIELD

A series of 12 deaths due to miscarriage-related infections in the early 1970s drove the popular IUD called the Dalkon Shield off the market, sent its manufacturer into bankruptcy, and tarnished the image of all IUDs for decades to come. No matter that some 2.8 million women had used the Shield, making the risk of death infinitesimally low, or that only one oversized version of the device was linked to the deaths: In little more than a decade, sales of all IUDs plummeted by more than two-thirds. Ironically, the fear of IUDs appears to be baseless. The rate of pelvic infection among IUD users is actually lower than among women using no contraceptive at all.

How IUDs Got a Bad Name

During the 1960s and 1970s, IUDs thrived. All of them were made of plastic (polyethylene), with some barium sulfate added so that they would show up on x­rays. The first American IUD, a large device called the Margulies Coil, caused a lot of bleeding and cramping and had a hard plastic tail that male sexual partners often found uncomfortable. The softer Lippes Loop replaced it. Later, the Saf­T­Coil and the short­lived Majzlin Spring came along.

Dalkon Shield became available at the same time as the U.S. Senate was holding inquiries into the safety of oral contraceptives. It was an immediate hit, especially among young women who had doubts about the pill. The year that A.H. Robins began marketing the Shield, the devices accounted for 66 percent of all IUDs sold, and by mid­1973, about 40 percent of all IUDs in use were Shields. By June 1974, when the FDA requested suspension of further sales, 2.8 million women had purchased the device.

Several months earlier, the FDA had urged physicians to remove IUDs immediately from any woman who became pregnant. Their recommendation was based on the fact that 12 IUD users had died after miscarriages left them with severe infections. Ten had the Dalkon Shield in place at the time, and two the Lippes Loop. After physicians began following the FDA's advice, IUD­related death from miscarriages ceased to be a problem. However, these events led to further scrutiny of the Shield, and sparked an explosion of fear and distrust of all IUDs.

The data connecting the Dalkon Shield to miscarriage and even to death seemed overwhelming. Doctors reported that Dalkon Shield users were twice as likely to be hospitalized as other women, and that those who became pregnant while wearing an IUD—especially the Shield—increased their chance of dying by up to 50 times that of women with no IUD in place. Although some scientists pointed out weaknesses in the studies, women still avoided the device.

In the wake of the Dalkon Shield scandal, some researchers began charging that IUDs were also responsible for an increased risk of pelvic inflammatory disease. Initial studies showed that women using other forms of birth control did indeed have a lower rate of PID than did IUD users. Barrier methods blocked bacteria; and the Pill, by thickening the mucus in the cervix, made bacterial entry difficult.

However, when compared with women using no form of contraception at all, IUD users actually have a lower risk of PID. And researchers during the Dalkon Shield period were unaware of what we now know: The greatest risk factor for PID is frequent sex with multiple partners. Since use of IUDs peaked during the sexual revolution of the 1960s and 70s, IUDs mistakenly got the blame that increased sexual freedom deserved.

The Dalkon Shield disaster continued to cast a pall over all forms of intrauterine devices. IUDs containing copper—introduced during and shortly after the Shield publicity—never became popular in the United States. Total IUD sales declined from 2.2 million to 0.7 million between 1981 and 1988, and manufacturers found that the costs of defending lawsuits were prohibitive. Although copper IUDs were never proved dangerous, most disappeared from the market by the late 1980s. Only two—the Copper­T 380A (the ParaGard) and the Progestasert—remain available in the United States today.

In other parts of the world, where the negative press about IUDs was never extensive, close to 100 million women now use these devices. In fact, they are the most popular form of birth control in such countries as China, Norway, Finland, and Egypt.

Recent worldwide studies suggest that:

• IUDs increase a monogamous woman's chances of getting PID only in the first 3 weeks to 3 months after insertion
• IUDs don't affect a woman's chances of having children in the future
• No women have died after an IUD­related miscarriage since 1977
• IUDs have the lowest failure rate of all reversible contraceptives (less than 1 percent)
• IUD users are more satisfied with their method than are women using any other type of birth control; 98 percent of IUD users report satisfaction, while 92 percent of Pill users and 87 percent of condom users say they are satisfied

Are Today's IUDs Right For You?

In order to decide whether you are a good candidate for an IUD, you need to know:

• How IUDs work
• How effective they are
• Who should avoid them
• What their advantages are
• Whether you can tolerate possible side effects and complications

How do IUDs Work?

