Original research articleUterine perforation on intrauterine device insertion: is the incidence higher than previously reported?
Introduction
Perforation of the uterus is a serious, if uncommon, complication of intrauterine device (IUD) insertion. Clinical trials of Multiload Cu375 have reported an incidence of less than one uterine perforation per 1,000 insertions [1], [2], [3]. Edelman’s review of Multiload Cu375 studies found no reported uterine perforations in 5617 insertions [4].
Studies of Multiload Cu375 before this post-marketing study have taken place in expert centers [1], [3] or with a limited number of inserting doctors [2] and with defined exclusion criteria [1], [2], [3]. The rate of perforation might be different in ‘real-life’ clinical practice outside the setting of a clinical trial, where many different doctors (of varying experience) insert IUDs in a range of women.
In New Zealand, Multiload Cu375 is included in the Intensive Medicines Monitoring Programme (IMMP) which undertakes prospective observational cohort studies on selected medicines in the early post-marketing period [5]. The IMMP has collected data from over 17,400 Multiload Cu375 insertions throughout New Zealand. This paper reports on the incidence of uterine perforation in this cohort and discusses why the incidence of this complication might differ between studies.
Section snippets
Materials and methods
The New Zealand IMMP uses Prescription Event Monitoring (PEM) methodology to prospectively study medicines as used in clinical practice after licensing and has been described in detail previously [5], [6]. Multiload Cu375 has been included in the IMMP since it was first marketed in New Zealand in 1991.
Between 1991 and 1997, Multiload Cu375 packages included a registration form which was completed by the inserting doctor and returned to the IMMP in a pre-paid envelope. The registration form
Results
The Multiload Cu375 cohort included 17,469 insertions (in 16,159 women) which took place between January 1991 and March 2001. The average age was 32 years (range 14 to 56 years) and for women whose parity was known (14,310 insertions), 40% had delivered two babies. About 9% of insertions were carried out in nulliparous women.
In this study, 1,699 different doctors in general practices, family planning clinics, hospitals and private specialist rooms throughout New Zealand performed the Multiload
Discussion
The incidence of uterine perforation in this study (when all possible cases were included) was 1.6 per 1,000 insertions, which is higher than the incidence reported in previous studies of Multiload Cu375 [1], [2], [3], [4]. This first raises the question whether it was correct to include all reports coded as ‘IUD embedded’ as uterine perforations. On examination of these case reports, some were suggestive of perforation at the time of insertion. Other reports, where the device was found to be
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