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Many doctors are uncertain about how safe it is to remove a Mirena intrauterine device (IUD) if a woman becomes pregnant after the birth control device migrates outside the uterus.
The Mirena IUD is a long-acting form of birth control that was introduced by Bayer Healthcare in 2000. The plastic, T-shaped device is inserted into the uterus to disrupt the egg and sperm, and it is designed to remain in place for up to five years.
While the IUD form of birth control has increased in popularity in recent years, a number of women have experienced serious complications from Mirena where the IUD perforates the uterine wall, migrates outside the uterus, causes infections or other problems. In many cases this results in the need for surgical removal of Mirena IUD and leaves the woman with permanent injuries.
A new case study published by the American Journal of Obstetrics and Gynecology on February 25 highlights the surgical removal of a Mirena IUD that had moved into the abdomen of a woman who was 12 weeks pregnant. While the procedure was a success, even the doctors involved indicated that the decision on whether to retrieve the device remains controversial, due to the potential risks with Mirena surgical removal.
Mirena Removal During Pregnancy
In the case examined, the 26-year-old woman had the IUD inserted nearly four years before, but problems occurred after it was implanted when the Mirena migrated and moved out of place in the uterus.
The guide strings that should have indicated it was in place were missing, and the woman was told that it had likely fallen out after it could not be located by ultrasound. However, the device was actually still inside of her and remained there for years undetected, until a year ago when it began to cause abdominal pain.
“With a properly placed IUD and a viable uterine pregnancy, it is recommended to remove the IUD if possible to prevent complications such as septic abortion and preterm labor,” according to the case study. “In our case, it was unclear whether removal was necessary during pregnancy. Removal during pregnancy would prevent possible complications of hormone exposure and foreign body. Leaving it in-situ and removal at the time of cesarean or thereafter would prevent the complications of surgery during pregnancy.”
The doctors involved said they were also concerned about adhesion formation, infection and organ injury.
Number of Women Pursuing Mirena Lawsuits After Requiring Surgical Removal
In recent years, Bayer has faced an increasing number of lawsuits over Mirena IUD, brought on behalf of women who allege the manufacturer failed to adequately warn about the risk of “spontaneous” migration, where the IUD may perforate the uterus long after it is implanted and migrate to other parts of the body.
While the Mirena warning label does include information on the risk of perforation, plaintiffs argue that the language suggests that these problems only occur during insertion and that the drug maker failed to adequately warn about the risk of migration long after Mirena insertion. Many of the lawsuits allege that severe Mirena IUD problems could have been avoided if more detailed and accurate warnings had been provided.
Amid the mounting Mirena IUD litigation, a motion was filed with the U.S. Judicial Panel on Multidistrict Litigation (JPML) in January, asking that all complaints filed in the federal court system be consolidated and centralized as part of an MDL, or multidistrict litigation.
The U.S. JPML is scheduled to hear oral arguments on the motion later this month, at an upcoming hearing date scheduled in San Diego, California on March 21, 2013.