The Mirena intrauterine device (IUD) is an implanted device designed to provide trouble-free birth control for upwards of five years. First introduced in 2000, the Mirena IUD has been gaining in popularity, not the least of which is due to recent health care changes in the US that provide women access to all forms of birth control, regardless of cost. To date, there are more than two million women in the US currently using the Mirena device.
But there have been growing concerns over Mirena uterine perforation, and the tendency for the device to migrate away from its placement zone over time. Lawsuits continue to be filed, and Kelli Baugh’s may be the first to go to trial. Kelli Baugh v. Bayer Corporation (USDC, District of South Carolina, 4:11-cv-00525) was scheduled for a May 6, 2013 trial date.
Lawsuits against Bayer Healthcare Pharmaceuticals, the manufacturer of the Mirena IUD, have been filed in state court in New Jersey, where Bayer maintains its US headquarters. More than 60 lawsuits against Bayer are currently pending in state court, together with all future Mirena lawsuits filed in the state of New Jersey transferred to state court in Bergen County. The centralization was so ordered by the state Supreme Court, with Judge Brian Martinotti having scheduled a hearing on the case for June 17.
Further cases in federal court are consolidated by way of Multidistrict Litigation (Mirena MDL In Re: Mirena IUD Products Liability Litigation, Multidistrict Litigation No. 2434, United States District Court, Southern District of New York).
The Mirena IUD is inserted into the uterus by a woman’s doctor, usually in his office. There is no surgery required. However, a surgical procedure is often undertaken to remove an IUD that has migrated away from the insertion site, perhaps causing damage to the uterine wall in the process. It is also generally held that IUD removal can be far more complex and carry greater risk to the patient, than the initial insertion.
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According to the US Food and Drug Administration (FDA), some of the more serious Mirena side effects include, but are not limited to, ectopic pregnancy, intrauterine pregnancy, pelvic inflammatory disease, and perforation of the uterine wall or cervix. In 2009, following issuance of the Bayer Mirena warnings, the FDA took Bayer Healthcare to task for overstating the effectiveness of Mirena, which is also prescribed to women plagued with heavy menstruation cycles.
Bayer has said it intends to defend itself vigorously against all claims of Mirena side effects, and continues to defend its product as safe and effective in spite of continuing reports of injury and complications.