A new intrauterine device is being marketed in the United States with sexually active adolescents in mind. Skyla, made by Bayer Healthcare, is raising concerns among some experts not because it is geared toward younger women, but because some IUDs, especially the Mirena, also made by Bayer, have been associated with injuries, some of which have been serious.
Skyla is a new version of Bayer’s Mirena. Both deliver a steady dose of the hormone levonorgestrel, but Skyla is smaller than the Mirena, lasts up to three years as opposed to five years with Mirena, and contains less of the hormone than the Mirena IUD.
The chief concern is regarding safety. Bayer is facing hundreds of lawsuits alleging the company did not adequately warn of serious adverse events that can occur with its Mirena IUD.
About one or two of every IUD insertions results in the device migrating from where it was placed and puncturing the uterine wall. This can cause organ and tissue damage resulting in pain and hemorrhaging. In many cases surgery is required when this happens, and some women have had to have hysterectomies, rendering them forever sterile.
The reports are not rare, either. the Food and Drug Administration (FDA) MedWatch Adverse Event records reveal the agency has received more than 70,000 reports of complications associated with the device. About 6,000 of the complaints involve device dislocation or perforation. The latest court records also show that the number of lawsuits against the maker – Bayer – has jumped from 105 on July 10 to 123 on August 15.