M. Vrijens

Precision intrauterine contraception may significantly increase continuation of use: a review of long-term clinical experience with frameless copper-releasing intrauterine contraception devices

Objective The purpose of this paper is to review the experience with the frameless, anchored, GyneFix copper-releasing intrauterine contraceptive devices (IUCDs/IUDs) (Contrel Europe, Belgium), and to demonstrate their high acceptability and low rate of discontinuation of use, which could contribute to current efforts that aim to reduce radically the high number of unintended pregnancies and induced abortions, particularly in young women. Materials and methods This paper is based on studies that examined the differences in uterine volume and cavity size, related to age and parity, and on original clinical research data and practical experience with frameless copper IUDs, as well as on literature data on the IUD–endometrial cavity relationship of conventional IUDs, with special reference to side effects and user discontinuation. Results The mean transverse diameter in nulliparous and parous women is significantly less than the length of the transverse arm of the TCu380A IUD (ParaGard, Duramed, NY, USA) or the levonorgestrel intrauterine system (Mirena, Bayer, Germany). Small, frameless, flexible, and unidimensional copper IUDs appear to be well tolerated, with less impact on menstrual bleeding, resulting in low discontinuation rates when compared with standard-size conventional IUDs, which often result in increased expulsion rates, complaints of pain and erratic or increased menstrual bleeding, and subsequent high rates of discontinuation, particularly in young women. Conclusion The unidimensional GyneFix IUDs fit the majority of uterine cavities. An IUD that fits is likely to result in increased tolerance and continued use of the method. As this would appeal to women, the logical result should be greater use of the method and fewer unintended pregnancies and induced abortions. Recommending the standard TCu380A (ParaGard) IUD or the Mirena levonorgestrel intrauterine system, primarily developed for use in parous women, for general use in nulliparous and adolescent women should be done with caution in the light of current scientific evidence, except if 3-D sonography indicates that the uterine cavity is sufficiently large.

IUD expulsion solved with implant technology

In an attempt to minimize the problem of IUD expulsion, implantation technology has been developed and tested. The trials have extended from 1985 until the present time for interval as well as for immediate postabortal and post-placental insertion and fixation of the CuFix IUD (Gyne-Fix). The present article reports on an ongoing study with GyneFix interval insertion, with an improved inserter, in 820 women, observed up to 3 years, of whom 213 (25.9%) are nulligravid/nulliparous. The cumulative expulsion rate is 0.6 per 100 women-years at 3 years and is not significantly higher in the nulligravid/nulliparous group. The cumulative pregnancy rate is 0.6 and the cumulative removal rate for medical reasons 3.2 at 3 years. The total experience in this multicenter study covers approximately 14,000 woman-months. It is concluded that the design characteristics of the GyneFix (fixed, frameless, and flexible) explain the low expulsion, high efficacy and high acceptability rates. The implantation technology is very effective and the improved inserter allows easy insertion and optimal anchoring.

Ultrasonic detection, localization and identification of intrauterine contraceptive devices

Abstract To assess the value of B-scan echography for the detection, localization, and identification of tailed IUDs, two studies were performed, each comprising 110 women. In the first the ultrasonographist was cognizant of the clinical context and the investigation was limited to the Lippes loop. The second was a blind study and concerned three types of IUDS : the Lippes loop, the Dalkon shield, and a copper device (Cu7TM). The diagnostic accuracy of the procedures for the detection and the localization of IUDs within the uterus was adequate in both series, although the best results were obtained with the Lippes loop, which-gives fairly typical sonographic patterns. With respect to IUD typing, the results were disappointing, especially for the Dalkon shield and the copper 7TM. The value of ultrasonic detection and localization of an IUD coexistent with an incipient pregnancy was analyzed in six women. That the diagnostic precision proved to be less satisfactory in these cases than in the entire series was apparently due to the disturbing effect of the pregnancy-ring. The genesis of the sonographic patterns derived from the various tailed IUDs was further analyzed in an in vitro investigation. This study provided corroborative evidence to explain the intrinsic failure rate of sonography for both the detection and typing of IUDs located within the uterus.

