In Our Control (16 page)

The Grafenberg ring, created by German gynecologist Ernst Grafenberg in the 1920s, was a coil made of silkworm thread with a silver or gold ring was the first commercially manufactured IUD. Grafenberg was initially encouraged by low pregnancy rates of women using his contraceptive. It wasn’t perfect: it was large, so insertion was either excruciatingly painful or required anesthesia. Despite this, he tested it on two thousand women without serious safety problems,
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including the risk of uterine perforation that had characterized earlier stem models. After many women later became sick and some died, however, both the German government and the doctor himself (who would soon seek refuge from the Nazis in the United States) disowned the ring.
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The technology hung on in Japan, where doctors altered both design and materials, increasing its safety.

While European and Japanese women embraced this new birth control option, American doctors continued to insist that it was dangerous. In the 1920s, J. Whitridge Williams, an obstetrician at Johns Hopkins Medical School and a critic of the device, carried his watch on a chain alongside a gold IUD ring that he claimed to have extracted from the placenta of a baby he delivered, using this as evidence that the method didn’t work and was a dangerous “fad” method of contraception.
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American scientists gradually began to think about developing and improving IUDs after the Second World War. Several technological advances encouraged this: the creation of malleable plastic allowed the production of IUDs that could be inserted without cervical dilation and anesthetic, and the antibiotics used to treat possible infections became more readily available. All of this meant that IUDs could be made and put in more cheaply, and that medical complications could be treated before serious and life-threatening problems developed. The first of this “new generation”
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of devices was created by New York gynecologist Lazar Margulies. This nonring, plastic item had a short life, in part because the long string that protruded from the cervix and assured female patients of its presence caused problems for male sexual partners.

Still, it was a brave new world, and by the 1960s the IUD, along with the Pill, entered the American consciousness in a major way. The two options, pharmaceutical and mechanical, had a lot in common, most notably the fact that they were both doctor-controlled methods that required medical supervision for their usage. The stories of the Pill and the IUD are historically aligned and intertwined, even as they are divergent. The Pill was—and is—a star on the rise. It has had ups and downs but remains today the top reversible option for American women. The IUD has proved less alluring, and while both pill and device have suffered safety black eyes, the latter has been less resilient at bouncing back in the public consciousness.

The IUD had supporters as it rose to prominence in the 1960s. The powerful Population Council, for one, liked the long-term effectiveness of the “coil.” Council members worried, among other things, about burgeoning fertility around the world and its potential to foster the growth of Communism. They also worried about the growing populations in America’s low-income communities and wondered whether women who lacked education and basic financial resources could be relied upon to consistently take pills. The idea of a device that could be inserted and left, without maintenance, for several years seemed impossibly appealing. By the late 1960s, the Council was not only funding research on the technology, but had sent over 6 million devices to developing nations,
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along with knowledge about how to manufacture them.

Domestically, the IUD was initially marketed, unsurprisingly, to women at public clinics. These women were disproportionately low income, and many were nonwhite. Even as the option grew in popularity among middle-class white women, doctors continued to discourage its use in those populations, advocating it only for poor women or for those who had finished bearing children.

By the end of the 1960s, another group of people were starting to think that the IUD provided a better alternative to the Pill: women’s health activists. Bolstered by alarming safety problems with the Pill, members of the women’s movement concerned with health issues wondered if perhaps this “new, safe” option provided the modern alternative to dangerous drugs. In her groundbreaking book,
The Doctors’ Case Against the Pill
, Barbara Seaman warned that although IUDs had problems—including
infection and uterine perforation—the serious problems seemed limited to older devices, and newer ones were safe. Decades later, when I asked her if she had any regrets about her long career, Seaman hesitated before responding, “Yes … I wish I had been more cautious on IUDs.”
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As concerns about the Pill grew, women dumped the drug in large numbers. Many looked for an alternative, and by 1971, they turned to the Dalkon Shield.

At this time, FDA lacked the ability to regulate devices. This meant that the IUD market was an open one, with numerous devices of varying safety, materials, and efficacy flooding the population. An image of twentieth-century options reveals an array of products that visually run the range from squiggles to pine tree–shaped towers to candy cane–like swirls, and even bat-shaped coils.

Historian Andrea Tone has pointed out that, in keeping with military metaphors common in discussions of population control in the 1960s and 1970s (think “population bomb”), images of conflict were frequently used to tout the effectiveness of IUDs: “ ‘aggressive, battle-hungry IUDs invade, irritate, infect, and finally subdue the ultimately powerless uteri.’ Toughness, visual and medical, was valued, and device makers struggled to make their versions look intimidating.”
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The Dalkon Shield got its name, in part, because it looked like a policeman’s badge.

Just as the bad safety information was emerging about the Pill—and the Nelson pill hearings, along with Seaman’s book, were taking it public in a big way—a gynecologist and vocal pill critic named Hugh Davis was publicizing the results of his testing of the new device, which he claimed had an efficacy rate on par with oral contraceptives. Only later, after the Shield proved tragic for many women, was it revealed that Davis secretly held a financial stake in the product and that he conducted methodologically compromised tests on it. On the face of things, the Dalkon Shield seemed to be the answer to women’s—and manufacturers’—prayers. In 1970 a company called A. H. Robins paid three quarters of a million dollars for the chance to make it, outbidding formidable challengers like Upjohn. Despite the fact that later trials had shown Davis’s pregnancy prevention estimates to be overly optimistic, the company went ahead with manufacturing and marketing the IUD.

It was a perfect storm: an inventor who hid his involvement and conducted
faulty trials, a manufacturer who knowingly published false information about its product, a new design that was undertested and marketed to a hungry population.

