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FDA approves Skyla, first new hormonal IUD since Mirena

The Food and Drug Administration has approved a new hormonal intrauterine device for sale in the U.S., the first product of its kind to be approved in more than 12 years. Known as Skyla, the new IUD provides contraception for up to three years by releasing the hormone progestin into the body after the device has been placed by a physician.

Skyla is the first hormonal IUD to be approved by the FDA since Mirena, which was approved by the agency in 2000. The use of IUDs such as Skyla and Mirena has become increasingly common in recent years. According to a 2012 study, about 8% of women currently use long-acting, reversible contraceptives such as a hormonal IUDs, up from just 2% seven years earlier.

The warning label for Skyla will alert patients that the IUD can increase their risk of a number of side effects, including changes in bleeding patterns, vulvovaginitis, abdominal pain or pelvic pain, acne, ovarian cysts, and headache.

The use of hormonal IUDs has also been associated with an increased risk of a number of more serious and potentially deadly side effects. According to warnings by U.S. and Canadian health officials, women who use Mirena may suffer uterine perforations or other side effects that could require surgical intervention. Women who become pregnant with Mirena may suffer an ectopic pregnancy, miscarriages, or other complications.