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December 7th, 2016 by:

“This is Not a Dalkon Shield”: The Renaissance of the Intrauterine Device in the United States

Heather Munro Prescott, PhD, is Professor of History at Central Connecticut State University.   She is the author of The Morning After: A History of Emergency Contraception in the United States

In March of 2015, a group of Colorado lawmakers began wearing earrings shaped like intrauterine devices (IUDs) to demonstrate their endorsement of a bipartisan but controversial bill that would provide IUDs and other long-acting contraceptives for low-income women.  The bill was controversial because some religious conservatives allege IUDs caused abortions. Even self-proclaimed “Redneck Republican” Don Coram was seen sporting this provocative political symbol, which he wore on his lapel next to his American flag pin.  By wearing the IUD earrings, lawmakers hoped to “demystify” the IUD and to “push back against” bitter debates about abortion and contraception.[1]

Earrings by Virginia Smith, shown on her Etsy shop SharlenCreations.

Those who remember the story of the Dalkon Shield IUD, which killed at least eighteen women and permanently injured hundreds of thousands of others in the 1970s and 1980s, may find this story quite ironic. This article will explore how the IUD went from being an icon of women’s victimization by medical technology in the 1980s to being a symbol of reproductive rights activism in the early twenty-first century.  My methodology will emulate that used by Adele Clarke and Theresa Montini’s work on RU-486 (mifepristone). Clarke and Montini offer an “arena analysis” of the “various actors, including scientists, pharmaceutical companies, medical groups, antiabortion groups, women’s health movement groups, and others who have produced situated knowledges” of RU-486.[2]

Likewise, this article will explore the multiple constituencies involved in the development and marketing of the second generation of IUDs in the United States.  It will expand on Chikako Takeshita’s recent book, which focuses on how science has constructed women as users of this contraceptive technology.[3] I will widen the lens by examining other actors involved in the construction and dissemination of the IUD. In doing so, I will draw on arguments I made in my book on the history of emergency contraception.  I will show that the renaissance of the IUD, like the campaign for emergency contraception, is an example of a new era of cooperation between feminist health activists and the pharmaceutical industry.

The Dalkon Shield and Women’s Health Activism

The Dalkon Shield IUD was first introduced in the United States in 1970. It soon became the most recommended IUD because of lower expulsion rates due to its unique design. The Dalkon Shield gained in popularity during the early 1970s after the publication of Barbara Seaman’s exposé, The Doctors’ Case Against the Pill (1969), which described severe health problems and deaths attributed to use of the Pill.[4] Hugh Davis, inventor of the Dalkon Shield, wrote the introduction to Seaman’s book and promoted the Dalkon Shield as a safer alternative.  Seaman agreed: compared to the Pill, the Dalkon Shield was “safe” because it was a mechanical device that did not contain hormones. Between 1970 and 1974, when the manufacturer withdrew the device because of safety concerns, 2.2 million women were fitted with Dalkon Shield, more than all other IUDs combined.[5]

Like the Pill before it, the Dalkon Shield soon became the target of women’s health activism. The device had a design flaw that greatly increased the risk of pelvic inflammatory disease and infection. At least eighteen deaths and hundreds of thousands of cases of infertility and/or severe injuries resulted from use of the Dalkon Shield.  More than 325,000 claims were filed against the manufacturer, A.H. Robbins, which went bankrupt in 1985.[6] Sociologist and Dalkon Shield survivor Karen Hicks created the Dalkon Shield Information Network in the early 1980s to help women who had suffered injury from the device.[7]

The National Women’s Health Network (NWHN), founded in 1975, helped file a class action lawsuit against A.H. Robbins. They also organized a Citizen’s Petition to the United States Food and Drug Administration (FDA) requesting that the Dalkon Shield be declared a banned product. Sybil Shainwald of the NWHN declared, “IUDs are an unsafe birth control device” that not only should not be sold but “should be removed from the bodies of women.”  As a result of these lawsuits and protests, by 1986 all but one brand—the Progestasert IUD manufactured by Alza Corporation—had been withdrawn from the market in the U.S.[8]

Some women reacted to news about the risks of IUDs by having their devices removed immediately. Others wanted to continue using this method of contraception but found it difficult to obtain an IUD. Alza Corporation was so risk averse that it only made Progestasert available to Planned Parenthood clinics and to clinicians who had used the device in the past. Fears of lawsuits made some providers and clinics unwilling to insert IUDs. Some doctors began referring women to colleagues in Canada, where IUDs were still being sold. Canadian family planning clinics reported increasing numbers of women coming from the United States to get IUDs.[9]

