ABSTRACT
PIP: The Copper T 380A and the Flexigard intrauterine devices were evaluated for safety, efficacy, and continuation rates in parous women. The Flexigard is a new concept of IUD technology with regard to the affixing of the device to the uterine fundus, the flexibility of the device, and the total absence of a plastic frame. A total of 186 women were enrolled in the study: Group I contained 90 women using Flexigard, and Group II 96 women using TCu380A. All participants were healthy women with at least one living child, regular menstrual cycles, and without previous history of pelvic inflammatory disease and/or ectopic pregnancy. The IUDs were inserted in the first 10 days of the cycle, and subsequent examinations were carried out on day 15, and 3, 6, 9, 12, and 24 months after insertion. The patients were followed up for a total of 2622 and 2589 woman-months for TCu380A and Flexigard, respectively. There were 96 TCu380A and 95 Flexigard insertions. Medical reasons for discontinuation were: desire to get pregnant (1.1%), complaint of partner (1.1%), blood loss (1.1%) for Flexigard; and desire to get pregnant (5.2%), partner's complaint (1.9%), and loss of blood (1.0%) for TCu380A. There were five insertion failures out of 95 insertions with the Flexigard and none out of 96 insertions with TCu380A. The age, parity, and continuation rates showed no differences between devices. The main difference between the devices was that the complete expulsion rate for Flexigard was significantly higher (5.55%) than for the TCu380A (p 0.05). This high rate of complete expulsions for Flexigard was attributable to improper insertion of the device rather than to the expulsion of a properly fitted one.^ieng
