(WXYZ) - The 7 Action News Investigators have uncovered questions about the safety of a popular form of birth control. More than 2 million women use the Mirena IUD. But we found thousands have complained about dangerous complications.
7 Action News analyzed thousands of rarely seen government records. They show women have been reporting problems with the Mirena IUD for years: they are problems that have left some women infertile, in pain, and in need of surgery.
Sara had the Mirena IUD – but she says "It turned out to be a nightmare." The Mirena IUD is a piece of plastic that has a hormone built into it. A doctor inserts the IUD into the uterus to prevent pregnancy.
Sara's IUD perforated her uterus and floated into her abdomen. Doctors had to perform surgery to remove it.
Sara is one of thousands of women who have complained about problems with the birth control.
The 7 Action News Investigators obtained rarely seen Food and Drug Administration reports which show 70,072 complaints since 2000.
Some are minor, like acne, headaches and back pain. Others are not.
- 4,775 women reported device dislocation--which can mean the IUD became embedded in the uterus or migrated outside of the uterus.
- 3,774 women complained about abdominal pain.
- 1,322 women reported the same problem as Sara -- the IUD perforated their uterus.
Attorneys Dawn Chimielewski and John Climaco have filed lawsuits on behalf of five women who experienced complications. They expect to file hundreds more.
"We have 900 cases in house," said Climaco.
"These are pretty horrific injuries," said Chimielewski.
Dawn says the IUD lacerated one client's liver. Another needed an appendectomy and hysterectomy as a result of a uterine perforation. She was 22.
"What these people aren't being told is that at any time after this device is in place/cut to/it can perforate the uterus and cause these complications," said Chimielewski.
There are currently more than 220 cases filed in federal and state courts
"The problem with this particular device is just astronomical," Rochester attorney Alyson Oliver told 7 Action News Investigator Heather Catallo. Oliver says she has 74 cases of women having problems with the Mirena.
"People plan on having, you know, three kids, and you know something like this happens and you know, it's over with. So, I mean, it's a big deal. It's a problem," said Oliver.
"I think it's really a crying shame. I think that if you polled physicians, we just don't have that opinion, that this is a defective product," said Dr. Thomas Frank, the Director of Family Planning at Metrohealth Medical Center in Cleveland .
"Medical evidence is quite clear that Mirena IUD is one of the absolute safest forms of contraception that's available today," said Dr. Frank.
There are currently two million women using Mirena. Dr. Frank has prescribed it since 2001.
"Mirena is really appropriate for any women who is potentially fertile who doesn't want to get pregnant," said Dr. Frank.
Like Ally Thompson.
"It's amazing it's so convenient," said Thompson. "You don't have to worry about taking [a] pill every day and it lasts for five years so you can't beat that."
Bayer Healthcare Pharmaceuticals manufactures Mirena but declined an on camera interview.
In a statement, they said they "take the safety of our products very seriously. For that reason, we continuously review the safety profile of all of our products worldwide. "
The FDA says "no drug is absolutely safe" and approved drugs show "their benefits outweigh their known risks."
"The overall risks of the Mirena IUD are tremendously less than the risk of the other devices that are available today and much less than the risk of not using any protection at all," said Dr. Frank.
Sara still has pain on her left side. Her doctor told her its nerve damage that will never go away.
"I mean you think you're doing something to help yourself and your family and then it just ends up turning into a disaster," said Sara.
But Sara still feels lucky. A few years after her ordeal she had a healthy baby boy.
If you have a story for Heather Catallo, please email her: email@example.com or call 248-827-4473.