In America, about one in 10 women use intrauterine devices (IUDs), T-shaped bits of plastic or copper that are inserted into the uterus to prevent pregnancy. In Sweden, those numbers are nearly double, with IUD use high in Norway and Finland as well. Though the devices aren't uniformly popular in Western and Northern Europe, they're sought after in parts of East and Southeast Asia. They're most popular in Vietnam, where an estimated 27 percent of Vietnamese women of childbearing age use the devices. In many other countries, even ones where IUD usage rates are similar to ours, there are tons of options on the market. In Great Britain, women have at least 20 options of diverse sizes and shapes. In the U.S, women have just five—four options for hormonal IUDs (Mirena, Kyleena, Liletta, and Skyla) and one option for copper IUDs (Paragard).
Though IUDs remain less popular, internationally, than the old standbys—condoms and the pill—why haven't American women gravitated more toward IUDs, given their long-acting nature? And, now that some 26 states will either no longer have legalized abortion or enact tighter restrictions, will IUDs rise in popularity, providing women with an option that cuts human error out of the equation and confers consistent protection against pregnancy?
The Dalkon Shield incident may hold some of the answers to low rates of IUD adoption. Back in the '70s, when people were still skeptical of the safety of the pill, a company named A.H. Robins cashed in on those fears to sell unsafe IUDs. When a whistleblower doctor brought these problems to the attention of the Food and Drug Administration (FDA), the agency demurred for many months. By 1974, at least 17 women had died from complications linked to their IUDs, though the actual number is likely much higher.
In the years that followed, somewhere between 200,000 and 300,000 lawsuits were filed, bankrupting the company.
These Dalkon Shields first came to market in 1971 and were quickly sought out by nearly 3 million women. They were cheap and long-acting, but their design was flawed. They were plastic, shaped like tiny crabs or beetles, with lots of spikes, and they contained small amounts of copper which acted as a spermicide. They had little strings at the base, designed to aid removal, but those strings served as a means for bacteria to travel up and easily enter the uterus.
Some doctors caught on to these design flaws early; Dorothy Lansing, a Pennsylvania OB-GYN, refused to offer it to her patients, citing the spikes, which made removal tough for the doctor and painful for women. She presciently called it a "veritable instrument of torture," and refused to buckle under pressure exerted by A.H. Robins' nagging salesmen.
As a contraceptive, the Dalkon Shield wasn't as effective as women had hoped. Patients still got pregnant after having IUDs inserted; the failure rate was estimated to be somewhere between 7 and 10 percent contra the company's claims that it was lower. ("Remember, the Dalkon Shield wouldn't be NUMBER ONE in sales if it wasn't NUMBER ONE in effectiveness," wrote the company in its marketing guides; it had used a highly questionable 1.1 percent failure rate figure in advertising campaigns throughout the early '70s.)
Worse still was the fact that the IUD led to lots of uterine infections, miscarriages, ectopic pregnancies, and complications so severe that some women had to later have their uteruses removed.
But it's not like the FDA hadn't looked into the Dalkon Shield's safety and efficacy; it had just failed to do a sufficiently good job.
"For all its concerns, the FDA is no guarantee of safety, even within the field of contraceptives," wrote Michael Fumento in Reason's June 1995 issue. "For instance, the FDA tested and approved the Dalkon Shield, an intrauterine birth-control device that killed 18 women and injured thousands more before being pulled off the market in 1975. Similarly, the tampons responsible for toxic-shock syndrome met all FDA regulations."
There's plenty of blame to go around: A.H. Robins was guilty of false advertising. Court documents indicate that the company was aware of design flaws as early as 1970, a year before the product went to market. It kept selling it anyway—and the U.S. Agency for International Development even dumped a bunch of discounted, unsterilized Dalkon Shields overseas starting in 1972, after suspicions that the device was unsafe had been raised.
The FDA is also to blame for failing to listen to early whistleblowers. OB-GYNs like C. Donald Christian, who had a Dalkon Shield–wearing patient die inexplicably in 1972, began to ask around and hear accounts from other doctors who'd encountered mysterious deaths and illnesses in their patients. Christian submitted his suspicious findings to the American Journal of Obstetrics and Gynecology in 1973. Word that the Dalkon Shield had been linked to problems began to circulate—Christian worked to raise both the company's and the FDA's attention—and his article was published in 1974. The FDA convened panels on the Dalkon Shield's safety in February 1974, to little avail; it took the agency until June to actually take Christian's Dalkon Shield concerns more seriously.
"In 1962, Congress passed the Kefauver-Harris Amendments to the Food, Drug, and Cosmetics Act, which required that the FDA test all drugs for efficacy, as well as safety, before approving them," wrote Sasha Volokh in Reason's May 1995 issue. "In 1976, because of problems with the Dalkon Shield IUD, Congress passed the Medical Device Amendments. These effectively extended the same requirements to medical devices—a broad category covering everything from pacemakers to Band-Aids. In 1990, because of defective heart valves and controversy over silicone-gel breast implants, Congress passed the Safe Medical Devices Act, which further restricted medical devices." IUDs, for their part, began to be regulated as drugs, which are more tightly regulated, not devices, since they contain either copper or hormones.
By 1986, they'd disappeared from the American market entirely (with the exception of Progestasert, which had a much shorter lifespan than other devices and was somewhat disputed in terms of whether it fit into the IUD category). That same year, the National Institutes of Health's Bruce Stadel told Time magazine that a pharmaceutical company "would have to be altruistic to the point of suicidal to market an IUD today."
The FDA has every incentive to overcorrect in the wake of scandals; to pat itself on the back for keeping drugs like thalidomide, linked to birth defects all over Europe, out of the country, and for hassling factories producing contraceptive sponges despite no evidence of problems with safety or efficacy. But it has no such similar incentive to provide people access to drugs or devices that might significantly improve their lives. It's an undoubtedly tough balance to strike, but the agency has a bad track record of letting the pendulum swing mighty far in the hypercautious direction once a scandal arises.
The FDA erred twice: First by failing to listen to early whistleblowers voicing concerns about the Dalkon Shield's safety, and second by regulating IUDs so strictly in the embarrassing aftermath of the incident that fewer brands could be approved and reach market in the decades after. This helps explain why British women have a vast array of options, but Americans don't.
Pursuing reciprocity with European health regulators, allowing more devices to enter the U.S. market, would be an easy fix on the FDA's part that may allow more American women to get devices that fit their needs and bodies (after all, not all uteruses are the same size and shape, something modern-day IUD makers have been responsive to).
In fact, pursuing greater reciprocity would benefit lots of Americans right now. The baby formula shortage could be more quickly alleviated (as Reason's Elizabeth Nolan Brown and Eric Boehm have covered); COVID-19 vaccines could have been more speedily administered; and a monkeypox vaccine, of which the U.S. has already purchased 1 million doses, could be deployed right now before outbreaks worsen. Reciprocity wouldn't taint the FDA's mission but allow other trusted health regulators—which sometimes have tighter standards for approval—to do the agency's job for it. Those who are more risk-averse, and only want to use a product once U.S. health regulators have given the go-ahead, could still freely choose to do so.
Making birth control pills widely available over the counter is the most common suggestion for how the government could get out of women's way in the wake of the Supreme Court's decision in Dobbs v. Jackson Women's Health Organization, which overturned Roe v. Wade. But allowing more types of IUDs to enter the market would be similarly welcome. There's no reason why the almost two dozen devices that have been approved by British regulators shouldn't be sold in the U.S.; more robust competition might even drive costs down, making IUDs more accessible for the millions of women who currently want them, but can't find an option or price that suits them.
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