DALKON SHIELD. Hugh Davis, a Johns Hopkins University gynecologist, created the Dalkon Shield intra-uterine device (IUD) in 1967 and 1968. A dime-sized plastic triangle, with five fins on each lower side (to prevent expulsion from the uterus) and a string hanging from its bottom corner (for removal), it resembled a police badge or shield. Marketed between 1971 and 1974 as a revolutionary advance in birth control technology, the A. H. Robins Corporation sold more than 2.2 million units in the United States and another 1.5 million abroad. During the next decade, doctors and lawyers traced eighteen deaths and over 200,000 illnesses to the device.
By the spring of 1974, A. H. Robins had received more than 400 complaints. Women often fainted from the pain of insertion. Many experienced cramping, bleeding, and infections that resulted in hysterectomies or sterility. Women who conceived despite wearing the device suffered a 60 percent miscarriage rate, often coupled with life-threatening blood infections. The remaining pregnancies resulted in premature births and severe birth defects.
A. H. Robins lost its first lawsuit in 1975, and the shield's defects came to light. The manufacturers claimed the device prevented 98.9 percent of pregnancies (much higher than other IUDs and comparable to the birth control pill) when they knew that its failure rate was actually 5.3 percent. The shield's fins predisposed it to becoming embedded in, and sometimes perforating, the uterine wall. The string transmitted bacteria from the vagina into the uterus, promoting infection. Company documents proved that corporate officers hid these problems to protect profits. This malfeasance, along with many physicians' insensitivity to women's suffering, made the Dalkon Shield synonymous with sexism, malpractice, and corporate irresponsibility. Protests against the shield helped fuel the women's health movement, and resulted in federal legislation regulating medical devices.
After paying more than $485.6 million in settlement and legal costs, A. H. Robins declared bankruptcy in 1986. A $2.5 billion trust fund settled claims from another 325,000 women. Until his death in 1996, Davis maintained that the shield never caused an injury. Subsequently, other intrauterine devices remained a controversial form of birth control.
Hawkins, Mary F. Unshielded: The Human Cost of the Dalkon Shield. Toronto: University of Toronto Press, 1997.
Mintz, Morton. At Any Cost: Corporate Greed, Women, and the Dalkon Shield. New York: Pantheon, 1985.
Tone, Andrea. Devices and Desires: A History of Contraceptives in America. New York: Hill and Wang, 2001.