Bayer's extended use IUD nets FDA go-ahead
Bayer's hormone-releasing IUD Skyla is set to become the first new device of its kind to hit the U.S. market in 12 years. After the FDA's recent approval, the device will be available by prescription in February.
As a drug delivery system, the 28 mm x 30 mm T-shaped intrauterine device is designed to release small amounts of the progestin hormone levonorgestrel into the blood. The 99%-effective birth control method may be implanted in the uterus for up to three years.
In a New England Journal of Medicine study last year, IUDs and contraceptive implants demonstrated a much lower unwanted pregnancy rate than pills, patches and vaginal rings.
Bayer touts the new device as a means to address the high number of unwanted pregnancies in the U.S. by providing a birth control option that doesn't need to be taken daily, increasing patient compliance. It may also be used by women regardless of whether they have already had a child, the company said.
In addition to a rise in popularity and their effectiveness as contraception, hormone-releasing IUDs may also work as a cost-effective treatment for endometrial cancer, which affects the lining of the womb. Women who were high-risk for the surgical treatment of this type of cancer responded well to the placement of an IUD, a study found last year, which reversed abnormal cell growth in the uterine wall.
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