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Mirena IUD Pseudotumor Cerebri and Uterine Perforation Lawsuits FAQ

What is Mirena?

Mirena is a levonorgestrel-releasing intrauterine system. It is a small, T-shaped device placed in the uterus that releases a small amount of a progestin hormone to prevent pregnancy.

Who uses Mirena?

The IUD device has been marketed to women as a “convenient” method of birth control. The Mirena manufacturer also advises that it be used by women who have had a child (but they don’t give an explanation why). It is also used to treat heavy periods. It is not to be used by women who are prone to infections or have certain cancers.

What are common Mirena side effects?

Some discomfort usually occurs after the IUD is inserted. Bleeding and spotting may increase for the first few months.

What Mirena side effects are attorneys investigating?

At this time, the only cases attorneys are investigating are perforations of the uterus or embedment in the uterine wall that requires surgery to have the device removed.

How can the Mirena cause these problems?

Occasionally a perforation can occur when the Mirena is inserted by a health provider, particularly if it is inserted by a nurse practitioner rather than a doctor.

Generally, the Mirena causes perforation either because there is a problem with the device’s design or because it releases the synthetic progestin levonorgestrel (also known as “the morning after pill”), which can thin out the uterus or cervix and thereby cause the device to perforate. Perforations can occur if the uterus or cervix is extra thin at any time.

How would I know if the Mirena has moved?

Women are supposed to see their health care provider on an annual basis (you can wear the Mirena for up to five years) to see if the string is still attached. If the Mirena cannot be pulled out with a tug on the strings, that is a sure indicator of embedment and/or perforation.

When did the FDA approve the Mirena?

The FDA approved the Mirena as a method of birth control in 2000 and in 2009 to treat heavy periods.

Is the FDA warning users of serious side effects?

Yes. The FDA has documented more than 45,000 adverse event reports, including device expulsion, device dislocation and vaginal hemorrhage. There are also reports that are life-threatening: ectopic pregnancy (pregnancy that occurs outside the uterus) and pelvic inflammatory disease (PID). Many women have also linked Mirena to miscarriages and infertility.

In 2009, the FDA warned Bayer that it was in violation of the Federal Food, Drug, and Cosmetic Act. The agency also told the drugmaker that its advertising included false or misleading presentations and misbranded the drug. Bayer falsely claimed that the use of Mirena would result in “increased levels of intimacy, romance and by implication emotional satisfaction.” It also insinuated that its IUD would make women “look and feel great,” when in reality many women using the product may experience weight gain, back pain, breast pain and acne. The advertising conveniently omitted risk information for complications.

If I file a lawsuit who will I be suing?

Cases are being filed only when the injury occurs after implantation. Bayer, the drug manufacturer, is being sued and not your doctor.

What is Bayer Pharmaceuticals accused of?

Bayer’s IUD is allegedly “defective and unreasonably dangerous.” Bayer is accused of negligence, intentionally selling a dangerous product, deceptive advertising and concealing the risk of complications.

Lawsuits that have been filed claim Bayer of misleading marketing, producing a defective product and failing to reveal the dangerous side effects of the device (as listed above). Further, the Mirena label failed to warn doctors and consumers about these serious complications and described them as uncommon, even though many women have suffered from these adverse events. Plaintiffs are also suing Bayer for punitive damages, claiming Bayer knowingly and willfully harmed them.

Is there a Mirena class action?

To date, no Mirena class action has been filed and a Mirena recall has not been issued.

Have individual lawsuits been settled?

To date, Bayer has not reached any Mirena settlement agreements. Although the first cases filed against Bayer involving Mirena injuries were filed in 2011, litigation is in the early stages. By early 2014, more than 1,000 claims were pending.

As of May 2014, a list was being drawn up for Mirena trial selections, which will happen some time in late 2015.

How much time do I have to file a Mirena lawsuit?

Check the Statute of Limitations (SOL) in your state - some states stipulate one year and some are more than three years, but most states have two-year Statutes of Limitations.

Bayer’s strategy is to throw out cases past the SOL. If you filed a case after perforation or embedment surgery beyond the SOL in your state, you will be pulled out of the multidistrict litigation. In other words, the SOL clock begins ticking once women knew of the injury. Mirena attorneys advise that you file a Mirena claim sooner than later.