- Medicines and Healthcare products Regulatory Agency
- 26 June 2015
- Therapeutic area:
- Obstetrics, gynaecology and fertility
The most important risk factors for uterine perforation are insertion during lactation and insertion in the 36 weeks after giving birth. Before inserting an IUS or IUD, inform women of the risk and the symptoms of perforation.
Before inserting an intrauterine system (IUS) or intrauterine device (IUD), inform women that perforation occurs in less than 1 in 1,000 women and that the symptoms include:
- severe pelvic pain after insertion (worse than period cramps)
- pain or heavy bleeding after insertion which continues for more than a few weeks
- sudden changes in periods
- pain during sex
- not being able to feel the threads
Explain to women how to check their threads and tell them to return for a check-up if they cannot feel them (especially if they also have significant pain). Partial perforation may have occurred even if the threads can still be seen; consider this if there is severe pain following insertion.
Intrauterine contraception includes levonorgestrel-releasing IUSs and copper IUDs.
IUSs are licensed for several gynaecological conditions including:
- long-term contraception (Jaydess, Levosert, Mirena)
- heavy menstrual bleeding (Levosert, Mirena)
- protection from endometrial hyperplasia during oestrogen replacement therapy (Mirena)
IUDs are used for long-term contraception.
Use of intrauterine contraception can rarely result in uterine perforation. Perforation most often occurs during insertion, but might not be detected until some time later. We have received 114 Yellow Card reports of uterine perforation and 22 reports of devices becoming embedded in the uterus, cervix or other local tissues in association with use of levonorgestrel-releasing IUSs up to 12 February 2015.
The European Active Surveillance Study for Intrauterine Devices (EURAS-IUD) was an observational study which examined the risk of uterine perforation with intrauterine contraception.1 The study followed 43,078 women who used levonorgestrel-releasing IUSs and 18,370 women who used copper IUDs.
The risk of perforation was increased in the following instances (see table):
- in women who were lactating (compared with women not lactating) at the time of insertion
- when the IUS or IUD was inserted up to 36 weeks (compared with more than 36 weeks) after giving birth
These risk factors were independent of the type of intrauterine contraception inserted.
Table: Incidence of perforation per 1,000 insertions for the entire study cohort (IUS and IUD), stratified by lactation and time since delivery at insertion
|Lactating at time of insertion||Not lactating at time of insertion|
|Insertion ≤36 weeks after delivery||5.6 (95% CI 3.9-7.9; n=6047 insertions)||1.7 (95% CI 0.8-3.1; n=5927 insertions)|
|Insertion >36 weeks after delivery||1.6 (95% CI 0.0-9.1; n=608 insertions)||0.7 (95% CI 0.5-1.1; n=41,910 insertions)|
CI: confidence interval, IUS: levonorgestrel-releasing intrauterine system, IUD: copper intrauterine device, n: number
Benefits still outweigh the risk
The benefits of intrauterine contraception still strongly outweigh the rare risk of perforation for most women, including those who are lactating or have recently given birth. Therefore we have not put in place any new restrictions on use of intrauterine contraception based on the study findings. The summaries of product characteristics and patient information leaflets have been updated with the information in this article.
Letter sent to healthcare professionals in June 2015
Article citation: Drug Safety Update volume 8 issue 11 June 2015: 3.
Heinemann K and others. ‘Risk of uterine perforation with levonorgestrel-releasing and copper intrauterine devices in the European Active Surveillance Study on Intrauterine Devices’ Contraception 2015: Volume 91, Issue 4, pages 274–279 (viewed on 25 June 2015) ↩
Published: 26 June 2015
Therapeutic area: Obstetrics, gynaecology and fertility