Real life study of ease of insertion of Levosert, a branded LNG-IUS 52mg
ESC Congress Library. Briggs P. May 10, 2018; 208186; ESC291
Dr. Paula Briggs
Dr. Paula Briggs
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Abstract
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Objective: This is a proof of concept study observing ease of insertion of Levosert, a recently introduced branded Levonorgestrel intrauterine system 52 mg. Levosert is licensed to provide both contraception (3 years) and management of heavy menstrual bleeding. The acquisition cost in the UK is lower than other intrauterine systems. Registration studies demonstrate equivalent effects to Mirena (LNG-IUS 52 mg). The introducer is a two handed device, very similar to a Nova T Cu IUD. Settings/Subjects:103 insertions were monitored in both a community sexual health clinic and a pregnancy advisory service over a 10 month period (Nov 2016 - Sep 2017). 99% of insertions were were successful with 98% being described as easy. The age range of women included was 17- 47 (average age 34.4). Parity ranged from 0-7, with 12.4 % of women being nulliparous.  Outcome: The blue flange was observed to slip in 3/103 insertions, but there was no associated adverse effect noted, possibly reflecting the reduced risk of perforation. All insertions were performed under ultrasound guidance and 2 devices were noted to have a suboptimal position post insertion. One of the affected patients returned for follow up scan, demonstrating fundal migration. The other patient did not return for follow up. Familiarity with the most familiar IUS (Mirena) should not restrict access to newer options which are less expensive and have addition potential benefits. NICE states that the average length of use of an IUS is just under 3.5 years, making Levosert an attractive choice for many women and service providers. A more formal Post authorisation safety (PASS) study is currently underway. Reasons for removal of Levosert will be monitored within the limitations associated with a real life setting.
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