Scientists aren't sure why the IUD is such an effective method of birth control. It was once thought that, as foreign objects, they produced an inflammatory response in the uterus that disrupted the implantation of a fertilized egg, but researchers haven't been able to prove this theory. In fact, when they look for fertilized eggs in the fallopian tubes of IUD users, they rarely find them. These studies should help ease the minds of women who are opposed to methods which prevent pregnancy by aborting a fertilized egg.

Now more researchers are fairly certain that IUDs are spermicidal. The inflammatory response may be enough to kill sperm before they ever get into the fallopian tubes to fertilize an egg.

There are two types of IUDs currently available in the United States, both of which have added pregnancy­preventing characteristics. The Copper T­380A, or ParaGard, is a T­shaped device with copper wire wound around the stem and copper tubing on the arms of the T. The frame also contains barium sulfate so that the IUD will show up on x­rays. The copper, besides intensifying the inflammatory response, has a chemical impact on the uterine lining, changing the normal levels of several enzymes. The environment copper creates throughout the reproductive tract is not friendly to eggs and sperm, making it unlikely that they will ever come together and form an embryo. The ParaGard remains effective for up to 8 years.

The Progestasert IUD is also T­shaped, but the vertical stem is actually a reservoir for 38 milligrams of progesterone, the naturally occurring hormone that helps bring about menstruation. Like Norplant implants or Depo­Provera (see chapter 21, “Hormonal Options: Pills, Shots, and Implants”) the device releases progesterone daily. This thickens cervical mucus, making it difficult for sperm to pass through the cervix. This IUD also diminishes cramping and blood loss, so it is an excellent choice for women who have heavy, uncomfortable periods. The Progestasert remains effective as long as it contains a sufficient amount of hormone; doctors usually replace it every year.

THE OPTIONS TODAY

Only two IUDs have survived into the nineties: the Copper-T (or ParaGard) and the Progest-asert. The Copper-T has the best track record of any contraceptive product: Your odds of becoming pregnant are only 1 in 500 during its first year of use. Odds with the Progestasert are not quite as favorable—over 1 in 100 in a given year—but it offers the added benefit of reduced cramping and bleeding for women with heavy periods.

A similar device called the LevoNova—which is not available in the U.S.—contains a hormone known as levonorgestrel. It seems to be as effective as copper IUDs, and can be left in place for 7 years.

How Effective are IUDs?

Like the famous battery, the IUD “keeps working, and working, and working.” Depending on the brand, it will protect you from pregnancy for up to 8 years. And, best of all, you don't have to do anything: There's no pill to remember or device to insert before sex. Some factors, however, including your age, your childbirth history, and your doctor's experience with IUD insertion, can reduce its effectiveness.

Failure rates for IUDs are the highest during the first two years. Still, in the first year of use for copper­releasing IUDs, only 2 women in every 1,000 will become pregnant. After eight years, the pregnancy rate for the ParaGard is still only 1.5 per 100 users—the lowest long­term rate of any copper IUD. For Progestasert, the pregnancy rate ranges from 1 to 3 women per 100 each year.

Who Should Avoid the IUD?

If you have a sexually transmitted disease—or risk getting one from a variety of sexual partners—you definitely should not use an IUD. In addition, if you're monogamous but aren't sure about your partner, an IUD might not be the best choice.

IUD manufacturers suggest that a good IUD candidate is a woman who already has had her children. Their concern arises, perhaps, from the potential for lawsuits over infertility, rather than from any medical data.

Known or suspected pregnancy precludes use of an IUD, as does active, recurrent, or recent pelvic infection. Here are some other problems you should discuss with your doctor before deciding whether an IUD is the right choice for you:

• Unexplained, irregular, or abnormal uterine bleeding
• Severe menstrual cramps or heavy periods
• Known or suspected cervical or uterine cancer, including a Pap smear whose results are inconclusive
• A history of endocarditis (heart inflammation), rheumatic heart disease, or the presence of artificial heart valves
• Problems with blood­clotting
• Reduced immune response (sometimes brought on by steroid treatment)
• Previous pregnancies while using an IUD
• A history of IUD expulsion from the uterus
• Abnormal uterine anatomy, such as a wall (septum) down the middle of the uterus, noncancerous tumors underneath the muscle surface which may increase bleeding, or a very thin cervical opening
• A copper allergy or Wilson's disease (excess copper in the body)
• Anemia
• A history of fainting

What Are the Advantages and Disadvantages?

