Mirena is a birth control device that is manufactured by Bayer. It is inserted into the uterus to provide long-term birth control for women. It is advertised to be close to 100 percent effective as birth control. However, like other intrauterine devices (IUD), Mirena has caused complications for women who have received the implant. While some side effects are comparatively mild, when the IUD migrates out of its initial position, more serious damage is caused. There have been countless lawsuits brought against Bayer for the complications that women have faced from the use of Mirena. If you or a loved one has suffered harm / Mirena complications from using Mirena, you should immediately contact a Mirena lawsuit iud lawyer to discuss your case. This mirena complications article explains mirena complications in detail.
***WE are no longer reviewing Mirena IUD lawsuits. We are currently reviewing Teva Paragard IUD lawsuits***
Bayer- Mirena IUD lawsuit
Update- 7/18/2020- There are three mass tort consolidated lawsuits pertaining to Mirena IUD
- MDL 2434- “IN RE: Mirena IUD Products Liability Litigation” Justice Seibel, Cathy- NYS There is only 1 case pending in this MDL as of 3/15/19. During the pendency of this lawsuit there was 1777 lawsuits pending. Read the transfer order here. “In the In Re Mirena IUD Products Liability Litigation, the Second Circuit affirmed a district court’s dismissal of a multi-district litigation after it held that the district court properly excluded expert witness opinion evidence on general causation (whether the type of injury at issue can be caused by the product). In Re Mirena IUD Products Liability Litigation, 2017 WL 4785947 (2d Cir. October 24, 2017). Plaintiffs-appellants were women who brought suit against Bayer HealthCare Pharmaceuticals Inc. for injuries when the intrauterine device (IUD) Mirena allegedly perforated, became embedded in, and/or migrated from their uteruses. Plaintiffs sued the manufacturer of the IUD, Bayer, alleging negligence, strict liability, manufacturing defect, design defect, failure to warn, breach of warranty (implied and express), negligent misrepresentation, fraud, and various state statutory violations. In 2013, nearly 1,300 cases were certified as part of the multi-district litigation.” American Bar
- MDL 2767 “IN RE: Mirena IUS Levonorgestrel-Related Products Liability Litigation (No. II)” Justice: Engelmayer, Paul A. – NYS There are 913 lawsuits pending in this MDL as of 3/15/19. “This multi-district litigation involves products liability claims regarding a contraceptive product: the Mirena intrauterine device developed, manufactured, and distributed by defendants Bayer HealthCare Pharmaceuticals, Inc., Bayer Pharma AG, and Bayer Oy (together, “Bayer”). The Mirena IUD functions by releasing a synthetic steroid hormone known as levonorgestrel (“LNG”). Plaintiffs claim that the hormonal component of Mirena caused them to suffer from a disease known as idiopathic intracranial hypertension (“IIH”), also known as pseudotumor cerebri (“PTC”). IIH is an uncommon disease marked by increased cerebrospinal fluid (“CSF”) pressure in the skull. If untreated, IIH can cause headaches and vision problems, including, in extreme cases, blindness.” Source “A New York federal judge ruled Tuesday (June 2019)that Bayer doesn’t have to face multidistrict litigation claiming its contraceptive Mirena leads to a rare condition causing increased pressure in users’ skulls, finding the women who sued fell short of showing the intrauterine device can cause the illness.” Law 360
- NJ MCL 297 in New Jersey State Courts- Read the Initial order for case management “The complaints filed allege that the plaintiffs suffered injuries and/or damages as a result of misplacement of the Mirena® device. On May 13, 2013, the Supreme Court designated all pending and future litigation involving the Mirena® contraceptive device as multicounty litigation and assigned it for centralized management in Bergen County by Judge Rachelle L. Harz.” NJ Courts
What is Mirena?
IUDs have long had a questionable history in this country. While they generally are effective, there are many who can remember the issues that plagued a product known as the Dalkon Shield. This particular form of IUD was pulled from the market in the 1970s after causing hospitalizations and fatalities. Many of the defects were related to the specific product as different types of IUDs continue to be sold.
