Long-term study of the safety of the Dalkon Shield and Gyne-T 200 intrauterine devices.

Between 1971 and 1973, 200 Dalkon Shield and 142 Gyne-T 200 intrauterine devices (IUDs) were inserted at the department of obstetrics and gynecology in a large urban hospital. In 1984 retrospective analysis of events associated with the use of these IUDs was done. Hospital and clinic charts were reviewed, and the women were contacted to obtain information on infertility and the outcome of pregnancy after discontinuation of IUD use. The rates of events leading to discontinuation of IUD use 2 years after insertion were similar in the two groups except for that of planned pregnancy, which was higher in the Dalkon Shield users (p less than 0.05). The rates of accidental pregnancy per 100 women were 3.8 for the Dalkon Shield users and 1 for the Gyne-T 200 users. The rates of pelvic inflammatory disease (PID) based on all cases of PID and follow-up information were similar in the two groups. There were no differences between the two groups in outcome of pregnancy with the IUD in situ or after expulsion or removal of the IUD because of planned pregnancy or other reasons. Infertility rates after discontinuation of IUD use were similar for the Dalkon Shield and Gyne-T 200 users. The results confirm the authors' opinion that the Dalkon Shield and Gyne-T 200 IUDs are safe and effective methods of intrauterine contraception.