Since Mirena was first approved by the U.S. Food and Drug Administration in 2000, millions of women have used the intrauterine device (IUD) to prevent unwanted pregnancies and treat heavy menstruation.
Most women use Mirena without issue. However, a growing number of women have reported serious side effects, such as infection, perforation, false brain tumors, device expulsion, and more. The severe and sometimes unexpected complications have led to thousands of women filing lawsuits against the manufacturer of Mirena.
Lawsuits have been working their way through the legal system as plaintiffs accuse drugmaker Bayer of overstating the benefits of Mirena, concealing risks, failing to warn consumers, and more.
Mirena is a small, T-shaped birth control device that releases a hormone called levonorgestrel. The intrauterine device is placed in the uterus by a doctor in a nonsurgical procedure that only takes a few minutes. The device is intended to stay in place as a long-term contraceptive for up to five years before needing to be replaced.
Hormonal IUDs were first developed in the 1970s. However, Mirena wasn’t officially created until a few years later when a Finnish doctor named Jouni Valtteri Tapani Luukkainen developed a device intended to release the hormone levonorgestrel over a five-year period.
Mirena was launched in Finland in 1990. The device wasn’t officially approved for use as a contraceptive in the United States until December 2000. By then, the device had already been used by around two million women in Europe.
Mirena was later approved by the FDA for the treatment of heavy menstrual bleeding.
Although the device is touted as more than 99 percent effective in preventing pregnancy, it remains unclear exactly how Mirena works. It is believed Mirena works in three ways.
The device, which releases a progestin hormone called levonorgestrel, is thought to inhibit the sperm from reaching and fertilizing the egg. It is also said to thin the lining of the uterus. Finally, the device is believed to thicken cervical mucus to prevent sperm from entering the uterus.
Some women experience adverse effects while implanted with the Mirena IUD. Here are some of the most common side effects:
Some women experience pain, bleeding, or dizziness during and immediately after placement.
Sometimes Mirena may come out fully or partially, resulting in bleeding, pain, and ineffectiveness.
An estimated 12 of every 100 women will develop cysts in the ovary. Most cysts will disappear within two months, but others require surgery.
Irregular spotting and bleeding between menstrual periods were among the most common side effects.
About 5 percent of women will gain around 4.4 pounds on average within the first year of device implantation.
Additional common side effects include acne, abdominal and pelvic pain, nausea, vaginal discharge, mood changes, headache, and more.
Most women experience only a few mild side effects. In rare instances, more serious complications and side effects can arise in those implanted with Mirena.
After Mirena is implanted in the uterus, there have been reports that the device has moved from its position. This can be dangerous because it may not only increase the chances of getting pregnant but also result in the perforation of the uterus.
When an IUD migrates or perforates the uterus, it can sometimes require multiple surgeries to find the device and repair the puncture. This doesn’t take into account the pain and additional complications associated with migration.
Although only about 1 percent of women contract pelvic inflammatory disease (PID) due to Mirena, the infection can be very serious. If caught early, PID can be treated with antibiotics. When left untreated, PID can cause irreversible damage like infertility, scarring of the tissue, long-term pelvic pain, and worse.
Some studies have also linked Mirena to a condition called pseudotumor cerebri or idiopathic intracranial hypertension. This is when an increase in pressure in the skull mimics the symptoms of a brain tumor, like migraines, vision troubles, and tinnitus. The condition can even result in brain damage or death.
As a result of painful and unexpected side effects, more than a thousand women have filed lawsuits against Bayer over claims that the company knowingly released an unsafe product to the public and was negligent.
Some of the first Mirena lawsuits filed dealt with cases of migration and perforation. In one case, for example, plaintiff Desaree Nicole Lee Johnson sued Bayer after her Mirena IUD perforated her uterus and migrated to her abdomen. She had to undergo surgery to remove it. She became pregnant later but suffered vaginal bleeding and had a miscarriage. She believes she may now be infertile.
In 2013, about 1,800 cases related to the perforations were consoliApril 17th, 2018d into multidistrict litigation (MDL) in federal court after the U.S. Judicial Panel on Multidistrict Litigation (JPML) saw that they had similar questions of fact.
The lawsuits were also bolstered by claims that Bayer had conducted misleading marketing campaigns for Mirena — a practice that resulted in a warning from the FDA.
However, about 1,200 cases were reluctantly dismissed in 2016 after a lack of expert testimony.
In August 2017, the two sides agreed to a tentative settlement that would resolve the perforation claims and hundreds of other lawsuits pending in New Jersey and California state courts.
Although the majority of cases dealt with perforation, a second MDL was created to deal with cases related to claims of pseudotumor cerebri.
Plaintiffs initially tried to get an MDL created in 2014, but the JPML denied the request due to a small number of lawsuits. Three years later in 2017, the JPML granted the motion to centralize the lawsuits after the number grew dramatically.
As of April 2018, 480 cases were pending in the second MDL.
Attorneys are currently looking for women who have been harmed by Mirena through unexpected side effects like device migration and perforation or intracranial hypertension. Those who have been affected by Mirena are encouraged to pursue justice by contacting a qualified attorney to find out more.
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