NASHVILLE, Tenn. – A Middle Tennessee woman has filed a federal lawsuit and raised questions about a birth control device used by millions of women.
Imagine a medical device implanted in your body. Then it mysteriously migrates elsewhere causing severe pain and even bleeding.
Katherine Kirkeminde's husband used a cellphone to help demonstrate how the Mirena birth control device somehow moved almost a foot from his wife's cervix to her hip.
"It wasn't like a bug crawling around inside. It moved and navigated itself over several years," said Kirkeminde.
She is now among a growing number of women suing Bayer Pharmaceuticals -- the device maker.
Her lawsuit stated, “The Mirena migrated from its original position and then buried itself in her abdominis muscle. She began experiencing digestive problems, severe cramping, nausea, mood swings and weight gain.
"The implant is supposed to be in one place and instead goes somewhere else," said attorney Clint Kelly.
"The doctor has a hand held device and it inserts the device into the cervix," said Kelly.
It releases hormones preventing pregnancy, but somehow Kirkeminde's device disappeared. She figured it fell out -- never dreaming it had moved to her hip.
Symptoms started, but doctors could never find the cause.
"I was actually myself starting to believe maybe I was going crazy," said Kirkeminde.
"The worst part about it is it makes women appear crazy when they are not," said Kelly.
It took four years of searching before doctors got lucky during yet another exam.
"They just happened to swing the CT scan to one side and, ‘oh my gosh, what is that,’" said Kirkeminde.
What they found required surgery to remove. Kelly shows a photo of the device in her abdomen.
"This is her gut. What are we seeing here? You see forceps and a Y. This forceps is removing that Y," said Kelly.
They finally found and removed the device. Now Kirkeminde is suing and wonders why Mirena is still on the market?
"I think it's irresponsible. It needs to be pulled back and have a second look at," said Kirkeminde.
Bayer did issue a statement in response to the lawsuit:
“At Bayer, we care about patients and take the safety of our products very seriously. We are saddened to hear of any serious health condition affecting a patient using one of our products, regardless of the cause. Mirena has been prescribed to millions of women worldwide since it was first launched in 2001. Furthermore, the American College of Obstetrics and Gynecology (ACOG) recommends the most effective methods, including IUDs, for all appropriate patients.
It is important to note that the FDA-approved label for Mirena includes information regarding the risk of perforation, i.e., “perforation (total or partial, including penetration/embedment of Mirena in the uterine wall or cervix) may occur most often during insertion, although the perforation may not be detected until sometime later.”
Based on the totality of data available to date, a positive benefit-risk profile consistent with approved labeling continues to be observed with Mirena.
Bayer is concerned, however, that advertisements from law firms may misrepresent the benefit-risk profile for Mirena and mislead women.
Moreover, in November 2013, ACOG posted a statement on IUDs:
Fact Over Fear and noted that legal advertisements “tout ‘serious injuries’ that are ‘linked to’ hormonal IUDs, highlighting rare side effects such as uterine perforation, migration of the device from the uterus, and ectopic pregnancy. For women unfamiliar with medical terms and risk profiles, these complications may seem more frequent and serious than they actually are.”
As with any medicine or device, it is important that women discuss the benefits and risks of any birth control option with their healthcare providers.
