Mirena (Levonorgestrel-releasing intrauterine system) is a small flexible, t-shaped plastic device that is inserted into the uterus by a healthcare provider and works as a contraceptive by releasing a low dose of levonorgestrel (a synthetic progestin hormone) directly into the uterus. The hormone in Mirena is designed to prevent pregnancy by thinning the lining of the uterus, thereby preventing sperm from reaching and fertilizing and egg, and by thickening cervical mucus to prevent sperm from entering the uterus.
Mirena was approved by the Food and Drug Administration (FDA) in 2000 and is recommended to women who have had at least one child. The device can be left in place for up to five years. Mirena was also FDA-approved in 2009 to treat heavy menstrual bleeding in women who prefer intrauterine contraception as their method of birth control, the first time that the FDA has approved an intrauterine device for this purpose.
Case Review Focus Areas:
1. Was the IUD placed?
2. Did the patient have any preexisting conditions, allergies or contraindications for the device
3. Past medical history – Any prior IUD placement, OBGYN medical issues from history?
E.g.: Past Medical History: Conditions affecting genito-urinary tract.
4. Need for IUD placement?
5. Was he/she a right candidate for IUD placement?
6. Did the patient develop Complications after IUD placement?
7. Treatment/management – Operative procedure, indications, complications, pathology and findings of side effects
8. Follow-up visits for side effects or complications
10. Any medical/surgical history, social history (smoking) that could have had an effect on the injury
Complications of Mirena use:
- Birth of a child with a birth defect
- Embedment in the uterus
- Erosion of adjacent areas such as the vagina
- Inflammation of the membrane that lines the abdominal cavity and internal organs (Peritonitis)
- Intestinal perforations or obstruction
- Pelvic Inflammatory Disease
- Perforation of the uterus
- Abdominal/pelvic pain
- Vaginal discharge
- Back pain
- Weight increase
- Breast pain/tenderness
- Decreased libido
- Depressed mood
Diagnosis and management of the post-operative complication:
- Whether the above mentioned symptoms were identified as a complication of IUD placement?
- Was it managed medically or surgically?
- If surgically, whether the IUD was removed?
- If IUD was removed or explanted, then the appearance of the IUD while removal
Operative note: Detailed operative procedure for the placement/explant
Condition of patient post mesh-explant:
- Medical status of the patient?
- Was the IUD removed or repalced
- Progress of the patient after removal
Mirena is contraindicated when one or more of the following conditions exist:
1. Pregnancy or suspicion of pregnancy.
2. Congenital or acquired uterine anomaly including fibroids if they distort the uterine cavity.
3. Acute pelvic inflammatory disease or a history of pelvic inflammatory disease unless there has been a subsequent intrauterine pregnancy.
4. Postpartum endometritis or infected abortion in the past 3 months.
5. Known or suspected uterine or cervical neoplasia or unresolved, abnormal Pap smear.
6. Genital bleeding of unknown etiology.
7. Untreated acute cervicitis or vaginitis, including bacterial vaginosis or other lower genital tract infections until infection is controlled.
8. Acute liver disease or liver tumor (benign or malignant).
9. Conditions associated with increased susceptibility to pelvic infections.
10. A previously inserted IUD that has not been removed.
11. Hypersensitivity to any component of this product.
12. Known or suspected carcinoma of the breast.
Product details – Sample:
|Snapshot of the Product label|
Missing records notification to Client
Important records related to
- Product details
- Operative notes
- Post-operative stay
- Follow-up visits stating the condition of the patient post IUD placement
- Missing records have to be identified and confirmed with MD Specialist and should be communicated to the client
Final Review by MD Specialist
- Chronology is reviewed by the MD Specialist before delivery. OBGYN Specialist opinion considered if there is a need.