Not Your Mother’s IUD: Benefits and Risks of Modern IUDs

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Women's Health Activist Newsletter
January/February 2011

By Ginny Cassidy-Brinn

I had an Intrauterine Devices (IUD) in the 70s, when a feminist outcry exposed serious problems caused by the Dalkon Shield IUD, including infertility, uterine perforation, and death. The Dalkon Shield was removed from the market and its manufacturer declared bankruptcy after paying millions of dollars in malpractice settlements. So, I was skeptical when a young feminist told me she loved her IUD and said: “For my generation, IUDs represent freedom and empowerment.” What had happened in the 40 years between my experience and hers, I wondered? Had the IUD really been transformed?

What I found when I looked into these questions was not simple. Thanks to persistent advocacy by the Network and other women’s health activists, today’s IUDs are safer and more popular, and seem to have fewer negative effects than those I knew in the 70s. But the IUD’s place in the array of modern contraception is not without problems. Challenges connected to both cost and coercion can undermine the benefits of this important contraceptive option. 

Hormonal & Non-hormonal IUDs

Two types of IUDs are available in the U.S: ParaGard and Mirena. Both are tiny, T-shaped polyethylene devices that, when inserted into the uterus, are over 99% effective at preventing pregnancy. (IUDs do not protect against HIV or other sexually transmitted infections [STIs].) It’s not known precisely how IUDs work, because it is hard to study conception without disrupting it, but they probably prevent conception by preventing sperm from travelling to, and penetrating, the egg; the fertilized egg from travelling to the uterus; and the embryo from implanting in the uterine wall.

ParaGard is effective for up to 10 years, and has been available in the U.S. since 1988. Its design includes a small amount of copper, which improves efficacy and comfort while reducing the IUD’s size. Heavier menstrual periods are a common side effect of ParaGard. Mirena, which has been available in the U.S. since 2001, was developed to address the severe menstrual bleeding and cramping that many ParaGard users experience. (Constant light bleeding or spotting is common with either IUD, but total blood loss is much lower with Mirena.) Effective for up to five years, Mirena includes the hormone progestogen to minimize cramping and bleeding; 20% of Mirena users stop having menstrual periods within a year (periods return when Mirena is removed). For those who don’t stop bleeding, regular and unpredictable periods and light spotting are common. Additional side effects of Mirena’s hormone content include: moodiness, headaches, acne, increased appetite, weight gain, and decreased sex drive and ability to orgasm. Many Mirena users do not experience any of these problems, however. 

Since Paragard tends to increase menstrual cramping and bleeding, women with extremely painful or heavy periods may prefer Mirena. Women who want to avoid artificial hormones, or who don’t want to interfere with their natural menstrual cycle, may prefer Paragard. Choosing between the IUDs would be easier if a woman could predict how her body would react to the copper or hormonal content, but IUDs seem to affect each woman differently. Fortunately, if the negative effects are unacceptable, an IUD can be painlessly removed in seconds; 10-25 percent of women have their IUD removed in the first year, most often due to irregular bleeding. Among women who keep their IUD for at least a year, many feel much the same as they did before it was inserted and are happy with it.

Who Can Use the IUD & Who Decides?

Studies done in the 70s, 80s, and early 90s showed an increase in serious pelvic infections and infertility among IUD users. As a result, for many years, practitioners strongly cautioned women against getting an IUD if they wanted to have children later, and often refused to provide IUDs to childless women due to fears about infertility. IUDs were also routinely denied to women who were not in long-term, stable relationships because of concerns they might get an STI that could be exacerbated by an IUD.

The Dalkon Shield (which was included in these studies) had a design flaw such that its string acted as a wick, pulling bacteria into the uterus, causing significant health risks. More recent studies of better-designed IUDs indicate the risk of pelvic infection is increased only in the first 20 days after an IUD is inserted. This is most likely because the woman had a pre-existing STI. In the last 25 years, STI testing has become much more available and more accurate, making it possible to identify and treat STIs before IUD insertion. In a recent study, clinicians tested and treated women for STIs before IUD insertion and found that IUD users had no higher chance of experiencing pelvic inflammatory disease or infertility than women without an IUD.

For many women, the IUD can be a great choice. It is convenient and effective, doesn’t require women to do anything for it to work, and doesn’t interfere with sexual spontaneity. Once inserted, an IUD is effective for 5-10 years or until it is removed. Yet, women who have not had children or are not in mutually monogamous relationships continue to be denied IUDs today — despite evidence showing IUDs are safe for them. This removes women’s control and hampers their access to an effective form of contraception. A more woman-centered approach would be to give patients all the information about the risks and benefits of using an IUD, and help them make their own decisions about what is right for them.

Costs & “Counterfeits”

At the time of the Dalkon Shield, IUDs specifically, and medical devices in general, were very loosely regulated. In fact, the Dalkon Shield was heavily marketed despite its manufacturers’ awareness that it caused serious health problems, including infections, infertility, injuries, and death. More rigorous oversight or consumer education might have prevented the disaster and saved women’s lives. As a friend and IUD user said back then, “I knew nothing about the IUD or Dalkon Shield from my doctor. If I had, I certainly wouldn’t have gotten it. In my women’s group, I heard about a woman dying and then had it removed.”

As a result of the Dalkon Shield scandal, women’s health activists successfully persuaded policymakers to change the regulatory system to prevent future tragedies of this sort. In 1976, Congress gave the Food and Drug Administration (FDA) new authority to require testing and approval of medical devices, including IUDs. The FDA also began to require clinicians to provide patients with unbiased information about IUDs, to ensure women could get a balanced view of the IUD’s risks and benefits.

