Abstract

PIP: 291 woman recieved Dalkon shields for 2143 woman-months of cummulative use. The failure rate was 6.2% (18 pregnancies). 4.5% of these pregnancies occurred during the first year of use, and 6.8% during the second year. The overall pregnancy rate was 10.1 per 100 woman years, with no discernable diminution with the passage of time. The pregnancy rate rose rapidly during the first 6 months of usage and remained high thereafter. The expulsion rate was 1.7% and expulsions occurred only within the first 6 months after insertion. Removals totaled 19.2% for bleeding, pain, and/or infection. There was a "moderate degree of difficulty" in removing the device. The institution in which this study occurred recommended discontinuing use of the Dalkon shield because of its unacceptably high pregnancy rate.