One-year clinical experience with FlexiGard.
In 1988, a clinical study with a new copper-containing IUD, the FlexiGard, was initiated at the Family Planning Center of the UMSD, Debrecen, Hungary. The aim of this trial was to measure the overall performance of the device with special attention to its frameless design and anchoring system. In one year (from May 1988 through May 1989), 344 FlexiGard devices were inserted in parous women during the first seven days of their menstrual cycle. This report summarizes the one-year results. By the end of the 12 -month follow-up period, 3484 woman-months of use (WMU) were accumulated. The number of women who completed the one-year follow-up period was 264. During this period, 33 cases were terminated for different reasons. The net continuation rate is 89.7 at the end of the first year of use. The device was well retained by the uterus (cumulative expulsion rate 1.5 at 12 months). The cumulative removal rate for bleeding/pain is 4.4 at 12 months and the cumulative pregnancy rate 0.6 at 12 months. The results confirm those of previously conducted multicenter studies with the device. This new generation intrauterine copper contraceptive (ICC) is well tolerated, which is attributed to its design characteristics. Besides, the device is highly effective, and its insertion is easy and safe. Removal of the ICC is equally easily accomplished.