Despite litigation and safety concerns, Mirena and other IUDs are experiencing a rapid rise in popularity. This rise is most notable among young women, who are choosing IUDs because they believe them to be long-acting, reversible, and safe. Our team of Mirena lawyers details the side effects of Mirena and the lawsuits stemming from these complications.
First, a little background: IUDs first became popular in the 1970s but were quickly recalled amid safety concerns. The FDA did not oversee devices then like it does now, and a particular IUD called the Dalkon Shield caused severe problems in women. More than 400,000 lawsuits were filed against the Shield’s manufacturer (including 18 wrongful death claims) causing the company to go bankrupt and the IUD market to collapse. Ultimately, $3 billion was paid to Dalkon Shield victims.
Decades later, one company chose to reintroduce a hormonal IUD into the American market. Mirena enjoyed massive success in European countries and in 2000 the FDA approved the device. There was one caveat: it was approved only for women who already had children, which was an important but sneaky marketing move. Submitting Mirena for FDA approval only for women who had children rendered any concerns about infertility irrelevant. In other words, Bayer never had to prove that Mirena was safe for young, childless women.
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In 2006, Bayer bought out the company that developed Mirena and continued aggressively marketing the product. One year later, the American College of Obstetricians and Gynecologists urged physicians to consider IUDs as a first-choice contraceptive for teens. By 2010, Bayer generated $714 million in Mirena sales.
So here is a hormonal contraceptive device that is federally approved for a specific subset of women, but is recommended by doctors to all women, including teenagers. What could go wrong?
IUD insertion can be painful. If the device does not stay in place, the pain worsens, making sexual intercourse and other activities impossible. One of the more serious complications of IUDs is the potential for it to migrate, cut through the uterus and lodge into other internal organs. If this occurs, doctors must surgically remove the device. This does not always fix the problem, though, as scar tissue that built up when the IUD perforated and migrated out of the uterus can cause cysts and organ blockage.
Many women have had to undergo numerous surgeries to remove this scar tissue. Others have had forced hysterectomies at extremely young ages, leaving women in their teens and twenties infertile. Thousands of women have filed lawsuits against Bayer for Mirena side effects including:
- Forced hysterectomies
- Migration and expulsion
- Ectopic pregnancies
- Pelvic inflammatory disease
- Painful surgeries
These women claim Bayer should have done more to warn patients – particularly young, childless women – about the potential complications. Plaintiffs point to FDA actions against Bayer for its marketing tactics for Mirena. Specifically, the agency warned Bayer that its Mirena ads purposefully minimized risks and overstated benefits, misleading the public about the actual indications. The FDA’s letter to Bayer can be found here.
Bayer recently introduced a new product that is a smaller version of Mirena with lower hormone levels. The device, Skyla, is a response to many doctors who expressed a desire for an IUD with specific data indicating its safety for young, childless women. We guide you through the legal process of filing a claim, and what to expect from litigation.