IUDs are extremely effective in preventing pregnancy, and they are safe for the right women. They are easy to use because there's nothing to remember, and they don't change your normal cyclic hormonal pattern.

However, unlike some methods of birth control, IUDs offer no protection from STDs. The devices can also cause cramping, pain and extra bleeding when first inserted. They can be expensive: The Progestasert costs about $100, and the ParaGard is approximately $160. Insertion fees can add another $160 to $400. And if the doctor has little experience with inserting IUDs, the effectiveness of the device could be compromised.

Potential Complications

The most serious problems you might have with an IUD are infection, tubal pregnancy, and perforation of the uterine wall. These and other complications cause 1 in about every 100 to 300 IUD users to be hospitalized for intensive antibiotic treatment or surgery every year.

Infections

Insertion of an IUD can introduce bacteria into your uterus. Experts believe that most infections occurring from 3 weeks to 3 months after placement of an IUD are caused by unsterile insertion. Infections after that time are thought to be STDs.

The World Health Organization conducted a study recently which put to rest the nagging suspicion that IUDs cause pelvic inflammatory disease. In almost 23,000 IUD users studied, researchers found only 81 cases of PID. They also determined that PID risk was 6 times higher during the 20 days after insertion; and that the risk remained low for the next 8 years.

This study showed that PID occurred infrequently in women at low risk of sexually transmitted disease. It also found that PID was extremely rare in China, where more than half of all women of childbearing age use IUDs and where there are few cases of STDs. The researchers suggest that IUDs be left in place for as long as they are effective, and that physicians refrain from removing them periodically to combat potential infections, as some now do. Ironically, this routine removal followed by reinsertion can lead to even more infections.

Scientists are also investigating the benefits of using antibiotics, such as doxycycline, at the time of insertion to prevent infection. While some doctors don't recommend this yet, studies with small numbers of women have shown that preventative antibiotics can reduce the chance of infection by about 31 percent.

Still, if you get an infection for whatever reason while using an IUD, it can cause serious problems, including tubal infertility, peritonitis (infection of the entire abdomen), and liver damage. If bacteria get into your bloodstream, it can prove fatal.

Doctors can treat early infections successfully with antibiotics. If the infection isn't severe, your physician may opt to leave your IUD in place for a few days to see if the infection goes away. You will probably get a shot of Cefoxitin (Mefoxin) plus an oral dose of probenecid (1 gram), or a shot of Ceftriaxone (Rocephin) and a 2­week prescription for oral doxycycline (Doryx).

If your infection is severe, your doctor will almost certainly remove the IUD. If you require hospitalization, you may need intravenous injections of Cefoxitin or Ceftriaxone, plus oral doxycycline over a two­week period.

Abdominal pain, a high temperature, bleeding, and discharge could be a sign of infection. If you experience any of these symptoms, contact your physician immediately.

Vaginitis and cervicitis (infections of the vagina and the passage to the uterus) are also more common among IUD users. It's possible that the strings irritate the cervix and predispose the user to this type of infection. Although vaginitis and cervicitis can easily be treated with antibiotics, their characteristic, strong­smelling discharge could signal a more serious uterine infection, such as PID. If your discharge has a peculiar odor, make sure your doctor checks you carefully to ensure your condition isn't serious.

Pregnancy

If pregnancy does occur, partial or complete—but undetected—expulsion of the IUD is at fault about one­third of the time. However, pregnancies can and will occur even when the IUD is properly placed.

IUD users have twice as many miscarriages as do nonusers; and ectopic pregnancy (a pregnancy developing outside the uterus) occurs more often among IUD users than among those who use the Pill, diaphragms, condoms, or spermicides.

If you do become pregnant, your doctor should remove your IUD immediately if the strings are still visible. After removal of an IUD with visible strings, the miscarriage rate is about 30 percent.

Removal is more difficult if the string can't be seen. If you want the pregnancy to continue, your doctor should not try to remove the IUD without the aid of sonographic guidance. This technique will help him or her avoid rupturing the membranes of the uterus.

Leaving the IUD in place during a pregnancy is not recommended. The chance of a miscarriage—and a life­threatening infection—increases 20­fold by the second trimester.

An ectopic pregnancy can cause a rupture and massive internal bleeding. Researchers believe that 1 in every 5 Progestasert users has an ectopic pregnancy each year, while 1 in 60 women using a copper IUD such as the ParaGard will have one. While women who use ParaGard have far fewer ectopic pregnancies than those who don't use any type of contraception, women using Progestasert have double the risk.

Learn to recognize the signs of possible miscarriage or ectopic pregnancy. (See the box about “Danger Signs In Early Pregnancy” nearby.)

Perforations

An IUD can puncture the wall of your uterus or your cervix, or can embed itself in the uterine wall. A puncture to the cervix can happen at any time, but a puncture to the uterus usually happens during insertion. Therefore, it is important to find a doctor experienced in placing IUDs. Your chance of perforation ranges from less than 1 in 1,000 to no more than 9 in 1,000.

You might not know that your IUD has slipped outside your uterus because there may not be any bleeding or pain. Other than pregnancy, disappearance of your IUD's strings may be the only sign you'll get that the IUD is no longer in place. X­rays can show lost IUDs, as can ultrasound; but ultrasound is not effective if fibrous tissue has built up in the abdomen or if the IUD is freely floating in the pelvic area.

A migrating IUD may or may not cause infection. An all­plastic device may not be a problem, even if you leave it in its new location. Copper IUDs usually get encased in fibrous adhesions and rarely produce serious symptoms. Talk with your doctor about the need to remove the IUD. Many health care professionals recommend leaving an out­of­place IUD in the abdomen. Removal requires laparoscopic surgery, in which a lighted tube is inserted through a one­inch incision in the abdomen.

Bleeding and Cramping

When you first get your IUD, it's not unusual to experience bleeding or spotting between periods, as well as heavier periods. This condition usually lasts for only a short time; most IUD users report that by their third period, the bleeding has become more regular. In some cases, increased bleeding can lead to anemia if you're prone to that condition. That's why doctors often recommend iron supplements for IUD users. Vitamin C (200 milligrams 3 times daily) can improve spotting problems.

You might notice cramps, backache, and pelvic pain within 24 hours after you start wearing your IUD. You may also notice cramps or pelvic pain accompanying intercourse or breastfeeding, both of which cause the uterus to contract. Ovulation may be slightly more painful than usual, and you may also experience spotting at that time.

Since bleeding and cramping are common side effects of IUD use, but also can be indicative of PID, how do you know when you are in danger? It is often difficult to distinguish between a harmless side effect and a warning of possible infection. In general, you should call your doctor if you have pain and cramps that last longer than 12 to 24 hours and do not respond to pain relievers such as ibuprofen (Advil, Motrin).

Expulsion From the Uterus

Uterine contractions can push an IUD out of your uterus. Although it may seem hard to believe, many women don't even feel it happening.

During the first year of use, between 5 percent and 20 percent of IUD users experience a spontaneous expulsion of the device. Like infections, this is most likely to happen in the first few months, when the body is getting used to something foreign inside the uterus. It's more common in women who have a small uterus (2 and three­quarter inches or less) and in those who've never been pregnant. The more skilled the person inserting the device, the less the possibility of expulsion. Other risk factors include childbirth at an early age, abnormal menstrual flow, and painful periods. Signs that could be a warning of expulsion are:

• Unusual vaginal discharge
• Bleeding or spotting
• Cramps and abdominal pain
• Strings that seem longer than normal or disappear
• An IUD tip that sticks out of the cervix
• An IUD that your partner can feel
• Signs of pregnancy

Expulsions are most likely to happen when you're menstruating, so always check sanitary pads and tampons, and don't forget to look into the toilet after you've used it. If you expel the device, you need to use another contraceptive until it's replaced.

Lost strings

Sometimes the string of an IUD can pull up into the uterus, giving you no way to know if the device is in its proper position. Your physician can use special instruments to find the strings. If they can't be found, he or she may have to remove the IUD and replace it with another one.

Reactions to copper

Allergies to copper are extremely rare, and it is even more unusual to retain high amounts of copper in body tissues (Wilson's disease). Copper IUDs release only about one-thirtieth of an adult's daily dietary requirement for copper.

If you are allergic to copper, you may notice a reaction resembling a skin rash after you start using the ParaGard.

THE INSERTION PROCEDURE

Though a copper IUD can be left in place for up to 8 years with minimal attention, the initial insertion can be a minor ordeal. Done in the doctor's office or clinic, the procedure can be painful; and cramping can continue for up to a day. To insert the device, the doctor will pass a special applicator through the cervix into the lower end of the uterus. As it is pushed upwards with a plunger, the device unfolds to form a “T.” A string is left protruding from the cervix to permit later removal.

What's Involved In Getting an IUD

If you've decided to use an IUD, you'll need to find a qualified physician to insert and eventually to remove the device. He or she should have completed at least 5 supervised insertions before trying it independently.

