Long-acting, reversible birth control is an increasingly popular method of contraception for women in the United States. More than 10% of women who used contraception 2013 chose IUDs as their preferred method, up from 6% in 2010. The number-one prescribed IUD in the US, called Mirena, came come under scrutiny in recent years after women began reporting serious side effects caused by the device. Learn more about the popular birth control that has potentially dangerous consequences.
What is the Mirena IUD?
Mirena is a reversible, long-acting form of contraception that releases a low dose of hormones over time to prevent pregnancy. Mirena is an intrauterine device, or IUD, made of soft, flexible plastic in the shape of a “T.” It is inserted by a doctor into the uterus where it can last up to five years before it needs to be taken out and replaced if desired.
Mirena is the number one IUD in America and has been dubbed the “birth control for busy moms” by its manufacturer. It is recommended for women who have already had children, but has been used by women who do not have children, as well.
How does Mirena work?
Mirena prevents pregnancy by releasing small amounts of the hormone levonorgestrel, a type of synthetic hormone that mimics the naturally occurring hormone progestogen. Mirena does not contain estrogen.
The hormones released by Mirena work to thicken the cervical mucus to prevent sperm from entering the uterus; inhibits sperm from reaching or fertilizing an egg; and thins the lining of the uterus. The makers of Mirena believe the combination of those actions help prevent pregnancy, though the company says there is no single explanation for how Mirena works.
Mirena is inserted into the uterus by a doctor, but contains strings or threads at the end so women can check to make sure it is still in the correct position. When inserted correctly, Mirena is 99% effective at preventing pregnancy.
Who makes Mirena?
Mirena is manufactured by German pharmaceutical company Bayer Healthcare. Bayer is one of the largest pharmaceutical companies in the world, with annual sales of about $51.6 billion in 2015.
When was Mirena approved by the FDA?
Mirena was approved by the Food and Drug Administration (FDA) on Dec. 6, 2000. Mirena is indicated to prevent pregnancy for up to 5 years; it is also approved to treat heavy menstrual bleeding.
How much does Mirena cost?
Mirena is often covered by major insurance plans, which includes the cost of the device, as well as placement and removal by a doctor. If Mirena is not covered by insurance, it can cost upwards of $500 to $900 out of pocket.
Are there generic versions of Mirena?
No, there are no generic equivalents to Mirena.
Are there comparable devices on the market?
There are a few IUDs currently approved by the FDA to prevent pregnancy, including Bayer’s Skyla, Allergan’s Liletta and the copper IUD ParaGard, made by Teva.
Like Mirena, Skyla and Liletta are hormonal IUDs, meaning they contain hormones that are released slowly over time in order to prevent pregnancy. Skyla and Liletta can prevent pregnancy for up to 3 years.
ParaGard, on the other hand, is a non-hormonal birth control. ParaGard is made of copper, which prevents pregnancy without the use of synthetic hormones. ParaGard causes an inflammatory reaction in the uterus that is toxic to sperm.
All of these devices have their pros and cons and may work differently for different women. Other hormonal options for contraception include the pill and NuvaRing.
What are the possible side effects of Mirena?
Mirena has the potential to cause side effects that can range from mild to severe. The following are the most reported side effects associated with Mirena, according to the device’s label:
- Pain, bleeding or dizziness during placement
- Missed menstrual periods (amenorrhea)
- Changes in bleeding, including spotting between periods, longer or shorter periods,
- Benign cysts on the ovary
- Breast tenderness or pain
- Abdominal or pelvic pain
- Headache, migraine
- Back pain
- Depression, depressive mood
- Blood clots, stroke
- Device breakage
- Hypersensitivity, including rash, hives, and swelling under the skin
- Increased blood pressure
- Hair loss (alopecia)
- Male-pattern hair growth on the face, chest and back (hirsutism)
- Pelvic inflammatory disease
Other reported side effects include:
- Weight gain
- Decreased libido
Other side effects
Mirena is often talked about and reviewed on online blogs and forums and many women have reported experiencing certain adverse effects they believe to be caused by the IUD.
Some women have reported that Mirena may have caused weight loss, joint pain and muscle pain and problems with their thyroids.
Women have also reported experiencing problems after having the device removed. Some women have called this the “Mirena crash.” Women have reported post-Mirena side effects like frequent mood swings, sadness, anger, anxiety and depression, tiredness, flu-like symptoms, nausea, bloating and stomach pain and breast tenderness. Women report the side effects can occur for a week or more following the removal of the Mirena device.
