GyneFix(R), conceived in 1985, was developed to minimize three major p
roblems frequently associated with discontinuation of IUD use : expuls
ion, bleeding and pain. Since the initial clinical investigations, ove
r 10,000 women years of experience and up to 8 years of follow-up in i
nternational, multicenter, non-comparative and comparative clinical tr
ials, including a large proportion of nulligravid/nulliparous women, h
ave been collected The following conclusions were reached : 1. The uni
que design characteristics of GyneFix (frameless, flexible and fixed t
o the fundus of the uterus) have resulted in optimal tolerance and alm
ost complete absence of expulsion. The result is enhanced effectivenes
s (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 surg
ical contraception. 2. Frameless and flexibility explain the absence o
f side-effects and adverse events caused by dimensional incompatibilit
y between the frame of conventional IUDs and the uterine cavity and ma
y also explain the absence of PID and ectopic pregnancies in any of th
e clinical studies. 3. Insertion of GyneFix, with or without local ana
esthesia, is easily accomplished in the office in a few minutes. Remov
al is easy, quick and painless. 4. GyneFix is an equally effective and
well accepted method for nulliparous women.