Please note: the information on this page is provided for informational purposes only. As of 2014, Simmons Hanly Conroy is no longer accepting cases involving Mirena.
A form of birth control, Mirena is an intrauterine device (IUD) that contains progestogen and is placed by a healthcare professional into the uterus. In this location, it releases hormones that work to prevent the release of an egg from an ovary. Mirena acts as a long-term, hormonal contraceptive device. This nonpermanent device can typically last for up to five years. It can be removed by a medical professional.
Simmons Hanly Conroy pharmaceutical lawyers are currently investigating health complications associated with the use of Mirena. This birth control was marketed to busy moms because of its simplicity and hassle-free benefits. However in 2009, the FDA released a warning related to the misbranding of the drug and the downplaying of serious risks and complications in violation of the Federal Food, Drug and Cosmetic Act.
The warning letter from the FDA examines the promotional efforts of the manufacturer, Bayer, including its marketing actions. The direct marketing program partnered with social networking site Mom Central and consisted of house visits by members of Mom Central to prospective consumers.
Problems with the marketing plan involve the description of Mirena to women as a birth control that can make women “look and feel great”. This was declared as misbranding because no evidence exists that the birth control actually has these effects on women. The FDA also stated that the marketing program overstated the efficacy of Mirena, included false or misleading presentations regarding Mirena and failed to mention risks and serious complications associated with using the contraception device.
Health complications associated with Mirena use has been reported by more than five percent of its users. Many of these reports involve life-threatening health problems resulting from lack of awareness about possible risks associated with its use.
Health Complications and Mirena Lawsuits
Reported side effects among Mirena users have included:
- Intrauterine pregnancy (a pregnancy that occurs with the device still in the uterus)
- Ectopic pregnancy (a pregnancy that occurs outside the uterus)
- Pelvic inflammatory disease
- Group A streptococcal sepsis
- Embedding of the device into the uterine wall
- Perforation of the device into the uterine wall or cervix
- Ovarian cysts
- Pelvic pain
- Painful menstruation
- Severe headaches
A majority of the reports involving health complications from Mirena use involve the perforation of the uterine wall or cervix by the device. When this complication is not detected right away, it has the potential to lead to further health risks. Perforation has also occurred at the time of insertion without notice by the medical professional.
Since 2014, Simmons Hanly Conroy no longer accepts Mirena cases. Learn more about past litigation areas of the pharmaceutical lawyers at the firm or explore more information on our current areas of litigation. Please contact us with any questions.
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