Product News and Recalls

Another IUD approved for Bayer

Reuters reports on a recently approved intrauterine device from Bayer, which is the first new device of its type that the FDA has approved in 12 years.

According to the report, the new IUD is called Skyla. It’s a T-shaped polyethylene device that prevents pregnancy by releasing low doses of the hormone progestin.

Bayer manufactures another IUD available on the U.S. market called Mirena. But where Mirena is designed for use by women who have already had children, Skyla is aimed at younger women who have not had children.

Since its introduction, the Mirena IUD has generated some health concerns. A number of women have filed lawsuits claiming the company overstated the device’s benefits in its advertising while trying to conceal some potentially dangerous side effects.

Those side effects include the possibility that the device will embed itself in the uterine wall and move from its implantation site, causing organ perforation or scarring. In some cases, according to the lawsuits, surgery is necessary to remove it.

The story says that some side effects were reported for Skyla, including bleeding pattern alterations, vulvovaginitis, abdominal/pelvic pain, acne/seborrhea, ovarian cyst and headache.

But according to data submitted by Bayer, it proved effective for birth control in a clinical trial. Of 1,432 women aged 18 to 35 years, the rate of pregnancy over a three-year period was 0.9 per 100 women. And 77 percent of the women who wished to become pregnant were able to do so within 12 months of Skyla’s removal.

Reuters reports that an increasing number of women are using long-acting reversible contraceptive methods such as the intrauterine device — 7.7 percent in 2009 compared to 2.0 percent in 2002.

Patients should consult their doctors before making any changes in their medication. A consultation with a Mirena lawyer is also important if surgery was required from Mirena.

See the story here: