Also ich zitiere mal ein wenig aus den Dokumenten, die mir Contrel gemailt hat:
Quellen:
- The reliability of the anchoring concept for suspension of bioactive substances in the human uterus evaluated by measuring the removal force: results after long-term use (István Batár*, Dirk Wildemeersch**]
- Contraceptive efficacy* and effect on menstrual blood loss"A review of 15 years of clinical experience has been published recently [2]. In randomized
and non-randomized clinical trials, expulsion rates have been variable. Long-term multicentre
clinical trials using the current GyneFix® insertion technique have shown low expulsion rates
(which includes failed insertion) both in parous and nulliparous women ranging from 0.5 to
3.0% during the first three years of use, compared with expulsion rates of between 2.7 and
7.4% with the TCu380A IUD. However, in post-marketing trials, especially in the United
Kingdom, expulsions have occurred in up to 8% during the first year [3-5]. Other centres in
the United Kingdom did not report any expulsions [6,7]."
"As most expulsions occur during the learning experience with GyneFix®, it has been
suggested that the skill of the physician performing the insertion is a major factor. Early
expulsion is likely if the implantation of the anchor is not properly performed. WHO has
described the term "insertion failure" when applied to the GyneFix® as the failure to implant
the knot in the fundal myometrium. Failure to implant the knot means that the device stays in
the uterine cavity but not attached to the uterine wall as intended resulting in the expulsion of
the frameless IUD usually within days or weeks of the attempted insertion. The fact that the
majority of expulsions occur in a minority of doctors (six of 28 centres accounted for 78% of
insertion failures in the large WHO randomized clinical trial [10]) suggests that skill and
experience played a part in failure to correctly insert the devices and this has been reported by
other investigators [11-14]."
"Conclusion
The results of this study indicate that early expulsion of the device may be explained by
failure to implant the knot adequately (no implantation or partial implantation) which requires
a degree of skill. The present study does not provide an explanation for the occurrence of late
expulsion. There is neither statistical difference in removal force between parous and
nulliparous women, nor is there any indication that the anchoring is becoming less strong with
time. Furthermore, spontaneous migration has not been detected in previous studies which
could explain the occurrence of late expulsion [18]. To minimize the risk of expulsion (early
and late), it is recommended not to pull at the tail after insertion as the anchoring might still
be weak, and to abstain from intercourse during the first week."
"Results: The cumulative pregnancy rate per 100 women after 3 years
was 0.48 (Table 1). The Cumulative removal rate at 3 years for medical
reasons was 1.65 and the expulsion rate 0.39. After 3 years 93.9% of women
were still continuing the method. No complications (e.g., perforation,
PID) were reported in the study. Menstrual blood loss in the 60 women did
not show an increase when compared with baseline. The median bleeding
score before insertion was 110.5 (range 28 to 265) and 110 (range 28 to
260) after 3 to 51 months of use (p = 0.596) (Table 2)."
Ist jetzt alles mäßig aussagekräftig und gibt offenbar die Zahlen wieder, die auch schon in der anderne Broschüre stehen.
Der PI ist bei 0,48 pro 100 Frauen
Die Ausstoßungsrate liegt bei 0,39
Die Entfernung aus medizinischen Gründen 1,65
Eine Erklärung für späteren Verlust ergeben die Studien wohl nicht, hier ging es wirklich eher um den zeitigen Verlust der Kette, was hauptsächlich an Einlagefehlern liegt
Viel Text, aber so richtig schlauer ist man trotzdem nicht
Ich weiß nicht, ob es irgendwo unabhängige Studien dazu gibt, aber wahrscheinlich eher nicht oder? Bei Pille & Co. wird sowas ja auch nicht üblich sein?
Falls jemand etwas besser Englisch beherrscht als ich und noch was Interessantes herauslesen kann, nur zu
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