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Abstract
The first 200 women to be fitted with GyneFix at the Margaret Pyke Centre, a National Health Service contraception clinic situated in central London, have been followed up at 1 year after insertion. Removals, expulsions and accidental pregnancies in that first year are recorded. Of the cohort, 80% had a known outcome at 12 months. There was one perforation with the inserter tube, leaving 199 women fitted with GyneFix who contributed 2033 woman-months of follow-up time. We recorded 22 early removals, of which 16 were for heavy or irregular bleeding and/or pain, three were because the women wished to conceive and three for other reasons. In addition there were 16 expulsions at intervals ranging from 1 day to 12 months after insertion. Four of the expulsions were unnoticed by the subjects (they were revealed by amenorrhea of pregnancy in two subjects and lost threads in the other two). There were no pregnancies with the GyneFix in situ. The expulsion rate of 8.4% (confidence interval (CI) 5.2-13.4%) and removal rate for bleeding and/or pain of 9.0% (CI 5.6-14.3%) at 12 months recorded in this cohort fall within acceptable ranges for framed intrauterine devices in a population with a large percentage of nulliparous women. However, they are perhaps not as good as had been anticipated for this revolutionary new intrauterine implant. Possible reasons for this are explored.