Bayer, the German pharmaceutical giant, is facing a number of lawsuits over its intrauterine device (IUD) Mirena. The device debuted after U.S. Food and Drug Administration (FDA) approval in 2000 and has been enormously popular with women looking for an alternative to oral contraceptives and permanent birth control procedures. Bayer has seen success with Mirena in part because of aggressive, and at times questionable, marketing.
Another controversial aspect of Mirena is the fact that it has caused some serious and painful side effects in some women. Many of these women are now claiming that Mirena was presented to them as safe and effective and they feel duped. These women are filing Mirena lawsuits and waiting to see if they will get compensation for their pain and suffering.
What is Mirena?
The FDA approved Mirena to be used as a contraceptive for up to five years at a time. It provides women with an option for birth control that doesn’t require taking a pill every day and that can be reversed. Mirena is called an intrauterine device because it is inserted into the uterus where it can stay for years. After five years, the device is removed and another can be inserted.
Like oral contraceptives, Mirena is a hormonal birth control. It releases small amounts of a synthetic form of progesterone, called levonorgestrel, every day. The hormone acts to prevent pregnancy by preventing fertilization. It changes the wall of the uterus, thickens cervical mucus, and makes the uterine environment hostile to sperm cells.
Problems with Mirena
As with any hormonal birth control Mirena can cause side effects. Some of these are similar to oral contraceptives, while others are unique to the IUD. Possible side effects include irregular bleeding, headaches, acne, breast tenderness, pelvic pain and cramping, weight gain, a loss of menstrual periods, most often after a year of implantation, mood swings, and ovarian cysts.
There are less common side effects and complications that are more serious than the typical side effects. These include an infection called pelvic inflammatory disease, which can become life-threatening, expulsion of the device, embedment of the device in the uterine wall, ectopic pregnancies, and migration and perforation of organs and tissues. These last few serious complications have led to most of the Mirena lawsuits now ongoing.
Embedment, Migration, and Perforation
Some women have had their IUDs move into the tissue of the uterus and become embedded in it. When this happens it can lessen the effectiveness of the contraceptive and could result in a dangerous pregnancy. An embedded IUD typically has to be removed surgically.
If the device moves out of position it is said to have migrated. Migration can lead to the device moving out of the uterus and into surrounding tissue, which can then lead to the perforation or puncturing of other organs. Not only does this have the potential to cause infections and abscesses, intestinal obstructions, pain, and bleeding, it can lead to an unwanted pregnancy. Many women who experienced migration and perforation of Mirena required surgeries to correct the damage done by the device.
The labeling for Mirena does include a warning about perforation, but it may not be strong enough. According to plaintiffs and their lawyers the warning that Bayer includes with Mirena, stating that it may cause perforation when inserted, is not adequate. Women also need to be warned that perforation can occur months or longer after the devices has been inserted. Too many women didn’t realize what happened, that the device had migrated, until a lot of damage was done to their bodies.
While Bayer claims nearly 100 percent effectiveness of Mirena in preventing pregnancies, those that do occur are often ectopic. Nearly half of all pregnancies with Mirena implanted occur when the egg is fertilized in the fallopian tube instead of in the uterus. This type of pregnancy threatens a woman’s life and the egg has to be removed surgically. Even when pregnancies while using Mirena are not ectopic, they can lead to serious complications including a septic abortion, miscarriage, or premature delivery.
Questionable Marketing Practices
Plaintiffs in cases against Bayer and Mirena accuse the company of many things, including marketing the device and representing it as safer than it really is. The FDA agrees with this claim in at least one instance. The agency came down on Bayer in 2009 for using marketing strategies that downplayed the risks of Mirena in a series of social networking and in-home events.
The controversy began with a social networking group called Mom Central. Bayer worked with this group to organize in-home events with women to market IUDs. According to the FDA, the Bayer representative at these events played up the romantic benefits of using Mirena, claiming that women would have better relationships with their partners thanks to Mirena, while also downplaying any risks. A warning letter from the FDA said that this was misleading marketing, that it overstated the efficacy of the device and minimized risks.
Many of the lawsuits started against Bayer because of Mirena have been consolidated into multidistrict litigation (MDL) in an attempt to streamline the cases and be more efficient. Most of the plaintiffs experienced perforation long after the device was inserted. They believe they should have been better warned about the risks of this happening much later, but Bayer continues to argue that perforation can only occur during insertion of Mirena. The company claims that this may occur during insertion, but not become obvious until later.
In early 2016 this argument, and others, won a major set of cases in favor of Bayer. The judge ruled in favor of the company and did not award settlements to five plaintiffs. The judge ruled that the label for Mirena did adequately warn of risks and that perforation could only occur as Bayer described according to their expert witnesses.
The women who lost their suits suffered greatly because of Mirena. They experienced perforation and migration, along with pain and bleeding, and required expensive and invasive surgeries to correct the problems. One woman even suffered because the device migrated all the way to her liver. Some of the women harmed may even have lost fertility because of Mirena.
What will happen with future cases against Mirena and Bayer remains to be seen. There are still hundreds, maybe thousands of women willing to fight against the drug giant to get justice and to get compensation for their pain and suffering. If you were harmed by Mirena and feel you weren’t adequately warned of the risks of relying on the device for contraception, you could be a part of future litigation against Bayer.