The Mirena intrauterine device (IUD) is a contraceptive device inserted into the uterus. It contains time-release hormones, and it is typically intended to be used for five years. Mirena IUDs are frequently used to prevent pregnancy, but they may also be inserted for other uses, such as to control heavy bleeding or other problems associated with the menstrual cycle.
Manufactured by Bayer Pharmaceuticals, the Mirena IUD has been available for several years – but reports of serious injuries caused by or linked to Mirena use have been growing. If you’re among those who have been injured while using Mirena, you have certain legal rights. The Mirena IUD injury lawyers at Farah & Farah can help you understand and protect those rights.
According to the U.S. Food and Drug Administration (FDA), over 45,000 reports of serious complications and side effects have been logged since Mirena was approved by the agency in 2000. Many of the problems associated with Mirena use can cause serious and permanent injury, and some may be life-threatening in some patients.
Commonly-reported Mirena-related injuries include:
- Migration of the IUD outside the uterus, which may include perforation of the uterine wall and/or damage to the uterus, other organs, or tissues;
- Embedding of the IUD in the uterus or other organs;
- Erosion of adjacent structures or their tissues, including erosion of the vaginal walls;
- Abscesses, infections, and inflammatory diseases;
- Intestinal obstructions;
- Excessive bleeding; and
- Intrauterine pregnancy, in which pregnancy occurs while the IUD is still in the uterus.
Many of these complications may require one or more surgeries to correct. Even after surgery, symptoms like pain and scarring may linger. If an intrauterine pregnancy occurs, the developing baby may be at risk for serious birth defects.
Were Mirena’s Benefits Exaggerated?
The FDA has taken Bayer Pharmaceuticals to task over concerns that the company exaggerated the benefits of its Mirena IUD. In 2009, the FDA sent a warning letter to Bayer, stating that the company’s “Mirena Simple Style Statements Program” “overstates the efficacy of Mirena, presents unsubstantiated claims, minimizes the risks of using Mirena, and includes false or misleading presentations regarding Mirena.” As a result, the FDA declared that the program “misbranded” Mirena in violation of FDA regulations.
Specific concerns the FDA investigated regarding misbranding included the below:
- Claims that Mirena would lead to increased confidence and increased sexual intimacy for its users, which have not been substantiated. In fact, studies have found that use of Mirena decreases libido in about 5 percent of users.
- Claims that Mirena would make its users look and feel better, which overlooked evidence that side effects like acne, bloating, and breast pain were well-known.
- Claims that Mirena users would not need follow-up visits once the device was inserted, which contradicted the device’s labeling requirements.
Many patients chose Mirena over other contraceptive products because of claims like these, only to find that the claims did not hold up. In some cases, Mirena users not only failed to experience the exaggerated results, but actually suffered serious harm as a result of using the device.
Mirena IUD Liability Attorneys Seeking Compensation for Clients
At Farah & Farah, our defective medical device attorneys believe every person who has been injured by a medical device like Mirena deserves legal representation. We strive to build the best possible cases for each of our clients in the pursuit of justice. To learn more about your legal options and our services, contact us at 855-797-9899.