Andrea Tone points out that the Shield had two major design flaws. The first was actually an innovation to prevent the uterus from expelling it as a foreign object. To prevent this problem, the Shield added prongs that blocked expulsion from the uterus, but also blocked doctors from easily inserting and removing the IUD. The second was the use of a fiber on the string that encouraged the growth of infection. This latter problem occurred despite the fact that manufacturers were warned of the danger. FDA veteran and women’s health advocate Susan Wood notes, “It was a bad design, plain and simple. And a lot of women suffered because of it.”
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In a tragic case of people valuing marketing over science, more IUD users and their doctors chose the Shield than all other devices combined—over 2.2 million in the United States and 1.5 million internationally. Of those, close to 700,000 had been bought by global aid organizations for international use.

The problems began right away. Doctors noticed that women having the Shield inserted had terrible pain and even trauma. The item’s brochure promised that it could be put in with minimal pain, but on the ground, doctors saw a different set of experiences. The dangers didn’t end there, and at least eighteen women died from complications that included septic abortion. Other serious problems were infection, pelvic inflammatory disease, and infertility.

A tidal wave of complaint letters and the threat of a damning medical journal article led the manufacturer to send letters to doctors admitting possible problems. Once the lawsuits began and horrific stories started making the papers—one woman told of a brain damaged baby born with the Shield—A. H. Robins took off the gloves and began to get down and dirty, claiming that promiscuity on the part of users led to problems. At the same time, they began quietly advising doctors to take the devices out of patients. Despite shocking stories of its dangers, the Dalkon Shield died a slow death. It took only four years for the device to rise to the top of the market and for its problems to lead its maker to stop marketing in the United States. It took ten more years of lawsuits, negative medical information, and media reports chipping away at A. H. Robins before the
company finally filed for bankruptcy in 1985. In all, 8 percent of women who used the Dalkon Shield—around 325,000 people—filed claims against the maker. Among other results of the debacle, the FDA gained the ability to regulate devices as well as drugs.
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The IUD Today

Modern IUDs are still, to a large extent, tainted by this history. Even as massive organizations like the Guttmacher Institute tout their usefulness, women remain suspicious. As a younger generation of women with no memory of the disasters of the 1970s and early 1980s make choices about birth control, this is changing—but slowly. One study interviewed thousands of women over the phone about their knowledge about IUDs. Researchers found that women lacked awareness of and information about the option when compared with other possibilities—the Pill, condoms, and so on—and also felt that it was unsafe.
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While women worldwide have embraced IUDs in large numbers,
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Americans have not. Doctors and female patients were slow to accept the technology and never chose it in numbers anywhere near those in other parts of the globe. By the 1970s, it is estimated that 10 million women were using IUDs. Today that number may be as high as 160 million. Despite this, the Guttmacher Institute reckons that only 2 percent of American women make the IUD their contraceptive of choice.
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The modern IUD is a small device, often plastic and T-shaped, that is inserted into a woman’s uterus. Once in the womb, the object causes mild irritation—usually not enough to allow real infection, but sufficient for inhibiting sperm mobility. Today there are two available FDA-approved IUD methods. The first, ParaGard, is a copper-releasing IUD. Copper has long been associated with contraception. In ancient Greece, one well-known potion for pregnancy prevention involved diluting copper ore with water and taking the concoction orally.
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It is thought that copper encourages the cells in the uterus to produce a compound that kills sperm.
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While introducing metals into the body is usually a dangerous enterprise, and copper is toxic, the amount of the metal in ParaGard is so small that it isn’t considered dangerous. The device can cause heavy periods and
increased cramping, particularly during the first few months of use. Some estimate that it increases menstrual flow by 50 to 75 percent.
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Newer nonhormonal models that are approved in Europe but not in the United States may decrease this problem by altering the T-shape design. But the new models may pose unique problems, such as higher expulsion rates (which occurs in some women when the body identifies the IUD as a foreign object and ejects it from the uterus).

The second American option, Mirena, is a hybrid device that works like traditional versions but also releases small amounts of the progestin levonorgestrel. Because it uses progestin, it is not a nonhormonal method. In this case the hormone works to thicken cervical mucus (which makes pregnancy more difficult) and partially inhibits ovulation. The amount of progestin is very small, and there is debate among scientists and doctors as to whether it works systemically (in the entire body) or remains local. Because of the hormonal component, some scientists refer to Mirena as an “IUS” or “Intrauterine System.” Some health advocates argue that Mirena is a wolf in sheep’s clothing—not really an IUD, but rather a hormonal implant similar to the disgraced Norplant. What is certain is that the two types of IUDs are erroneously lumped together in conversation when their profiles—and often the patients for whom they would be appropriate—are different.

Both hormonal and nonhormonal IUDs can cause bleeding trouble. Mirena can cause irregular bleeding, and some women have the device removed for this reason. On the other hand, Dr. Jerilynn Prior of Canada’s Centre for Menstrual Cycle and Ovulation Research (CeMCOR) recommends the device for treating severe and disruptive perimenopausal bleeding, the erratic and often disruptive flow that can happen in the months and years before periods stop.
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Because women in perimenopause still need contraception, this is one population that might benefit from choosing Mirena, although of course the results of the Women’s Health Initiative suggest that any hormonal option must be carefully considered in aging women, particularly for long-term use. As with other menstrual suppression drugs, while bleeding patterns are likely to become irregular when use is initiated, complete period cessation is a frequent outcome for many women. Bayer, which makes Mirena, estimates that 20 percent of women will stop bleeding after a year of use.
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