Lawsuit Says Bayer Failed to Report Mirena Complications to FDA

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Mirena IUD user Kaci Lewis has filed a lawsuit against Bayer Healthcare Pharmaceuticals Inc., alleging that its Mirena contraceptive device caused her serious medical complications, resulting in pain, medical costs, and other expenses.

The Mirena Intrauterine Device (IUD) is a form of birth control. It is designed to be implanted into the uterus by a trained physician. Once in place, the device blocks contraception. Some of the details remain elusive, but it does so through several mechanism, including the release of several synthetic hormones which block ovulation. However, the Mirena IUD has allegedly been linked to a number of serious complications. Hundreds of Mirena lawsuits and several recalls have plagued the IUD.

According to Lewis’ Mirena lawsuit, she received the IUD from her physician in June of 2012. The text of her lawsuit indicates that there was no sign of any complications during the insertion. However, an X-ray revealed that the device had embedded itself with her omentum, the lining of her internal organs. It required surgical removal in July of 2012, a little more than a month after the initial implantation. This left her with a high risk of infertility, pregnancy complications, and the need for lifelong medical care and monitoring.

The Mirena lawsuit alleges that Bayer was aware – or reasonably should have been aware – of the serious risks associated with the Mirena IUD. To support this assertion, the lawsuit cites peer-reviewed journal articles which found a risk of serious complications associated with the device. Additionally, the lawsuit asserts that the manufacturer was aware of postmarket reports of complications associated with the IUD.

Additionally, the Mirena lawsuit further alleges that the manufacturers were not only aware of the risks, but actively concealed this knowledge. The lawsuit points out that the manufacturers failed to report the articles and the post market reports to regulatory agencies like the FDA, in accordance with federal law. The lawsuit holds these actions to constitute negligence, fraud and

The Mirena IUD lawsuit is Kaci Lewis v. Bayer Healthcare Pharmaceuticals Incorporated et al, case No. 3:13-cv-06034, filed within the MDL In Re: Mirena IUD Products Liability Litigation, MDL No. 2434, filed in the United States District Court for the Western District of Washington.

Help for Victims of Mirena IUD Complications

If you or a loved one had a Mirena IUD inserted after January 1, 2000 or later and had to have surgery – or will be required to have surgery – to have it remove because it migrated, you may be eligible to take legal action against the manufacturer. Filing a Mirena IUD lawsuit may help you recover compensation for medical bills, pain and suffering and other damages. See if you qualify by filling out the short form at the Mirena IUD Injury Class Action Lawsuit Settlement Investigation.