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Uterine perforation with the levonorgestrel-releasing intrauterine device: analysis of reports from four national pharmacovigilance centres.
Drug Saf. 2011 Jan 01; 34(1):83-8.DS

Abstract

BACKGROUND

Levonorgestrel-releasing intrauterine devices (LNG-IUD) are commonly used for contraception and other indications in many countries. National pharmacovigilance centres have been receiving reports from healthcare professionals and patients of uterine perforation associated with the use of these LNG-IUDs.

METHODS

National pharmacovigilance centres in the Netherlands, New Zealand, Switzerland and Germany did a search on their adverse drug reaction databases for reports of cases of uterine perforation after insertion of a LNG-IUD received between the introduction of the LNG-IUD onto the market in the late 1990s and 15 July 2007. The number of women affected and patient characteristics such as age, parity and breastfeeding status were examined. In addition, the method of detection of the perforation and the time until discovery of the perforation were analysed.

RESULTS

Between the introduction of the LNG-IUD onto the market in each country and 15 July 2007, 701 cases of uterine perforation with a LNG-IUD were reported; 8.5% of the perforations were detected at the time of insertion. Abdominal pain and control/check-up visits were the most common events that lead to the detection of a perforation. Of 462 women known to be parous, 192 (42%) were breastfeeding at the time the perforation was discovered.

CONCLUSIONS

Uterine perforations can be asymptomatic and may remain undetected for a long time after IUD insertion. Abdominal pain, control/check-up visits or changes in bleeding patterns are triggers for detection of perforation and should therefore be taken seriously.

Authors+Show Affiliations

Netherlands Pharmacovigilance Centre Lareb, s-Hertogenbosch, the Netherlands. ac.vangrootheest@lareb.nlNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article

Language

eng

PubMed ID

21142273

Citation

van Grootheest, Kees, et al. "Uterine Perforation With the Levonorgestrel-releasing Intrauterine Device: Analysis of Reports From Four National Pharmacovigilance Centres." Drug Safety, vol. 34, no. 1, 2011, pp. 83-8.
van Grootheest K, Sachs B, Harrison-Woolrych M, et al. Uterine perforation with the levonorgestrel-releasing intrauterine device: analysis of reports from four national pharmacovigilance centres. Drug Saf. 2011;34(1):83-8.
van Grootheest, K., Sachs, B., Harrison-Woolrych, M., Caduff-Janosa, P., & van Puijenbroek, E. (2011). Uterine perforation with the levonorgestrel-releasing intrauterine device: analysis of reports from four national pharmacovigilance centres. Drug Safety, 34(1), 83-8. https://doi.org/10.2165/11585050-000000000-00000
van Grootheest K, et al. Uterine Perforation With the Levonorgestrel-releasing Intrauterine Device: Analysis of Reports From Four National Pharmacovigilance Centres. Drug Saf. 2011 Jan 1;34(1):83-8. PubMed PMID: 21142273.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Uterine perforation with the levonorgestrel-releasing intrauterine device: analysis of reports from four national pharmacovigilance centres. AU - van Grootheest,Kees, AU - Sachs,Bernhardt, AU - Harrison-Woolrych,Mira, AU - Caduff-Janosa,Pia, AU - van Puijenbroek,Eugène, PY - 2010/12/15/entrez PY - 2010/12/15/pubmed PY - 2011/3/17/medline SP - 83 EP - 8 JF - Drug safety JO - Drug Saf VL - 34 IS - 1 N2 - BACKGROUND: Levonorgestrel-releasing intrauterine devices (LNG-IUD) are commonly used for contraception and other indications in many countries. National pharmacovigilance centres have been receiving reports from healthcare professionals and patients of uterine perforation associated with the use of these LNG-IUDs. METHODS: National pharmacovigilance centres in the Netherlands, New Zealand, Switzerland and Germany did a search on their adverse drug reaction databases for reports of cases of uterine perforation after insertion of a LNG-IUD received between the introduction of the LNG-IUD onto the market in the late 1990s and 15 July 2007. The number of women affected and patient characteristics such as age, parity and breastfeeding status were examined. In addition, the method of detection of the perforation and the time until discovery of the perforation were analysed. RESULTS: Between the introduction of the LNG-IUD onto the market in each country and 15 July 2007, 701 cases of uterine perforation with a LNG-IUD were reported; 8.5% of the perforations were detected at the time of insertion. Abdominal pain and control/check-up visits were the most common events that lead to the detection of a perforation. Of 462 women known to be parous, 192 (42%) were breastfeeding at the time the perforation was discovered. CONCLUSIONS: Uterine perforations can be asymptomatic and may remain undetected for a long time after IUD insertion. Abdominal pain, control/check-up visits or changes in bleeding patterns are triggers for detection of perforation and should therefore be taken seriously. SN - 1179-1942 UR - https://www.unboundmedicine.com/medline/citation/21142273/Uterine_perforation_with_the_levonorgestrel_releasing_intrauterine_device:_analysis_of_reports_from_four_national_pharmacovigilance_centres_ L2 - https://dx.doi.org/10.2165/11585050-000000000-00000 DB - PRIME DP - Unbound Medicine ER -