About Mirena IUD

The Mirena intrauterine device (IUD) is a popular form of birth control that is used by more than two million women nationwide.  Despite its widespread use, hundreds of women have complained to the U.S. Food and Drug Administration about serious health issues they have experienced with the device, including uterine perforation, migration of the IUD to other parts of the body, and embedment of the IUD in uterus. As a result, women who have suffered serious injuries have filed product liability lawsuits in courts throughout the country against Bayer Pharmaceuticals, the manufacturer of Mirena birth control.

How does Mirena work?

Mirena is an intrauterine device (IUD) made of polyethylene plastic that releases a hormone called levornorgestrel into the uterus.

When the hormone is released it has the following effects:

• Thickening of the cervical mucus to stop sperm from entering the uterus
• Stops sperm from fertilizing the woman’s egg
• Thins the uterus lining
• May prevent the ovaries from releasing the egg in some women

The Mirena IUD is a T-shaped device placed in the uterus by a trained doctor or healthcare provider.  The horizontal part of the IUD anchors it in place in the uterus while the vertical side contains polyethylene strings, which the healthcare professional uses for removal.  Women are advised to check the strings periodically to ensure that the device remains in the place.

Bayer claims Mirena IUD is safe for long-term birth control

Mirena prevents pregnancy more than 99% of the time, and lasts up to five years after insertion, according to Bayer.  Once it is removed, fertility is quickly restored.  If a woman wants to continue with it beyond the five-year period, it must be replaced with a new device.

Mirena is the only hormonal IUD that has been approved by the FDA.    In 2009, it received agency approval for treatment of heavy bleeding.  Mirena is recommended for women who already have one child. Bayer markets it as safe and convenient, and ideal for busy moms.

Mirena IUD side effects

The FDA has received more than 45,000 reports of adverse events regarding the Mirena IUD.  Many women have suffered serious injuries caused by the IUD spontaneously migrating from its original location.  As many as two women in 1,000 experience this uterine perforation and migration, which can be extremely painful.  It can lead to infection, sepsis, infertility, and hemorrhaging.  Surgery is generally required to remove the intrauterine device and correct the problems it caused.

Serious side effects of the Mirena IUD can include:

• Migration of the device
• Perforation of the uterus
• Perforation of other organs including the bladder & intestines
• Ectopic pregnancy
• Infertility
• Embedment in uterine wall
• Spontaneous expulsion of the device
• Pelvic Inflammatory Disease (PID)
• Ovarian Cysts

Mirena IUD migration can increase the chance of conception.  If a woman becomes pregnant, an intrauterine device poses a significant health threat to the mother and the baby.  The IUD can create a higher risk of septic abortion, premature labor, miscarriage, and premature delivery.

Women who become pregnant or who suffer serious side effects of Mirena may require surgery to have the device removed.  In some cases, women will have to undergo several surgeries to repair damage to internal organs.Such patients may need continued medical attention even after the surgery is over.

Bayer warned about deceptive marketing

Four years ago, the FDA issued a letter to Bayer, warning them about exaggerating the benefits of  its IUD, while minimizing the serious risks of Mirena side effects. The FDA claimed that Bayer participated in misleading marketing practices in its unfounded claims that Mirena can create more romance between couples.   .

Furthermore, the FDA admonished Bayer for failing to include information regarding Mirena health risks. The FDA said that Bayer’s advertisement does not adequately convey that if a woman becomes pregnant while using Mirena, she may lose her baby or her fertility.  The agency also stated that Bayer failed to provide adequate warning to consumers about other side effects, including ovarian cysts, uterine perforation and irregular bleeding, among others.

Neither the FDA nor the manufacturer has issued a Mirena recall.

Product liability claims against Mirena manufacturer

As a result of severe Mirena side effects and complications, women have been filing lawsuits against Bayer.  Some of the cases are proceeding in state court, while hundreds of other claims have been centralized into a multidistrict litigation (MDL).  The Mirena MDL is pending in the United States District Court for the Southern District of New York.  The cases have been consolidated for the purpose of avoiding conflicting rulings during discovery and pretrial proceedings, and promoting efficiency.  Once the discovery process is concluded, each case will proceed individually in the jurisdiction in which it was originally filed.

Most Mirena lawsuits are based on the theory of product liability.  Under product liability law, manufacturers and sellers of medical devices have a duty to their consumers to ensure that their products are safe.  If a manufacturer or seller breaches this duty, they can be held liable for the injuries that are caused by the device. Manufacturers also have a duty to warn consumers about risks associated with Mirena.  In Mirena IUD lawsuits, plaintiffs argue that Bayer failed to warn of potential side effects of the device.

Some complaints also contend that Bayer is liable for negligence and deceptive marketing practices. The company is being charged with intentionally withholding information about Mirena risks from consumers and their physicians.

If the court decides in favor of the plaintiffs, the patients could be awarded damages for lost wages and future earnings, past and future medical expenses, and pain and suffering that resulted from their injuries. A Mirena attorney can discuss your legal options with women who were harmed by Bayer’s IUD.

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