Bayer HealthCare gets FDA approval for new inserter for Mirena 52mg

3 June 2014 (Last Updated June 3rd, 2014 18:30)

Bayer HealthCare Pharmaceuticals has received approval from the US Food and Drug Administration (FDA) for a new inserter for Mirena.

Bayer Inserter

Bayer HealthCare Pharmaceuticals has received approval from the US Food and Drug Administration (FDA) for a new inserter for Mirena.

The company now provides the same inserter design and technique for both Mirena and Skyla (levonorgestrel-releasing intrauterine system) 13.5mg.

The new inserter for Skyla and Mirena features a thin, flexible insertion tube and it 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's US medical affairs for women's healthcare vice-president Edio Zampaglione said: "The launch of the Bayer Inserter for Mirena demonstrates our commitment to one of the leading contraceptive options available in the US."

Skyla 13.5mg is indicated for the prevention of pregnancy for up to three years, and should be replaced after three years if continued use is required.

Mirena 52mg is indicated for intrauterine contraception for up to five years, as well as to treat heavy menstrual bleeding in women who choose to use intrauterine contraception as their method of contraception.

The intrauterine device (IUD) is recommended for women who have had a child and should be replaced after five years if there is a need to continue use.

"Skyla 13.5mg is indicated for the prevention of pregnancy for up to three years, and should be replaced after three years if continued use is required."

According to the company, use of Skyla or Mirena is used for women with conditions that include known or suspected pregnancy and cannot be used for post-coital contraception, as well as congenital or acquired uterine anomaly, including fibroids if they distort the uterine cavity. In addition, they can be used for women with known or suspected breast cancer or other progestin-sensitive cancer, now or in the past; known or suspected uterine or cervical neoplasia; liver disease, including tumours.

It also cannot be used by women with untreated acute cervicitis or vaginitis, including lower genital tract infections until infection is controlled; postpartum endometritis or infected abortion in the past three months; unexplained uterine bleeding; current IUD; acute pelvic inflammatory disease (PID) or history of PID; conditions increasing susceptibility to pelvic infection; or hypersensitivity to any component of Skyla or Mirena.

The most common adverse reactions observed with Skyla were vulvovaginitis, abdominal/pelvic pain, acne/seborrhea, ovarian cyst, headache, dysmenorrhea, breast pain/discomfort, increased bleeding, and nausea.

While most regular adverse reactions seen in Mirena are uterine/vaginal bleeding alterations, amenorrhea, intermenstrual bleeding and spotting, abdominal/pelvic pain, ovarian cysts, headache/migraine, acne, depressed/altered mood, menorrhagia, breast tenderness/pain, vaginal discharge and IUD expulsion.


Image: New Bayer Inserter for Mirena and Skyla. Photo: courtesy of PRNewsFoto / Bayer HealthCare Pharmaceuticals.