The History of Women’s Contraceptives:

Background:

Throughout history, the development of contraceptives was seen as a major step for women’s rights and the feminist movement, but that is simply not true. There was a time in early history when what currently protects women’s reproductive rights was only seen as a means for population control and limiting patient autonomy.

In the 1950s, birth control trials were conducted on women from poor families with minimal access to healthcare. While they were receiving birth control, many were not fully informed that they were part of an experimental study, much like in the Tuskegee study for syphilis. Unlike the Tuskegee study, however, participants experienced serious side effects because versions of the pill used at the time contained much higher hormone doses than those used today. The main focus of researchers was not the well-being of these women, but rather on proving the drug’s effectiveness, even at the cost of hundreds of women’s health. (PBS, 2019).

These issues became even more visible with the introduction of intrauterine devices (IUDs) in the late 1960s and 1970s. Devices like the Dalkon Shield were widely marketed before being properly tested for safety, resulting in severe health complications for many women.

The Dalkon Shield IUD Crisis:

The early development of contraceptives reflects a broader pattern of institutional control over women’s bodies than the public thought. Birth control was seen as a form of population control and was designed by medical professionals and government officials without the input of the people they were designed to serve: women.

In the late 1970s, the Dalkon Shield device, a type of IUD, was introduced. The Dalkon Shield was marketed as safe to use, and according to “…physicians had prescribed the Dalkon Shield to over 2.2 million women.” This was later found out to be not the case, as around two hundred thousand women filed claims relating to medical injuries caused by the IUD. Because of poor design, the Dalkon Shield led to “septic infection, miscarriage, and an array of other related complications, including death.” The product remained on the market for millions of women to use, and the manufacturer claimed that the harm was simply caused by misuse of the product. It was only taken off the shelves after intense pressure from the public, continuous lawsuits, and severe injuries. (Mumford, 1992)

This medical tech crisis exposed the institutional priorities of profit and authority over the health and safety of patients, specifically women. It showed that the real issue was not just the Dalkon Shield itself, but the system that allowed it to remain in use despite clear evidence of harm. Women had little control over technologies that affected their bodies, as power remained concentrated in the hands of institutions rather than the individuals using the devices.

Movement and Reform:

After the scandal regarding the Dalkon Shield, activists demanded transparency and pushed for accountability in the testing and approval of reproductive technologies. As more people reported medical injuries regarding early contraceptive technologies, women’s health activists began organizing to challenge the authority of pharmaceutical companies and medical institutions.

A key moment came during U.S. Senate hearings on the safety of the birth control pill in 1970, where women protested the fact that contraceptives were made for women, yet there was little to no female input in decisions regarding safety. This pressure led to a major institutional change: the requirement that oral contraceptives include written information for patients that explained the risks and potential side effects.

At the same time, the harm caused by devices like the Dalkon Shield exposed major gaps in medical regulation. Public pressure and lawsuits led to the Medical Device Amendments of 1976, which expanded FDA authority by introducing risk-based classification, requiring premarket approval, mandating evidence of safety and effectiveness before distribution, and requiring ongoing monitoring and reporting of adverse effects. While these reforms improved transparency and oversight, they did not fully shift decision-making power away from medical and corporate institutions, highlighting the limits of reform within the existing system. (Horwitz, 2018)

Why Non-Reformist Reform:

The reforms that followed were different on a social scale. The requirement for patient information ensured that women were no longer passive recipients of medical treatment, but informed participants in their own healthcare. Similarly, increased regulation of medical devices and the inclusion of women in clinical research challenged the idea that medical knowledge could be produced without considering women’s experiences. These changes shifted reproductive healthcare toward a system that recognized patient autonomy rather than institutional control.

In this way, contraceptive reform can be understood as a non-reformist reform. Rather than simply improving existing technologies, these changes disrupted the underlying power dynamics between patients and institutions. By redefining women’s role from subjects of control to active decision-makers, the movement transformed not only medical practices but also the broader relationship between individuals with less power and the healthcare system.

References:

“A History of Medical Device Regulation & Oversight in the United States.” FDA, 8 July 2019, www.fda.gov/medical-devices/overview-device-regulation/history-medical-device-regulation-oversight-united-states.

“Birth Control.” FDA, 2024, www.fda.gov/consumers/womens-health-topics/birth-control.

“Birth Control.” U.S. Food and Drug Administration, 2024, www.fda.gov/consumers/womens-health-topics/birth-control?s2=N106168107_1683417608922715640#Contraceptive_Injection_Shot.

Horwitz, Rainey. “The Dalkon Shield

The Embryo Project Encyclopedia.” Embryo Project Encyclopedia, 10 Jan. 2018, embryo.asu.edu/pages/dalkon-shield.

Liu, Katherine A., and Natalie A. DiPietro Mager. “Women’s Involvement in Clinical Trials: Historical Perspective and Future Implications.” Pharmacy Practice, vol. 14, no. 1, 6 Mar. 2016, pp. 708–708, www.ncbi.nlm.nih.gov/pmc/articles/PMC4800017/.

Mumford, Stephen D., and Elton Kessel. “Was the Dalkon Shield a Safe and Effective Intrauterine Device? The Conflict between Case-Control and Clinical Trial Study Findings.” Studies in Family Planning, vol. 23, no. 5, 1 Sept. 1992, pp. 341–341, https://doi.org/10.2307/1966533.

National Institutes of Health. “History of Women’s Participation in Clinical Research

Office of Research on Women’s Health.” NIH, 2017, orwh.od.nih.gov/toolkit/recruitment/history.

National Institutes of Health. “NIH Policy and Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research.” Grants & Funding, 2019, grants.nih.gov/policy-and-compliance/policy-topics/inclusion/women-and-minorities/guideline.

PBS. “The Puerto Rico Pill Trials.” PBS, 2019, www.pbs.org/wgbh/americanexperience/features/pill-puerto-rico-pill-trials/.