By the early 1990s, alarming media reports about an alleged “birth control backlash” were appearing in the popular press in the United States.  In a New York Times Magazine article in 1990, contraceptive chemical engineer Roderick MacKenzie commented on the lack of contraceptive options for American women. Since the introduction of the contraceptive pill in 1960, the United States had fallen behind other countries in contraceptive research and development. The number of U.S. pharmaceutical companies involved in contraceptive research and development fell from nine in 1980 to only one, Ortho Pharmaceutical, in 1990. Some population experts blamed this “birth-control backlash” on an “unwitting coalition” of courtroom litigators, feminists, right-to-life groups, and religious activists. Mackenzie, who had once directed Ortho Pharmaceutical Corporation in Canada and the United States, said the situation was more complex. He heaped scorn on manufacturers who perpetuated the myth that feminist activism and a litigious climate were to blame for the lack of women’s birth control options in the United States. The truth, he said, was that the cost of litigation was very small compared with potential sales of contraceptives. Rather, pharmaceutical companies were more interested in developing products for ulcers, cardiovascular disease, and other drugs that were highly profitable and did not carry with them “a sea of bad publicity endangering other drugs.”[10]

Mackenzie was among the few professionals in the pharmaceutical industry willing to work with women’s health groups to develop and market new contraceptive products. In 1984, McKenzie founded the company GynoPharma to manufacture and market the Copper-T380A intrauterine device in the United States at a time when other companies were unwilling to do so because of fears of lawsuits.[11] In 1988, the U.S. FDA approved the Copper-T380A IUD under the trade name ParaGard™. However, lingering fears about litigation made many clinicians cautious about prescribing this method to their patients. McKenzie decided it was time to give the IUD an image makeover.

The IUD Reconsidered Campaign

The group primarily responsible for the rehabilitation of the IUD in the United States was the public relations firm Bass and Howes, founded by political consultants Marie Bass and Joanne Howes in Washington, D.C. in 1987. Howes had been a senior analyst in the national office of the Planned Parenthood Federation of America. Bass had served as political action director of the National Abortion Rights Action League (NARAL) during the 1980s. In November 1988, Bass and Howes helped form the Reproductive Health Technologies Project (RHTP), a loose coalition of reproductive health activists who shared the goal of raising awareness about new technologies, especially among women, and making the climate for the introduction of these new options more favorable in the United States.  The RHTP was especially concerned about misinformation about new contraceptives being spread by abortion opponents.  For example, the right to life movement called the medical abortifacient RU-486 “a chemical Dalkon Shield.”[12]

In order to include a diverse range of perspectives, the RHTP invited representatives from various organizations committed to reproductive rights, including NARAL, Planned Parenthood, the International Women’s Health Coalition, the National Women’s Health Network, the Boston Women’s Health Book Collective, the National Black Women’s Health Project, the Population Crisis Committee, and the Food and Drug Administration Center for Drug Evaluation and Research to join the RHTP board of directors. The RHTP also invited prominent women health activists of color to join the board.[13] Although everyone involved in the RHTP was pro-choice, they had differing opinions about the possibilities and problems of new birth control options. Loretta Ross, Director of Women of Color Programs for the National Organization for Women, drew on her own experience with the Dalkon Shield to stress both her commitment to reproductive choice and her concerns about rushing new technologies to market. At age twenty-three, she decided to use the IUD while a student at Howard University in the early 1970s. Ross recalled, “I was not what they call a good contraceptor, because I’d just forget the things.” At first, Ross recalled, “I thought I’d been blessed. I thought it was the greatest birth control, effortless, thoughtless, birth control.” Three years after the device was implanted, Ross acquired a severe case of peritonitis and doctors performed a total hysterectomy to save her life.[14]

Ross observed that many supporters of high tech forms of birth control, “in their panic and desperation for more birth control options, have compromised their once-vigilant concern for women’s health.” Ross warned that this “atmosphere of excitement about a new option” had led some to trivialize or dismiss outright possible drug risks. “Women should have learned from our experiences with noninvasive treatments such as DES and the birth control pill,” Ross noted, “but in this struggle we have sometimes overlooked our history of being victimized by medical ‘solutions.’”[15]

Judy Norsigian of the National Women’s Health Network pointed to earlier examples of racism and coercion in population control policy. She asked whether introducing new technologies to the United States would replicate this prior history. She also raised the issue of whether women in rural areas would have access to emergency health care in case of complications from drugs and devices that required medical assistance from health care professionals.[16]

