Dalkon Shield Two years after its 1971 introduction to the American market, the Centers for Disease Control conducted a survey of intrauterine devices that detected a dangerous design flaw in one of these products, the Dalkon Shield. The string that enabled removal of the device was made of a porous weave of multiple filaments that harbored bacteria, leading to vaginal bacterial infections that caused septic pregnancies, spontaneous abortion, pelvic inflammatory disease, infertility and even death. This tragedy led to the passage of the 1976 Medical Device Amendments, which provided FDA with
Dalkon Shield Two years after its 1971 introduction to the American market, the Centers for Disease Control conducted a survey of intrauterine devices that detected a dangerous design flaw in one of these products, the Dalkon Shield. The string that enabled removal of the device was made of a porous weave of multiple filaments that harbored bacteria, leading to vaginal bacterial infections that caused septic pregnancies, spontaneous abortion, pelvic inflammatory disease, infertility and even death. This tragedy led to the passage of the 1976 Medical Device Amendments, which provided FDA with regulatory power to ensure the safety and effectiveness of medical devices.
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