Researchers conducted this study to calculate expulsion rates in routine clinical use and look at possible expulsion reasons.
The study design was retrospective case note analysis and opportunistic client consultation.
Participants were the first 1000 GyneFix insertions.
The primary outcome measures were the client’s parity, the clinician’s experience carrying out insertion, and time from device insertion to expulsion.
The overall expulsion rate was 7.6%. There was no significant difference in parity of clients experiencing expulsion. Most (4.7%) removals were early, occurring within three months of insertion. There was considerable variation in the early expulsion rate from one clinician to another. Later expulsions also occurred, up to 28 months after insertion. Increasing experience of the inserting clinician led to lower rates of late expulsion. Unnoticed removal led to four unplanned pregnancies.
The study concluded that the GyneFix expulsion rate in our service is higher than quoted in clinical trials. Early expulsions may be related to the insertion technique, representing insufficient implantation of the anchoring knot into the fundal myometrium. Late displacements also occur, often many months after insertion; the reason for these is unclear. Users should be taught to check for the thread’s presence after each menstrual period, and unnoticed expulsion should be confirmed by ultrasound and abdominopelvic plain X-ray.
Reference: https://srh.bmj.com/content/27/3/135
