Migration Risks of Mirena IUD Raise Safety Concerns about the Contraceptive Device
While intrauterine devices fell out of favor after the Dalkon shield debacle several decades ago, the Mirena intrauterine device, which is manufactured by Bayer Healthcare Pharmaceuticals, revived the popularity of IUDs with appealing marketing campaigns that offered increased intimacy and convenience.
Approximately two million women in the U.S. use the Mirena IUD, but there are now lawsuits pending across the country that indicate that the Mirena IUD may cause serious injuries, including the risk of perforation caused by spontaneous post-implantation migration of the IUD contraceptive device.
The Mirena IUD, which was approved for use by the FDA in 2000, is a T-shaped plastic device that slowly releases levongorgestrel hormone. Bayer marketed the device based on the notion that it provided no fuss birth control because it could be implanted and remain effective for five years. However, lawsuits are being filed around the country by women who have suffered serious injury or needed to have the device surgically removed.
There were more than 47,000 adverse incident reports to the FDA between 2004 and 2013, involving a range of complications and injuries, such as "device expulsion, device dislocation and vaginal hemorrhage" according to an FDA report. Many of those who have suffered injury caused by the Mirena IUD system experienced perforation of the uterus or other organs when the device migrated. Some women have suffered injuries so severe that they have had to receive hysterectomies. The rate of complications is 1 in 1,000 which is extremely high for a medical device.
There are a wide range of injuries that have been associated with the use of the Mirena IUD, which include the following:
- Implantation of the device in the uterine wall
- Migration to the abdominal cavity
- Infertility risk
- Perforation or penetration of the uterus, intestines or other organs
- Pelvic inflammatory disease
- Intense pain
- Intrauterine pregnancy
The Mirena contraceptive device was marketed by Bayer as a way for "busy moms" to simplify their lives. Bayer created a direct marketing program that involved a social networking site called Mom Central. Members of the site would host parties where a representative promoting the product would inform attendees that the Mirena IUD device would promote reconnecting with their partners and make them "look and feel great." This marketing campaign elicited a warning letter from the FDA in December of 2009, which indicated that Bayer's representations that the product would improve romance, intimacy and emotional fulfillment in users' relationships exaggerated the effectiveness of the device. The warning letter from the FDA also warned that this marketing campaign omitted mention of the potential adverse effects associated with use of the Mirena IUD.
If you or someone you love has been injured by the Mirena IUD device, our Georgia personal injury attorneys are currently reviewing claims against Bayer for injuries caused by the Mirena IUD contraceptive system.
Montlick and Associates is available to provide effective legal representation to clients throughout all of Georgia and the Southeast, including but not limited to Albany, Athens, Atlanta, Augusta, Columbus, Gainesville, Macon, Marietta, Rome, Roswell, Savannah, Smyrna, Valdosta, Warner Robins and all smaller cities and rural areas in the state. No matter where you are located our attorneys are just a phone call away, and we will even come to you.
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