The Health Sciences Authority (HSA), Singapore posted a medical device safety alert concerning intrauterine devices (IUD).
HSA informs healthcare professionals about the final findings from the European Active Surveillance Study for Intrauterine Devices (EURAS-IUD), which showed a higher risk of uterine perforation associated with both levonorgestrel-intrauterine system (LNG-IUS) and copper intrauterine devices (Cu IUDs) in breastfeeding women, as well as in women who are up to 36 weeks post-partum at time of insertion. The uterine perforation rate with the devices in the entire study population was classified as uncommon (1.3 per 1,000 insertions).
The rate of uterine perforation per 1,000 insertions has been reported at 0.9 with LNG-IUS1 and 0.6–1.6 with Cu IUDs. Potential risks of uterine perforation such as insertion of IUDs in the first six months post-partum, lactation, and women with an atypical uterine anatomy (such as fixed retroverted uterus) have been reported.
Breastfeeding has been reported in the literature as a potential risk factor for uterine perforation because of low serum oestrogen levels and therefore a more contracted uterus. A pooled analysis of uterine perforation after insertion of LNG-IUS from four national pharmacovigilance centres from 1990 to 2007 found that 42% of 462 women were breastfeeding at the time the perforations were discovered.
The HSA advises healthcare professionals to take the above information into consideration when selecting IUDs for use in women who are less than 36 weeks post-partum or breastfeeding at time of insertion.
For details, please refer to the following HSA website:
http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/fieldsafetynotices/CON449734
Posted on 11 September 2014