FDA Approves First New Intrauterine Device in 12 Years

January 10, 2013 — FDA on Wednesday approved Bayer AG's Skyla intrauterine device, the first new IUD in the U.S. in 12 years, Reuters/Huffington Post reports.

Skyla is a T-shaped polyethylene device that releases a low, decreasing dosage of progestin to prevent pregnancy for up to three years. During a trial, the pregnancy rate among 1,432 women ages 18 through 35 was 0.9 pregnancies per 100 women over a three-year period. Additionally, 77% of women who wanted to become pregnant after the device was removed conceived within one year.

Bayer also manufactures Mirena, one of two IUDs already available in the U.S. Skyla will launch next month and be aimed at younger women who have not yet had children, whereas Mirena is targeted toward women who already have children.

According to a recent study by the Guttmacher Institute, 7.7% of women used long-acting reversible contraceptives, such as IUDs, in 2009, up from 2.0% in 2002. Women most likely to use LARCs were those ages 25 through 39 who had already had one child (Reuters/Huffington Post, 1/9).