Mirena IUD Attorneys
What is the Mirena IUD?
Mirena is a t-shaped plastic (polyethylene) intrauterine device (IUD) that is inserted directly into a woman’s uterus by her healthcare provider. Mirena also has strings attached to it that hang down from the plastic reservoir, which are supposed to provide easy retrieval and removal. Mirena is approved by the U.S. Food & Drug Administration for use for up to five years. Mirena is indicated for contraception and to treat heavy menstrual bleeding. It is recommended to women who have had at least one child.
Although Mirena has been inserted in an estimated 15 million women worldwide (2 million in the U.S.), Mirena’s manufacturer does not know exactly how the IUD works. Mirena contains a reservoir that holds and releases the hormone levonorgestrel at a rate of 20 micrograms per day. According to Mirena’s manufacturer—Bayer HealthCare Pharmaceuticals, Inc.—there are numerous mechanisms with Mirena that work to prevent pregnancy, including:
- Thickening of the cervical mucous, to prevent sperm from entering the uterus;
- Inhibiting sperm movement;
- Thinning of the uterine lining; and
- Possibly stopping the release of eggs from the ovary
The Mirena IUD is inserted by a doctor into the “fundus” or top of the uterus. This is its proper position. Mirena’s label asks that patients follow up with their doctor within 4-6 weeks of insertion so the doctor can do an examination and ultrasound to ensure Mirena is properly placed. Although considered a medical device, Mirena is regulated by the FDA as a drug, because of its use of levonorgestrel.
Mirena was approved for use in the U.S. on December 6, 2000. Mirena’s indication for heavy menstrual bleeding was not approved until September of 2009.
Has Mirena Been Recalled?
No. Despite advertisements to the contrary, the Mirena IUD has not yet been recalled. However, Mirena’s manufacturer has gotten in trouble for deceptive marketing and advertising. On December 30, 2009, the FDA’s Division of Drug Marketing, Advertising, and Communication (“DDMAC”) warned Bayer that its “Mirena Simple Style Statements Program”—which included live home presentation—“overstates the efficacy of Mirena, presents unsubstantiated claims, minimizes the risk of using Mirena, and includes false or misleading presentations regarding Mirena.”
According to the FDA’s review, Bayer’s claims that Mirena could make a woman “look and feel great” and also benefit her “romantically” were not supported by any evidence. In fact, the FDA concluded that reported side effects of Mirena show just the opposite.
What Are The Risks of Mirena?
There are numerous serious risks associated with Mirena, including ectopic pregnancy (pregnancy outside of the uterus), intrauterine pregnancy, which can result in septic abortion and may lead to death, increased risk of miscarriage, sepsis, premature labor and delivery, Group A streptococcal sepsis (a severe bacterial infection), pelvic inflammatory disease, irregular bleeidng and amenorrhea, ovarian cysts, and breast cancer.
Mirena also comes with risks due to displacement or embedment. Mirena or its strings may become embedded in the uterine wall, which often requires surgery to remove. Mirena may move around or “migrate,” which can result in uterine perforation. If Mirena perforates through the uterus, it can travel throughout the abdominal cavity causing damage, tearing, and scarring. Perforation also typically requires surgery to locate and remove Mirena.
What Are The Claims About Mirena?
Women across the country have been injured—sometimes severely—because of Mirena’s tendency to migrate, perforate through the uterus, or become embedded in the uterine wall. Mirena’s label only warns doctors that it may cause perforation upon insertion. Mirena’s label does not warn that Mirena can spontaneously migrate and perforate the uterus, sometimes even years after insertion.
The Mirena IUD can also become embedded in the uterine wall, which Bayer claims “in some cases, surgical removal may be necessary.” Unfortunately, embedment is an all too common occurrence, and typically requires surgery to remove.
What Information is Available About the Lawsuits?
Mirena IUD claims have been consolidated into a Multi-District Litigation (MDL) in the U.S. District Court for the Southern District of New York under the Honorable Cathy Seibel.
An MDL is not a class action lawsuit. The cases are consolidated under one judge in one federal court only for pre-trial purposes. Jones Ward PLC is actively involved in the MDL litigation on behalf of injured Mirena IUD recipients. Other cases are filed in state court in New Jersey.
What kind of damages are available in a Mirena IUD injury case?
Each case is different because each injured plaintiff’s injuries and experience is different. At Jones Ward PLC, your case will receive the individual attention that it deserves. Our attorneys are dedicated to fighting for your rights. Some of these details may include:
- Lost wages from your job due to your injuries, any surgery and related recovery.
- Pain and suffering from any injuries related to your Mirena IUD, including surgery and any recovery.
- Medical bills related to your Mirena IUD injuries.
- Future pain and suffering and lost wages until you reach the age of retirement
- Loss of consortium for your spouse due to strain on your marriage, loss of intimacy, inability to do household chores and participating in daily activities.
- Punitive damages for Bayer’s failure to share information about the dangers of the Mirena IUD, even after it knew about safety problems.
How do I preserve my rights?
Contact an attorney as soon as possible. If you do not file a lawsuit within a certain amount of time, you may lose your right to compensation due to state Statute of Limitations. This deadline is different in each state, and it varies depending on the claims you are making in the lawsuit. In Kentucky, for example, the deadline for a product liability claim is one year. However, the same claim in Indiana is two years, and in Florida it is four years. For a free evaluation of your potential Mirena IUD claim, please call us toll free at 1-888-595-2922. You can also fill out a form on our website for someone to get back to you.