FDA approves Bayer's new IUD

Kyleena--Courtesy of Bayer

Bayer, whose Essure device has been struggling for years with safety complaints and lawsuits, is introducing a new IUD. The FDA approved its new intrauterine system for the prevention of pregnancy for up for 5 years.

The Kyleena IUS contains 19.5 mg of the progestin hormone levonorgestrel. It is inserted by a healthcare provider and will be available by prescription next month, Bayer said in a statement Monday.

The device demonstrated its contraceptive efficacy in a randomized, open-label study conducted in 11 countries in Europe and the Americas, Bayer said in the statement. It enrolled 1,452 women, of whom 60% completed three years of the study, 49% chose to continue the study for up to 5 years and 38% used the device for 5 years. The most common adverse reactions were vulvovaginitis, ovarian cyst, abdominal or pelvic pain and headache or migraine, according to the statement.

Kyleena is Bayer’s third IUS. It markets two other levonorgestrel-releasing devices: Mirena, which is approved for up to 5 years of use, and Skyla, which is intended to be used for three years. Bayer also markets oral birth control medication.

Bayer acquired the troubled Essure birth control implant in its $1.1 billion acquisition of Conceptus in 2013. The device, placed through the cervix, comprises two flexible metal coils that create a barrier to the fallopian tubes to prevent pregnancy permanently. At the time, Bayer said the device would make up for slipping sales in the company’s birth control pills, which faced stiff competition from generics.

In May last year, the FDA announced it would review the safety and efficacy of Essure in response to more than 5,000 complaints about the device since its approval in 2002. The agency held an advisory meeting the following September, and in February this year slapped a black-box warning on the device.