This page contains a selection of publications about GyneFix available for download as PDF file.
Intrauterine systems: a frameless future?
Introduction: 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.
AuthorsDirk Wildemeersch, Norman D. Goldstuck and Thomas Hasskamp
A multicenter study assessing uterine cavity width in over 400 nulliparous women seeking IUD insertion using 2D and 3D sonography
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.
AuthorsDirk Wildemeersch,Thomas Hasskamp, Kilian Nolte,Sohela Jandi,Ansgar Pett, Sabine Linden, Maarten van Santen, Olivier Julen
Management of primary dysmenorrhea in young women with frameless LNG-IUS
AbstractThe 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.
AuthorsDirk wildemeersch, Sohela Jandi, Ansgar Pett, Thomas Hasskamp
Precision intrauterine contraception
AbstractThe 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.
AuthorsDirk Wildemeersch, Ansgar Pett, Sohela Jandi, Thomas Hasskamp, Patrick Rowe, Marc Vrijens
Precision intrauterine contraception.pdf
Uterine forces in intrauterine device
AbstractThe 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.
AuthorsDirk Wildemeersch, Norman D Goldstuck
The anchor of the frameless iud does not migrate
AbstractThis 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).
AuthorsDirk Wildemeersch, Ansgar Pett, Sohela Jandi, Kilian Nolte, Wolfgang Albrecht
Intrauterine device quo vadis
AbstractThis 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.
AuthorsDirk Wildemeersch, Norman Goldstuck, Thomas Hasskamp, Sohela Jandi, Ansgar Pett
Use of frameless IUD and IUS in nulliparous and adolescent women
AbstractThe 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.
AuthorsDirk Wildemeersch, Sohela Jandi, Ansgar Pett, Kilian nolte, Thomas Hasskamp, Marc Vrijens
How to become Proficient with Insertion of Frameless IUD's
AbstractMillions 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.
AuthorsDirk Wildemeersch, Thomas Hasskamp
GyneFix for interval, emergency and postabortal contraception
AbstractThis 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.
AuthorsD Wildemeersch, IBatar, A Webb, BA Gbolade, W Delbarge, M Temmerman, M Dhont, J Guillebaud
MRI Safety Information for GyneFix & GYN-CS
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
- Maximum spatial field gradient of 12,900 G/cm (129 T/m)
- Maximum force product of 229,000,000 G2/cm (229 T2/m)
- Theoretically estimated maximum whole body averaged (WBA) specific absorption rate (SAR) of 2 W/kg (Normal Operating Mode)
Under the scan conditions defined above, the "GyneFix 330" is expected to produce a maximum temperature rise of less than 2.0°C (2 W/kg, 1.5 Tesla) RF-related temperature increase with a background temperature increase of ≈ 1.7°C (2 W/kg, 1.5 Tesla) 2.8°C (2 W/kg, 3 Tesla) RF-related temperature increase with a background temperature increase of ≈ 2.2°C (2 W/kg, 3 Tesla) after 15 minutes of continuous scanning.
FSN document available here.