The Mirena IUD consists of a T-shaped polyethylene frame with a steroid reservoir around a vertical stem. The T-body is 32 mm by 32 mm (vertical and horizontal). The reservoir contains 52mg of levonorgestrel (a type of hormone) and small amounts are released daily.
While the package inserts and literature do warn about complications associated with the Mirena IUD, the patient is not warned that after the IUD is inserted it can perforate or pass through the uterus into other body parts such as the abdomen. If this occurs, it is necessary to remove the IUD through a surgical procedure such as a laparotomy.
In 2009, Bayer was reprimanded by the Department of Health and Human Services’ Division of Drug Marketing, Advertising, and Communications (DDMAC) for making false and unsubstantiated claims about Mirena® in their “Simple Style” program.
Here is a partial list of warnings:
WARNINGS
- Intrauterine Pregnancy
- Long-term effects and congenital anomalies
- Embedment
- Perforation
- Expulsion
- Ovarian Cysts
- Breast Cancer
PRECAUTIONS
- Patient Counseling Information
- Patient Evaluation and Clinical Considerations
- A physical examination should include...
- Irregular bleeding may mask symptoms and signs of endometrial polys or cancer...
- ...If involution is substantially delayed, consider waiting 12 weeks postpartum...
- Mirena should be used with caution in patients who have:
- migraine, focal migraine with asymmetrical visual loss or other symptoms indicating transient cerebral ischemia
- exceptionally severe headache
- marked increase of blood pressure
- severe arterial disease such as stroke or myocardial infarction
- Insertion Precautions
- Observe strict asepsis during insertion...
- Fundal positioning of Mirena is important to prevent expulsion...
- If the patient develops decreased pulse, perspiration, or pallor, have her remain supine until these signs resolve. Insertion may be associated with some pain and/or bleeding...
- Continuation and Removal
- Re-examine and evaluate patients 4 to 12 weeks after insertion and once a year thereafter...
- If the threads are not visible, they may have retracted into the uterus or broken, or Mirena may have broken...
- Promptly examine users with complaints of pain, odorous discharge...
- Consider the possibility of ectopic pregnancy...
- Removal may be associated with pain and/or bleeding or neurovascular episodes.
ADVERSE REACTIONS
- ...Very common adverse reactions (>1/10 users) include uterine/vaginal bleeding (including spotting, irregular bleeding, heavy bleeding, oligomenorrhea and amenorrhea) and ovarian cysts...
PATIENT PACKAGE INSERT
- Who should not use Mirena?
- Do not use Mirena if you...
- have or suspect you might have cancer of the uterus or cervix
- have breast cancer now or in the past or suspect you have breast cancer
- Tell your healthcare provider if you
- have high blood pressure
- How is Mirena placed?
- Should I check that Mirena is in the proper position?
- How soon after placement of Mirena should I return to my healthcare provider?
- What are the possible side effects of using Mirena?
http://www.fda.gov/Safety/MedWatch/SafetyInformation/Safety-RelatedDrugLabelingChanges/ucm121936.htm
