By Sonia Shah
Tuesday, September 25, 2001
A new study indicates that the intrauterine device, or IUD, is highly safe, and experts and manufacturers hope more women will adopt it. Yet the new, improved IUDs must first live down the stigma of the dangerous Dalkon Shield a quarter century ago.
(WOMENSENEWS)--Birth control experts and manufacturers hope a new study published by the New England Journal of Medicine affirming the safety of current intrauterine contraceptive devices will resurrect the long-forgotten and often-maligned birth control method. The new, improved IUDs, however, remain in the shadow of the defective Dalkon Shield of more than a quarter century ago.
Epidemiologist David Hubacher of Family Health International and his co-authors examined almost 2,000 women in Mexico, finding that previous IUD use was not a risk factor for tubal infertility, as many previous studies had claimed.
"Contemporary copper IUDs may be among the safest, most effective and least expensive reversible contraceptives available," Hubacher concludes in his Aug. 23 article. Funded by the U.S. Agency for International Development, the study was conducted by researchers at the nonprofit Family Health International and the National Perinatology Institute in Mexico City.
Although 106 million women around the world use IUDs, less than 1 percent of U.S. women who use contraception choose them. Many U.S. women's health activists remain cautious about the device, not only because of the damage caused by the Dalkon Shield, but also because they are aware that many women need protection from sexually transmitted diseases as well as pregnancy. In addition, some, but not all, insurers cover the cost of the device.
But the IUD's reputation is probably the chief deterrent to its use.
The devices fell dramatically in popularity after a popular intrauterine device known as the Dalkon Shield was pulled from the market in 1974 after major problems with it became apparent. Its faulty design left women vulnerable to dangerous pelvic infections, some of which were so severe that infertility resulted, as well as actual internal punctures from the device that resulted in some women needing immediate hysterectomies.
Currently, two different IUDs are available to U.S. women.
The Copper T 380A IUD, sold under the name ParaGard in the United States, is one of two devices currently available. It was developed in the early 1970s by researchers at the Population Council, an international nonprofit research institution. Approved by the Food and Drug Administration in 1984, the device consists of a flexible polyethylene T-shaped body with copper wire coiled around the shaft. A tailstring hangs from the bottom of the device into the upper vagina, so the device can be removed by a clinician and checked periodically by the user.
Once inserted, ParaGard leaks copper ions into the uterus, which "damage the egg and kill the sperm" explains Dr. Irving Sivin, senior scientist at the Population Council. As well, the device creates a "local inflammatory response" within the uterus, says Hubacher. "So when sperm enter the uterus, they meet this hostile environment, and they can't swim into the fallopian tubes," he says.
ParaGard is 99 percent effective in preventing pregnancy, requires no daily maintenance, contains no hormones and works for up to 10 years, making its $500 price tag cost-effective over time, its proponents say.
While that may sound like a dream come true to U.S. women hungry for more contraceptive choices, the device is not for everyone. It obviously doesn't offer protection against HIV or other sexually transmitted diseases.
Ortho-McNeil Pharmaceuticals, which markets ParaGard in the United States, recommends it for women who have had at least one child, are in stable, mutually monogamous relationships and have no history of pelvic inflammatory disease.
Pelvic inflammatory disease includes infections of the lining of the uterus, the fallopian tubes or the ovaries, which range from unnoticeable to severely painful.
These recommendations stem from two serious risks posed by device's use. First, IUDs may be expelled without women knowing it. Women who haven't had their uteruses stretched by pregnancy are more likely to unknowingly expel the device during menstruation, says Hubacher.
The second, more serious risk is of infection. "When you insert an IUD you have to go through the cervix, and you push any bacteria in the cervix into the uterus, and there it could cause damage," including pelvic inflammatory disease, says Hubacher. Pelvic inflammatory disease leads to infertility in 20 percent of its sufferers, according to the Centers for Disease Control.
"If a woman is at risk for a sexually transmitted disease or has recently had a risky exposure, then she should not get an IUD inserted," Hubacher says.
In addition, women who use ParaGard can expect more bleeding and pain during their periods, says Hubacher.
In December 2000, the Food and Drug Administration approved Mirena, which is being distributed in the United States by Berlex Laboratories, a division of Schering Pharmaceuticals. The Population Council developed this levonorgestrel-releasing IUD in 1990. Mirena is as effective as ParaGard and works in a similar way, except that by releasing the hormone levonorgestrel, Mirena ultimately reduces menstrual bleeding and in some cases ends it altogether.
