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Dalkon Shield
1971-1974
The clawlike appendages that kept the Dalkon Shield in place made removal painful and could perforate the uterus. The Shield also caused cases of pelvic inflammatory disease, infertility, and spontaneous septic abortion.
Photo: Jamie Chung; IUD Courtesy of Dittrick Medical History Center and Museum/Case Western Reserve University

Jeffrey Peipert’s theory about how to prevent unplanned pregnancies isn’t complicated. In 2007, Peipert, an obstetrician-gynecologist at Washington University in St. Louis, began a groundbreaking study of women’s preferences when it comes to birth control. His team began recruiting 10,000 women of childbearing age, counseling them on available contraceptives and offering them whichever form they wanted, free of charge. The goal was twofold: to see whether more women picked contraceptives that they didn’t really have to think about (as opposed to, say, taking a pill every day) and whether those “forgettable” methods in turn reduced unwanted pregnancies and abortions.

Peipert’s hypothesis: The preferred contraceptive would be highly effective and, once activated, require no intervention for years. Forgettable. And in fact, such a device has been around for eight decades, in the form of the intrauterine device, or IUD. But this forgettable contraceptive has been all but forgotten itself. And that’s a shame. While birth control pills fail about 8 percent of the time, less than 1 percent of women with an IUD get pregnant. That’s about the same as the pregnancy rate in women who’ve been surgically sterilized. But when you remove an IUD—boom, fertility rebounds.

The problem is, IUDs have been at the bottom of the contraceptive heap for years, the victim of bad press and a four-decade-old scandal. But Peipert is finding that you can let the past go—of the 8,300 women who have received counseling in his study so far, about 50 percent have chosen an IUD, making it by far the most popular choice.

IUDs are on the verge of a remarkable return to popularity. Nationally, 5.5 percent of women using contraception choose them. That sounds unimpressive, but it’s the first time in more than 20 years that the number has risen above 2 percent; in 1995, it was 1.3 percent. By that baseline, 5.5 percent represents a sea change. And a few pharmaceutical companies believe that number is poised to grow. Only two IUDs are on the market in the US, but two more are in late-stage clinical trials. Revenue for the Mirena, an IUD made by German drug company Bayer, went from $219 million in 2006 to $714 million in 2010; sales of oral contraceptives fell 2 percent over the same period.

What happened? A small contingent of doctors and researchers never stopped believing in the IUD even when a medical scandal almost erased it from history. The ultimate set-it-and-forget-it contraceptive is finally making a comeback.

When it comes to the intertwined histories of modern birth control and the sexual revolution, the pill gets all the attention. Approved by the FDA in 1960, it obviously did a lot to enable sexual freedom and women’s rights. But hormone levels in early versions of the pill were about 10 times higher than they are today, and newspaper articles and medical journals soon began documenting health risks like breast cancer and heart attacks. The 1969 book The Doctor’s Case Against the Pill argued that safety risks abounded, and in a Senate hearing on the pill’s health risks, women’s rights activist Alice Wolfson jumped up from the audience and demanded to know why there wasn’t a birth control pill for men.

All that controversy primed IUDs for takeoff. Somewhat unbelievably, no one is quite sure how they work, but the theory goes like this: The human uterus has one overriding purpose, which is to protect and sustain a fetus for nine months. If you stick a poker-chip-sized bit of plastic in there, the body reacts the way it does to any foreign object, releasing white blood cells to chase after the invader. Once those white blood cells are set free in the uterus, they start killing foreign cells with efficient zeal. And sperm, it turns out, are very, very foreign. White blood cells scavenge them mercilessly, preventing pregnancy. In copper- containing IUDs, metal ions dissolving from the device add another layer of spermicidal action.

By the early 1970s, 17 IUDs were under development by 15 different companies. The problems started with the fourth one to actually hit the market: the Dalkon Shield. AH Robins (which also made ChapStick and Robitussin) marketed one version of it as a smaller option for women who didn’t have children. Like all medical devices at the time, the Shield wasn’t vetted by the FDA. While drugs got careful screening, safety and efficacy claims on device labels did not. The FDA stepped in only if people started reporting problems.

And report they did. Women with the Shield came to doctors ravaged by infection. Some complained of uterine bleeding or pain during sex. In others, the symptoms were less severe, like vaginal discharge or vague abdominal pain. Doctors diagnosed some of them with a condition called pelvic inflammatory disease—PID—which can be caused by chlamydia and gonorrhea or by normal vaginal bacteria. The women took antibiotics and usually got better, though a few rare cases led to hysterectomies. Furthermore, the Shield had a higher failure rate than originally reported, and some women who became pregnant with the Shield in place experienced spontaneous septic abortion, a miscarriage complicated by infection. At least 18 died. In 1974, faced with a flood of Shield-linked complaints, AH Robins took it off the market.

The fallout persisted for years. Some women who never had symptoms of PID—and others who got treatment and thought they had recovered—later learned that their fallopian tubes were damaged by scar tissue, rendering them infertile. Those users brought more than 400,000 lawsuits against the company. Panic spread; eventually the IUD market cratered. AH Robins went bankrupt in 1985; a year later, public service announcements on TV urged women to have their Dalkon Shields removed. A trust set up to compensate the injured eventually paid out nearly $3 billion.

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