Bayer Pharmaceuticals, Inc. is facing litigation concerning its Mirena intrauterine device (IUD). In addition to thousands of lawsuits concerning Bayer’s birth control pills Yaz and Yasmin, for which the company has already paid over $400 million in settlements, Bayer is now defending lawsuits alleging the Mirena IUD caused women serious injuries.
According to a recent report, a total of 16 cases have been filed in the New Jersey Superior Court, Morris County. Each case claims that Bayer overstated the benefits of the device while understating the side effects and failing to warn about the risks. Bayer is currently seeking to centralize the litigation in New Jersey.
FDA Approves Mirena in 2000
The FDA approved the Mirena IUD device in 2000. Prior to that, the device had been marketed for 10 years in Europe.
Mirena is a small, T-shaped, plastic device inserted by a trained healthcare professional into the uterus to prevent pregnancy. While in the uterus, it gradually releases the hormone levonorgestrel into the body, where it reduces the chances of pregnancy for up to five years. The device itself also disrupts the egg and sperm to discourage pregnancy.
In 2009, the FDA approved Mirena for the additional use of treating heavy menstrual bleeding. In the primary clinical trial submitted to the FDA, women using Mirena showed a statistically significant reduction in menstrual blood loss.
At the time of the second approval, the FDA noted that the most serious adverse events reported included ectopic pregnancy (where the fertilized egg grows outside the uterus), intrauterine pregnancy (pregnancy with the Mirena in place), pelvic inflammatory disease, embedment of the device into the uterine wall, and perforation of the uterine wall or cervix.
Reports of Serious Mirena Side Effects
Other post-marketing reports have indicated that Mirena may also be associated with additional side effects. For example, the device may migrate outside the uterus causing scarring and other complications. This type of migration can also result in organ perforation or the device becoming embedded in the uterus or into another organ. In these cases, surgery is typically needed to remove the device. Such surgeries have been reported to affect a woman’s ability to have children in the future.
In addition, women have reported experiencing abscesses, infertility, intestinal perforations or obstructions, infections, and erosion of adjacent areas, such as the vagina.
Women Filing Mirena IUD Lawsuits
More women have been coming forward to seek compensation for their Mirena IUD injuries. Lawsuits allege that Bayer failed to properly study the device to be sure of its risks and side effects before releasing it onto the market. Plaintiffs also claim the company failed to adequately warn patients and doctors about the risks, and over-promoted the benefits through its “Simple Style” program, which claimed Mirena increased intimacy and helped women look and feel great.
The first Mirena IUD lawsuit was filed on April 12, 2012, on behalf of an Ohio woman. Her complaint alleged that she required a hysteroscopy to remove the device. Considering over two million women have used Mirena in the U.S., many more injured women may be coming forward with complaints in the near future.
Exclusively focused on representing plaintiffs, especially in mass tort litigation, Eric Chaffin prides himself on providing unsurpassed professional legal services in pursuit of the specific goals of his clients and their families. Both his work and his cases have been featured in the national press, including on ABC’s Good Morning America.
4 Comments
Karrah Merkley
I did not end up injured by the Mirena IUD, but when I went to have mine removed, it was gone! It had come out at some point apparently. The doctor did ultrasounds and xrays to see if it had moved elsewhere in my body, but it was missing entirely. So much for safe birth control...
Emily Clifton
I was advised to use Mirena by a gynecologist I trusted, but she did not adequately warn me about the risks, including the fact that Mirena is not recommended for women who have not have a child (which applies in my case). Mirena caused me to have constain, debilitating pain almost all of the time for about six months, after which I found a new gynecologist and had it removed. When she removed it, she remarked that its threads were not reachable, and had to use an instrument to reach past the cervix to grasp the device. It had migrated into the folds of the uterine wall - un-stretched by childbirth. I am not convinced this is the end of it, but I have not yet tried to conceive. I am assured that my tests are normal, my tissues are healthy and I have a regular cycle now while maintaining my birth control regimen via Implanon, a simple rod device that is inserted in your inner arm and is not visible or bothersome. I can't believe my initial gynecologist didn't take the time to review my options and weigh the pros and cons of each.
Kristin
I had the Mirena IUD inserted in 2007 after the birth of my daughter. I never had any complications with it whatsoever. When I had it removed at the 5 year mark (APR 12) it was painless and my cycle started back on track within 60 days and we just conceived our baby in August of this year. As women we all know our bodies are different and react to things in different ways. I understand that its not fool proof but sometimes, with a lot of things, its operator error. Don't rule out Mirena just because it didn't work for a few people. Theres thousands of others that had no problems at all. I would most def get another one!!
Sam
I'm really shocked by the ignorance of these women. When I chose the Mirena I knew what the risks were, perforation being one of them. Perforation can happen even with the Paragard IUD. IT's a risk for any IUD inserted period, not just the Mirena. I have not had any issues with my IUD at all. I love that I have no heavy bleeding and actually I wish the makers of the Mirena would do a study on how women get pregnant quite quickly once it's removed! My has stayed in place and have had no issues. I suggest women look up about the IUD before you decide to get it. Mirena does give warning. I remember reading about perforation being one of them. I don't think that woman will win this case because it's a case of perforation which they usually warn about. I suggest you read all the material before you get it. But don't get discouraged from using it!. It's one of the best decisions I have made for myself. ALL IUDS HAVE SIDE EFFECTS NOT JUST MIRENA!
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