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Study Shows Mirena Reduces Heavy Bleeding, But Lawsuits Indicate Risks

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According to a new study published by the New England Journal of Medicine, the Mirena IUD is more effective than usual medical treatment in reducing the effect of heavy menstrual bleeding on quality of life. The FDA approved the Mirena for use in women with heavy periods on October 1, 2009, reporting that participants in the primary clinical trial showed a statistically significant reduction in menstrual blood loss.

Women who are considering using the Mirena IUD for relief from heavy periods should be aware of the potential health risks. As of June 2012, the FDA received 45,000 reports of problems related to the birth control device. Manufacturer Bayer now faces an increasing number of Mirena lawsuits as women around the nation seek to recover damages.

Mirena IUD Linked with Serious Health Complications

The FDA approved the Mirena IUD as a birth control option in 2000. The T-shaped plastic device is inserted into the uterus by a healthcare professional, where it gradually releases the progestin levonorgestrel to prevent pregnancy.

Bayer advertised Mirena as a more convenient option for women who didn’t want to worry about taking a pill everyday, and stated it would last for up to five years. Post-marketing reports, however, indicate many women are suffering from serious health complications after implantation that may require corrective surgeries.

FDA Warns Bayer of Overstating Benefits

According to FDA reports, the Mirena device can lead to serious side effects including migration out of the uterus, uterus perforation, embedment into the wall of the uterus, perforation of other organs including the stomach, bowel, and bladder, ectopic pregnancy (pregnancy that occurs outside the uterus), infections, bleeding, abscesses, and infertility.

Bayer has come under fire for allegedly knowing about these health risks, yet failing to adequately warn patients and healthcare providers. The FDA sent the company a warning letter in December 2009 saying they were overstating the Mirena’s benefits while downplaying the risks.

The agency specifically noted that Bayer-sponsored live presentations to consumer audiences indicated the Mirena would result in “increased levels of intimacy, romance, and by implication, emotional satisfaction. These claims misleadingly overstate the proven efficacy of Mirena.” They went on to add, “at least 5 percent of clinical trial patients reported decreased libido as a side effect of Mirena use. Patients also experienced abdominal/pelvic pain, nausea, headache, nervousness, and depressed mood, which could adversely affect a woman’s feelings related to romance or intimacy.”

Women Need to Consider the Health Risks

When the FDA approved Mirena for women with heavy periods, they quoted Kathleen Uhl, M.D., director of the FDA’s Office of Women’s Health, who said, “Women who suffer heavy, prolonged menstrual periods find the condition unpleasant, disabling, and frightening. Bleeding can be so heavy that women must miss work, school, or social activities.”

The results of the latest study may encourage women to try Mirena in the hopes of finding relief from heavy bleeding. Yet the number of lawsuits related to the product continues to increase. An Arkansas woman, for example, recently filed a lawsuit stating that four years after implantation of the device, she suffered from abdominal pain and vomiting. A CT scan showed that the Mirena had left the uterus and was in the pelvis. She had to undergo surgery to have it removed.

Plaintiffs have recently petitioned the U.S. Judicial Panel on Multidistrict Litigation to consolidate all federal Mirena lawsuits into one court, as experts expect the litigation to continue to grow.