Is Mirena the Next Dalkon Shield?

Mirena, a long-acting birth control called an intrauterine device (IUD) which has been responsible for over 47,000 reports of serious adverse events on adverseevents.com as well as over 40 lawsuits filed against the drug manufacturer for serious problems resulting from the device, is not the first IUD that has caused severe side effects in women.

In the 1970s, A.H. Robins Company sold an estimated 2.5 million Dalkon Shields, the first popular IUD on the market. The Dalkon Shield killed 17 and caused physical injury, miscarriages, infection and hysterectomies to over 200,000 women. The product was pulled from the market just three years later, but not before over 300,000 women filed lawsuits against the company. The largest settlement amounted to $2.2 million. A.H. Robins filed for bankruptcy in 1985 and is still engaged in legal arguments over whether the $1.75 billion it proposes as a compensatory fund to women who claim to have been injured by the shield is anywhere near enough.

Both pharmaceutical companies have been faulted for their marketing campaigns. Mirena was marketed by maker Bayer Pharmaceuticals to busy moms while Dalkon Shield was promoted as a birth control for teenagers in college and the underprivileged as a highly effective, inexpensive and non-intrusive birth control. Bayer received an official warning from the Food and Drug Administration (FDA) for overstating the effectiveness of Mirena, while minimizing the risks associated with it during its marketing campaign. A.H. Robins, through its “Designed for Greater Comfort” marketing campaign, allegedly promoted a device with an ill-designed removal string that caused bacteria in the uterus, often causing Pelvic Inflammatory Disease (PID) and sepsis (blood poisoning) which, when untreated, can cause infertility and death. Lawsuits claimed A.H. Robins knew about the poor design when it purchased the rights to the device.

There are some similarities between medical complications associated to Mirena and Dalkon Shield. However, Mirena could prove to be more dangerous in the end as most of the complaints revolve around the device spontaneously migrating or expelling from the body. Device migration is serious in that it has been shown to puncture the uterus and surrounding organs, sometimes requiring surgery and even causing infertility.  

Though it has been 40 years since the Dalkon Shield was pulled from the market, the similarities between that device and Mirena is shocking. While there are only just over 40 lawsuits currently pending against Bayer Pharmaceuticals related to Mirena, the number of lawsuits could grow to the level of Dalkon Shield given that the Mirena IUD is used by two million women in the United States and 15 million worldwide. 

The lawyers at Nolan Law Group are currently evaluating Mirena IUD cases. If you or someone you know has suffered an injury after using Mirena,  please Contact Us or call 312-630-4000.