Mirena Perforation

The FDA approved the Mirena intrauterine device (IUD), made by Bayer, for use as a birth control option in 2000. Bayer marketed the device as being a more convenient and hassle-free alternative to birth control pills, since it is intended to last for up to five years.

Post-marketing reports and studies, however, indicated that some women were suffering debilitating Mirena IUD side effects. By June 2012, the FDA’s Adverse Event Database had received over 45,000 reports related to problems with the IUD, with one of the most serious being Mirena perforation.

Many women have taken their claims to court in an effort to recover damages. In January 2013, plaintiffs petitioned the U.S. Judicial Panel on Multidistrict Litigation (JPML) to consolidate all federal Mirena lawsuits. The Mirena Lawsuit MDL (No. 2434) was formed in April, 2013,  in the Southern District of New York. At the time, 40 cases were consolidated, though many more are expected to join in the coming months and years.

What is Mirena perforation?

The Mirena IUD is a flexible plastic device that gradually releases hormones into a woman’s uterus to prevent pregnancy. Women who have suffered from Mirena perforation have had the IUD actually puncture or make a hole in the uterus, after which several more complications may develop.

Two types of Mirena perforation include:

• Partial Mirena perforation, in which only part the T-shaped device becomes stuck in or lodged in the uterine wall. Complications may include infection and cramps, among others.
• Complete perforation, where the entire IUD punctures the uterine wall and migrates out into the fluid-filled cavity between the abdominal wall and organs. Infection, organ damage, adhesions, and other complications often ensue.

When does Mirena perforation occur?

Perforation of the uterus was originally thought only likely during insertion, but reports have indicated this is not always the case.

Mirena uterine perforation has been known to occur:

• During insertion: Inserting the IUD is a delicate process that requires a trained physician. If the doctor makes a mistake, the device may partially or completely perforate the uterine wall. Women may experience no symptoms until later, when they suffer cramps and pelvic pain.
• Over time: Some women have reported that the Mirena migrated from its original position weeks, months, or even years after insertion, resulting in uterine perforation.

A 2011 study published in the Journal of the Society of Laparoendoscopic Surgeons called the device “The Wandering Mirena,” and noted two cases of device migration following insertion by family physicians. In the first case, the device moved to the patient’s abdomen, and in the second, the Mirena IUD migrated to the peritoneal cavity close to the diaphragm.

In both instances, the women had to go through laparoscopic surgery to retrieve the IUD. “Uterine perforation related to the insertion of this device is one of the recognized side effects of Mirena,” the authors wrote. “In case number 1 above, the uterine perforation was thought to have happened more than a year after insertion.”

In the second case, the woman experienced “severe, excruciating pelvic pain, a common symptom of uterine perforation.”

Symptoms of uterine perforation

Women who suffer Mirena perforation may not be aware of the complication at first. Over time, however, the following symptoms may develop:

• Pelvic pain, possibly extreme
• Fatigue
• Bloating
• Unexpected pregnancy
• Lower abdominal pain
• Missing Mirena strings
• Nausea or vomiting
• Fever and chills
• Rapid heartbeat
• Heavy vaginal bleeding
• Irregular menstrual periods

Women who experience any of these symptoms after having a Mirena IUD inserted are encouraged to seek medical attention as soon as possible.

What are the potential complications of Mirena perforation?

If uterine perforation occurs, the following complications are possible:

• Perforation of other organs
• Uterine tearing and malposition
• Uterine scarring
• Infection
• Bleeding
• Hemorrhaging
• Infertility
• Miscarriage

In most cases, uterine perforation requires surgery to remove the device, but these procedures may create more complications, as the IUD can be difficult to locate and remove. A 2009 study, published in the British Journal of Medical Practitioners, documented a woman who suffered Mirena perforation. She had a Mirena IUD inserted in 2004, and a month later was admitted to the hospital for problematic bleeding and pain. An ultrasound could not detect the Mirena, so it was assumed it had fallen out.

The patient went through a vaginal hysterectomy in 2005. In 2007, she returned to the hospital again with pain, and was treated for a gastric ulcer. A year later, she still complained of pelvic pain. An abdominal X-ray revealed the Mirena IUD near her bladder—four years after insertion. She had it removed in 2008.

Risk factors for uterine perforation

Though any woman who uses Mirena may be at risk of uterine perforation, some may have an increased risk based on other factors.

Risk factors for Mirena uterine perforation include:

• Having the IUD inserted within six months after having a child
• Currently breastfeeding
• Have an atypical uterine shape
• Have recently undergone a C-section or abortion
• Have suffered previous injury or damage to the uterus
• Have previously experienced pelvic infections

In February 2013, New York resident Julie Miller filed a Mirena lawsuit against Bayer, claiming they failed to warn of the potential for life-threatening injuries related to their device. Miller had the IUD inserted in 2009 and two years later, had to go through surgery because of Mirena perforation. The device punctured her uterine wall and migrated into her abdominal cavity. Miller claimed she was left with debilitating injuries on top of pain and suffering.

Other Mirena IUD side effects

Though Mirena migration and perforation are some of the most serious IUD side effects, there are others that have been reported. These include:

• Embedment in the uterine wall
• Infections
• Bleeding
• Abscesses
• Pelvic inflammatory disease (PID)
• Erosion of the device into the uterus
• Scarring
• Ectopic pregnancy

When a Mirena lawyer can help

Women who have suffered Mirena perforation or other adverse side effects may be able to recover damages in court. A Mirena lawyer understands the claims that can be made in cases like these, and can help guide you through the legal process to recovery.