Mirena costs about $400, says Kim Schillace, a public relations manager at Berlex Laboratories, and prevents pregnancy for up to five years. Berlex plans to launch a direct-to-consumer advertising campaign for Mirena this fall.
Most, but not all, feminists and women's health advocates agree that the IUD can be a good birth control option for some women. But they raise a range of concerns about its use, from the dangers of direct-to-consumer advertising, inadequate research on safety and the potential for abuse both in this country and abroad.
"I would suspect, as with much other direct-to-consumer advertising" of medical products, says Boston Women's Health Book Collective's Judy Norsigian, "you will see many people using products for which they are not good candidates." Misinformation about the pill abounds, feminist critics say, and many women don't know whether their partners are monogamous or whether they've been exposed to sexually transmitted diseases.
Safety concerns linger. Hubacher himself admits that case-control studies like his, while rigorous, can only go so far in making conclusions about whether IUDs cause infection or any other outcome.
Yet for women concerned about the risks of high-tech contraception, "single studies with small groups of people over short periods of time are not good enough," says Karen M. Hicks, who organized women survivors of the Dalkon Shield in the 1980s.
Pelvic inflammatory disease and related problems can plague women for years, she says, yet there are no safety studies tracking the thousands of women who have used IUDs over their entire adult lifespan as there are for the pill.
Perhaps the most troubling aspect for many feminists is the potential for abuse of IUDs in developing countries. According to Hampshire College feminist scholar Betsy Hartmann, the IUD was originally embraced as a population control method, even though it was considered to be potentially dangerous to individual women. A staunch critic of many population control policies, Hartmann writes that the U.S. Agency for International Development distributed over 400,000 Dalkon Shields to developing countries, some even after the defective IUD was pulled from the U.S. market in 1974.
"Perhaps the individual patient is expendable in the general scheme of things," gynecologist J. Robert Willson is quoted as saying at the Population Council's 1962 international conference on IUDs, "particularly if the infection she acquires is sterilizing but not lethal."
Today, over half of the world's IUD users live in China, where government officials police IUD use in order to satisfy the one-child policy, says Hartmann. There, the tailless IUDs frequently inserted into women are "considered more effective since they aren't under women's control," Hartmann says.
The U.S. Agency for International Development and the United Nations Population Fund have been distributing free IUDs to developing countries for years. Last year, the United Nations Population Fund distributed one million IUDs and expects to distribute over 2 million this year, according to Christian Saunders, head of procurement services.
Today, the United Nations Population Fund buys IUDs in bulk from manufacturers for less than 50 cents apiece, Saunders says.
U.S. women desperately need better contraceptive choices, says gynecologist Philip D. Darney, who wrote an editorial accompanying the Hubacher study. According to Darney, too many U.S. women "feel there is just nothing that works well for them, so they have unintended pregnancies and abortions ... and end up getting their tubes tied," an irreversible decision that one in four may later regret, studies show.
U.S. rates of abortions and voluntary sterilizations soar above those in Western Europe, where a range of birth control options, including IUDs, are used.
While many U.S. women shunned IUDs because of safety concerns, clinicians and manufacturers--who could have promoted IUD use--didn't for fear of litigation in the wake of the Dalkon Shield disaster, clinicians say. By the mid-1980s, over 300,000 women had filed for damages against A.H. Robins, which manufactured the poorly tested and poorly designed device. Studies later showed that the Shield's braided tail acted as a wick, contaminating the uterus with bacteria, while its spiny margins punctured the uterus.
While copper IUDs were not implicated in the IUD-safety research nor in the litigation against A.H. Robins, lawsuit-weary manufacturers soon withdrew from the market. Malpractice-conscious clinicians stopped recommending IUDs, and medical schools stopped training students on how to insert them.
But today's IUDs are different, manufacturers say, and now that the Food and Drug Administration regulates medical devices, obviously defective products like the Dalkon Shield are much less likely to make it to market. Plus, profit-savvy manufacturers are unlikely to forget the nearly $3 billion A.H. Robins ultimately doled out to about 200,000 women for the Shield.
Manufacturers hope that women will soon put the controversial IUD back on the menu of birth control options. Then, "like many things," says Norsigian, "women will have to try it and see how it works."
Sonia Shah is a free-lance writer based in Storrs, Conn.
Abstract of David Hubacher's article in the New England Journal of Medicine:
Ortho-McNeil's promotional information on Paragard:
Berlex's promotional information on Mirena:
Boston Women's Health Book Collective: