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Mirena IUD

FDA Drug Warnings

Summary of Changes to Contraindications and Warnings


Intrauterine Pregnancy
If pregnancy should occur with Mirena in place, Mirena should be removed. Removal or manipulation of Mirena may result in pregnancy loss...

Long-term effects and congenital anomalies
Some observational data support a small increased risk of masculinization of the external genitalia of the female fetus following exposure to progestins at doses greater than those currently used for oral contraception. Whether these data apply to Mirena is unknown.

Embedment may decrease contraceptive effectiveness and result in pregnancy (see WARNINGS, Ectopic Pregnancy and Intrauterine Pregnancy). An embedded Mirena should be removed. Embedment can result in difficult removal and, in some cases surgical removal may be necessary.

If perforation occurs, pregnancy may result (see WARNINGS, Ectopic Pregnancy and Intrauterine Pregnancy). Mirena must be located and removed; surgery may be required. Delayed detection of perforation may result in migration outside the uterine cavity, adhesions

The risk of perforation may be increased in lactating women, in women with fixed retroverted uteri, and during the postpartum period. To decrease the risk of perforation postpartum, Mirena insertion should be delayed a minimum of 6 weeks after delivery or until uterine involution is complete. If involution is substantially delayed, consider waiting until 12 weeks postpartum

Partial or complete expulsion of Mirena may occur (see PRECAUTIONS, Continuation and Removal). Symptoms of the partial or complete expulsion of any lUD may include bleeding or pain. However, the system can be expelled from the uterine cavity without the woman noticing it. Partial expulsion may decrease the effectiveness of Mirena. As menstrual flow typically decreases after the first 3 to 6 months of Mirena use, an increase of menstrual flow may be indicative of an expulsion. If expulsion has occurred, Mirena may be replaced within 7 days of a menstrual period after pregnancy has been ruled out.

Ovarian Cysts
Most of these follicles are asymptomatic, although some may be accompanied by pelvic pain or dyspareunia. In most cases the enlarged follicles disappear spontaneously during two to three months observation. Persistent enlarged follicles should be evaluated.

Breast Cancer
Women who currently have or have had breast cancer, or have a suspicion of breast cancer, should not use hormonal contraception because breast cancer is a hormone sensitive tumor.

People whom have been injured by the Mirena IUD do have legal options

If you are a patient of the Mirena IUD, and after having followed the instructions of your physician you have found yourself with a diagnosis of any of the listed side effects, you do have options. The obvious first step that you should take is seeing a medical specialist and getting your condition taken care of.

You may not be able to continue working or taking care of your family, and may need to hire somebody to assist you. When a drug manufacturer puts patients’ and well-being at risk, the American legal system has remedies available. These include:

  • Mass Torts and Multi District Litigation: A mass tort is when a group of plaintiffs file their legal proceedings in a state court, while a multi district litigation (MDL) is held in a federal court.
  • Class Action Lawsuit: In a class-action lawsuit, plaintiffs with similar injuries all combine into one single lawsuit.
  • Individual lawsuits: In an individual lawsuit, the injured party sues the drug manufacturer directly both for the expenses that they have incurred as a result of their actions and for punitive damages.

Our firm works on a contingency basis which means you will not be asked to pay any money out of pocket.

This process will be very easy. Please feel free to answer all questions honestly as your information is confidential.

This process will be very easy. Please feel free to answer all questions honestly as your information is confidential.

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