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FDA OKs 3-Year Birth Control System

Hormone birth control works for 3 years

UPI Health News (Business) - Jan. 09, 2013
U.S. Food and Drug Administration officials said it approved Skyla a hormone-releasing system in the uterus that prevents pregnancy for up to three years.

Dr. Anita L. Nelson, a professor of obstetrics and gynecology at Harbor-UCLA Medical Center in Torrance, Calif., said Skyla is a small, flexible plastic T-shaped device by Bayer HealthCare Pharmaceuticals, a Montville, N.J., subsidiary of the German pharmaceutical giant Bayer, that contains 13.5 milligrams of a progestin hormone levonorgestrel.

Because Skyla slowly releases levonorgestrel into the uterus, only small amounts of the hormone enter the blood. During the first three to six months of using Skyla, women might experience irregular periods and an increase in the number of bleeding days.

Nelson said women might also have frequent spotting or light bleeding, while some women might have heavy bleeding. After using Skyla for a while, the number of bleeding and spotting days is likely to lessen.

"Research shows that nearly 50 percent of U.S. pregnancies are unintended, which emphasizes the need for increased education and access to effective birth control options," Nelson said in a statement.

"Skyla is more than 99 percent effective at preventing pregnancy and might be appropriate for women who want a birth control method that they do not have to take daily."

Women can have Skyla placed by a healthcare provider during an in-office visit for up to three years but may be removed by a healthcare provider at any time, Nelson said.

Skyla -- levonorgestrel-releasing intrauterine system -- will be available by prescription the week of Feb. 11, Bayer officials said.


Posted: January 2013