The late 1970s and early 1980s was the historical peak of public and medical interest in the cervical cap in the United States. At the time, the cervical cap appeared to be an ideal alternative for women wary of the potentially damaging side effects of the Pill and IUD. Its brief prominence on the reproductive technology landscape illustrates an important moment in women’s health history and the history of contraception. When medical and pharmaceutical companies rapidly increased production of hormonal birth control but slowed the production of barrier contraceptives, members of the women’s health movement needed to manage trials of their favored medical device on their own. While the cervical cap never became popular among American women, the cap trials nonetheless show that women’s desires for safe, inexpensive, reliable, easily reversible, and non-harmful forms of contraception continue to structure the activities and advocacy of the feminist women’s health movement.
In 1976, following the FDA’s recall of the injurious Dalkon Shield IUD, its Bureau of Medical Devices revised its standards. After the Medical Device Amendments were enacted in May 1976, all medical devices were reclassified according to potential risks to patient health. The FDA reclassified the three types of cervical caps (Vimule, Prentif, and Dumas), only available in the U.S. from the English firm Lamberts (Dalston) Ltd., as Class III devices: devices that presented high risks to users. The company’s leaders were reluctant to obtain a Class I (low risk) or Class II (moderate risk) designation, and thus expose it to legal problems if the devices failed or harmed women, akin to the thousands of lawsuits and eventual bankruptcy of A. H. Robins, the manufacturer of the Dalkon Shield.
At the same time, the medical problems that many women were suffering from subpar gynecological care galvanized the nascent women’s self-help health movement. It gained more momentum after the Boston Women’s Health Book Collective published the first commercial edition of Our Bodies, Ourselves in 1973, the same year abortion became legal nationwide. The Feminist Women’s Health Network (FWHN) was founded in 1975, in order to link the burgeoning number of self-run women’s health centers in the U.S. and Canada. Barbara Seaman, one of the FWHN founders, and her husband Gideon Seaman, a physician, published Women and the Crisis in Sex Hormones in 1977, detailing the long-term harms of the pill and IUDs and promoting woman-controlled birth control methods such as the diaphragm and cervical cap.
Women’s health centers, inspired by a desire to improve access to non-hormonal birth control for their patients, became involved in trials to reclassify the cervical cap as a Class I or Class II device, making it easier for their patients to access. The Emma Goldman Clinic (EGC) in Iowa City, Iowa, and New Hampshire Women’s Health Services (now the Concord Feminist Health Center) in Concord, New Hampshire, were the two women’s health centers to participate in the first trial, which the National Institute of Child Health and Human Development (NICHHD) oversaw in 1980. The EGC supervised a small trial with one hundred women. It found that most women fit with the cap considered it a superior method to other women-controlled methods such as the pill and IUD, and to male-controlled methods, such as condoms and withdrawal.
Inspired by the success of the NICHHD trial and patients’ largely positive experiences, a larger group of women’s health centers, including the Feminist Women’s Health Center in Atlanta, decided to take the next step in the process of obtaining approval to distribute the cervical cap: completing an investigational device exemption (IDE), which allowed them to test the device on a larger sample of female volunteers. The cap received a mixture of positive and negative reviews, with one woman in the Atlanta study stating in January 1982 that “I feel real[ly] safe as far as the rest of my bodily health is concerned and also safe from pregnancy. I like it much better than the diaphragm.” A second Atlanta woman asserted, “The cervical cap has been a godsend.” A third was more hesitant: “If I did not feel a cramping [sic] I would like it very much.” Yet another drew a picture of the way that the cap should ideally fit on her cervix.
Multiple periodicals in 1980–1981 included articles detailing the women’s health clinics’ involvement in the cervical cap trials. Clinics received hundreds of letters from women around the U.S., in Canada, and from countries farther away such as France and the Philippines. Many women inquired about the safety and efficacy of the cap, as did many doctors whose patients brought the existence of the cap to their attention. Many women also wanted to start cervical cap studies at their own clinics or universities. The benefits of the cap—its ease of use, lack of hormones, non-permanence, and relative inexpensiveness—struck a chord with many women.
However, a November 1982 article in the journal Contraception, authored by a physician testing Vimule caps, found that the caps left abrasions and lacerations on the cervixes of eight of twelve women. The FDA Bureau of Medical Devices staff thus halted the clinics’ study of the caps in February 1984. The Atlanta Feminist Women’s Health Center requested a hearing to defend the use of the Vimule caps. In September 1984, clinic staff and their allies put forward their defense of the cervical cap: the damage to women’s cervixes was temporary and minimal compared to the damage from other contraceptive devices. Nonetheless, the FDA found the evidence of damage compelling enough to remove Vimule caps completely from the American market.
The EGC and several other clinics involved in the cervical cap trials continued testing another of Lamberts’ cervical caps, the Prentif, which the Bureau of Medical Devices eventually approved in May 1988. However, the cervical cap never caught on among American women for many reasons. These included the limited availability of trained fitters and irregular shipments from overseas, its higher failure rate (approximately 15 percent with standard use) compared to the Pill, the unpleasant smell after removal, the discomfort that women and their male partners often felt, and the difficulty of fitting women who had already been pregnant or who had cervixes that did not fit the cap’s standard sizes. For many women, the disadvantages of the cap eventually outweighed its advantages.
The history of the cervical cap in the late twentieth-century U.S. illuminates ongoing legal, medical, and pharmaceutical tensions over women’s health. This history shows that in the case of the cervical cap — and the morning-after pill in the 1990s — women’s health advocates had to expand their reach in order to manage clinical trials and to found their own companies in order to increase reproductive options for their clients. That they had to throw their weight behind a problematic technology like the cervical cap only shows how far we have to go in designing and manufacturing contraception that addresses each individual’s needs. That many American women’s health centers in the twenty-first century have closed or are under near-constant threat of closure via lawmaking or anti-choice violence shows that access to basic reproductive health care remains at risk—and that we need to keep fighting for it.
The author thanks the Sallie Bingham Center for Women’s History and Culture, Rare Book, Manuscript, and Special Collections Library, Duke University, Durham, North Carolina, and the Iowa Women’s Archives, University of Iowa, Iowa City, Iowa, for support in completing this article. For more on the morning-after pill, see Heather Munro Prescott, The Morning After (Rutgers, 2011), especially chapter 6.
Donna J. Drucker is a guest professor in the Department of Civil and Environmental Engineering at Technische Universität Darmstadt, Germany. She is the author of The Classification of Sex: Alfred Kinsey and the Organization of Knowledge (Pittsburgh, 2014) and The Machines of Sex Research: Technology and the Politics of Identity, 1945–1985 (Springer, 2014). Her new research project focuses on the history of non-hormonal contraceptives.
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