Bayer HealthCare Pharmaceuticals has announced the US Food and Drug Administration (FDA) approval of a new inserter for Mirena.
Bayer now offers the same inserter design and technique for both Mirena and Skyla (levonorgestrel-releasing intrauterine system) 13.5mg.
The Bayer Inserter for Skyla and Mirena features a thin, flexible insertion tube. The inserter is preloaded with a small, rounded flexible T-body and enables single-handed loading. The diameter of the insertion tube for Skyla is 3.8mm and 4.4mm for Mirena.
Bayer US Medical Affairs for Women’s Healthcare vice president Edio Zampaglione said that as a leading women’s healthcare company, it is dedicated to providing innovative options for healthcare providers and their patients.
"The launch of the Bayer Inserter for Mirena demonstrates our commitment to one of the leading contraceptive options available in the US," Zampaglione added.
Skyla is indicated for the prevention of pregnancy for up to three years. Skyla should be replaced after three years if continued use is desired.
Mirena is indicated for intrauterine contraception for up to five years. Mirena is also indicated to treat heavy menstrual bleeding in women who choose to use intrauterine contraception as their method of contraception. Mirena is recommended for women who have had a child. Mirena should be replaced after five years if continued use is desired.