Elsewhere I have discussed the RHTP’s work to promote emergency contraceptive pills in the United States.[17] Here, I examine how the RHTP helped rehabilitate the image of the IUD, and more specifically, ParaGard™. Roderick MacKenzie had been part of RHTP since the beginning and had helped the organization promote RU-486 and emergency contraception in the United States, and had also helped combat the anti-abortion movement’s campaign against new drugs and devices.[18]

In 1994, MacKenzie asked Bass and Howes to launch a campaign called “The IUD Reconsidered” to help raise awareness about ParaGard™ in the United States.  The IUD Reconsidered campaign was intertwined with the RHTP’s work on emergency contraceptive pills, since some clinicians promoted the Copper-T as a form of postcoital contraception. However, GynoPharma’s director of marketing, Sherry Bump, said the company “very much discouraged” using ParaGard™ for this purpose.[19] In public relations material for GynoPharma, Bass and Howes deliberately chose the tag line, “This is not a Dalkon Shield” in order “take the Dalkon Shield issue on directly,” and to “address the difficulty that any company, but particularly a small one, has in overcoming the legacy of a bad product that has been the target of significant media attention and liability awards.” The IUD Reconsidered campaign hoped to generate “outrage” among American women by showing that ParaGard™, like emergency contraceptive pills, was another “well-kept secret” in the United States because doctors did not use it or understand it. The campaign intended to tell the “real story” of the Copper-T IUD by cutting through the media hype and addressing how the device was used by millions of women around the world.[20]

One of the advertisements created by the IUD Reconsidered campaign claimed, “ParaGard represents the third generation of copper-bearing IUDs, which means its shape, size, and especially its strings are different from the Dalkon Shield.”  More importantly, the ad noted, the safety profile of ParaGard™ was different from the Dalkon Shield: “The experience with thousands of woman-years of use with ParaGard T380A indicated there was “little increase” in pelvic inflammatory disease (PID) among women who were “at low risk of acquiring STDs.” Studies showed the highest rate of PID occurred shortly after insertion and remained low and constant thereafter.  “Don’t let yesterday’s data determine your opinion about today’s IUD,” the ad concluded.

In 1996, these public relations efforts culminated in “IUDs: a state-of-the-art conference,” organized by the Department of Health and Human Services and the National Institute of Child Health and Human Development to “help facilitate a greater awareness among clinicians and their patients regarding today’s IUDs.” Dr. Felicia Hance Stewart, former deputy assistant director of the U.S. Office of Population Affairs, opened the conference by describing the erroneous misconceptions clinicians and patients held regarding the latest generation of IUDs because the tragic events surrounding the Dalkon Shield had been “inappropriately generalized to all IUDs.” The ensuing litigation surrounding the IUD also left many clinicians “hesitant to prescribe this method for fear of their own liability.” To address this, the manufacturer of ParaGard™ included a consent form in the product’s package that the patient had to sign before she could have the device inserted. Stewart and other presenters hoped the conference proceedings would “help clinicians gain a greater appreciation of the IUD as a safe, effective, and cost beneficial contraceptive,” that could “help reduce the substantial number of unintended pregnancies” in the United States.[21]

Conclusion

The IUD Reconsidered campaign was partly successful in remaking the image of intrauterine devices by clearly distinguishing between ParaGard™ and the Dalkon Shield. Still, twenty years later only 12% of contraceptive-using women in the United States chose this method of birth control.[22] Today, opposition to the use of IUDs comes primarily from religious conservatives who believe these devices work to prevent implantation of fertilized eggs. The Colorado legislators mentioned at the beginning of this paper sported IUD earrings because they opposed this position and believed all contraceptive options should be covered by the state’s family planning programs.  In April of 2015, their hopes were dashed when Colorado Senate Republicans killed a bill to fund the Colorado Family Planning Initiative that provided IUDs free of cost to low-income women. “Redneck” Republican Rep. Don Coram expressed his disappointment, stating that funding family planning was the fiscally responsible thing to do: “if we’re going to break the cycle of poverty,” he said “this is a very good tool.”[23]

I end with this quote from Rep. Coram because I want to caution against framing discussions of contraceptive technologies as simply a two-sided battle between pro-choice activists and abortion opponents. According to Clarke and Montini, an arena analysis shows that there are not simply two sides, but rather “multiple perspectives on any technology.” Indeed, they suggest, “delimiting contestation to two sides may in itself be a hegemonic strategy” that silences the voices of less powerful actors.[24]  In the case of current debates about IUDs and other long-acting, reversible contraceptives (LARCs), we need to consider the circumstances under which these technologies can be considered “feminist.” In their introduction to the volume Feminist Technology, Linda L. Layne, Sharra L. Vostral, and Kate Boyer point out that a given technology may be considered feminist if it empowers women, but warn that not all women are the same and a technology that empowers some women may disempower others.[25]  As we engage in debates about the virtues and limitations of IUDs, we need to be mindful of how these devices remain problematic for low-income women and women of color, who are often the target of family planning initiatives.[26]

Download Prescott This is not a Dalkon Shield

Notes

[1] John Frank, “IUD jewelry emerges at Colorado capitol to demystify and educate on birth control,” Denver Post 13 March 2015.

