Mirena IUD Problems
Approved by the FDA in 2000 as a 5-year option for intrauterine contraception, the Mirena IUD was designed to disrupt the release of eggs from the ovary by incrementally distributing the progestin levonorgestrel into the body. The device, used by an estimated two million women in the U.S., is purported to have an advantage over oral contraceptives because it requires no monthly maintenance or monitoring. Pre-clinical trials demonstrated that women using the device had a less than one percent risk of becoming pregnant. Manufacturer Bayer Healthcare Pharmaceuticals promoted the Mirena IUD as a safe, reversible from of birth control, but according to a growing number of lawsuits filed against the company, some women who have used the device have experienced serious Mirena IUD problems, including spontaneous migration and uterine perforation.
The FDA has received thousands of adverse event reports detailing Mirena IUD problems.
Some of the common side effects of Mirena IUD include:
- Pain, bleeding, or dizziness immediately after placement. Symptoms should stop within 30 minutes of having the device fitted. If symptoms continue, the IUD may need to be removed or replaced.
- Expulsion. The Mirena IUD may come out by itself. If expulsion goes unnoticed, you are susceptible to pregnancy. Contact your physician if you notice the Mirena IUD has come out, and use another form of birth control in the meantime.
- Missed periods. Around 20% of women stop having periods after one year of using the device. If this happens, contact your physician.
- Changes in bleeding. Especially common during the first 3 to 6 months, bleeding and spotting between menstrual periods should become lighter than usual. Contact your physician if the bleeding remains heavy or becomes heavier than usual.
- Ovarian cysts. Around 12% of women using the Mirena IUD develop a cyst on the ovary. They usually disappear within a couple of months. However, some cysts may require surgery.
Surgical removal of Mirena intrauterine device
There are other more serious, less common Mirena IUD problems. Some of them may require surgical removal of the Mirena intrauterine device:
- Pelvic inflammatory disease (PID):. Some patients may experience this serious pelvic infection. PID can cause infertility, ectopic pregnancy or persistent pelvic pain. Commonly caused by contraction of a sexually transmitted disease, PID is usually treated with antibiotics, but more serious cases require surgery. In extreme circumstances, PID can require a hysterectomy (surgical removal of the uterus), and it has been known to cause death. Symptoms of PID include long-lasting or heavy bleeding, unusual vaginal discharge, abdominal pain, painful sex, chills, or fever.
- Life-threatening infections can occur within a few days of having the device fitted. Tell your doctor if you develop severe pain within a few hours of the device being fitted.
- Embedment. The IUD may become attached to the uterine wall. It may no longer work as a contraceptive, and may require surgical removal.
- Perforation of uterus. If the IUD migrates, or becomes displaced from its initial position after insertion, it can cause uterine perforation. The IUD may then enter the abdominal cavity, pelvis, bladder, or blood vessels. This can cause internal scarring, infection, and intestinal damage, and organ damage. A radiologist may need to use ultrasound or X-rays to locate the device. Surgical removal of the Mirena intrauterine device may be required. Mirena peforation is a particular risk for women who have delivered a child within six months prior to the device being fitted.
Women who have filed lawsuits seeking to hold Bayer liable for injuries derived from Mirena IUD problems allege that the product warning label makes no mention of the risk of spontaneous migration after initial insertion. The warning label does acknowledge a risk of uterine perforation, but indicates that it is only possible at the time the device is inserted by a healthcare practitioner.
Pregnancy problems caused by migration of IUD
Women who experience Mirena IUD migration are vulnerable to pregnancy. Women who become pregnant while the Mirena device is still in their body run an increased risk of pregnancy complications. In many cases, doctors may recommend the surgical removal of the fertilized egg.
Women who become pregnant while using levonogesterel face additional Mirena IUD problems such as:
- Septic abortion
- Premature delivery
- Ectopic pregnancy
Ectopic pregnancy (also referred to as tubal pregnancy, or cervical pregnancy) occurs when the zygote, or fertilized egg, begins to develop in a part of the body other than the womb, usually in the fallopian tubes. There is no chance that a fetus can survive an ectopic pregnancy. Symptoms of ectopic pregnancy, which is life-threatening for the mother, include:
- Unusual vaginal bleeding
- Lower back pain
- Pelvic cramping
- Breast pain
- Intense rectal pressure
- Low blood pressure
Mirena lawsuit options
Mirena lawsuit plaintiffs allege that Bayer Healthcare Pharmaceuticals failed to sufficiently warn them about the risks of Mirena IUD problems and the injuries that could be sustained as a result. They contend that the IUD was defectively designed and manufactured, and that Bayer failed in its duty to conduct adequate pre-market and post-market testing of the device. They also claim that Bayer falsely marketed the IUD to consumers, citing a 2009 warning letter to Bayer from the FDA’s Division of Drug Marketing, Advertising, and Communications. In the letter, an FDA regulatory reviewer concludes that Bayer’s consumer-directed marketing program “overstates the efficacy of Mirena, presents unsubstantiated claims, minimizes the risks of using Mirena, and includes false or misleading presentations regarding Mirena.”
The FDA concludes that “the program misbrands the drug in violation of the Federal Food, Drug, and Cosmetic Act … and FDA’s implementing regulations.”
Lawsuits over Mirena IUD problems have been filed in state and federal courts. If you believe you have suffered harm due to a Mirena IUD, you may be entitled to legal compensation for your injuries and other damages. Consulting a Mirena IUD lawyer is the first step in determining whether litigation is a viable option.
- U.S. National Library of Medicine; National Institutes of Health, Medline Plus: Hysterectomy, http://www.nlm.nih.gov/medlineplus/hyst...
- Planned Parenthood, Pelvic Inflammatory Disease (PID), http://www.plannedparenthood.org/health-topics/stds-hiv-safer-sex/pelvic-inflammatory-dis...
- U.S. National Library of Medicine, PubMed Health: Ectopic Pregnancy, http://www.ncbi.nlm.nih.gov/pubmedhealth/P...
- Food and Drug Administration (FDA), (December 30, 2009) Warning Letter and Notice of Violation to Bayer Healthcare Pharmaceuticals, http://www.fda.gov/downloads/Drugs...