update RLG Cautiously Monitors Developments with Bayer’s New Skyla IUD, the First FDA-Approved IUD in 12 years

The U.S. Food and Drug Administration approved the new Bayer Skyla hormonal intrauterine device (IUD), the first such move since it approved Bayer’s similar Mirena hormonal IUD 12 years ago, according to a Reuters report. Given Mirena IUD lawsuits and the side effects demonstrated since Mirena’s release, the Rottenstein Law Group will monitor the Skyla IUD developments cautiously.

“The devices’ similarities are a concern,” said Rochelle Rottenstein, principal of RLG, “especially when considering Mirena’s FDA drug label.”

Unlike the Mirena IUD, which was marketed as a device for women who have already had children, the Skyla is marketed at young women who have not had children, according to the Reuters article. The other difference is that Skyla is designed for a three-year lifespan, whereas the Mirena was designed for five years of constant hormone emission.

Still, the similarities are enough to give RLG pause. Both Bayer IUDs are plastic devices that are inserted into the uterus to provide a low but local dose of a hormone designed to make the uterus inhospitable to fertilization. Both have a similar T-shape, as well. The Mirena IUD was known to cause serious side effects, including perforation of the uterine wall, migration of the device outside of the uterus and infertility, according to the FDA drug label.

Bayer is currently a defendant in several lawsuits (Case No. MRS-L-924-12 et al) in New Jersey Supreme Court over its Mirena IUD. Most recently, the state’s Supreme Court denied the pharmaceutical maker’s request to combine Mirena IUD lawsuits into a single “multicounty litigation” in Middlesex County, according to a Jan. 8 notice from Glenn A. Grant, acting administrative director of the New Jersey Supreme Court.


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