This was a victory for women’s health activists and had far-reaching benefits for consumers, who gained protection from dangerous medical devices. Yet, it also made it more expensive to bring an IUD to market, since companies must gain FDA approval before they can sell an IUD in the U.S. This may be one reason there are only two IUDs available in the U.S. today. This lack of competition also contributes to IUDs’ high cost. Last year, Bayer raised Mirena’s price from $450 to over $700 — an enormous increase for a product estimated to cost less than $4 to produce.1  With only one other IUD on the market, women and clinicians have limited alternatives to paying these exorbitant prices.

The result is that, while today’s IUDs are safe, they are out of reach for many women. For an uninsured woman paying out-of-pocket, an IUD costs $500—$1500, including exams, tests, the IUD, insertion, and removal.2  If she continues to use the IUD for several years, that cost is spread out and may be less than the cost of a seemingly less expensive option. But, having to pay such a high price up-front is a significant barrier for many women.

In some states, when Medicaid and insurance reimbursements fell short of IUDs’ cost, many providers simply stopped offering them. Others began buying IUDs from outside the U.S., where prices are lower. The FDA and state health officers investigated, fearing the IUDs might be dangerous or ineffective. Some providers faced criminal charges and severe financial penalties; all were required to contact women who had received the unapproved IUDs and offer a replacement.

These developments create a conundrum for women’s health activists. After working so hard to gain the protections afforded by FDA regulation, activists don’t want IUDs to be provided in a way that circumvents the regulatory system. But, it’s likely that many of the imported IUDs were manufactured in factories that also produce IUDs for sale in the U.S., and may be virtually identical to the products available here. Unfortunately, women don’t always have the information they need to determine if that’s the case.

Many of the so-called counterfeits uncovered in the investigations were purchased in Canada, which has a strong and reliable approval process for medical devices. Licensed Canadian pharmacies are prohibited from dispensing any unapproved IUDs, so IUDs purchased there are likely to be as safe and reliable as those for sale in the U.S. Canadian IUDs are less expensive simply due to price controls imposed by that government. IUDs purchased on-line from undisclosed countries, however, may not be safe. When information about the source of the IUD is unavailable, it’s impossible to know if the devices are safe and effective, so women should not use them.

This problem may be resolved, however, with implementation of the new health care reform law. The Patient Protection and Affordable Care Act requires insurance companies to cover preventive health services without imposing costs on patients. When Congress debated the bill, members specifically noted their expectation that this would guarantee family planning coverage without cost barriers like co-payments and deductibles. Once insurers pay for contraceptive services and supplies, women who want an IUD will be able to get it without breaking the budget to pay IUD manufacturers’ high up-front costs.

The Two Sides to IUDs and Coercion

The IUD also helps women avoid pregnancy coercion (when a partner refuses to use contraception or pressures her into becoming pregnant; see “Violence Against Women and Unintended Pregnancy: Building Connections”, WHA, Sept. 2010.) For a woman experiencing reproductive coercion, who needs a method she can use secretly, an IUD is ideal: it’s long-acting, effective, and almost impossible for a partner to detect. But, there’s another side to the IUD and coercion, and women who don’t get full information when making their contraceptive choices may find their reproductive autonomy challenged in a different way.

The IUD has strong advocates in the family planning community who see it as a magic bullet that can dramatically reduce unplanned pregnancies. But, over-worked providers in under-funded clinics who are enthusiastic about the IUD may lack the time to discuss all options with their patients; women who have not been given complete information can’t make an informed choice about the IUD. Women must not be rushed into using an IUD without getting full information about risks, benefits, and alternatives. One abortion clinic staff person said she tells patients who use condoms for contraception: “Well, obviously that isn’t working for you,” and suggests an IUD insertion be done the same day as the woman’s abortion. In that situation, a woman could easily feel shamed and pressured into accepting an IUD. 

Additionally, when a woman can’t have the IUD removed when she wishes, it is also a form of coercion. Women are dependent on health care providers to stop IUD use, but it might be hard for a woman to succeed if her health care provider thinks she should keep using the IUD. Some women report their health care providers refuse to remove an IUD after complaints such as bleeding or spotting. While these common symptoms tend to go away after the first few months of IUD use, clinicians who are not responsive to a woman’s concerns remove her reproductive autonomy and choice. Finally, cost can also be a coercive element, since removing an IUD has costs. Some public funding programs pay for IUD insertion but not removal, but don’t tell women about that when they choose the device.

Conclusion

The IUD is a powerful tool for women, and offers an effective, convenient, and unobtrusive contraceptive method. In order for women who choose an IUD to realize its full value, the method must be available at a reasonable cost, with high-quality counseling, and education to ensure that women can make fully informed decisions.

Ginny Cassidy-Brinn is a nurse practitioner in Seattle, Washington. She works with the Center for Health Training and Cedar River Clinics and is on the board of Women's Health Specialists, a group of clinics in California.

References:

1. Male Contraception Information Project Website, “Limitations of current contraceptives for women-Intrauterine Devices -- The Politics of Mirena Pricing.” San Francisco, CA: Male Contraception Information Project, no date. Retrieved Sept. 21, 2010 from: http://www.newmalecontraception.org/women.htm#mirena.
2. Planned Parenthood Federation of America (PPFA) Website, “IUD,” New York City: PPFA, no date. Retrieved Sept. 3, 2010 from http://www.plannedparenthood.org/health-topics/birth-control/idu-4245.htm.