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The Dalkon Shield Scandal. Works Cited Included

1735 words - 7 pages

The Dalkon Shield Scandal The Dalkon Shield was a highly controversial Intrauterine Device (IUD) available in the early 1970's. IUD's have been used historically, but the first modern device, a Polish model, did not appear until 1909 (Perry 9). The devices were not available for American use until the 1960's. They were made of plastic with a multi-purposed tail attached. The tail assured the wearer than the device was in place as well as allowing doctors to remove them if desired (Wikipedia Encyclopedia). This device, the "superior modern contraceptive" was heralded as revolutionary (Bloss). It could be inserted and then forgotten, no pills necessary. Evidence of negative side ...view middle of the document...

" Davis developed an IUD called the Incon Ring in 1965 (Mintz 25). Studies, however, showed problems with expulsion. In addition, studies of similar products were experiencing problems with perforation of the uterus and bowel strangulation (Bloss). Lerner Laboratories picked up on Davis' design. They invented the Dalkon shield by adding a central membrane to the frame of the ring, in addition to lateral spikes and a multifilament string that reached from the device in the uterus, through the cervix and into the vagina. (Wikipedia Encyclopedia). The device was adapted in order to increase surface area. The innovators thought this was an important factor in preventing pregnancy. The adaptations also allowed physicians to check the position of the apparatus with ease (Bloss). The first tests for the Dalkon Shield were held at John's Hopkins in 1968 (Perry 33). The tests studied six hundred and forty women; they lasted an average of five months (Bloss). For added protection against pregnancy, the participants in the study were instructed to use spermicidal foam. This was not present in the final report nor was the fact that, while testing was in progress, sixty percent of the women using the apparatus discontinued its use (Perry 32). A.H. Robins purchased the patent to the Dalkon Shield in 1970. Two corporate executives pushed to delay the purchase until more conclusive studies could be completed pointing to inconsistencies between Davis' reports and the results of subsequent studies (Bloss). They, however, were ignored, and the Dalkon Shield was available for purchase in January of 1971 (Perry 245). Soon after its market release, criticism began to accumulate. Dr. Mary Gabrielson of the American Association of Planned Parenthood asserted that the failure rates of the devise were more than four or five times higher than reported by Davis (Bloss). Contemporary medical literature found fault with all IUD's, and though some tried to prove the particular danger of the Dalkon Shield, the medical warnings for infection, injuries, and death were extended to all IUD's (Grant 68). The media began to raise questions about skewed test results and began to distrust the manufacturers. However, medical reassurance of the safety of the IUD often accompanied the uncertainties (54). As sales of the device began their steady decline in 1972, A. H. Robins launched a massive advertising campaign. The company also shipped some two million un-sterilized devices overseas. They were sent with one inserted per ten devices and one instruction booklet, available in English only, per one thousand (Bloss). In 1974, the Dalkon Shield was pulled from shelves pending additional safety testing. The multifilament string was replaced, and the product was back on the market after six months of inactivity. Accompanying its re-release, the FDA stated that the Dalkon Shield held no higher risks than other IUD's. Following additional...

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