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What is Mirena
Mirena is a hormonal intrauterine device (IUD) that is used as a form of birth control manufactured by Bayer Healthcare Pharmaceuticals, Inc. The IUD is a flexible, soft T-shaped piece of plastic that contains the hormone levonorgestrel. Mirena is a long-acting reversible contraceptive said to last up to 5 years. Mirena prevents pregnancy by releasing the hormone progestin (levonorgestrel) which prevents sperm from entering the uterus by thickening the cervical mucous. It also thins the lining of the uterus which decreases the chances that a fertilized egg will implant and grow. The device needs to be inserted and removed by a qualified medical professional and is desgnedto release 20 micrograms of the hormone levonorgestrelt he per day, eventually decreeasing the dose to 14 micrograms after 5 years.
Dangerous Side Effects Experienced After Mirena Implantation
Some women have experienced serious adverse side-effects and potentially life-threatening complications following the implantation of the Mirena device, including:
Most Serious Complications
- Perforation of the Uterine Wall
- Perforation of the intestine
- Obstruction of the intestine
- Erosion of the IUD into the uterus or embedment into the adjecent area
- Migration of the IUD to Outside the Uterus
- Complications that Result in Surgery to Remove Mirena IUD
Less Serious Complications
- Expulsion of the Mirena IUD
- Pelvic inflammatory disease
- Ectopic pregnancy
Perforation of the uterus is one of the most serious complications and in many cases has to be removed or repaired surgically. If the IUD perforates the uterus it can travel into the abdominal cavity and cause potentially life-threatening complications such as intestinal obstruction, organ damage and infection/sepsis.
If you, or someone you love, experienced any of the serious complications after implanation of Mirena and would like the attorneys at Nolan Law Group to review your case, please contact us.
FDA Birth Control Warnings
Mirena was approved by the Food and Drug Administration (FDA) in 2000 and is recommended to women who have had at least one child. Mirena was also FDA-approved in 2009 to treat heavy menstrual bleeding in women who prefer intrauterine contraception as their method of birth control, the first time that the FDA has approved an intrauterine device for this purpose.
Bayer is the subject of numerous lawsuits across the United States alleging Bayer failed to adequately warn women of the risks of the Mirena IUD. Bayer has received two warning letters from the U.S. Food and Drug Administration (FDA) alleging Bayer failed to adequately relay risk information about Mirena to potential users.
In December 2009, the FDA sent Bayer a warning letter regarding a Bayer marketing program for Mirena called “Mom Central.” The direct marketing program centered around “Mirena parties” that took place in the consumer’s home or other private setting. The parties were hosted by Mirena experts who followed a script developed by Bayer, that made several misleading representations about Mirena. These Mirena experts would claim that Mirena could help a women “look and feel great” and could improve the recipient’s sex life, among other misleading statements. The FDA noted, “The program overstates the efficacy of Mirena, presents unsubstantiated claims, minimizes the risks of using Mirena and includes false or misleading statements regarding Mirena.”
Earlier in 2009, Bayer received a warning letter from the FDA regarding other forms of Mirena marketing that were misleading because they make representations about the efficacy of Mirena but failed to communicate any risk information.
If you, or someone you love, have been injured using Mirena, and would like the attorneys at Nolan Law Group to review your case, please contact us.
If you or someone you love have experienced serious side effects after using Mirena, you have the right to file a legal claim. Our attorneys can help you determine if you have a case and how to file a claim. All claims are handled on a contingency fee basis, meaning you do not have to pay attorney fees unless you are awarded compensation.
If you would like the attorneys at Nolan Law Group to review your case, please contact us.