The Mirena IUD has been on the U.S. market since 2000. A long-term form of birth control, it works by emitting hormones to thicken the uterine lining and kill sperm.

Since winning U.S. Food and Drug Administration (FDA) approval, Mirena IUD side effects have been the subject of more than 45,000 adverse event reports as well as a growing number of lawsuits filed against the drug giant Bayer.

The most common allegations accuse Bayer of:

• Misrepresenting the benefits of the Mirena IUD
• Deceptive marketing tactics
• Failure to warn consumers of Mirena side effects
• Knowingly designing, producing and selling a defective, dangerous product

The Mirena IUD

The Mirena IUD is a small, T-shaped device that is implanted in the uterus to prevent pregnancy. By gradually releasing hormones, the device is supposed to prevent pregnancy for up to 5 years. Bayer marketed Mirena as a way to “look and feel great.”

This marketing campaign did not go over well with regulators. In 2009, the FDA sent Bayer a letter that warned against using such unsubstantiated claims in its marketing.

Mirena IUD Side Effects

Mirena has been associated with serious, debilitating, and even life-threatening side effects. In some cases, the device can migrate from the original position where it was inserted and can perforate the uterus or become embedded in the uterus. Mirena uterus perforation is a serious side effect that can lead to infection, infertility, and other side problems.

Mirena IUD side effects include:

• Abscesses/infection
• Complications that result in Mirena removal surgery
• Embedment in the uterus
• Erosion of adjacent areas such as vagina
• Expulsion of the Mirena IUD
• Infertility
• Inflammation of the membrane that lines the abdominal cavity and internal organs (peritonitis)
• Intestinal perforation or obstruction
• Migration of the IUD to outside the uterus
• Pelvic Inflammatory Disease
• Mirena uterine perforation

Bayer’s Marketing Tactics

Among the accusations against Mirena’s manufacturer, Bayer, is that deceptive marketing tactics were used to promote the product to women. Bayer’s marketing targeted busy moms by claiming that using Mirena, instead of other contraceptive methods, will simplify their lives and lead to increased intimacy, romance and emotional satisfaction.

The FDA’s response to the program was that there was no evidence that substantiated these claims, and that the program clearly overstated the efficacy of Mirena while downplaying the potentially severe Mirena IUD side effects. The marketing program also made statements indicating that using Mirena helped women to look and feel great – claims that were not substantiated by any clinical evidence.

In a 2009 FDA warning, Bayer was advised that it was in violation of the federal Food, Drug and Cosmetic Act. The FDA accused Bayer of false advertising and misrepresentation and required Bayer to immediately cease the promotional program for Mirena, but many women had already been exposed to the ads.

More than 2 million women in the United States use the Mirena IUD. Due to the numerous adverse and life-threatening side effects associated with Mirena, the number of Mirena IUD lawsuits has skyrocketed in recent years. The FDA has received more than 70,000 complaints, which has prompted the establishment of a Mirena multidistrict litigation in the Southern District of New York (MDL No. 2434).