Management of primary dysmenorrhea in young women with frameless LNG-IUS

Dirk Wildemeersch,1 Sohela Jandi,2 Ansgar Pett,2 Thomas Hasskamp3 1Gynecological Outpatient Clinic and IUD Training Center, Ghent, Belgium; 2Gynecological Outpatient Clinic, Berlin, Germany; 3GynMünster, Münster, Germany Abstract: The objective of this paper is to discuss the potential advantages of intrauterine treatment with a frameless levonorgestrel (LNG)-releasing intrauterine system (IUS) in young women presenting with primary dysmenorrhea associated with heavy menstrual bleeding. The paper is based on clinical reports of 21 cases of primary and secondary dysmenorrhea treated with the frameless LNG-IUS. Three typical examples of young women between 16 and 20 years of age, who presented with moderate-to-severe primary dysmenorrhea associated with heavy menstrual bleeding, are presented as examples. Following pelvic examination, including vaginal sonography, a frameless LNG-IUS, releasing 20 µg of LNG/day, was inserted. The three patients developed amenorrhea, or scanty menstrual bleeding, and absence of pain complaints within a few months. We conclude that continuous, intrauterine progestogen delivery could be a treatment of choice of this inconvenient condition. In addition, the good experiences with the frameless LNG-IUS in other studies suggests that the frameless design may be preferred over a framed LNG-IUS, as the absence of a frame, resulting in optimal tolerance, is particularly advantageous in these women. Keywords: heavy menstrual bleeding, contraception, FibroPlant, intrauterine syste

The anchor of the frameless intrauterine device does not migrate over time: an analysis in over 300 women

Dirk Wildemeersch,1 Ansgar Pett,2 Sohela Jandi,2 Kilian Nolte,3 Wolfgang Albrecht4 1Gynecological Outpatient Clinic and IUD Training Centre, Ghent, Belgium; 2Gynecological Outpatient Clinic, Berlin, Germany; 3Gynecological Outpatient Clinic, Uetze, Germany; 4Gynecological Outpatient Clinic, Feldkirchen, Austria Objective: To evaluate the correct position of the anchor at insertion and follow-up and assess if migration of the anchor occurs over time. Materials and methods: This was an insertion-related, prospective, postmarketing study in 309 women. Following insertion, women were followed up at 4–6 weeks, 6 months, and yearly thereafter. The position of the visualized anchor in the fundus of the uterus was evaluated using ultrasound by measuring its distance from the serosal surface of the uterus (SA-distance). Results: A total of 309 parous (n=115) and nulliparous (n=194) women were fitted with the frameless GyneFix 200 or the GyneFix 330 intrauterine device for contraception. The mean SA-distance in 306 parous and nulliparous women was 6.0 mm (range 2.0–24.0 mm) at insertion in the parous group and 5.4 mm (range 1.3–11.0 mm) in the nulliparous group. At the first follow-up in 281 women, the SA-distance was 6.0 mm (range 2.0–12.0 mm) in the parous group and 5.5 mm (range 1.1–11.0 mm) in the nulliparous group. The SA-distance was not significantly different. One patient had an exceptionally large SA-distance of 24 mm, probably due to insertion in the posterior wall. No follow-up could be done in this patient. In 77 women, the SA-distance was measured up to 42 months. The mean SA-distance at insertion in the parous group was 5.2 mm (range 3.0–8.5 mm) and 4.8 mm (range 1.3–7.0 mm) in the nulliparous group. At the last follow-up up to 36 months or longer, the SA-distance was 5.1 mm (range 3.0–8.5 mm) in the parous group and 4.9 mm (range 1.3–7.0 mm) in the nulliparous group. The SA-distance was not significantly different. The visualized anchor was highly visible on ultrasound in all cases. Conclusion: The visualized anchor is a key element in the optimization of frameless technology, with the aim of allowing the provider to check its placement at insertion and at follow-up, which enhances provider confidence and assurance. The authors recommend measuring the thickness of the fundus prior to inserting the frameless intrauterine device and to measure the distance between the serosa and the visualized anchor following insertion and at the first follow-up examination. Keywords: frameless IUD, anchoring technology, visualizatio

Intrauterine device quo vadis? Why intrauterine device use should be revisited particularly in nulliparous women?

