The frameless GyneFix® intrauterine implant: A major improvement in efficacy, expulsion and tolerance

Abstract

The CuFix (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 woman 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. Based on new clinical information about the GyneFix from a long-term multicenter clinical trial, conducted in young nulligravid/nulliparous and parous women, the importance of this new contraceptive is discussed. The following conclusions were reached: The unique design characteristics of the 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. The GyneFix reduces the IUD failure rate to a minimum and is, therefore, a welcome reversible alternative to OCs and female surgical contraception. Framelessness 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. The GyneFix is a promising new, highly effective and safe, contraceptive option for parous women and an equally effective and well-accepted method for nulliparous women.

Expulsions following 1000 GyneFix insertions

“…The 3-year expulsion rate in a non-comparative trial involving both nulliparous and parous women was 0.7%. 1 A randomised comparative trial in parous women in China found the expulsion rate with the GyneFix to be significantly lower (3.0%) than that of the framed device, the T380A (7.4%), at 3 years. 4 The authors state that most expulsions with GyneFix occur within 3 months of insertion, representing 'insertion failures' due to insufficient implantation of the anchoring knot into the fundal myometrium through lack of experience with the technique.…”

Uterine perforation by GyneFix frameless IUD: Two case reports

“…3 Perforation at insertion, delayed perforation, or migration has not been recorded in large international multicenter clinical trials with the frameless device. 4,5 It might be supposed that a frameless device anchored in the myometrium might erode through more easily than a framed device. The absence in perforation rates may refute this supposition although there may be considerable underreporting.…”

Intrauterine contraceptives that do not fit well contribute to early discontinuation

“…Significant reasons for discontinuation were expulsion, bleeding and/or pain. 20 The initial trials with the frameless IUD conducted in Belgium, and later internationally, in parous and nulliparous women, were promising 21,22 . However, the WHO randomised clinical trial comparing the TCu380A with the frameless Flexigard 1 IUD (Flexigard 1 , developed by GynoPharma, Inc. in the USA, uses the same frameless design as that of the current GyneFix 1 IUD but a different inserter), involving parous women only, did not show a difference in removal rate for bleeding and pain 23 .…”