Intrauterine Contraception in Adolescent Women The Gynefix Intrauterine Implant

Pregnancy rates among adolescents have not decreased over the last 10 years, despite numerous efforts. To solve this important health problem, the major strategy recommended is to encourage contraceptive use among sexually active teenagers. An important means of obtaining this is by promoting methods that are not dependent on daily administration in order to avoid noncompliance. One such method (Norplant) has already shown to be much more effective than the combination pill in preventing pregnancy in adolescent women. The frameless intrauterine implant system (fixed, frameless, and completely flexible) has been studied since 1985 in women between 14 and 50 years of age. The results in young nulligravid women confirm its very high effectiveness (cumulative pregnancy rate at 36 months: 1.4%), its low expulsion rate (cumulative rate at 36 months: 0.9%) and its optimal tolerance (cumulative removal rate for medical reasons at 36 months: 2.4%), resulting in a high acceptance of the implant and a high continued use. The system (GyneFix) offers long-term protection (5 years), and its insertion, with or without anesthetic, is easily accomplished in the office. The GyneFix should therefore be recommended as an excellent alternative for birth control pills for young women with low risk for STDs, especially when compliance is a problem, without an increased risk for complications and without systemic side effects. Removal of the device is accomplished by traction on the tail. It can also be used for emergency contraception and for insertion immediately after termination of pregnancy.

Use of frameless intrauterine devices and systems in young nulliparous and adolescent women: results of a multicenter study

Background The purpose of this study was to provide additional data on the experience with frameless copper and levonorgestrel (LNG) intrauterine devices (IUDs) in nulliparous and adolescent women. Methods Nulliparous and adolescent women, 25 years of age or younger, using the frameless copper IUD or the frameless LNG-releasing intrauterine system (IUS), were selected from previous studies and a current multicenter post-marketing study with the frameless copper IUD. The small copper-releasing GyneFix® 200 IUD consists of four copper cylinders, each 5 mm long and only 2.2 mm wide. The frameless FibroPlant® LNG-IUS consists of a fibrous delivery system releasing the hormone levonorgestrel (LNG-IUS). The main features of these intrauterine contraceptives are that they are frameless, flexible, and anchored to the fundus of the uterus. Results One hundred and fifty-four nulliparous and adolescent women participated in the combined study. One pregnancy occurred with the GyneFix 200 IUD after unnoticed early expulsion of the device (cumulative pregnancy rate 1.1 at one year). Two further expulsions were reported, one with the GyneFix 200 IUD and the other with the FibroPlant LNG-IUS. The cumulative expulsion rate at one year was 1.1 with the copper IUD and 2.2 with the LNG-IUS. The total discontinuation rate at one year was low (3.3 and 4.3 with the copper IUD and LNG-IUS, respectively) and resulted in a high rate of continuation of use at one year (96.7 with the copper IUD and 95.7 with the LNG-IUS, respectively). Continuation rates for both frameless copper IUD and frameless LNG-IUS remained high at 3 years (>90%). There were no cases of perforations or pelvic inflammatory disease reported during or following insertion. Conclusion This report confirms earlier studies with frameless devices and suggests that the high user continuation rate is attributable to the optimal relationship between the IUD and the uterine cavity. IUD studies have shown that an IUD that does not fit well will often lead to side effects (ie, pain, bleeding, embedment, expulsion) and subsequent removal of the IUD. Early discontinuation is not the aim of long-acting reversible contraception.

TRANSLOCATION OF INTRAUTERINE CONTRACEPTIVE DEVICES

In their paper on the diagnosis of translocation of intrauterine contraceptive devices Dr. Mackay and Dr. Mowat (April 13 p. 652) recommend starting with an ultrasonic examination which will merely demonstrate that the uterus does not contain an IUD. In several of their patients heysteroscopy confirmed this finding although in their discussion the authors question the necessity of the latter examination if ultrasonics have shown that the uterine cavity is empty. We tackled this problem some time ago and learned from a blind investigation that the diagnostic accuracy of ultrasonogrphy for the detection of an IUD (Lippes loop Dalkon Shield. and Cu-7) located within the uterine cavity is not absolute. In that study 8% of the devices known to be in situ could not be displayed by this method and interesting enough 3 of these failures were found to concern an incipient intrauterine pregnancy. Therefore although we basically agree with MacKay and Mowats proposition we wish to temper their enthusiasm by restating our reservations about the diagnostic accuracy of sonar for locating IUDs within the uterus.(FULL TEXT)