Many women seeking a long-term birth control solution have turned to the Mirena IUD. The small, T-shaped plastic device is placed in the uterus where it releases the hormone Levonorgestrel to prevent pregnancy. Since receiving approval from the Food and Drug Administration (FDA) in 2000, Mirena has proven popular among both women and doctors. Designed to last up to five years, IUDs require less maintenance than condoms and birth control pills and can be removed at any time. However, like most birth control methods, potential complications exist. Injuries linked to Mirena complications have led to lawsuits and government warnings.
Some women have experienced problems with their Mirena IUD. The device can pierce (perforate) the uterine wall or cervix, migrate from the uterus to other parts of the body, cause pelvic inflammatory disease, and lead to infections. Other complications include headaches, breast tenderness, irregular menstrual bleeding, pelvic pain, ovarian cysts, and vaginitis. These injuries can lead to pain, excessive bleeding, and potential problems in other areas of the body. Some risk of pregnancy exists as well. A fertilized egg may implant outside the uterus, a potentially dangerous situation known as an ectopic pregnancy. Failure of the device may also lead to normal pregnancy inside the uterus, called intrauterine pregnancy.
Mirena complications generally require removal of the device. This can lead to additional medical costs, time off work, and pain and suffering. More serious cases, including those in which the Mirena IUD migrates from the uterus, can require surgery to remove the device and treatment for the damaged internal organs.
Government Warning and Lawsuits
Mirena IUD's problems have not gone unnoticed by the government. In December 2009, the Food and Drug Administration issued a warning letter to the maker of Mirena, Bayer Healthcare Pharmaceuticals. The letter alleged that Bayer's promotional materials had overstated Mirena's effectiveness at rekindling intimacy, minimized or omitted risks of infections and pregnancies, and falsely claimed that using Mirena involves no monthly routines. The FDA requested Bayer stop using the inaccurate promotional materials.
In addition, a number of lawsuits have been brought by women suffering from Mirena complications. Companies that make and manufacture consumer products that injure people may be potentially liable under product liability law. The law generally requires that products meet the ordinary expectations of consumers. Products that are defectively designed, manufactured, or marketed violate this rule. Many of the lawsuits focus on Bayer's promotional materials that led to the FDA's warning letter.
In addition to the makers of the IUD, doctors and medical professionals can also be sued for certain injuries caused by Mirena complications. For example, a doctor who improperly implants an IUD into a patient or fails to discuss the possible risks involved with the procedure can be sued for medical malpractice. The law requires doctors to avoid negligent acts or omissions that can lead to a patient injury.
Continued Use of Mirena IUD
Despite lawsuits and FDA warning letters, the Mirena IUD has not yet been recalled. More and more women use IUDs each year, and the Mirena IUD is still a popular choice. In addition, most medical professionals continue to stand by IUDs as an effective form of birth control. However, women who experience Mirena complications may want to consult with an attorney to learn more about their legal options.
Discuss Your Mirena Claims with an Experienced Attorney
Many women have turned to the legal system after being harmed by Mirena. If you think you might have been injured by your use of the IUD, you may want to discuss the facts of your situation with a legal professional. Get in contact with an attorney with experience with drug and medical device cases who can help you understand all your options and protect your legal rights.
Contact a qualified product liability attorney to make sure your rights are protected.