“I want this Mirena IUD out, over and done with.”

Toronto, ON. Nickey followed her doctor’s orders, and the Mirena manufacturer’s orders: five years after the IUD was implanted, she made an appointment to have it removed. But it wasn’t that easy. Next month will be the fourth, and she hopes final, attempt to have all of the birth control device removed from her uterus.

“On the first attempt, my OB/gyn couldn’t find the string so he sent me to another specialist where I had an ultrasound to see where exactly this Mirena was,” says Nickey. “He found the Mirena in my uterus—where it was supposed to be—but when he tried to remove it, the metal piece broke.”

Next up, Nickey had to undergo a general anesthetic, but her doctor told her during the follow-up appointment that the Mirena had perforated her uterus. “He told me that a Da Vinci surgical robot was supposed to have been used in this procedure but it wasn’t available that day,” Nickey says. he didn’t tell Nickey when and how her uterus was perforated by the Mirena. “He is definitely going to use the robot next month to retrieve this broken piece— it will be the fourth attempt to have this Mirena entirely removed.”

A study published by the International Journal of Women’s Health concluded that IUD perforation, “is a rare but serious complication of IUD use”. If a device perforates the uterine wall, it can continue to migrate elsewhere in the body and extensive surgery may be necessary to repair the damage. Nickey is 33 years old and the mother of a 10-year-old boy. She wants to have another child, so this complication is extremely worrisome.

Given the number of lawsuits filed against the manufacturer, Bayer Healthcare, alleging permanent injuries and trauma due to complications that necessitated surgical removal, IUD perforation is not so rare. (The study was conducted in 2014). Between 2000 and 2013, the FDA had received 70,072 complaints about the Mirena IUD, according to a report by
7 Action News investigators. (Here is the FDA’s adverse event reporting system, called FAERS.)

“Since the first surgery to have the Mirena removed I have had such heavy bleeding that I needed to take iron pills and often found myself shaking,” says Nickey. “As well, I had a lot of pain after the surgery—I’m not looking forward to the surgery on January 24th. And it’s a one-hour drive to the hospital. Who is paying for my time?
“If I knew what I know now about Mirena, I would never have gotten this IUD. I’m weighing my options about other kinds of birth control but before that, I have to get my body back to normal. And I am concerned that I have damage to my uterus because I want more kids one day. My doctor knows I want more kids and he has given me options if it cannot be removed. If push comes to shove, he mentioned hysterectomy. Emotionally and physically, this IUD has taken a lot out of me…I just want it out.”

If the Mirena has perforated the uterine wall, robotic surgery or laparoscopic surgery is necessary. A number of women who have undergone surgery to have the device removed have charged Bayer with manufacturing a defective product. They seek damages to cover medical expenses, lost wages, and ongoing care needs, and to compensate them for pain and suffering. Sadly, many women have also undergone hysterectomies.