Omaha, NE - An Omaha mother of two named Galina asked us not to share her last name with the public, but she did want to share her story.
She said after she and her husband had their second child, they weren't ready to have another child right away. She had a doctor insert an intrauterine device (IUD) called Mirena.
Dr. Brigid McCue said, "IUD is a little piece of plastic. It is inserted into the uterus in the doctor's office." Dr. McCue is an OBGYN but has never treated Galina. She and other doctors often suggest Mirena because of its convenience.
It bills itself as a birth control for busy moms. It can stay inserted for five years and prevents pregnancies by releasing a hormone.
Many women like the IUD because their periods over time usually become shorter, lighter or may stop. Galina says that didn't happen for her, and coupled with some pain, that was her first sign of problems.
"Thirteen months after I had it inserted, I stopped breast feeding. That's when I started to have my periods, and I started to have them twice a month, every two weeks," Galina said. This lasted for at least another year.
Then Galina decided to have the IUD taken out. She says that's when her doctor noticed the IUD had moved and had perforated her uterus. "Once they told me it was outside, I was in complete shock. My family was in shock."
She needed surgery to remove the device. And she's not alone.
Her attorney, Michael Doyle, plans to file a lawsuit on Galina's behalf in the coming weeks. He says right now there are more than 370 lawsuits involving women across the country that claim Mirena caused medical problems for clients.
"In the worst cases you had women who lost their uteruses--had to have a hysterectomy." Doyle went on to say, "I think there's certainly a need for the manufacturer to share a whole lot more information with women and their doctors about this hazard and hazards with this device." He says doctors need to do more follow-ups with patients because the device may move after doctors check its placement. He says that happened with Galina.
Famous advocate Erin Brockovich has gotten behind the cause. Mirena is listed on her web site under current work. (You can see Erin Brockovich's page regarding Mirena by clicking here.)
We called Bayer Pharmaceuticals which makes Mirena. They issued a statement saying, in part, "We care about patients and take the safety of our products very seriously." They also quoted the American College of Obstetricians and Gynecologists (ACOG), "today's IUDs are much improved from earlier versions, and complications are extremely rare." (You can go to Mirena's web site by clicking here.)
The FDA told us the agency believes Mirena's risks and benefits are acceptably labled. They also said a study is underway, and interim results suggest the risk of uterine perforation is increased when inserted in lactating women. (You can read about the FDA's labeling by clicking here.)
Galina was breastfeeding when she had Mirena inserted.
Galina told us, she and her husband once planned on having more children, but now they won't. "I did ask the doctors, and they said it's probably going to be safe for me to have children. But they told me Mirena was safe too so personally, I don't believe that it's safe.