The Dalkon Shield

FDA Consum. 1975 Feb;9(1):21.

Abstract

PIP: In May 1974, A.H. Robins Company, manufacturers of the Dalkon Shield, notified physicians that 36 septic abortions including 4 deaths had been reported in users of the Dalkon Shield. All these cases occurred during the 2nd trimester of pregnancy. Figures have since risen to 13 deaths among 219 septic abortion cases. Physicians are advised to administer a pregnancy test to every Dalkon Shield user who misses a menstrual period, remove the device as soon as pregnancy is confirmed, advise a therapeutic abortion in cases where IUD removal is difficult, and warn patients preinsertion that abortion will be recommended in the case of accidental pregnancy. In June 1974, at the request of the FDA (Food and Drug Administration), sale of the Dalkon Shield was suspended. An Advisory Committee of the FDA has since reported that IUDs as a whole are relatively safe and reliable and compare favorably with OCs (oral contraceptives), the most popular contraceptive. The Dalkon Shield, under FDA ruling, is now available under closely supervised distribution. The design has been switched from a multi- to a single-filament string. The newly designed Shields can be distributed only to physicians who will maintain a register of patients who receive them. These data are to be used in a study of the possible hazards of all IUDs, particularly the DAlkon Shield.

MeSH terms

  • Drug Industry
  • Female
  • Humans
  • Intrauterine Devices* / adverse effects
  • Intrauterine Devices* / statistics & numerical data
  • Registries
  • United States
  • United States Food and Drug Administration