Mirena IUD Lawsuit
When implanted correctly, the Mirena intrauterine device is more than 99 percent effective at preventing pregnancies. While no method is 100 percent foolproof, Mirena is a dependable long-term contraceptive. That’s why it’s not surprising millions of women around the world have opted to get a Mirena IUD.
But, what thousands of women learned the hard way is that Mirena carries unexpected side effects that could leave them in severe pain, blind, infertile, or dead. Drugmaker Bayer has been the target of thousands of lawsuits related to its Mirena IUD after women claim the pharmaceutical company failed to protect the public from side effects like ovarian cysts, infections, intracranial hypertension, perforation, and more.
Bayer has attempted to settle with women claiming that their Mirena IUD moved and pierced a hole in their uterus. However, hundreds of cases related to claims of intracranial hypertension are still making their way through court.
What is Mirena and How Does it Work?
Mirena is an intrauterine device (IUD) that releases a progestin hormone called levonorgestrel to prevent pregnancies. The T-shaped device is implanted in the uterus by a healthcare provider and is intended to last for up to five years.
According to Bayer 1, the device likely works by thickening cervical mucus to stop sperm from entering the uterus, keeping sperm from fertilizing the egg, and thinning uterine lining. It remains unclear precisely how these actions stop pregnancy.
Background of Mirena
The first IUDs were developed in the early 1900s, but the more modern iterations of the devices weren’t created until the 1960s. IUDs that released hormones were developed in the years after. Eventually, a Finnish doctor used the hormone levonorgestrel to be released from his device over a five-year period, elongating the time the IUD could be implanted. The device was called Mirena.
Mirena was first approved for medical use in Finland in 1990 and later approved by the U.S. Food and Drug Administration (FDA) in 2000. The drug is now manufactured by German drug company Bayer.
Over the years, Mirena has grown in popularity. This has led to an increase in profits. From 2006 to 2010 2, revenue for Mirena went from $219 million to $714 million. During that time, the FDA also approved Minera for the treatment of heavy menstrual bleeding. The revenue for Bayer has only gone up since then.
Mild Mirena Side Effects
Like nearly all birth control methods, Mirena is linked to several common side effects. Common side effects can be broken down into two categories: during placement and after placement.
A patient may experience the following side effects during or immediately after placement:
- Pale skin
After Mirena has been placed inside the uterus for several weeks, these side effects may occur:
- Weight gain
- Irregular bleeding
- Loss of menstrual period
- Hair loss
- Abdominal and pelvic pain
- Unwanted hair growth
Severe Mirena IUD Complications
Studies and reports have also linked Mirena to more serious complications. Here are just a few.
Device Migration and Perforation
When a Mirena IUD is not properly implanted or fails, it can result in migration or perforation. The consequences of IUD migration to another part of the body can be traumatic. In some cases, perforation can happen during placement. Perforation of the uterus could result in unexpected pregnancies with the device implanted.
Migration or perforation could require surgery for removal. There have been cases where women had to undergo multiple surgeries to find the device.
Pelvic Inflammatory Disease (PID)
Pelvic inflammatory disease (PID) is an infection of the reproductive organs and is typically caused by untreated sexually transmitted diseases.3 However, a little less than 1 percent of women with Mirena will also suffer from the disease. Early diagnosis is important because damage cannot be undone. When left untreated, PID could scar the fallopian tubes, cause infertility, and lead to long-term abdominal pain.
Though rare, some women have become pregnant with Mirena implanted. Half of pregnancies that occur with Mirena are ectopic pregnancies, a condition where the egg is fertilized outside the uterus. This poses a danger to the mother’s life and could result in infertility. Other complications related to pregnancy can be premature delivery and miscarriage.
Idiopathic Intracranial Hypertension
Idiopathic intracranial hypertension, also known as pseudotumor cerebri, is a condition caused by increased pressure in the brain. It can manifest itself as symptoms of a brain tumor, such as headaches, vision loss, and ringing in the ears.
The condition could also result in progressive and sometimes permanent loss of vision if left untreated, according to Johns Hopkins Medicine.4
While research like a 2011 study 5 in the Contraception Journal has found no link between Mirena and breast cancer, there have been some reports of breast cancer in women taking Mirena. This has prompted Bayer to add a warning to the label that “spontaneous reports of breast cancer have been received during postmarketing experience with Mirena.”
Mirena Lawsuits Filed in State & Federal Courts
Since 2000, the FDA has received more than 70,000 injury reports related to Mirena. This has resulted in thousands of women across the country filing lawsuits against Bayer.
The first lawsuits dealt solely with injuries related to perforation. In one case, plaintiff Melody Williams said she suffered pain and cramping within a year of receiving the implant. She underwent several surgeries and procedures to retrieve the Mirena IUD, which had migrated through the opening of her fallopian tube. She and her husband accused Bayer of negligence and a disregard for public safety.
Thousands of women had filed lawsuits related to migration and perforation injuries in federal and state courts. In 2013, 1,800 federal cases were consolidated into multidistrict litigation. That same year, thousands of cases in New Jersey state court were also consolidated into multicounty litigation.
After no expert testimony could back up the claims of the plaintiff, the court dismissed more than a thousand cases in federal court in 2016. Plaintiffs tried to appeal the decision but were denied in 2017.6
A settlement was eventually reached between the two sides in August 2017.7 The tentative agreement would cover cases dealing with migration and perforation in federal and state courts.
Mirena Intracranial Hypertension Claims Still Pending
Although a resolution to the claims that Mirena migrated and perforated organs has been tentatively reached, more federal lawsuits are still pending.
A newer group of lawsuits have been filed against Bayer related to pseudotumor cerebri. Plaintiffs say that the hormones in Mirena led to increased pressure in the brain and adverse effects.
Plaintiffs were successfully able to centralize all the cases relating to the condition in April 2017 after the U.S. Judicial Panel on Multidistrict Litigation found they all dealt with similar questions of fact. More than 450 cases are currently pending in district court in New York.8 Lawyers expect more cases to be filed against Bayer.9