FDA Warns About Mirena Risks
Serious risks include embedment, perforation and expulsion of the IUD device.
The Mirena intrauterine device is a t-shaped contraceptive device manufactured by Bayer, Inc. This IUD has caused numerous complications for women who use the contraceptive device, including perforation of the uterine wall, migration from the original location, and embedment in the uterine wall. An increasing concern over complications like these led the FDA to change the prescribing information for Mirena in July 2008 to include warning of embedment, perforation, expulsion and other previously unknown risks.
Mirena (Levonorgestrel) is an intrauterine contraceptive system (IUD) approved for women who have already had at least one child. It’s made of a soft, flexible plastic with a string or “tail” also made of plastic and is placed by a medical professional.
This birth control device contains the female hormone, levonorgestrel. Available only by prescription, it is placed in the uterus where it slowly releases the hormone. When it is in place, Mirena stops a woman’s egg from fully developing which prevents fertilization by a sperm and prevents pregnancy. Once implanted, the system can be left in place for up to five years and is more than 99 percent effective at preventing pregnancy.
The FDA has also approved Mirena for use to treat heavy menstrual bleeding, primarily recommended for women that have already given birth.
For many American women, using an IUD such as Mirena is a convenient choice for birth control. No daily pills to remember to take and once inserted, it can almost be forgotten for up to five years. However, this option can also be responsible for dangerous side effects.
Mirena Side Effects
Mirena was approved by the FDA in 2000. Since then, there have been thousands of serious adverse complications reported to the FDA. Some of the injuries reported include:
- Perforation of the uterine wall
- Device embedding in the uterine wall
- Device migrating from the original implanted location
- Becoming pregnant while using device
The use of Mirena is associated with a number of other risks such as pelvic inflammatory disease (PID), ovarian cysts, irregular bleeding, and permanent loss of fertility.
In 2009, the FDA cited Bayer for its Mirena promotions, stating they were misleading and downplayed risks associated with the device. The lawsuits allege that the company should have a warning on the IUD to make consumers aware of the dangers and possible adverse side effects.
According to a letter from the FDA Division of Drug Marketing, Advertising, and Communications, Bayer had made “unsubstantiated claims” about the efficacy of their product while minimizing the risks to the consumer of using Mirena. They were told to not make any further “false or misleading presentations regarding Mirena.”
We are filing claims now on behalf of women that used Mirena and experienced serious complications such as perforation of the IUD particularly if they required surgery to remove and repair the damage caused by Mirena.
To see if you might qualify for a claim against the manufacturer, all you need to do is call us or fill out the convenient form on this page and a member of our legal team with contact you. There may be a time limit to submit your case, so please do not delay.
It is time that drug and medical device makers stop putting money ahead of the emotional and monetary costs to us and our families. Please contact us now to find out immediately if your Mirena experience qualifies you for a claim.
Lawsuits Being Considered For An Additional Mirena Side Effect
Mirena Side Effects Might Include Pseudotumor Cerebri
Lawsuits are being considered for an additional Mirena side effect. Bayer may have known of a risk between the use of their IUD and neurological problems such as pseudotumor cerebri (PTC).
Symptoms of PTC are similar to that of a brain tumor but without the presence of a tumor. The patient will have increased pressure inside their skull possibly affecting their brain and optic nerve. PTC can cause vision loss or blindness and there is no treatment to reverse the damage.
Bayer did not include a warning about the risk of PTC or other possible neurological side effects in the prescribing information. Lawsuits are being considered accusing them of hiding this serious risk.
If you have used the Mirena IUD and were diagnosed with pseudotumor cerebri, please contact us immediately to find out if you might have a case.