A Massachusetts woman is suing Bayer AG claiming the company’s Mirena intrauterine device (IUD) moved within her body resulting in an unintended pregnancy, and caused her to undergo painful surgeries.
The Mirena IUD is a T-shaped device that is implanted in the cervix to prevent pregnancy for up to five years. Plaintiff Jessica Fountaine alleges she had a Mirena IUD implanted in 2009, but a year later she became pregnant. She had an abortion during which the doctor did not see the device and believed it had fallen out.
In 2011, Fountaine had a second Mirena IUD implanted, but after suffering abdominal pain she returned to the doctor who discovered she had two IUDs in her body. The original IUD had not fallen out, as assumed, but had migrated from its intended position within her body.
Fountaine filed a lawsuit against Bayer claiming she was mislead by the drug company, which had advertised the contraceptive as being a safe and effective form of birth control. According to her complaint, “the defendants’ labeling failed to adequately warn consumers and prescribers of, among other things, the risk of embedment and migration of the Mirena post-insertion, uterine perforation post-insertion, surgical removal, or the possibility that device complications such as migration and perforation may cause abscesses, infections, require surgery for removal and/or may necessitate hysterectomy, oophorectomy (ovary removal) and other complications.”
Two years ago, the New Jersey Supreme Court consolidated lawsuits alleging injuries with the Mirena IUD and that Bayer had downplayed potential side effects and failed to warn consumers that the IUD could migrate outside the uterus and perforate other organs and tissues.
Source: Law 360