The GyneFix intrauterine contraceptive system is different from conventional “framed” IUDs. It consists of a length of non-biodegradable, 0-size monofilament surgical thread with a varying number of hollow copper tubes mounted on it. The upper and lower tubes are crimped onto the thread to keep them in place. The effective copper surface area is >200 mm2 (for GyneFix 200, hysterometry < 8cm) and >330 mm2 (GyneFix 330, hysterometry ≥ 8cm).
The thread is provided with a knot, which is anchored into the fundal myometrium, thereby securing the device in the uterine cavity. A small highly echogenic stainless steel visualisation element immediately below the anchoring knot, enables post-insertion ultrasound verification of the device position.
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Request TrainingIntroduction: Intrauterine devices (IUD) are viewed as important contraceptive methodologies to prevent unintended pregnancy.
Areas covered: This expert opinion examines the place of frameless devices for use in young women in order to minimize side effect, improve patient comfort and maximize continuation of use to help reduce unintended pregnancies.
Expert opinion: Frameless designed IUDs have the ability to be used in both small and large uterine cavities of varied shapes and can significantly reduce abnormal bleeding, pain, embedment and expulsion and likely account for higher continuation rates than that seen with framed IUDs.
Dirk Wildemeersch, Norman D. Goldstuck and Thomas Hasskamp
Background: In the selection of an appropriate IUD little consideration is placed on device size or adequacy of t. Properly tting IUDs will likely lead to less adverse effects or patient discomfort resulting in enhanced continuation of use.
Methods: A multicenter study conducted at 7 centers in 410 nulliparous women, to measure the width of the uterine cavity using 2D and 3D ultrasound.
Results: Measurements of maximal fundal cavity width was performed by either 2D or 3D ultrasound by experienced sonographists. The mean width of the uterine cavity in the fundus was 22.2 mm (range 6.0- 41.1 mm). There was no statistical difference in the values whether determined by 2D (n = 258) or 3D (n = 152) measurements having a median value of 22.5 mm and 21.6 mm, respectively, 79% of women had a uterine cavity width between 15 mm and 28 mm, 32% < 20 mm and 6.8% < 15 mm, respectively. Discussion: Uterine cavities in nulliparous women are narrow and rarely wide enough to t conventional IUDs. Gross discrepancy between the IUD and the uterine cavity leads to side effect (e.g., expulsion, embedment, bleeding, pain) and early discontinuation. Historically, devices too large for the uterine cavity have been routinely inserted which may account for their 5-year continuation rates being only 40 to 50%. Our study suggests that preprocedural 2D or 3D sonography to measure the width of the uterine cavity may result in the selection of a suitable IUD to maximize continuation of use. Measurement of the cavity width is not necessary with a frameless IUD.
Dirk Wildemeersch,Thomas Hasskamp, Kilian Nolte,Sohela Jandi,Ansgar Pett, Sabine Linden, Maarten van Santen, Olivier Julen
The objective of this paper is to discuss the potential advantages of intrauterine treat-ment 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.
Dirk wildemeersch, Sohela Jandi, Ansgar Pett, Thomas Hasskamp
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.
Dirk Wildemeersch, Ansgar Pett, Sohela Jandi, Thomas Hasskamp, Patrick Rowe, Marc Vrijens
The purpose of this study was to examine factors that could help reduce primaryperforation during insertion of a framed intrauterine device (IUD) and to determine factors that contribute in generating enough uterine muscle force to cause embedment and secondary perforation of an IUD. The objective was also to evaluate the main underlying mechanism of IUD expulsion.
Dirk Wildemeersch, Norman D Goldstuck
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).
Dirk Wildemeersch, Ansgar Pett, Sohela Jandi, Kilian Nolte, Wolfgang Albrecht
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.
Dirk Wildemeersch, Norman Goldstuck, Thomas Hasskamp, Sohela Jandi, Ansgar Pett
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.
Dirk Wildemeersch, Sohela Jandi, Ansgar Pett, Kilian nolte, Thomas Hasskamp, Marc Vrijens
Millions of women start using an IUD because doctors tell them that IUDs are safe, effective and long-lasting. Unlike the pill, vaginal ring or the contraceptive patch, IUDs are fit and forget methods. In many women, this statement is true. Many women are happy with their IUD and don’t complain. However, about 50 to 60% have their IUD removed long before the usual 5-year lifespan of the IUD. Early IUD/ IUS removal is frequent due to side effects, mostly bleeding and pain, because the uterus, like any organ, cannot tolerate a foreign body that is cumbersome for long periods of time. Young women are specifically vulnerable to side effects. They are also the most vulnerable to unintended pregnancy and this is precisely why many organizations and institutions advocate IUDs in order not to become pregnant unintendedly. However, early IUD discontinuation undermines their potential to prevent unintended pregnancy and has numerous drawbacks as many women switch to other, less effective methods or to no method at all. Continuation over time is the primary determinant of effectiveness for IUDs.
As researchers, active in the field of intrauterine contraception since several decades, we have tried to maximize continuation of use by designing nonhormonal and hormonal intrauterine devices that accommodate to every anatomically normal uterus. Frameless devices are small; they are flexible as they have no frame; they provide highly effective and well tolerated contraception simply because they fit. Embedment, a frequent complication of current framed IUDs, is not possible with the frameless IUD as the uterine contractions have no impact on the flexible body and can therefore not be forced in the uterine wall. However, frameless IUDs need to be attached to the uterus to prevent expulsion. Precisely how correct anchoring is accomplished, including the pitfalls, and how to check the correct position of the anchored IUD is the subject of this paper.
Dirk Wildemeersch, Thomas Hasskamp
how-to-become-proficient-with-insertion-of-frameless-iuds.pdf
This article reviews the clinical experience with the GyneFix intrauterine implant system for interval,emergency and post-abortal contraception. The relatively high rate of unintended pregnancies and abortions in the world signifies that greater access to contraception is necessary. Unwanted pregnancies and abortions could be avoided by widening the range of effective and acceptable contraceptive methods for use in situations where current methods are far from optimal. High effectiveness, protection against sexual transmitted “infections, long duration of action, reversibility and safety are some of the most important attributes of contraceptives valued by women.
The development of the frameless intrauterine device is a response to the need to develop contraceptives with high user continuation rate. GyneFix has the lowest failure rate of all copper IUDs currently available. Its performance is further optimised by the atraumatic frameless design which minimises the side effects and discomfort experienced with conventional IUDs. GyneFix could, therefore, be a useful new contraceptive option in looking at ways to reduce the number of unwanted pregnancies and induced abortions.
D Wildemeersch, IBatar, A Webb, BA Gbolade, W Delbarge, M Temmerman, M Dhont, J Guillebaud
MR Conditional
Non-clinical testing has demonstrated that “GyneFix® 330” is MR Conditional. A patient with this device can be safely scanned in an MR system meeting the following conditions:
Static magnetic field of 1.5 Tesla and 3 Tesla, with:
The test object GyneFix® 330/GyneFix® 10/GYN-CS® 10/ReLARC® 10 has been exposed within a 64 MHz RF-laboratory system (equivalent 1.5 Tesla) and within a 128 MHz RF-laboratory system (equivalent 3 Tesla).
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For product leaflets for doctors please visit www.contrel.be/ifu .