Bayer’s popular intrauterine device (IUD) Mirena has recently been linked to a number of serious side effects, the most severe of which is perforation of the uterus. In a large number of recipients, Mirena has been reported to migrate from its original position after being inserted, perforating the uterus or embedding itself in the womb. In either case, the woman must undergo painful revision surgery to remove the Mirena IUD.
Mirena Lawsuit Update 9/24/13: The number of lawsuits filed against pharmaceutical giant Bayer over its controversial Mirena intrauterine device (IUD) continues to increase, with nearly 400 cases currently pending in courthouses around the country. The vast majority of these complaints were filed on behalf of women who allegedly suffered serious injuries after receiving Mirena, such as organ perforation, abscesses, infections, and migration from the implant site. Click here to learn more.
Free Mirena Lawsuit Evaluation: If you or a loved one suffered uterine perforation after being implanted with the Mirena IUD, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturer of Mirena and our lawyers can help.
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
- 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.
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. Click here to learn more.
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.
Free Confidential Case Evaluation: 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.