Three-year efficacy and acceptability of the GyneFix® 200 intrauterine system

Cao, Xiaoming; Zhang, Wenhao; Xuan, Zhao; Lin, Nong; Wang, Limei; Li, Chunhua; Song, Lijuan; Zhang, Weijia; Wildemeersch, Dirk

doi:10.1016/j.contraception.2003.10.009

Cited by 27 publications

(11 citation statements)

References 8 publications

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“…3 In order to minimise the risk of litigation, the need for adequate documentation and the use of a checklist as an important part of informed consent procedures was identified in a previous study. 4 The present authors have now demonstrated that the introduction of a standardised proforma can significantly improve the level of compliance with the RCOG's guidelines by improving the quality of documentation. 1 If our ultimate goal is to improve the quality of care and thereby reduce the high level of complaints and litigation associated with female sterilisation, then the available evidence would suggest that units providing the female sterilisation service should seriously consider the use of a standardised proforma that would ensure that a consistent and adequate information as recommended by the RCOG is provided to all patients requesting sterilisation.…”

Section: Audit Of Documentation Of Female Sterilisationmentioning

confidence: 69%

Audit of documentation of female sterilisation

Yunus¹,

Sarkar²

2006

j fam plann reprod health care

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Section: Audit Of Documentation Of Female Sterilisationmentioning

confidence: 69%

Audit of documentation of female sterilisation

Yunus¹,

Sarkar²

2006

j fam plann reprod health care

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“…The data for the current study were extracted from an earlier study12 with the frameless copper IUD (small version) and supplemented with data recently collected from a currently ongoing post-marketing study. Data for the frameless LNG-IUS in nulliparous women younger than 25 years of age and adolescent women were taken from previous contraceptive studies13 with this system.…”

Section: Methodsmentioning

confidence: 99%

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

Wildemeersch¹,

Jandi²,

Pett³

et al. 2014

IJWH

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BackgroundThe 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.MethodsNulliparous 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.ResultsOne 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.ConclusionThis 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.

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“…Interestingly, the reduction in size of the small frameless IUD (whose total foreign body surface area is three times smaller than that of the TCu380A) did not result in a significantly higher failure rate. At three years, the latter was less than 1/ 100 women per year 26 . These design characteristics, including the anchoring in the uterine fundus, resulted in the high continuation rate of this small, frameless IUD (4 90% at three years).…”

Section: A S M a L L E R I U D I S A S S O C I A T E D W I T H L E S mentioning

confidence: 98%

“…Indeed, new randomised comparative trials with an improved GyneFix 1 inserter showed a significantly lower expulsion rate and a significantly better continuation rate at three years for the frameless device than for the TCu380A although, again, only parous women were involved 25 . Use of a smaller version of the GyneFix 1 IUD by both nulliparous and parous women was associated with high acceptability and continuation, due to reduced side effects 26 . Figure 3 shows the small frameless IUD in a tiny uterine cavity.…”

Section: F R a M E L E S S I N T R A U T E R I N E C O N T R A C E P mentioning

confidence: 99%