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Mirena IUD Organ Perforation Risk Higher in New Mothers, Study Shows

Mirena patientMirena, a popular contraceptive, is one of only two hormonal intrauterine devices (IUDs) approved by the U.S. Food and Drug Administration (FDA). Interesting in light of the recent reports of Mirena IUD organ perforation, a recent German study compared injuries between copper and hormone-releasing intrauterine devices.

The study found no difference between IUD types but found a significant difference between whether women were breastfeeding at the time of IUD insertion and whether she had delivered within the past 36 weeks.

IUD perforation risks

The study focused on routine conditions in typical users. It involved over 60,000 women spanning six European countries. The researchers asked both the women and their doctors a series of baseline questions and then provided each with a follow-up questionnaire after one year. The patients’ reports were verified by their treating physicians.

There were 61 cases of uterine perforation in women who received the hormonal IUD, and 20 perforations related to the copper IUD. The rate of organ perforation for each type of IUD was 1.4 per 1,000 insertions and 1.1 per 1,000 insertions, respectively. Women who were breastfeeding at the time the device was inserted were six times more likely experience an organ perforation. They were also more likely to have given birth within the past 36 weeks, which similarly increased perforation risk.

The study results are sure to be disappointing for new mothers. Both the American Academy of Pediatrics and the World Health Organization recommend breastfeeding for at least six months. They recommend continuing breastfeeding beyond that, to at least 1-2 years old.

Rate of IUD expulsion higher than organ perforation

While the German study found that the rate of organ perforation was than one in 500 insertions, a 2014 study found that the rate of IUD expulsion is much higher. In an IUD expulsion, the device is moved either partly out of position where it may be less effective at contraception, or pushed completely out of the uterus into the vagina. Some of the effects of an expelled IUD include pain, increased bleeding, no period, pregnancy, and even a perforated uterus.

Like the recent German study, the earlier American College of Obstetrics & Gynecology study compared the complication rates between hormonal and copper IUDs. It also tracked age as a factor in expulsion. Following over 5,000 women across three years, the researchers found that more than 10% of the IUDs were expelled. The rate of IUD expulsion was the same between hormonal and copper devices but there were differences by age – younger women, aged 14-19, were at a greater risk for expulsion than older women.

Bayer downplays Mirena IUD risks

In 2009, the FDA stepped in to issue Bayer, the manufacturer of Mirena, a warning letter. According to the letter, Bayer failed to disclose potential adverse side effects of Mirena and at the same time, overstated its benefits.

By 2012, the FDA had received over 45,000 reports of injuries attributed to Mirena. The reports ranged from pain after insertion to more serious complications like Mirena organ perforation.

There are now more than 1,000 lawsuits involving Mirena organ perforation and IUD migration pending against Bayer in multidistrict litigation in the U.S. District Court for the Southern District of New York.

  1. Contraception Journal, Risk of uterine perforation with levonorgestrel-releasing and copper intrauterine devices in the European Active Surveillance Study on Intrauterine Devices,
  2. U.S. National Library of Medicine National Institute of Health, Association of Age and Parity With Intrauterine Device Explulsion,
  3. United States Food & Drug Administration, Warning Letters 2009,
  4. American Academy of Pediatrics, Breastfeeding Initiatives,
  5. World Health Organization, The World Health Organization’s infant feeding recommendation,