IUD tolerance in nulligravid and parous women: optimal acceptance with the frameless CuFix implant system (GyneFix). Long-term results with a new inserter.

Since 1985 clinical researchers have developed and tested the frameless and flexible copper IUD the CuFix Implant System or GyneFix. They have found that women tend to tolerate it well even women with small nulligravid uterine cavities. The modified applicator implants the IUDs stylet and anchoring knot a full 1 cm into the myometrium. This implantation technology is designed to reduce the incidence of expulsion and removals for medical reasons. Between October 1988 and December 1993 clinicians at the University Hospital of Gent Belgium and those at other institutions inserted 525 GyneFix IUDs into 199 nulligravid and nulliparous women and 326 parous women to examine this IUDs acceptance particularly in young nulligravid and nulliparous women. No one experienced pelvic inflammatory disease or uterine perforations. The 60-month removal rate for medical reasons was 4.4%. Bleeding was the most frequent side effect. The removal rate for bleeding and pain at 24 months for nulligravida and nulliparous women was just 0.6%. At 60 months only 3 intrauterine pregnancies occurred for a pregnancy rate of 0.9%. No woman had an ectopic pregnancy. 2 expulsions occurred for an expulsion rate of 0.3% at 60 months. The contraception continuation rate was 81.5% at 24 months in the nulligravid and nulliparous group and 67.7% at 60 months for all women. At 60 months the removal rate for planned pregnancy was 25.1%. These findings show that both nulligravid and parous women tolerate GyneFix well. Its frameless and flexible design explains why potentially serious complications do not occur. The researchers conclude that GyneFix is an efficient practical contraceptive option for nulligravid/nulliparous women.