The newer form of IUDs are T-shaped plastic devices. There are some types of IUDs that are made out of copper that last longer than the plastic varieties. Mirena is a plastic IUD that relies upon the hormone progestin to provide birth control. This hormone is released over the course of time where the IUD is present in the body. There are two primary ways in which the device works. First, the mucus in the cervix becomes thickened. This forms a type of barrier that prevents the sperm from reaching the egg. Second, the lining of the uterus is thinned. This partially suppresses ovulation, which is the process that results in pregnancy.
Mirena inserted into Uterus
Mirena is inserted in a procedure that can be done in a doctor’s office. It is inserted into the uterus through the cervical canal. An applicator string is used to put the IUD into place. Mirena is intended to be used by women who have already had at least one child. The reason why Mirena is supposed to be used by women with children is because the test data submitted to the FDA that resulted in approval had sampled women with children. The device was approved by the FDA for usage in 2000.
Complications From Mirena iud
While every device has some level of side effects and complications, the possible problems with Mirena can be severe. An IUD is supposed to remain in place over the course of the five years where it is implanted. In some women, the IUD can shift in place. When that happens, it can cause severe damage to internal organs. This requires emergency surgery to remove the IUD as well as to repair the damage that was caused to the organ.
Even when Mirena remains in place, there is the possibility for damage. The IUD can perforate the uterus, causing severe pain. When the uterus is damaged, women can no longer have children even after they no longer wish to use the device. In addition, the device can perforate abdominal walls and can cause hemorrhage or serious internal bleeding. In 2008, the FDA required Bayer to update its warning label to include warnings for the possibility of a perforated uterus and perforation or expulsion of the device.
Thousands of cases were filed against Bayer with regard to these mirena complications. In 2013, a judge dismissed many of these mirena complications lawsuits against Bayer. The judge had barred the plaintiffs’ expert witness from testifying. The judge had ruled that the expert witnesses were unqualified or unreliable. Without expert testimony, the judge dismissed all of the Mirena complications lawsuits in the multi-district litigation. Other cases were dismissed since a court held that they were filed outside of the statute of limitations. Numerous claims remained in a multi-district litigation that is in New Jersey.
Side Effects in the Brain
There is another group of lawsuits claiming a different set of complications from the use of Mirena. These lawsuits allege that Mirena has caused brain injury in women. Specifically, women have experiences issues with balance and blurred vision. Further, lawsuits have alleged that Mirena causes idiopathic intracranial hypertension and Pseudotumor cerebri. The possible linkage between these conditions and Mirena is due to the synthetic hormone that Mirena uses to provide birth control. There is a long history of birth control devices being linked with intercranial hypertension.
2015, Canada research
In 2015, researchers in Canada undertook a study after reviewing adverse events that were reported to the FDA. This study found that women with Mirena were 78 percent more likely to develop pseudotumor cerebri. This condition increases pressure inside the skull and causes various side effects, including death in a worst-case scenario. This condition is similar to a brain tumor, but without the actual growth of the tumor. This condition is never fully healed.
Pseudotumor cerebri cases represent Bayer’s greatest challenge in litigation
The recent category of lawsuits have alleged that Mirena is a defective product. There have been hundreds of lawsuits that have been filed, and they are just at their early stages. Of recent, the total of lawsuits filed is nearing 1,000. These lawsuits have been granted multi-district litigation status in New York. These cases will be beginning discovery, but are still a far way from a jury trial. Given that the perforation lawsuits have not yet been successful, the pseudotumor cerebri cases represent Bayer’s greatest challenge in litigation. There are currently new cases being filed monthly under this theory of liability. In part, they allege that Bayer knew that this type of synthetic hormone could cause this side effect given the research that went back many years.
If you or a loved one have had a Mirena IUD implanted and have experienced any of these Mirena complications or Mirena side effects, you should immediately consult with a Mirena lawsuit lawyer to discuss the facts of your case. The Mirena lawsuit attorney can inform you of the prospects for a legal recovery and the process that would need to be followed to reach that point.