Dirk Wildemeersch,1 Norman Goldstuck,2 Thomas Hasskamp,3 Sohela Jandi,4 Ansgar Pett4 1Gynecological Outpatient Clinic and IUD Training Center, Ghent, Belgium; 2Department of Obstetrics and Gynaecology, Faculty of Medicine and Health Sciences, Stellenbosch University and Tygerberg Hospital, Western Cape, South Africa; 3GynMünster, Münster, 4Gynecological Outpatient Clinic, Berlin, Germany Background: Long-acting reversible contraceptive (LARC) methods, including intrauterine devices (IUDs) and the contraceptive implant, are considered the best methods for preventing unintended pregnancies, rapid repeat pregnancy, and abortion in young women. An opinion paper of 2012 by the American College of Obstetricians and Gynecologists recommends Mirena and Paragard for use in nulliparous and adolescent women. However, these IUDs are not designed for young women and are not optimal as they often lead to early discontinuation. Objective: This article was written with the objective to respond to the urgent need to improve intrauterine contraception as it is likely that the objectives of LARC will not be met without significant improvement of IUD design. Anatomical variations in size and shape of the uterus are not sufficiently considered, producing harm and suffering, which often lead to early removal of the IUD. Proposed problem solving: The article describes why IUDs should be revisited to meet the challenge of LARC and proposes how to solve these problems. The opinion statement presented here may be considered provocative but is based on hundreds of women with IUD problems who consult or are referred to the practices of the authors of this article due to the disproportion between the IUD and their small uterine cavity. The solution is simple but requires a revision of the current design of IUDs. One-dimensional (longitudinal) IUDs are likely to be the first option. Framed devices with shortened transverse arm and IUDs which adapt to the width of the given uterus are viewed as second best. Conclusion: One of the reasons of the high unintended pregnancy rate in the USA may be the paucity of suitable IUDs. Also, the legal climate in the USA seems to be a problem for developers as many lawsuits have recently been reported. Clinical studies conducted in young nulliparous and adolescent women suggest that IUDs that fit well in the uterine cavity, like a shoe, result in better tolerance, less side effects, and last but not least, higher use continuation rates. Keywords: IUD screening, counseling, frameless IUD/IUS, adapted IUDs, efficacy, tolerance, continuation rat

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

Dirk Wildemeersch,1 Sohela Jandi,2 Ansgar Pett,2 Kilian Nolte,3 Thomas Hasskamp,4 Marc Vrijens5 1Gynecological Outpatient Clinic and IUD Training Center, Ghent, Belgium; 2Gynecological Outpatient Clinic, Berlin, 3Gynecological Outpatient Clinic, Uetze, 4GynMünster, Münster, Germany; 5Gynecological Outpatient Clinic, Ghent, Belgium 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. Keywords: GyneFix®, FibroPlant®, frameless, intrauterine device, intrauterine system, efficacy, tolerance, continuation rat

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

Dirk Wildemeersch,1 Ansgar Pett,2 Sohela Jandi,2 Thomas Hasskamp,3 Patrick Rowe,4 Marc Vrijens5 1Gynecological Outpatient Clinic and IUD Training Center, Ghent, Belgium; 2Gynecological Outpatient Clinic, Berlin, Germany; 3Gynecological Outpatient Clinic, Münster, Germany; 4Formely IUD Research Group at the UNDP/UNFPA/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction, World Health Organization, Geneva, Switzerland; 5Gynecological Outpatient Clinic, Ghent, Belgium 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. Keywords: GyneFix; anchored IUS; frameless IUS; tolerance, acceptability, continuation, discontinuatio