Warnings & Recalls for Mirena
Severe Warnings
Mirena has been associated with severe complications due to malfunctions in the IUD. Mirena has been known to cause infections, internal lacerations and eventual infertility from uterus perforation/embedding in the uterine wall. Many women have required serious hospitalization and surgery to remove Mirena, and as a result can suffer from physical and emotional pain. If you or a loved one have suffered from Mirena's effects, complete the form to the right to get the help you deserve.
Family Planning Warnings
- The hormone used in Mirena, Levonorgestrel, has been rated category X by the FDA and can cause miscarriages, ectopic pregnancy or birth defects in those who are pregnant or may become pregnant while Mirena is inserted.
- The hormone is also excreted through breast milk, however nursing mothers should be advised that studies have shown that no adverse effects on the development infants.
- Studies have shown no signs of fetal harm or negative side effects on breastfeeding associated with long-term use of progestins.
General Warnings
Patients considering Mirena are strongly advised to notify their doctors of the following conditions:
- History of migraines or exceptionally severe headaches
- Increase of blood pressure
- Severe arterial disease such as stroke or heart attack
- Pregnancy
- Congenital or acquired uterine anomaly including fibroids if they distort the uterine cavity
- Breast carcinoma
- Uterine or cervical neoplasia
- Abnormal Pap smear
- Liver disease including tumors
- Untreated acute cervicitis or vaginitis, including lower genital tract infections (e.g., bacterial vaginosis)
- Postpartum endometritis or infected abortion in past 3 months
- Unexplained vaginal bleeding
- Current IUD
- History of acute pelvic inflammatory disease (PID) or conditions increasing susceptibility to pelvic infections
- Diabetes
Mirena will not protect against STDs or HIV, and will not prevent their spread.
It is rare to become pregnant while using Mirena, but patients who do become pregnant while using Mirena are advised to alert a doctor immediately to have the IUD safely removed.
Mirena may come out at some point, or be shifted out of place. This can occur at any time, but is most common while menstruating. If the device comes out or you can no longer see the threads, tell your doctor immediately so that they can reinsert or replace the device.
Interactions
- barbiturates
- bosentan
- carbamazepine
- felbamate
- griseofulvin
- oxcarbazepine
- phenytoin
- rifampin
- St. John’s wort
- topiramate
Mirena Treatment and Use
What is Mirena?
Mirena | (levonorgestrel-releasing intrauterine system) is a intrauterine device (IUD) which is is indicated for the use of long-term birth control and can also be used to treat heavy menstrual flows. Mirena may prevent pregnancy for up to five years and is often recommended in women who have already had at least one child.
How Mirena works
Mirena is an estrogen-free contraceptive, and instead releases the hormone progestin, which is thought to prevent pregnancy in the following ways:
- Thinning the lining of the uterus.
- Preventing the sperm from fertilizing an egg.
- Thickening the cervical mucus to interfere with sperm entering the uterus.
How Mirena is administered
Mirena is inserted into the uterus by a healthcare professional 7 days after the beginning of the menstrual cycle, and can prevent pregnancy up to five years after insertion.
