Mirena birth control may be causing complications in women
Connie Colla, ABC15 Mornings , Maria Tomasch, ABC15.com
11:17 PM, Jun 24, 2013
9:21 PM, Jul 1, 2013
TAMPA - Sarah's IUD perforated her uterus and floated into her abdomen. Doctors had to perform surgery to remove it. Sara is one of thousands who say they've had complications with this birth control.
The Mirena intrauterine device (IUD) is quickly becoming a popular form of birth control. Women like it because they don't run the same risks as taking oral contraception and some no longer get their period.
Today, more than 2 million women use it.
But, not everyone has a good experience.
"I started getting severe pain," said Sarah, a mother of three who lives in the Valley.
Sarah got a Mirena about three years ago, and from the very moment it was inserted, she felt pain. It got so severe that she went to the emergency room.
"They told me that it needed to be removed as soon as possible," said Sarah. "It was horrible. I would never recommend it to anyone."
Sarah's IUD perforated her uterus and floated into her abdomen. Doctors had to perform surgery to remove it.
Sara is one of thousands who say they've had complications with this birth control.
Complaints to the FDA
The ABC15 Investigators obtained complaint records from the Food and Drug Administration (see the complaint records at
http://wfts.tv/1a8uV3N ). It shows 59,229 complaints were made since 2004.
There are a wide range of issues reported. Some are as common as acne, migraines and back pain.
But, there are also more complicated issues reported. The most common of those included "expulsion", where the IUD came out on its own. There are 12,047 reports of that occurring in 2008-2012.
Abdominal pain is also common, with 3,774 complaints in 2008-2012. And uterine perforation, which is what happened to Sarah, has 1,322 reports in 2008-2012.
Doctor Angela DeRosa is board certified in internal medicine, with a practice that focuses on women's health.
"Anytime you do a medical procedure, there is always that risk of chance of complications," said DeRosa. "When bad things happen, we always hear about it. Most of those were not serious complaints. But, there are 2 million women out there who are running around with IUDs and have had no problems."
Ally Thompson of Peoria is a patient of DeRosa's. She finds the IUD convenient.
"It makes everything so much lighter if you have a bad period, and you don't have to worry about taking a pill every day, and it lasts for five years so you can't beat that," said Ally.
There are currently 50 cases filed in federal court against the manufacturer. Five of them were filed by attorneys Dawn Chmielewski and John Climaco. But, they are looking at about 900 more.
"It says to me that there's a problem with this device," said Chmielewski.
Many law firms are searching for clients, including here in Arizona.
"What these people aren't being told is that at any time after this device is in place," said Chmielewski. "It can perforate the uterus and cause these complications."
"There's nothing in the warning that gives these individuals any idea that once they walk out of their doctor's office with this device in place that they need to be cognizant of this risk."
Bayer, the maker of the Mirena, gave us this statement:
At Bayer, we care about patients and take the safety of our products very seriously. For that reason, we continuously review the safety profile of all of our products worldwide. We are saddened to hear of any serious health condition affecting a patient using one of our products, irrespective of the cause.
Although we are unable to comment on specific lawsuits, Bayer continues to stand behind Mirena as an important option for women who have had a child and are seeking a safe and effective contraception option. Based on the totality of data available to Bayer since the launch of Mirena in 2002, a positive benefit-risk profile continues to be observed and is fully aligned with what was seen during the clinical development program that formed the basis for the product's approval worldwide.
The FDA gave us this statement:
It's important to note that all drugs have side effects; no drug is absolutely safe. FDA-approved drugs have demonstrated that their benefits outweigh their known risks. The agency continuously monitors all approved drugs for new safety concerns, and we update the drug labeling or take regulatory action as appropriate.
Mirena's benefits and risks are outlined in the drug labeling, including the risks of embedment in the myometrium and perforation of the uterine wall or cervix. There are currently many FDA-approved birth control methods available. Women should discuss with their doctor the most appropriate birth control method for them.
According to DeRosa, one of those benefits includes protecting against uterine cancer during hormone replacement therapy. It also eases common menstrual symptoms and eliminates periods in a majority of patients.
Sarah continues to have pain on her left side. She says the doctor told her she has nerve damage that will probably never go away.
But she stills feels lucky. A couple of years after the surgery, Sarah had a baby boy.