Records obtained from the U.S. Food and Drug Administration (FDA) reveal tens of thousands of injury reports tied to use of the Mirena intrauterine device (IUD). The Mirena IUD is manufactured and marketed by Bayer Healthcare Pharmaceuticals
The investigation, conducted by NewsChannel5 investigators, found that 70,072 complaints have been filed over the Mirena IUD since 2000, according to complaint records investigators obtained from the federal regulator, Scripps Media Inc. reported. About 2 million women use the Mirena.
Many of the complaints concerned serious complications. Since 2008, 4,775 women reported that they allegedly suffered from “device dislocation,” which may involve the Mirena embedding in the uterus out of its original placement, which is at the top of the cervix; device location could also involve the Mirena moving outside of the uterus, an FDA spokesperson explained to Scripps Media. A total of 1,322 women reported suffering from uterine perforations since 2008.
At least 100 lawsuits have been filed in New Jersey against Bayer Healthcare Pharmaceuticals and another 50 lawsuits have been filed in federal court, and many more are expected, noted Scripps Media. Most litigation alleges that Bayer neglects to warn physicians and patients about the risks associated with the Mirena.
Lawsuits allege severe pain, uterine perforation, and the Mirena migrating to other areas of the body. Allegations include, for instance, one woman having had suffered liver lacerations; another underwent appendectomy and hysterectomy, as well as stomach tissue removal; and another said the Mirena ended up in her rib cage, according to Scripps Media. Surgery is almost always required when the Mirena migrates.
Some lawsuits also allege that Bayer has a history of misrepresenting Mirena. In 2009, the Department of Health and Human Services’ Division of Drug Marketing, Advertising, and Communications (DDMAC) contacted Bayer over its having made unsubstantiated claims about Mirena while failing to mention its risks in Bayer’s “Simple Style” program. The DDMAC criticized Bayer for a number of statements, including the assertion that Mirena helps women “look and feel great.”
Approved in 2000, Bayer’s Mirena IUD is a contraceptive meant to prevent pregnancy for up to five years. A small, plastic device attached to two strings, the Mirena is placed inside the uterus by a healthcare professional, where it releases the hormone levonorgestrel for up to five years.
An October 2009 FDA press release indicates that the most serious side effects associated with the Mirena IUD include:
- Perforation of the uterine wall
- Embedment of the device in the uterine wall
- Intrauterine pregnancy
- Ectopic pregnancy
- Group A streptococcal sepsis
- Pelvic inflammatory disease (PID)
