ABSTRACT
GyneFix, conceived in 1985, was developed to minimize three major problems frequently associated with discontinuation of IUD use: expulsion, bleeding and pain. Since the initial clinical investigations, over 10,000 women years of experience and up to 8 years of follow-up in international, multicenter, non-comparative and comparative clinical trials, including a large proportion of nulligravid/nulliparous women, have been collected. The following conclusions were reached: 1. The unique design characteristics of GyneFix (frameless, flexible and fixed to the fundus of the uterus) have resulted in optimal tolerance and almost complete absence of expulsion. The result is enhanced effectiveness (comparable to OCs and male/female sterilization) and a high rate of continued use. GyneFix reduces the IUD-failure rate to a minimum and is, therefore, a welcome reversible alternative to OCs and female surgical contraception. 2. Frameless and flexibility explain the absence of side-effects and adverse events caused by dimensional incompatibility between the frame of conventional IUDs and the uterine cavity and may also explain the absence of PID and ectopic pregnancies in any of the clinical studies. 3. Insertion of GyneFix, with or without local anaesthesia, is easily accomplished in the office of a few minutes. Removal is easy, quick and painless. 4. GyneFix is an equally effective and well accepted method fro nulliparous women.
