Dalkon Shield

The Dalkon Shield was a contraceptive intrauterine device (IUD) developed by the Dalkon Corporation and marketed by the A.H. Robins Company. The Dalkon Shield was found to cause severe injury to a disproportionately large percentage of its users, which eventually led to numerous lawsuits in which juries awarded millions of dollars in compensatory and punitive damages.

In 1970 the A.H. Robins Company acquired the Dalkon Shield from the Dalkon Corporation, founded by Hugh J. Davis, M.D. The Dalkon Corporation had only four shareholders: the inventors Davis and Irwin Lerner, their attorney Robert Cohn, and Thad J. Earl, M.D., a medical practitioner in Defiance, Ohio. In 1971, Dalkon Shields went to the market, beginning in the United States and Puerto Rico, spearheaded by a large marketing campaign. At its peak, about 2.8 million women used the Dalkon Shield in the U.S.

At the time of its introduction, the Dalkon Shield was promoted as a safer alternative to birth control pills, which at the time were the subject of many safety concerns. Initial reports in the medical literature raised questions about whether its efficacy in preventing pregnancy and expulsion rate were as good as those claimed by the manufacturer, but failed to detect the tendency of the device to cause septic abortion and other severe infections.

In June 1973 the CDC conducted a survey of 34,544 physicians with practices in gynecology or obstetrics regarding women who had been hospitalized or had died with complications related to the use of an IUD in the previous 6 months. A total of 16,994 physicians responded, yielding 3,502 unique case reports of women hospitalized in the first 6 months of 1973. Based on the survey response rate, the CDC estimated that a total of 7,900 IUD related hospitalizations occurred during this 6-month period. Based on an estimate of 3.2 million IUD users, the CDC estimated an annual device-related hospitalization rate of 5 per 1000 IUD users. The survey also provided 5 reports of device-related fatalities, with four of these related to severe infection. One of the five was associated with the Dalkon Shield. Based on these data the CDC estimated an IUD-related fatality rate of 3 per million users per year of use, which it compared favorably to the mortality risks associated with pregnancy and other forms of contraception. Importantly, the survey showed that the Dalkon Shield was associated with an increased rate of pregnancy-associated complications leading to hospitalization.

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