Other women have reported that the Mirena device sent them into early menopause so they could not have kids naturally after having the device removed.
It is unclear whether or not Mirena caused the above-mentioned side effects.
What are the possible complications of Mirena?
Mirena has the potential to cause serious, long-term side effects and complications in some women, including migration and perforation, expulsion, sepsis and ectopic pregnancies.
Migration & Perforation
In both clinical trials and real-world practice, Mirena has been shown to perforate, or pierce, the uterus or cervix. In some cases, Mirena can perforate the uterus and migrate into organs in the pelvic or abdominal cavity, including the bladder. In rare cases, the device can perforate the rectum.
Perforation is a potentially serious complication and can cause scarring, infection and damage to other organs. The risk of perforation is about one in 1,000 users.
Studies show that perforation is usually the result of poor placement of the device within the uterus. If the device moves, it may not protect a woman against unwanted pregnancy. A perforated device must be removed and surgery may be required to do so.
Breastfeeding women have a higher risk of perforation because their uterine walls are softer. The Mirena label was updated in 2013 to indicate this risk.
Even if the device doesn’t perforate the uterine wall, it can still be expelled from the correct position and increase the risk for unwanted pregnancy. It is possible for the device to slip slightly from the correct position, called partial expulsion, or it can slip completely out of place, called complete expulsion. A device that is expelled must be removed.
Symptoms of expulsion may include:
- Increased menstrual flow
Sepsis is a potentially life-threatening complication that can occur within the first few days of insertion. Sepsis occurs when the chemicals released by the body into the blood stream to fight infection trigger inflammation, which can lead to tissue damage, organ failure and death.
Symptoms of sepsis may include:
- Difficulty breathing
- Abdominal pain
- Unusually fast heart rate
Ectopic pregnancy, pregnancy
The risk of pregnancy while the Mirena device is inserted is about one per 1,000 users, but half of all pregnancies that do occur are ectopic. Ectopic pregnancies occur when the egg implants itself in the fallopian tube instead of the uterus. Ectopic pregnancies require emergency treatment as they can cause internal bleeding, infertility and even death.
Symptoms and ectopic pregnancy include:
- Vaginal bleeding
- Nausea and vomiting with pain
- Lower abdominal pain
- Sharp abdominal cramps
- Dizziness or weakness
Has Mirena been recalled?
Mirena has not been recalled by either the FDA or Bayer.
Has the FDA issued any warnings about Mirena?
The FDA has not issued warnings about Mirena in regard to its safety or efficacy. The FDA has, however, sent warning letters to Bayer regarding Mirena and false and misleading claims the company made during an advertisement.
In 2009, the FDA sent a warning to Bayer about a live consumer-directed program the company made about Mirena. The FDA said the program “overstates the efficacy of Mirena, presents unsubstantiated claims, minimizes the risks of using Mirena, and includes false or misleading presentations regarding Mirena.”
According to the FDA’s warning letter, Bayer claimed Mirena could increase a woman’s level of intimacy and, therefore, make her happier. The FDA said it “is not aware of any evidence that suggests that women using Mirena for birth control experience an increase in reconnection, romance, or intimacy with their partners.”
Bayer also claimed Mirena could make women “look and feel great,” and falsely stated the device required no monthly routines despite the fact that women are advised to have their IUD checked 4 to 12 weeks after initial insertion and once a year thereafter.
Have lawsuits been filed against the maker of Mirena?
Women who were injured by the Mirena IUD have begun filing lawsuits against Bayer Healthcare saying the company failed to warn them about potential risks of the device.
Cases have been filed in federal court and are consolidated in a multidistrict litigation (MDL) in the U.S. District Court for the Southern District of New York.
U.S. District Judge Cathy Seibel is presiding over the cases which have now reached over 1,300.
I suffered harm as a result of the Mirena IUD. Can I file a lawsuit?
If you or a loved one was injured by the Mirena IUD, you may be entitled to compensation but you need to act now as cases are currently pending in U.S. federal court.
The Mirena lawyers and attorneys at Hood National Law Group can help you take on the pharmaceutical companies and seek the compensation you deserve.
Call the Hood National Law Group today to speak with a member of our legal team. We can answer your questions and help you determine if you have a case. Call us at 1-800-214-1010 for a free case evaluation or use the form on the right-hand side of your screen.