Mirena is an intrauterine device (IUD) that is inserted into the uterus to prevent pregnancy. It is a hormonal birth control method that involves the release of progestin in order to suppress ovulation, thin the uterine lining, and prevent fertilization of an egg. Mirena is intended to offer long-term pregnancy prevention, and women may have the device in for up to five years before a replacement is needed.
Common Mirena IUD side effects
Many serious Mirena side effects have been reported to the FDA. About 45,000 adverse events have already been reported.
Possible side effects of Mirena IUD birth control can include:
- Nausea and vomiting
- Yellowing of the skin and eyes
- Pain during intercourse
- Infection (fever, chills)
- Allergic reaction (trouble breathing, swelling of the facial region, hives)
- Pale skin/easy bruising
- Extreme dizziness
- Pelvic pain and cramps
- Vaginal bleeding, sores, or discharge
- Embedment in the uterine wall
- Erosion of the IUD
Some women have also experienced Mirena side effects like back pain, mood changes, weight gain, nausea, vomiting, and bloating. It’s also possible to experience heavy menstrual bleeding or breakthrough bleeding, along with other irregularities in menstruation. While taking Mirena, nausea and vomiting have been some of the most common symptoms. However, these symptoms could be part of a larger issue.
Mirena can also cause ovarian cysts, which are abnormal growths of the ovaries that can rupture. If this complication occurs, internal bleeding and ovarian torsion may result.
IUD Migration May Lead to Perforation of the Uterus
The Mirena IUD is inserted by a healthcare professional, and it is intended to remain in place until the healthcare professional removes it. However, the uterine wall can be perforated, or punctured, by the IUD when the doctor inserts it. In addition, the FDA has received many reports of perforation that occurred at some point after insertion. This adverse event can lead to infection, organ damage, and adhesions.
Uterine perforation often requires surgery, and sometimes multiple surgeries may be needed. Scar tissue that develops as a result of surgery may cause infertility. Women who have experienced these Mirena IUD side effects have reported heart palpitations, nausea, vomiting, fever, and abdominal pain.
Migration of Mirena Necessitates Surgery
It’s critical for Mirena patients to see their healthcare providers upon experiencing any possible symptoms of uterine perforation. If treatment is delayed, the device can migrate further until it is outside the uterine cavity. This risk is heightened in women who have this birth control device inserted shortly after giving birth, particularly while they are breastfeeding.
Some women have suffered from intestinal perforation due to migration of the Mirena device. This can lead to abscesses, intestinal obstruction, and damage to other organs and tissues, along with adhesions and scarring. Patients might require surgical intervention to remove the IUD once it has migrated, and surgeries carry additional risks, such as adverse reactions to anesthesia and infections.
Pelvic Inflammatory Disease (PID) Reported
Mirena side effects can also include pelvic inflammatory disease, which is a bacterial infection. Severe indications of PID include symptoms of shock, including fainting, as well as a high fever, vomiting, and severe lower abdominal pain. Some women may also have difficulty passing urine, fatigue, and a heavy, foul-smelling vaginal discharge. If it is left untreated, PID can lead to chronic pelvic pain, infertility, and an ectopic pregnancy.
If an ectopic pregnancy occurs, it is a potentially life-threatening situation that requires prompt medical care to remedy significant internal bleeding. It occurs when a fertilized egg is unable to travel through the fallopian tube. Emergency surgery is required to treat it.
More Women Using IUDs
It has been estimated that 15 million women worldwide have used the Mirena IUD, with 2 million women in the U.S. relying on the birth control device manufactured by Bayer. Positive reviews have noted the convenience of the device; unlike a pill, it does not need to be taken daily. Clinical trials have shown Mirena to be more effective in stopping pregnancy than oral contraceptives: the failure rate with Mirena, when working correctly, is less than 1% over five years.
In 2002, about 1.4 percent of contraceptives used were IUDs, whereas in 2010, IUDs made up about 10.4 percent of prescribed birth control.
Mirena FDA Warnings
The FDA approved Mirena for consumer use in 2000. However, in 2009, the FDA sent a warning to Bayer, the manufacturer. The FDA noted a misbranding of the product and stated that the company made misleading claims regarding its indications. Bayer had launched a marketing campaign that insinuated that the Mirena IUD would improve a couple’s intimacy and romance.
In that same warning letter, the FDA noted the potential for serious Mirena IUD side effects. The warning letter stated that Bayer had failed to adequately warn consumers of the side effects of the IUD, and that the company did not make accurate statements regarding the proper functioning of the device.
Mirena Side Effects Prompt Lawsuits
These potentially permanent complications have prompted many to file Mirena lawsuits against Bayer. Many of the lawsuits claim that the company failed to warn doctors and patients of the risks of the IUD device. Mirena lawyers for the plaintiffs have often cited migration of the device and the potential for uterine perforation as injuries for which Bayer is liable. Lawsuits allege that the company has claimed that these side effects are not common.