Gynecological endocrinology : the official journal of the International Society of Gynecological Endocrinology · 2010
Review of clinical experience with the frameless LNG-IUS for contraception and treatment of heavy menstrual bleeding.
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Wildemeersch Dirk, Andrade A
Аннотация
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.
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.