The Mirena IUD (intrauterine device) is a contraceptive implant that has been linked to severe side effects — including spontaneous uterine perforation and a rare brain disease that can cause chronic headaches and blindness. Now, thousands of women have already filed lawsuits against Bayer in federal court, accusing the company of failing to communicate risk information.
What You Can Do & How a Mirena Lawsuit Can Help
The Schmidt Firm, LLP is currently accepting Mirena induced injury cases in all 50 states. If you or somebody you know has been injured by Mirena, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Product Liability & Defective Medical Device Litigation Group or call us toll-free 24 hours a day at (866) 920-0753.
UPDATE: 2,500 Mirena Lawsuits Filed for Uterine Perforation, Migration Injuries
November 19, 2014 — Bayer is facing nearly 2,500 Mirena lawsuits in state court in New Jersey and a federal MDL in New York. Click here to read more.
September 22, 2014 — Courthouse News reports that a lawsuit has been filed by a woman who says Bayer’s Mirena IUD perforated her uterus and migrated into her rectum — the first known lawsuit of its kind. Click here to read more.
August 13, 2014 — Law360 reports that federal judges have refused to centralize nine lawsuits involving neurological side effects of Mirena, ruling that there are too few cases. Meanwhile, attorneys have submitted a list of 12 cases, one of which will be selected for the first “bellwether” trial in 2016. Click here to read more.
July 28, 2014 — Obstetrics & Gynecology has published a study finding a 20% increased risk of breast cancer associated with levonorgestrel-releasing contraceptives, such as Mirena, but a lower risk of pancreatic, ovarian, lung, and endometrial cancer. Click here to read more.
May 28, 2014 — Plaintiffs have filed a motion to create a centralized federal litigation for 9 lawsuits involving Mirena and non-stroke neurological side effects, including pseudotumor cerebri (PTC) and/or idiopathic intracranial hypertension (IIH). Click here to read more.
May 2, 2014 — Over 1,800 women have filed a Mirena lawsuit for uterine perforations or ectopic pregnancy, according to a stockholders report issued by Bayer AG, the manufacturer of Mirena. Click here to read more.
February 27, 2014 – Over 1,000 Mirena lawusits are pending in federal court in New York and state court in New Jersey. There are 408 lawsuits in the federal MDL and 628 in Bergen County, New Jersey. Click here to read more.
November 25, 2013 – Mirena lawsuit filed by Pennsylvania woman who needed surgery after her Mirena spontaneously migrated, perforated her uterus, and moved into her abdomen. Click here to read more.
October 17, 2013 – There are 211 Mirena IUD lawsuits pending in the federal Multi-District Litigation in New York.
August 27, 2013 – The FDA has received over 70,000 reports of complications associated with Mirena, including nearly 5,000 women who suffered “device dislocation.” More than 220 lawsuits have been filed in state and federal litigation. Click here to read more.
July 16, 2013 – Within 3 months, more than 105 Mirena lawsuits have been filed in the centralized federal litigation. Click here to read more.
June 13, 2013 – A federal panel of judges has created a Multi-District Litigation (MDL) to centralize lawsuits alleging that Mirena caused uterine perforations. Click here to read more.
January 23, 2013 – A motion has been filed requesting the centralization of federal Mirena lawsuits into one court in Ohio. Click here to read more.
January 2, 2013 – A Mirena IUD lawsuit has been filed by a woman in Kentucky who suffered a spontaneous uterine perforation and required surgical removal of Mirena. Click here to read more.
December 4, 2012 – A Florida woman has filed a Mirena lawsuit after the IUD migrated from its intended position, perforated her uterus, and required surgery to remove. Click here to read more.
What is Mirena?
Mirena is an intrauterine device (IUD). It is implanted into a woman’s uterus, where it slowly releases levonorgestrel (a synthetic version of the hormone progestin). This hormone may thicken the cervical mucous, which prevents sperm from entering the uterus. It also makes the lining of the uterus thinner, which reduces the chances that a fertilized egg will implant and grow. Mirena is more than 99% effective at preventing pregnancy for up to five years.