[2] Adele Clarke and Theresa Montini, “The Many Faces of RU486: Tales of Situated Knowledges and Technological Contestations,” Science, Technology, & Human Values 18:1 (1993): 42–78.

[3] Chikako Takeshita, The Global Biopolitics of the IUD: How Science Constructs Contraceptive Users and Women’s Bodies (Cambridge, MA:  MIT Press, 2012).

[4] Barbara Seaman, The Doctors’ Case Against the Pill (New York: Peter H. Wyden, 1969).

[5] Elaine Tyler May, America and the Pill (New York: Basic Books, 2010), 131-32.

[6] Flora Davis, Moving the Mountain: The Women’s Movement since 1960 (New York: Simon and Schuster, 1991), 239-41.

[7] Karen Hicks, Surviving the Dalkon Shield IUD: Women v. the Pharmaceutical Industry (New York: Teachers College Press, 1994).

[8] Ann Pappert, “The Rise and Fall of the IUD,” in Kathleen McDonnell, ed, Adverse Effects: Women and the Pharmaceutical Industry (Toronto: Women’s Educational Press, 1986), 171.

[9] Francisco J. Ramirez and Ann M. Starrs, “The Ending of IUD Sales in the United States: What Are the International Implications?” International Family Planning Perspectives 13:2 (1987), 71-74 .

[10] Philip J. Hilts, “Birth-Control Backlash,” New York Times Magazine 16 December 1990, SM41.

[11] “Roderick L. Mackenzie on the development of Gynetics and the emergency contraceptive kit,” Business News New Jersey 21 September 1998.

[12] Memo to Meeting Participants, 7 November 1988, MC 634 Box 226, Folder 8, Bass and Howes Papers, The Arthur and Elizabeth Schlesinger Library on the History of Women in America, Radcliffe Institute of Advanced Study, Cambridge, MA, hereafter referred to as Bass and Howes Papers.

[13] Marie Bass, “Toward Coalition: The Reproductive Health Technologies Project,” in Rickie Solinger, ed., Abortion Wars: A Half Century of Struggle, 1950-2000 (Berkeley: University of California Press, 1998), 251-68.

[14] Transcript of interview of Loretta Ross by Joyce Follett, 3-5 November 2004, 1-3 December 2004, Voices of Feminism Project, Sophia Smith Collection, Smith College, Northampton, MA, 76-78.

[15] Loretta Ross, “RU-486: Are You Sure or RU Sure You Want It?” Draft manuscript, n.d., Box 2, Folder 43, Loretta Ross Papers, Sophia Smith Collection, Smith College.

[16] Bass, “Toward Coalition,” 359-361.

[17] Heather Munro Prescott, The Morning After: A History of Emergency Contraception in the United States (New Brunswick, NJ: Rutgers University Press, 2011).

[18] Marie Bass to Roderick L. Mackenzie, 7 March 1989, Box 11a, Bass & Howes Papers.

[19] “IUD most effective post-coital contraception,” Contraceptive Technology Update June 1995, 78.

[20] Suggested memo to Deeda Blair, n.d., Box 134, Folder 8, Bass and Howes Papers.

[21] Florence Haseltine and Felicia Stewart, “IUDs: A State of the Art Conference: Introduction,” Obstetrical and Gynecological Survey 51:12 Supp (1996): S1-3.

[22] Erin Schumaker, “Five Myths about IUDs you have to stop believing,” Huffington Post 25 August 2015. <http://www.huffingtonpost.com/entry/5-myths-about-iuds-you-need-to-stop-believing_55d74c7fe4b04ae49702f896> Accessed 4 September 2015.

[23] Peter Marcus, “Contraceptive funding dies in Senate,” Durango Herald April 29, 2015. <http://www.durangoherald.com/article/20150429/NEWS01/150429564/> Accessed September 4, 2015.

[24] Clarke and Montini, “The Many Faces of RU486,” 44.

[25] Linda L. Layne, Sharra L. Vostral, and Kate Boyer, eds, Feminist Technology (Urbana: University of Illinois Press, 2010), 2-3.

[26] Coco Jervis, “The Great LARC Debate,” Women’s Health Activist 40:4 (2015): 3-4.