Dalkon Shield

THE DALKON SHIELD was a defective intrauterine birth control device manufactured and sold by the A. H. Robins Co. Of Richmond, Virginia, from January 1971 through June 1974. It cost $3, but caused numerous injuries, including miscarriages, loss of female organs, and infertility. Like other intrauterine devices, the Dalkon Shield was designed to be inserted inside the uterus, where it usually prevented pregnancy by making it difficult for a fertilized egg to attached itself to the wall of the womb. Robins sold 4.5 million Dalkon Shields around the world, including 2.8 million in the United States.

The Dalkon Shield appeared on the market just after the sexual revolution of the 1960s. Women, whether married or not, were no longer bound by compulsory images of motherhood, yet there was no 100-percent effective birth control method yet developed. The “pill” required a woman to remember to take it on a daily basis. There were also the various health concerns and adverse effects of the pill to contend with. The Dalkon Shield was touted as being a safer and more effective method of birth control than the pill.

When the Dalkon Shield was marketed, there were no required tests by the Food and Drug Administration (FDA) for the manufacturing of medical devices to prove that they were safe and/or effective. Only one small study was performed on the Dalkon Shield, after it was sold worldwide. The testing of the Shield is a clear-cut case of conflict of interest. The inventor of the Shield was the person who tested it. Moreover, if that was not bad enough, he was heavily invested in the product. He was entitled to a percentage of the profits from its sale. Before A. H. Robins purchased the rights to the Shield, executives were informed that the tests may not have been adequate, but they ignored the warnings.

The device was defective. It had a major design flaw. The device had a nylon tail that hung through the opening of the uterus for doctors to check to make sure the device was still in proper place. The tail, however, allowed bacteria to travel up the device's wick and into the womb causing infection, which sometimes resulted in sterility. The Shield was not a very effective birth control device, yet A. H. Robins promoted it as the most effective form of birth control on the market. They advertised it as having a 1.1 percent failure rate. This was false because approximately 5 percent of the women using the Shield actually became pregnant.

The women who became pregnant suffered miscarriages and other reproductive system problems, like PID (pelvic inflammatory disease). Twenty women died from complications associated with the Dalkon Shield. The death rate may be higher, especially in Third World countries where statistics are not collected. The women who wore the device were not the only victims. Hundreds of children were born with injuries inflicted by the Dalkon Shield because it was not removed during pregnancy. Children were born inflicted with blindness, cerebral palsy, and mental retardation.

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