Mirena IUD: The FDA and Bayer Pharmaceuticals
In 2001, Bayer Pharmaceuticals introduced and promoted the Mirena Intrauterine Device (IUD) as a highly effective birth control method. Mirena is a flexible, plastic, T-shaped device inserted through the cervix and into the uterus by a healthcare professional. The IUD can remain in place for up to 5 years and prevents pregnancy by releasing a progestin hormone called levonorgestrel into the body. Bayer recommended Mirena to women who already had a child and were looking for a simple, hassle-free form of birth control. However, the company neglected to adequately warn device users of the dangerous side effects associated with its IUD product.
Bayer marketed Mirena as a birth control that would make users “look and feel great,” increase intimacy, and foster an improved sex life. In its advertisements, Bayer downplayed the product’s possible negative side effects. These negative side effects include uterine perforation, pelvic inflammatory disease, ectopic pregnancy, and intracranial hypertension. The ad campaign convinced over a million women to try Mirena, resulting in handsome profits for Bayer. Unfortunately, many of those women suffered from serious health complications after insertion of the device. The FDA received over 45,000 adverse event reports, causing a reevaluation of the IUD’s safety guidelines and warning labels.
The FDA characterized Bayer’s failure to list and explain Mirena’s dangerous side effects as “deceptive marketing.” As a result, they required Bayer to make major updates to the Mirena warning label. Several known side effects have now been added to the label, including the risk of pelvic infections and an increased risk of perforation. However, the risk of developing intracranial hypertension remains absent from the warnings. The FDA also criticized Bayer’s advertising methods, deeming them as “misleading.” The agency concluded that there is no evidence to suggest “that women using Mirena for birth control experience an increase in reconnection, romance, or intimacy with their partners.”
Bayer’s “deceptive” and “misleading” representations regarding Mirena have caused thousands of women to suffer serious injuries. By withholding the truth, Bayer’s sales increased while the health of many innocent women deteriorated. Our experienced lawyers fight for individuals who have been harmed by defective drugs and products. If you or someone you know has suffered because they used Mirena, call The Yost Legal Group at 1-800-YOST-LAW for a FREE, confidential consultation. At The Yost Legal Group, there is no fee or expense unless you recover.