Since its’ introduction in 2000, there have been noted Mirena complications by women who have used this form of birth control. The device is T-shaped and is inserted into the uterus to prevent pregnancy. Ovulation does not occur with this process. A patient can use this device for up to five years. After five years, the device is not as effective and must be removed by a physician. In recent years, the Food and Drug Administration, FDA, has approved its use for women who experience heavy menstrual cycles. Healthcare providers also only recommend this IUD, or intrauterine device, for patients who have had at least one child. Various patients, however, have had a host of issues and side effects when using this particular IUD. It is important to understand how this birth control works and the issues that may arise from its use.
From the time of this IUD’s initial release, there have been issues noted by patients. Some have been mild while others have been much more serious. There have been approximately 59,000 complaints made to the FDA since 2004. The list of Mirena complications includes the following:
- Uterine perforations
- Ovarian cysts
- Higher risk of ectopic pregnancy
- Vaginal hemorrhage
- Device expulsion and dislocation
- Pelvic inflammatory disease
- Chronic pelvic pain
Some other lesser side effects experienced include dizziness, headaches, nausea, and changes in the menstrual cycle. Doctors have diagnosed some of the above more serious complications as being related to this particular IUD. Due to the number and frequency of issues with this product, many patients have filed lawsuits against the maker of this product, Bayer Pharmaceuticals. There are over 200 cases right now in federal and state courts. Currently, there have been approximately 45,000 separate adverse events reported to the FDA. In addition to the Mirena complications listed above, plaintiffs have asserted that the maker of this product has deliberately sold a dangerous product, and concealed or downplayed many of the issues that have arisen. Other complaints against the manufacturer include the following:
- Benefit misrepresentation
- Failure to warn about spontaneous migration of device
- Listing the serious reactions as uncommon when statistics prove otherwise
- Adequate warnings and instructions omitted
- Designed and knowingly sold a defective product
Claimants are often filing suit to obtain compensation for pain and suffering and medical expenses. Mirena complications can lead to very expensive doctor bills for the patient. Lawsuits have been filed across the United States. In 2009, the FDA warned Bayer that the company issued false or misleading representations of the product.
When beginning any birth control, it is important to discuss all questions and concerns with the healthcare provider. While this type of IUD may work for some, many others have had numerous issues. It is vital to weigh both the pros and cons. Mirena can cause serious issues in some people, and it is critical to have all the facts up front.