Mirena was approved by the U.S. Food and Drug Administration (FDA) in 2000. It is manufactured by Bayer HealthCare Pharmaceuticals Inc. It is used by more than 2 million women in the United States.
What is the problem with Mirena?
Bayer is facing dozens of Mirena lawsuits from women throughout the United States, and Bayer expects the number of lawsuits to increase. This is because many women have suffered severe, life-threatening Mirena side effects — including embedment or perforation of the uterus.
Many of the Mirena lawsuits allege that Bayer failed to adequately convey information about the risk of side effects. In fact, the FDA has sent Bayer two warning letters for failing to communicate risk information about Mirena.
If you were injured by Mirena, you are not alone. If you decide to file a Mirena lawsuit for your injuries, you could be entitled to compensation for your pain and suffering, medical expenses, permanent injuries (such as infertility), and more.
Mirena Brain Injury Lawsuits
In early 2014, Bayer was hit with 9 lawsuits accusing them of downplaying risk information about brain injuries from Mirena, including:
Attorneys petitioned a panel of federal judges to centralize the litigation in May 2014. However, in August, the judges denied the petition because there were not enough cases. The cases will proceed individually at the state level. In the future, it is possible that a class action lawsuit will be filed. Click here to read more.
Mirena Side Effects
Some of the most serious complications of Mirena include:
- Perforation of the uterus
- Migration of the device into the uterus, or outside the uterus
- Organ damage
- Intestinal perforation or obstruction
- Pelvic Inflammatory Disease
- Ectopic pregnancy
- Surgical removal
Other serious side effects include:
- Abdominal pain
- Ovarian cysts
- Irregular bleeding
- Expulsion of the device
- Embedment in the uterus
- Erosion into the uterus or adjacent areas, such as the vagina
- Peritonitis (inflammation of the membrane in the abdominal cavity)
When serious complications occur, a woman may suffer irreversible scarring and/or damage to the uterus. This may cause permanent infertility.
Mirena and Uterus Perforation
Mirena perforation of the uterus is a rare but serious complication associated with IUDs. It often occurs during insertion of the device. Health Canada has warned that the rate of perforation is about 1 in 1,000 to 10,000 insertions. Mirena can also erode into the uterus and puncture the uterine wall.
Health Canada also warned that in some cases, uterine perforation went unnoticed after the insertion was complete. The insertion is very painful, and a healthcare professional might not notice signs of this serious complication. Uterine perforation is very dangerous, because Mirena can migrate outside the uterus, into the abdominal cavity, perforate the intestines, or cause other serious complications.
In many cases, women who suffer from a perforated uterus require immediate surgery. Long-term complications may include infertility.
The risk of uterine perforation is highest for women who have recently given birth, are nursing, or women with an atypical uterine shape (such as a fixed, retroverted uterus).
FDA Warning Letters for Mirena
In December 2009, the FDA sent a warning letter to Bayer due to a promotional program for Mirena. The marketing program featured parties hosted by experts who claimed that Mirena could help a woman “look and feel great,” improve a woman’s sexual relationships, and quality of life.
According to the FDA, “The program overstates the efficacy of Mirena, presents unsubstantiated claims, minimizes the risks of using Mirena, and includes false or misleading presentations regarding Mirena.”
The FDA also pointed out that many women do not “feel better” — about 5% of women who use Mirena actually reported a decrease in libido, which could potentially harm sexual relationships. Other troublesome side effects include irregular bleeding, weight increase, breast pain, acne.
The FDA also sent Bayer a Warning Letter in March 2009. This time, the FDA was concerned that Bayer’s sponsored links on internet search engines are misleading because they make representations and/or suggestions about the efficacy of Mirena, but fail to communicate any risk information.
By law, advertisements for drugs and medical devices must include risk information. By omitting important risk information, including the most frequently occurring risks and side effects, the ads misleadingly suggest that Mirena is safer than it really is.
Do I have a Mirena Lawsuit?
The Schmidt Firm, LLP is currently accepting Mirena induced injury cases in all 50 states. If you or somebody you know has been injured by Mirena, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Product Liability & Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.
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