Update: Mirena Lawsuits Consolidated in New York
April 26, 2017: More than 100 federal Mirena lawsuits have been consolidated as part of a multidistrict litigation (MDL No. 2767) in the District of New York. The complaints allege that the levonorgestrel released by Mirena increases the risk of idiopathic intracranial hypertension (IIH), also known as pseudotumor cerebri (PTC) and benign intracranial hypertension (BIH).
First approved by the U.S. Food & Drug Administration (FDA) in 2000, Mirena is a small, t-shaped device that works by releasing a low dose of levonorgestrel (a so-called ‘third generation’ synthetic progestin) directly into the uterus. Like other similar contraceptive devices, the levonorgestrel contained in Mirena is designed to prevent pregnancy by thinning the line of the uterus, thereby blocking sperm from reaching and fertilizing the egg, and by thickening the cervical mucus to prevent sperm from entering the womb. Mirena is typically recommended to women who have had at least one child, and can remain in place for up to five years. In 2009, the device was approved to control heavy menstrual bleeding in women who prefer IUDs as their method of birth control, the first time the FDA has ever approved such a device for this purpose.
Mirena Side Effects
Despite its considerable effectiveness as a contraceptive device, Mirena may have the potential to cause the following serious side effects:
- Device migration
- Perforation of the uterus
- Pseudotumor Cerebri (PTC)
- Idiopathic Intracranial Hypertension (IIH)
- Benign Intracranial Hypertension (BIH)
- Embedment in the uterine lining
- Erosion of adjacent areas such as the vagina
- Inflammation of the membrane that lines the abdominal cavity and internal organs (Peritonitis)
- Intestinal perforations or obstruction
- Pelvic Inflammatory Disease
- Ovarian cysts
- Irregular spotting or bleeding
- Painful menstruation
- Pelvic pain
- Weight gain
- Breast tenderness
- Streptococcal sepsis
- Ectopic Pregnancy
- Intrauterine pregnancy
- Wrongful death
In a number of recipients, Mirena has been found to have the ability to puncture the uterus or embed itself in the uterine wall. When this occurs, it can cause extensive internal scarring, infection, or damage to other organs, and may result in the need for surgery. If the perforation goes undetected, the Mirena IUD may migrate through the intra-abdominal cavity, causing intestinal perforations or obstruction, abscesses or adhesions.
There have also been numerous reports of partial or complete expulsion of the Mirena IUD. This complication has been found to occur most often in younger women implanted with the device, and among those who have had no children or women who have had Mirena inserted immediately after childbirth or abortion. As a result, recipients may suffer serious scarring that may jeopardize their future ability to conceive, and in severe cases, resulting infections may be life-threatening and result in death from Mirena.
FDA Warning Letter on Mirena
In December 2009, the FDA sent Bayer executives a warning letter concerning the company’s marketing tactics over Mirena. The administration stated that Bayer “overstates the efficacy of Mirena, presents unsubstantiated claims, minimizes the risks of using Mirena, and includes false or misleading presentations regarding Mirena.”
In its letter, the administration accused Bayer of conducting live, in-home Mirena promotional events which claimed that use of the device would improve couples’ relationships and sex lives. The FDA also noted that Bayer representatives told prospective users that Mirena would help them ‘look and feel great,’ even though there was absolutely no evidence to support such claims.
The FDA went on to point out that at least 5% of women implanted with the Mirena IUD reported a decrease in libido, which would certainly not help a couple’s sex life. Additionally, the administration stated that a large number of Mirena recipients had complained about side effects including irregular bleeding, ovarian cysts, back pain, weight increase, breast pain and tenderness, and acne. None of these complications would help a woman look or feel ‘great,’ the FDA letter said.
Mirena lawsuits are currently being reviewed and evaluated by lawyers nationwide on behalf of women who may have suffered severe, potentially-irreversible injuries from the Mirena IUD. According to the claims, these complications could have been prevented if Bayer had properly researched Mirena and warned the public about the potential health risks associated with the device.
Georgia Woman Alleges Stillborn Baby from Mirena IUD
April 22, 2016 – A wrongful death lawsuit has been filed against Bayer by a woman who allegedly gave birth to a stillborn baby after receiving the Mirena IUD, according to The Telegraph. Plaintiff Abigail Lane claims that when she was implanted with Mirena by her physician in 2009, Bayer failed to adequately warn of the serious health risks involved with using the contraceptive. The complaint further alleges that risks were omitted in a manufacturer’s pamphlet on Mirena given to Lane’s doctor, who subsequently gave the document to Lane to consider whether she wanted to use it.
New Jersey Lawsuit Alleges Lack of Warning on Mirena Side Effects
June 9, 2015 – A lawsuit filed today in New Jersey federal court accuses Bayer of failing to adequately warn of the potential health risks associated with the Mirena IUD. After being implanted with the birth control device in Feb. 2013, plaintiff Chelsea Dawn McClune began experiencing severe abdominal pain and was admitted to an emergency room, where it was determined that the IUD had pierced her uterus and become embedded near the uterosacral ligament.
Do I Have a Mirena Lawsuit?
The Medical Device Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Mirena lawsuits. We are handling individual litigation nationwide and currently accepting new Mirena perforation of the uterus cases in all 50 states.
If you or a loved one was injured by Mirena IUD side effects, you should contact our law firm immediately. You may be entitled to compensation by filing a lawsuit and our lawyers can help.