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Allergan and Medicines360 have just launched a single-handed inserter for their Liletta levonorgestrel-releasing intrauterine device (IUD), which can prevent pregnancy up to 3 years.
Allergan and Medicines360 have just launched a single-handed inserter for their Liletta levonorgestrel-releasing intrauterine device (IUD), which can prevent pregnancy up to 3 years.
The inserter received FDA approval in January 2016 based on data from the ACCESS IUS trial, which demonstrated that the product was safe and effective in a broad range of women, with a 99.2% success rate for insertions. The product succeeds the IUD’s 2-handed inserter, which was approved in February 2015.
“We…anticipate that the single-handed process may lead to broader use by health care providers, thereby increasing the number of women who have access to this effective contraceptive,” stated Jessica Grossman, MD, CEO of Medicines360, in a press release.
Dr. Grossman further explained that the inserter includes:
One of the most common adverse effects associated with Liletta is irregular bleeding. Some women may experience short or lighter periods after 3 to 6 months of use, though their menstrual cycles may feature irregular or heavy bleeding before this time.
Women who receive Liletta may also experience perforation during insertion, which may reduce the product’s efficacy. In the event that pregnancy occurs, the IUD should be removed.