Review of clinical experience with the frameless LNG-IUS for contraception and treatment of heavy menstrual bleeding

Abstract

Objective. Review the clinical experience with the frameless FibroPlant® levonorgestrel intrauterine system (FP-LNG-IUS).

Study design. An open, prospective non-comparative contraceptive 5-year study; a 1-year MBL study in women with heavy menstrual bleeding (HMB), using a PBAC and a 2-year MBL study in women with HMB and with normal menstruation using the quantitative alkaline hematin method. A literature review on perforation rate with the frameless GyneFix® and FibroPlant®.

Results. 304 insertions were performed with the FP-LNG-IUS. The total observation period was 11,299 woman-months. Only one pregnancy occurred. There were two expulsions and two uterine perforations at insertion during the first year. In the first 1-year MBL study, the median MBL decreased by more than 90%. In the second 2-year MBL study, MBL reduced drastically and 80% had amenorrhoea after 24 months. The ferritin values increased significantly. On a total of approximately 17,000 insertions, the perforation rate was between 1.2 and 2.0/1000 insertions.

Conclusion. The frameless FP-LNG-IUS is an effective and well-tolerated long-acting reversible contraceptive and is also highly effective for the treatment of HMB. The perforation rate is similar to traditional copper and levonorgestrel-releasing intrauterine devices and systems. Strict adherence to the manufacturer's insertion instructions is recommended.

Keywords:

• Hormonal contraception
• uterus
• endometrium
• LNG-IUS

Acknowledgements

We are grateful to Dr. Dirk Janssens, Turnhout, Belgium for his contribution to the FibroPlant contraceptive study. We also thank Miss. Bernadette De Vel for monitoring the contraceptive study.