You may have to go to the clinic a few days before your scheduled insertion to be checked for infections. In any case, you will need a routine physical exam and a Pap test to check for the signs of infection right before the insertion.

To reduce the pain and cramping that usually occurs during the first 12 to 24 hours after an IUD insertion, take aspirin or ibuprofin an hour before your appointment. You may also want to have someone go with you to the clinic and drive you home, in case you feel queasy, shaky, or weak.

Insertion

The insertion procedure is simple and takes only 5 minutes. Many women feel pain, but some don't. To help you deal with the pain, your doctor may give you a “paracervical block,” which consists of injections of lidocaine into your cervix. It will take effect in 2 to 5 minutes.

After the pelvic exam, your physician will determine the size and position of your uterus by using a procedure known as “sounding.” He or she will open your vagina with an instrument called a speculum, and wash your cervix with a disinfectant. A long clamp called a tenaculum grasps your cervix and helps steady your uterus, minimizing the likelihood of perforation. Your doctor will push a uterine sound, a blunt rod­shaped instrument, through your cervical canal and into the uterus to determine whether your uterus is big enough to accommodate an IUD (it should be at least 2 and one­quarter inches) and if so, how deep he or she will need to insert the IUD to reach the top of the uterus (the fundus).

At this point, you're ready for the IUD. The doctor folds down the arms of the T­shaped device and loads it into a long tube. He or she inserts the tube into the uterus and releases the IUD by slowly and gently withdrawing the tube. This part of the procedure may cause cramping due to uterine contractions.

After insertion, you'll need to put one or two fingers into your vagina to check for your strings. Once you've located your cervix—it will feel smooth and round—you can touch the strings, which feel like nylon fishing line. Every month after your period you should check in this manner to ensure that you haven't expelled the device. You'll also want to make sure you can't feel the hard tip of the IUD coming out of your cervix.

You may have some bleeding and spotting during the first few days after insertion. This is normal, so don't worry. If the bleeding is heavy and constant, contact your doctor to rule out the possibility of infection.

Your first period will probably be a little heavier than normal; it also may come a few days early. You should schedule a follow­up appointment after your first period, sometime within 4 to 6 weeks of insertion. Don't wait longer than 3 months to have a checkup.

Unless you've just had a baby, you can have sex as soon as you like after an IUD insertion. Some doctors recommend using a backup method such as a condom during the first month to reduce your risk of infection. You don't need a backup method to protect you from pregnancy because an IUD is effective immediately.

Adverse Reactions After an Insertion

When the nerves of your cervix are stimulated, your blood pressure sometimes drops, or your heart rate may slow down. This could make you feel dizzy, nauseous, faint, and weak. Although most such reactions are mild and last only 15 to 30 minutes, convulsions and even heart arrest is possible. If your reaction is severe, your doctor may give you a drug called atropine.

Removal

There are several reasons to have an IUD removed. You may find you don't like it. You may wish to become pregnant. You may develop an infection or persistent side effects you can't tolerate. And, of course, at the end of an IUD's effective life—one year for the Progestasert and eight years for the ParaGard— you must have it removed and, if you wish, replaced.

Removal is usually easier and less painful than insertion. Your physician will take some of the same preliminary steps done for insertion, such as determining the position of the uterus. Once the strings are located, he or she will use a clamp to grab them and slowly pull the IUD out. The flexible arms of the T will fold up again as the device comes through the cervical canal.

If the strings can't be found, they may be just inside the cervical canal. The doctor may try to coax them out of your cervix with cotton­tipped swabs. If that fails, he or she will need to use a uterine sound again. Once the device is located, the physician will extract it with a pair of tweezer­like clamps. If this too fails, sonography may be necessary to locate the IUD.

The Next Generation of IUDs

Scientists are working on intrauterine devices that could cut down on expulsion rates and bleeding. One promising new IUD is called the FlexiGard or Cu­Fix. It is frameless, consisting of six copper sleeves strung on a surgical nylon thread that is knotted at one end. This string of copper is then “harpooned” into the lining at the top of the uterus, using a notched needle. So far, insertion has proved difficult for doctors taking part in the studies because the needle must be pushed hard­but not too hard­ to attach the device.

Other modified and improved devices, including the French Ombrelle­250, the Cu­Safe (designed to be more flexible), and the TCu­380 Slimline (designed to make insertion easier), may also reach the market in the near future.